DK201570891A1 - Improved sunscreen composition - Google Patents

Improved sunscreen composition Download PDF

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DK201570891A1
DK201570891A1 DK201570891A DKPA201570891A DK201570891A1 DK 201570891 A1 DK201570891 A1 DK 201570891A1 DK 201570891 A DK201570891 A DK 201570891A DK PA201570891 A DKPA201570891 A DK PA201570891A DK 201570891 A1 DK201570891 A1 DK 201570891A1
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composition
sunscreen
sun protection
protection factor
thickening agent
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DK201570891A
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Lene Britze
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Riemann Trading Aps
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Abstract

One aspect of the invention relates to a sunscreen composition comprising at least one sunscreen agent, at least one solvent, at least one thickening agent, and at least one film forming polymer, wherein said thickening agent is present in an amount in the range of 0.01-0.50 %(w/w), and wherein said film forming polymer is present in an amount of less than 2.0 %(w/w). Another aspect of the present invention relates to the use of a thickening agent for increasing the sun protection factor of a sunscreen composition comprising at least one sunscreen agent, at least one film forming polymer, and at least one solvent. Yet another aspect of the present invention relates to a process for the manufacture of a sunscreen composition comprising the steps of i) providing at least one solvent, at least one thickening agent in an amount in the range of 0.01-0.50 %(w/w), at least one film forming polymer in an amount of less than 2.0 %(w/w), and at least one sunscreen agent, ii) admixing the components of step i) to provide a sunscreen composition.

Description

Improved sunscreen composition Technica! field of the invention
The present invention relates to sunscreen compositions. In particular the present invention relates to sunscreen compositions comprising a small amount of thickening agent for the purpose of boosting the sun protection factor of the composition. Also, the present invention relates to sunscreen compositions with reduced amounts of film forming polymers and high water resistance.
The use of thickening agents to enhance the sun protection factor of a sunscreen composition is also described, as well as a method for manufacturing such sunscreen compositions.
Background of the invention
It is a well-established fact that UV irradiation causes skin burns, loss of skin elasticity and the appearance of wrinkles, promoting premature skin aging. In addition, UV irradiation promotes the triggering of the erythema! reaction or accentuates this reaction in certain individuals and may even be the source of phototoxic or photoaliergic reactions. Last, but not least important, UV irradiation has carcinogenic effects. For these reasons, continuous need exists for means for protecting the skin against the harmful effects of UV irradiation.
Numerous requirements exist for dermatological compositions for photoprotection of the human skin: Compositions are preferred which have a pleasant feel and are formulated as non-greasy sprays, milks and creams that are easily applied. It is further preferred that the compositions exhibit non-adherence to sand, as users of these compositions are often in contact with sand at beaches and play areas.
In addition to being convenient for the user the compositions must contain adequate solvent to hold the necessary amount of UV-filter. Need continues to exist for compositions which simultaneously have a low or zero content of preservatives, while exhibiting an optimum stability which is maintained throughout the time of storage and ultimate use of the products. Such optimum stability is required to also encompass that neither the odour nor the visual and/or tactile appearance of such a composition changes. In addition, such a composition must not change its appearance when applied to the human skin as this will leave the user in doubt whether or not the quality of the composition has been compromised. Finally, in instances where a particularly high and lasting protection is desired, as for children's skin or for sensitive skin, it is also preferable to employ compositions which exhibit good water resistance and which thus retain a very good photo protective power even after coming into contact with water. For example WO 2009/016537 describes sunscreen formulations comprising dimethicone derivatives, wherein from about 75% to about 100% of an SPF rating of the composition is retained after immersion into water for 80 minutes. Corresponding formulation without dimethicone derivatives perform poorly with respect to water resistance.
Many photoprotective, dermatological compositions are oil-in-water emulsions. However, one of the disadvantages of traditional oil-in-water emulsions is that they very easily lose their effectiveness with respect to UV protection as soon as they come into contact with water; this because the screening agents which they contain in their aqueous phase are removed by the water, during bathing in the sea or in swimming pools, for example, or, alternatively, under the shower or when playing water sports, and the overall photo protective power of these compositions thus is greatly reduced. Thus, sunscreen compositions which are solvent solutions with a low water content rather than oil-in-water emulsions would be advantageous.
Finally, it is also desirable to achieve a high Sun Protection Factor (SPF) while using relatively small amounts of sunscreen agents in the composition. Sunscreen agents are expensive additives and there are consumer trends towards deselecting certain UV-filters.
One way of improving the SPF of a sunscreen composition without adding further sunscreen agents, is to employ SPF booster's, which are normally compounds or additives which do not adsorb UV radiation, but still improves the SPF in various other ways. For example, WO 2004/110366 discloses photoprotective compositions comprising optimizing agents selected from the group consisting of diols, alcohol, glycol and polyhydrlc alcohol or derivatives thereof. The optimizing agents boost the SPF of the compositions by several SPF units. Also, WO 2011/100275 describes a method of boosting the SPF of a sunscreen composition comprising an acidic film former by the addition of amine neutralizing agent. Further, WO2014/015879 discloses sprayable sunscreen compositions with small amounts of thickening agent (0.01-0.2%(w/w)) wherein said thickening agent is used for increasing the sun protection factor of the sunscreen composition.
Improved or alternative sunscreen compositions which have improved SPF ratings would be advantageous, and in particular providing sunscreen compositions which have an improved SPF rating and simultaneously maintain a high water resistance, are non~greasy and easily applicable would be advantageous.
Generally, film forming polymers or water proofing agents are added to sunscreen compositions to enhance resistance to water in vivo, For example WO 2011/100275 describes a sunscreen composition formulated as a spray comprising a film former in an amount of 2.5% by weight (w/w) and WO 2014/015880 describes a sprayable sunscreen composition comprising a film former in an amount of less than 2.0% by weight (w/w). Film forming polymers are however expensive additives and generally it is desirable to reduce the amount of additives in cosmetic compositions such as sunscreen agents.
Therefore, improved or alternative sunscreen compositions which have a high SPF rating and simultaneously maintain a high water resistance, are non-greasy and easily applicable, while comprising reduced amount of additives, such as film forming polymers would be advantageous.
Also, improved or alternative sunscreen compositions which have a high SPF rating, maintain a high water resistance, are non-greasy and easily applicable, while comprising reduced amount of additives, such as film forming polymers and while simultaneously maintaining their ability to be formulated as lotions would be advantageous.
In addition, improved or alternative sunscreen compositions which maintain their ability to be formulated as lotions concomitant with being sprayabie would be advantageous.
Further, improved or alternative sunscreen composition which are stable upon storage would be advantageous, and in particular a sunscreen composition which is stable even with low temperatures, such as e.g. storage at -10 °C for 1 month would be advantageous.
Hence, an improved or alternative sunscreen composition which is stable during transportation would be advantageous and in particular a sunscreen composition which is stabie during longer periods of transportation, such as for weeks or even months, would be advantageous.
Hence, an improved or alternative sunscreen composition that upon storage for longer periods (e.g. 4-8 weeks) does not change appearances when applied to the skin (such as leaving whiter spots) and in particular, a sunscreen composition which upon storage for even longer periods (e.g. 10-14 weeks) does not change appearances when applied to the skin would be advantageous.
Also, an improved or alternative sunscreen composition which remains fragrant stable (i.e. the odour of the sunscreen composition does not change) under the irradiation with light at room temperature for longer periods of 4-8 or 8-12 weeks would be advantageous and in particular a sunscreen composition which remains fragrant stabie during longer periods of transportation in hot and humid surroundings such as for weeks or even months, would be advantageous.
Further, an improved or alternative sunscreen composition which remains colour stable (i.e. the colour of the sunscreen composition does not change) for longer periods of 4-8 or 8-12 weeks under the irradiation with light in a dear glass vessel at room temperature (20°C) would be advantageous.
In addition, improved or alternative sunscreen composition which are stable upon storage under the irradiation of light at room temperature (20°C) would be advantageous.
Summary of the invention
Thus, an object of the present invention relates to the provision of improved or alternative sunscreen compositions.
In particular, it is an object of the present invention to provide a sunscreen composition that solves the above mentioned problems of providing sunscreen compositions which are safe, have an improved SPF rating and simultaneously maintain a high water resistance. Thus, the present inventors surprisingly found that the addition of a small amount of thickening agent, such as for example a polysaccharide thickening agent increases the sun protection factor of the sunscreen composition of the present invention by several units, thereby reducing the needed amount of sunscreen agents to achieve a given sun protection factor.
In particular, it is also an object of the present invention to provide a sunscreen composition that solves the above mentioned problems of providing sunscreen compositions with reduced amount of additives, particularly film forming polymers, while maintaining a very high level of water resistance in vivo and a high SPF rating.
Further, it is also an object of the present invention to provide a sunscreen composition that solves the above mentioned problems of providing sunscreen compositions that simultaneously maintain their ability to be formulated as lotions, preferably lotions that are also sprayabie.
Further, it is also an object of the present invention to provide a sunscreen composition that solves the above mentioned problems of providing sunscreen compositions that are stable, e.g, storage stable, temperature stable, does not precipitate, does not change appearance when applied and fragrant stable.
Thus, one aspect of the invention relates to a sunscreen composition comprising at least one sunscreen agent, at least one solvent, at least one thickening agent, and at least one film forming polymer, wherein said thickening agent is present in an amount in the range of 0.01-0.50 %(w/w), and wherein said film forming polymer is present in an amount of less than 2.0 %(w/w).
Another aspect of the present invention relates to the use of a thickening agent for increasing the sun protection factor of a sunscreen composition comprising at least one sunscreen agent, at least one solvent, and at least one film forming polymer,
Yet another aspect of the present invention relates to a process for the manufacture of a sunscreen composition comprising the steps of i) providing at least one solvent, at least one thickening agent in an amount in the range of 0.01-0,50 %(w/w), at least one film forming polymer in an amount of less than 2.0 %(w/w), and at least one sunscreen agent, ii) admixing the components of step i) to provide a sunscreen composition.
The present invention will now be described in more detail in the foilowing.
Detailed description of the Invention
Definitions
Prior to discussing the present invention in further details, the following terms and conventions wiil first be defined:
In the present context "sunscreen composition" or photoprotective composition is to be understood as a liquid composition comprising agents that reduces the amount of UV radiation being absorbed by the skin, when said sunscreen composition is applied to the skin. A sunscreen composition may either absorb or block the UV rays. UV radiation may Include UVA and UVB radiation. Sunscreen compositions may be formulated as solutions, emulsions, milks or oils, and may be applied to the skin by the means of sprays, creams, or lotions.
By a "stable sunscreen composition" is meant a product which does not form any precipitate or changes physical appearance, such as colour, odour, separation of different liquids of the composition etc.
In the context of the present invention "sunscreen agent" is any cosmetologicaiiy approved agent capable of adsorbing or blocking UV radiation, such as UVA and/or UVB radiation. Sunscreen agents that absorb UV radiation are also referred to as UV filters, UVA, UVB or broad spectrum filters. Such sunscreen agents are often organic compounds or molecules, which absorb light in the UV region, the UV region being at wavelengths from 290 to 400 nanometers. Sunscreen agents that block the UV rays may include substances that leave a white coating on the skin, such as certain metal oxides including for example titanium oxide or other white substances.
In the present context "film forming polymer", also sometimes referred to as a "waterproofing agent", is a polymer capable of forming a film on e.g. skin as the carrier or solvent that it is dissolved in evaporates. A fiim forming polymer may be a uniform homo-polymer or a co-polymer, such as for example a block-copolymer. The polymer should be suitable for use in cosmetic products and may preferably be cosmetologicaiiy approved. In the present context the term "co-polymer" relates to a polymer formed when two (or more) different types of monomer are linked in the same poiymer chain, as opposed to a homo-polymer where only one monomer is used.
Herein "solvent", also sometimes referred to as a carrier, is any liquid capable of dissolving the components of the sunscreen composition. A solvent may be a mixture of different solvents or it may be a single solvent. The solvent should be suitable for use in cosmetics and may preferably be cosmetoiogically approved.
In relation to the present invention the term "alcohol" refers to an organic compound in which a hydroxyl group (-OH) is attached to a saturated carbon atom. Alcohols have the general formula ROH, where R may be a lower-aliphatic or cyclic carbon chain and may include aromatic rings. Alcohols are further classified as primary, secondary or tertiary, according to the position of the hydroxyl group on the lower-aliphatic carbon chain. Alcohols may also be classified by the number of hydroxyl groups present in the molecule; for example, a compound with two hydroxyl groups (a diol), and with three hydroxyl groups (a triol). The alcohol may comprise a denaturant. In the present context the term "Alcohol Denaturant" relates to ethyl alcohol that is denatured with one or more denaturing agents. One such denaturing agent may be Denatonium Benzoate.
Herein "polysaccharide" is any saccharide or derivative thereof that comprises several monosaccharide units, such as more than 2 monosaccharide units, more than 5 monosaccharide units, preferably more than 10 monosaccharide units. Hence, a "polysaccharide thickening agent" is any thickening agent based on a polysaccharide or derivative thereof.
A "solution" according to the present invention consists of a solvent and a range of ingredients which are ail entirely dissolved in said solvent. Thus, a solution does not comprise any solid dispersed material, i.e. it is not a dispersion. Also a solution does not comprise other liquid immiscible components which may or may not form vesicles that are dispersed in said solution, i.e. the solution is not an emulsion.
In the present context an "anhydrous" composition means a composition which is essentially free of water. Essentially free of water entails that no water is added to a composition, however minor amounts of water may be present since other components added to the composition may comprise small amount of water. Preferably, anhydrous composition means a composition entirely free of water.
In the present context the term "minimal erythema dose (MED)" refers to the quantity of erythema-effective energy (expressed as Joules per square meter or milli joules per square centimetre) required to produce the first perceptible, redness reaction in the skin with dearly defined borders.
Guidelines for labelling of Sun Protection Factor (SPF) number and product categories are suggested by COLIPA (The European Cosmetic Toiletry and perfumery Association) in Europe. These are listed in the table 1 below:
Table 1
Figure DK201570891A1D00101
Figure DK201570891A1D00111
In the present context the term "Sun protection factor" (SPF) refers to the UV energy required to produce an MED on protected skin divided by the UV energy required to produce an MED on unprotected skin. The "sun protection factor" term may also be defined as the ratio of the minimum erythema! dose on protected skin (MEDp) to the minimum erythemal dose on unprotected skin (MEDU): SPF=MEDp/MEDu
The Sun Protection Factor value on an individual subject (SPFi), for any product or composition, either before or after water immersion, may be determined as the ratio of the minimum erythema! dose on protected skin (MEDp) to the minimum erythema! dose on unprotected skin (MEDu) of the same subject.
Further, the term "static sun protection factor", (SPFs), relates to the sun protection factor before water immersion, while the term "wet sun protection factor" (SPFw) refers to the sun protection factor after water immersion.
The static and wet SPF values are determined according to the current published Internationa! Sun Protection Factor (SPF) Test Method (I-SPF-TM) as defined in 2006 by CO LI PA (CTFA SA - JCIA - CFTA US) as well as international standard ISO 24444:2010(E).
Herein "thickening agent" is any agent which is capable of increasing the viscosity of a cosmetic composition such as for example a sunscreen composition. The agent may preferably be cosmetologically approved.
Sunscreen composition
Thus, one aspect of the invention relates to a sunscreen composition comprising at least one sunscreen agent, at least one solvent, at least one thickening agent, and at least one film forming polymer, wherein said thickening agent is present in an amount in the range of 0.01-0,50 %(w/w), and wherein said film forming polymer is present in an amount of less than 2.0 %(w/w),
The sunscreen composition may preferably be a sprayable sunscreen composition. Herein "sprayable" or "sprayable sunscreen composition" relates to a composition which is capable of being formulated and dispensed as a spray. In the context of sunscreen compositions a further preferred quality to a sprayable composition is that said composition when dispensed using a spray dispenser, preferably a spray dispenser not comprising a propellant, is dispensed in a way which allows sufficient and even distribution of the composition onto the skin. In this respect a sprayable sunscreen composition should preferably have a viscosity which allows it to form an aerosol upon dispensing it as a spray, and it should preferably be dispensable in a volume which allows for sufficient coverage of the skin.
Preferably the present sunscreen composition is formulated as a spray and/or is formulated as a lotion. Preferably, the sunscreen composition may form an aerosol upon dispensing it as a spray, either by using a pump-spray, a continuous spray or other types of sprays, and the sunscreen composition would be dispensable In a volume which allows for sufficient coverage of the skin.
In order to enhance the sunscreen compositions performance as a sprayable sunscreen composition the viscosity of said sunscreen composition may be below 150 cP at 25 °C, such as below 140 cP at 25 °C, 130 cP at 25 °C, 120 cP at 25 °C 110 cP, at 25 °C, 100 cP at 25 °C, 80 cP at 25 °C, 60 cP at 25 °C, 40 cP at 25 °C, 20 cP at 25 °C, 15 cP at 25 °C, such as below 10 cP at 25 °C. The sunscreen composition may thus have a viscosity in the range of 1-150 cP at 25 °C, such as in the range of 1-140 cP at 25 °C, 1-130 cP at 25 °C, 1-120 cP at 25 °C, 1-110 cP at 25 °C, 1-100 cP at 25 °C, 1-80 cP at 25 °C, 1-60 cP at 25 °C, 1-40 cP at 25 °C, 1-30 cP at 25 °C, 1-20 cP at 25 °C, 1-15 cP at 25 °C, 1-14 cP at 25 °C, 2-13 cP at 25 °C, 3-12 cP at 25 °C, preferably in the range of 4-11 cP at 25 °C. The viscosity may preferable be the viscosity as measured at 25 °C and 60 rpm on a Brookfield LVOV II+P viscometer or preferably in the range of 90-150 cP at 25 °C.
The sunscreen composition may further preferably be a lotion sunscreen composition i.e. a sunscreen composition that preferably may be a sunscreen composition formulated as a lotion, Herein "lotion" or "lotion sunscreen composition" relates to a composition which is capable of being formulated and dispensed as a lotion. In the context of sunscreen compositions a further preferred quality to a lotion composition is that said composition when dispensed using a spray dispenser, preferably a spray dispenser not comprising a propellant, is dispensed in a way which allows sufficient and even distribution of the lotion composition onto the skin. In this respect a sprayable lotion sunscreen composition should preferably have a viscosity which allows it to form an aerosol upon dispensing it as a spray, and it should preferably be dispensable in a volume which allows for sufficient coverage of the skin.
Thus, the present sunscreen composition preferably is a composition that is formulated as a lotion and/or wherein said composition is a sprayable sunscreen composition, Thus, more preferred, the present sunscreen composition is a composition that is formulated as a lotion i.e. said sunscreen composition is a lotion sunscreen composition.
The thickening agent which provides the surprising effect in terms of increased SPF values in comparison to similar or equal composition with no thickening agent or less thickening agent may preferably be a polysaccharide thickening agent. The polysaccharide thickening agent may preferably be a cellulosic material or cellulose derivative. Preferably the polysaccharide thickening agent is selected from the group consisting of cellulose, carboxymethyl hydroxyethylcellulose, hydroxypropyl methyiceilulose, methyl hydroxyethylcellulose, microcrystalline cellulose, sodium cellulose sulphate, hydroxyethylcellulose, hydroxypropylcellulose, and any mixtures thereof. Even more preferred thickening agents are hydroxyethylcellulose or hydroxypropylcellulose, and the most preferred thickening agent is hydroxypropylcellulose.
The thickening agent may surprisingly boost the SPF of the composition of the present invention even when present in relatively small amounts. Also, the inventors must consider that the viscosity of the composition must not become too high, particularly for preferred embodiments wherein the composition is formulated as a spray. Achieving the correct balance between viscosity and SPF boosting effect may therefore be important and thus the thickening agent is preferably present in an amount in the range of 0.01-0.50%(w/w), such as 0.01- 0.45%(w/w), 0.01-0.40%(w/w), 0.01-0.35%(w/w), 0.10-0.50%(w/w), 0,10-0.45%(w/w), 0.10-0.40%(w/w), 0.10-0.35%(w/w), 0.15-0.50%(w/w), 0,15-0.40%(w/w), 0.15-0.35%(w/w), 0.20-0.50%(w/w), 0.20-0.45%(w/w), 0,20-0.40%(w/w), 0.20-0.35%(w/w), 0.25-0.50%(w/w), 0.25-0.45%(w/w), 0,25-0.40%(w/w), 0.25-0.35%(w/w), 0.30-0.50%(w/w), 0.30-0.45%(w/w), 0.30-0.40%(w/w), 0.30-0.35%(w/w), 0.35-0.50%(w/w), 0.35-0.45%(w/w), 0,35-0.40%(w/w), such as about 0.25%(w/w), such as about 0.35%(w/w),or such as about 0.45%(w/w). Even more preferred is a composition where the thickening agent is present in an amount of about 0.35%(w/w).
Unexpectedly, water does not need to be added to the present sunscreen composition, since solvation of the added components and the desired properties of the composition, such as stability, viscosity and clarity is achieved without adding water. Thus in as preferred embodiment said sunscreen composition comprises water in an amount of 0-2%(w/w), such as 0-l%(w/w), such as 0-0.8%(w/w), 0-0.6%(w/w), 0-0.4%(w/w), 0-0.2%(w/w), Q-Q,l%(w/w), 0-0.05%(w/w), such as 0-0.01%(w/w). In an even more preferred embodiment the composition is essentially anhydrous and most preferably the composition is anhydrous.
The solvent of the present invention may preferably be an alcohol. Said alcohol may be a mono alcohol having 2-8 carbon atoms, such as 2-4 carbon atoms. Preferably the alcohol is selected from the group consisting of ethanol, 1-propanol, 2-propanol, ethyleneglycol, 1-butanol, 2-butanol or any combination thereof. Ethanol is particularly preferred. The alcohol may comprise a denaturant, particularly when the alcohol is ethanol. The solvent content may preferably be in the range of 10-90%(w/w), such as in the range of 15-85%(w/w), 20-80%(w/w), 30-70%(w/w), 35-65%(w/w), 40~60%(w/w), 40-55%(w/w), such as in the range of 40-50%(w/w).
Preferably the sunscreen composition according to the present invention is a solution. Thus the components of the present compositions are preferably dissolved entirely in the solvent without forming for example emulsions or milks, and even more preferably the sunscreen composition does not comprise emulsifiers.
The sunscreen composition comprises one or more sunscreen agents, which provide the adsorption or blocking of the UV radiation, before it reaches the skin. The sunscreen agent may be selected from the group consisting of Avobenzone, Cinoxate, Dioxybenzone, Homosalate, Menthyl anthranilate, Octocrylene, Octyl methoxycinnamate, Octyl salicylate, Oxybenzone, Padimate 0, Phenylbenzimidazoie sulfonic add, Sulisobenzone, Titanium dioxide, Troiamine salicylate, Zinc oxide, Benzophenone-3 , Ethyihexyl Methoxycinnamate, Octocrylene, Butyl Metboxydibenzoylmethane (BMBM), Dietbylamino hydroxybenzoyl Hexyl Benzoate, Diethylhexyl Butamido Triazone, PABA, camphor benzalkonium methosulfate, phenylbenzimidazoie sulfonic acid, terephthaiidene dicamphor sulfonic acid, benzylidene camphor sulfonic acid, poiyacrylamsdomethy! benzylidene camphor, PEG-25 PABA, isoamyl p-methoxycinnamate, ethyihexyl triazone, drometrizole trielloxane, 4-methylbenzylidene camphor, 3-benzylidene camphor, ethyihexyl salicylate, ethyihexyl dimethyl PABA, benzopbenone-4, methylene bls-benztriazoiyl tetramethylbutylphenol, disodium phenyl dibenzimidazole tetrasulfonate, bis-ethylhexyloxyphenol methoxyphenol triazine, methylene bisbenzotriazolyl tetramethylbutylphenol, bisethylhexyloxyphenol methoxyphenyl triazine and any combination thereof.
In an even more preferred embodiment the at ieast one sunscreen agent is selected from the group consisting of Homosalate, Octocrylene, Butyl Methoxydibenzoylmetbane (BMBM), Dietbylamino Hydroxybenzoyl Hexyl Benzoate, diethylhexyl butamido triazone, ethyihexyl salicylate or any combination thereof. Even more preferred is a composition comprising Homosalate, Octocrylene, Ethyihexyl Methoxycinnamate, Butyl Methoxydibenzoylmetbane (BMBM), Dietbylamino Hydroxybenzoyl Hexyl Benzoate and diethylhexyl butamido triazone. The sunscreen composition may comprise Ethyihexyl Methoxycinnamate. Preferably, the sunscreen composition does not comprise Ethyihexyl Methoxycinnamate.
In another preferred embodiment the present composition does not comprise ethyihexyi salicylate and/or butyloctyl salicylate. In a preferred embodiment the present composition comprises ethyihexyi salicylate and/or diethylhexyl butamido triazone. Said salicylate may be present in the composition in concentrations of at the most 3%(w/w), such as at the most 2.5, such as in the range of 0.1-2.5%(w/w), e.g. l-2.5%(w/w), such as 1.5-2.5%(w/w). Butyloctyl salicylate may function as SPF booster and as co-solvent.
The amount of each individual sunscreen agent used in a given sunscreen composition is determined by the desired SPF value and regulatory limitations for the percentage (w/w) of sunscreen agent aliowed in sunscreen compositions for a given jurisdiction. To achieve broad range UV protection it may be advantageous to add both UVA, UVB and broad range UV filters. Finally, if the desired SPF is not achieved with a given set of sunscreen agents, further amounts of a different sunscreen agent may be added or preferably the SPF may be boosted by other means, such as described herein. Therefore, in preferred embodiments Diethyiamino Hydroxybenzoy! Hexyi Benzoate is used in concentrations of at the most 10 %(w/w) e.g. in the range of 0.1-10%(w/w), such as in the range of 3-10%(w/w), e.g. in the range 5-10%(w/w), such as in the range of 7-10%(w/w), and/or Octocrylene is used in concentrations of at the most 12 %(w/w), such as at the most ll%(w/w), such as at the most 10%(w/w), e.g. in the range of 0.1-10%(w/w), such as in the range of 0.5-8%(w/w), e.g. in the range l-6%(w/w), such as in the range of 3-5%(w/w), e.g. in the range 6-10%(w/w), such as in the range of 8-10%(w/w) and/or Butyl Methoxydibenzoylmethane (BMBM) is used in concentrations of at the most 6 %(w/w), such as of at the most 5%(w/w), such as in the range of 0.5-5%(w/w), e.g. in the range 3-5%(w/w), such as in the range of 4~6%(w/w), such as in the range of 4-5%(w/w), and/or homosalate is used in concentrations of at the most 10%(w/w), such as at the most 9%(w/w) e.g. in the range of 0.1-10%(w/w), such as in the range of 0.5-8%(w/w), e.g. in the range 6-10%(w/w), such as in the range of 8-10%(w/w) and/or diethylhexyl butamido triazone is used in concentrations of at the most 2%(w/w), such as at the most l%(w/w) such as in the range of 0.1 -2%(w/w), e.g. Q,l-1.75%(w/w), such as 0.1-1.50, such as 0.1-l%(w/w), such as 0.5-1.5%(w/w), and/or ethyihexyi salicylate is used in concentrations of at the most 3%(w/w), such as at the most 2.5, such as in the range of 0.1-2.5%(w/w), e.g. l-2.5%(w/w), such as 1.5-2.5%(w/w). If the sunscreen composition comprises Ethylhexyi Methoxycinnamate, it is used in concentrations of at the most 2%(w/w), e.g. in the range of 0.01-2%(w/w), such as in the range of 0.01-l%(w/w), e.g. in the range 0.01-0.05%(w/w).
In a highly preferred embodiment Diethylamino Hydroxybenzoyl Hexyl Benzoate is used in concentrations about 10%(w/w), and optionally Ethylhexyi Methoxycinnamate is used in concentrations of 0.01 (w/w), and Octocrylene is used in concentrations of about 10%(w/w), and Butyl Methoxydibenzoylmethane (BMBM) is used in concentrations of about 5%(w/w) and homosalate is used in concentrations of about 10%(w/w), and diethylhexyl butamido triazone is used in concentrations of about 1.0%(w/w), and ethylhexyi salicylate is used in concentrations of about 2.5%(w/w),
The present sunscreen composition may advantageously comprise an alkoxylated alcohol, which may serve as an emollient and/or co-solvent. The alkoxylated alcohol may preferably a long chain C11-C15 aliphatic alkoxylated alcohol and may be selected from the group consisting of PPG-11 stearyl ether, PPG-15 Stearyl ether, or any combination thereof. The alkoxylated alcohol may be added in an amount in the range of 0.1-20%(w/w), such as in the range of 0.5-15%(w/w), e.g. in the range of l-10%(w/w), such as in the range of 2-7%(w/w), e.g. in the range of 5-7%(w/w), such as in the range of 4-6%(w/w).
The present composition may further comprise an ester, which may serve as an emollient and/or co-solvent. The ester may preferably be selected from the group consisting of Ethylhexyi Benzoate, Dibutyl Adipate, Neopentyl Glycol Dicapryiate/Dicaprate, C12-15 Alkyl benzoate or any combination thereof. The ester may be present in an amount in the range of l-20%(w/w), such as present in an amount of less than 17.5%(w/w), less than 15%(w/w), less than 14%(w/w), less than 13%(w/w), less than 12%(w/w), such as less than ll%(w/w) such as less than 7%(w/w), such as less than 6%(w/w), such as in the range of 0.01-20%(w/w), 0.01-17.5%(w/w), 0.01-15%(w/w), 0.01-12%(w/w), l-20%(w/w), 3-18%(w/w), 4-16%(w/w), 5-15%(w/w), 5.5-14%(w/w), 10-14%(w/w), 5- 6%(w/w), such as about ll%(w/w) or such as about 14%(w/w). In a preferred embodiment, the composition does not comprise Dibutyi Adipate,
Silicone derivatives are used as emollients in for example sunscreen compositions and they also provide for improved skin feel, Since silicone derivatives may become subject of regulatory limitations "silicone alternatives" are also available, which provide similar effects to silicone derivatives but are mostly non-silicone compounds or compound mixtures derived from natural sources. Thus, in a preferred embodiment the composition further comprises a siloxane or a silane or silicone alternative, such as a siloxane, silane or silicone alternative selected from the group consisting of C13-16 isoparaffin, C12-14 isoparaffin, Cis-is Alkane,
Isodecane and Hydrogenated Polydecene and Bis-Behenyl/Isostearyl/Phytostearyl Dimer Dilinoleyl/Dimer Dilinoleate, Silyburn Marianum Ethyl Ester, Cs-is Alkyl Ester, cyclic dimethyl polysiloxane or cyclopentasiloxane. The siloxane, silane or silicone alternative may be present in an amount in the range of 0.1-10%(w/w), such as in the range of 0.5-10%(w/w), e.g. in the range of l-7%(w/w), such as in the range of 2-7%(w/w), e.g, in the range of 2-5%(w/w), such as in the range of 2-4%(w/w), e.g. in the range of 2-3%(w/w) or about 2.5%(w/w). In a preferred embodiment, said composition does not comprise a siloxane, silane or silicone alternative. In another preferred embodiment, said composition does not comprise cyclopentasiloxane and/or Dibutyl Adipate,
The sunscreen composition may comprise several sunscreen agents to achieve the desired SPF value. Thus in a preferred embodiment the composition comprises at least 2 sunscreen agents, such as 3 sunscreen agents, e.g. 4 sunscreen agents, such as 5 sunscreen agents, e.g. 6 sunscreen agents, such as 7 sunscreen agents. The composition may comprise 2-7 sunscreen agents, such as 3-7, 4-7, 5-7, such as preferably 6-7 sunscreen agents.
The present sunscreen composition comprises a film forming polymer, which provides for better water resistance of the composition. In a preferred embodiment the film forming polymer is selected from the group consisting of polyvinylpyrrolidone (PVP), acrylates, acrylamides, and any copolymers thereof or any combination thereof. Preferably the film forming polymer is selected from the group consisting of acryiate/octylacryiamide copolymer, acrylates copolymer, acrylates/Ci2-22 alkyl methacrylate copolymer, butylated PVP), VA/butyl maleate/isobornyl acrylate copolymer vinyl caprolactam/VP/dimethylaminoethyi methacrylate copolymer, most preferably acrylate/octylacrylamide copolymer.
The inventors surprisingly found that the film forming polymer would provide excellent water resistance of the present sunscreen compositions even at very low weight percentages. Thus, the film forming polymer may preferably be present in the sunscreen composition in an amount of less than 2.0, such as in the range of 0.1-1.9%(w/w), e.g. such as in the range of 0.2-1.8%(w/w), such as in the range of 0.3-1.7%(w/w), such as in the range of 0.4-1.6%(w/w), such as in the range of 0.5-1.5%(w/w), such as in the range of 0.5-1.2%(w/w), e.g. in the range of 0.6-1.0%(w/w), such as in the range of 0.6-0.9%(w/w), e.g. in the range of 0.7-0.8%(w/w), such as about 0.75%(w/w).
The ability of a sunscreen composition to be water resistant is highly desirable as explained above. A remarkably high water resistance was achieved for the present sunscreen composition, even when using very small amounts of film forming polymer as waterproofing agent. Thus, in a preferred embodiment the composition having a static sun protection factor after the composition has been applied to the skin of a human, the wet sun protection factor of the composition is at least 60% of the static sun protection factor, such as at least 65%, 70%, 75%, 80%, 85%, 90%, 95%, 100%, 105%, 110%, 115%, such as at least 120% when the composition is contacted with water, particularly after the composition has been Immersed in water in vivo for 80 minutes.
In a highly preferred embodiment the composition having a static sun protection factor after the composition has been applied to the skin of a human, the sun protection factor of the composition is capable of being increased to a higher wet sun protection factor when the composition is contacted with water, particularly after the composition has been immersed in water in vivo for 80 minutes. A preferred sunscreen composition is a composition wherein the wet sun protection factor is increased by at least 5% relative to the static sun protection factor, such as increased by at least 10% relative to the static sun protection factor, e.g. increased by at least 15% relative to the static sun protection factor, such as increased by at least 20% relative to the static sun protection facto, e.g.
increased by at least 25% relative to the static sun protection factor. Particularly, after the composition has been immersed in water in vivo for 80 minutes.
The water resistance of a sunscreen composition may be measured according to internationally or regionally approved standards such as for example the Guidelines for Evaluating Sun Product Water Resistance (COLIPA 2005). A sunscreen having a particularly high water resistance according to the regional or international standard may be designated by a "very water resistance" (VWR) value. Very Water Resistance is measured in vivo after a test subject has been immersed in water for a total of 80 minutes i.e. 4 times 20 minutes with 15 min drying time in between. Thus, in a preferred embodiment the present invention is a composition wherein the Very Water Resistance vaiue of said composition is above 50, such as above 60, above 70, above 80, such as above 85, above 90, above 95, above 100, above 105, above 110, such as above 115,
One purpose of the present invention is to provide a sunscreen composition with a boosted SPF vaiue in the sense that the SPF value achieved is not achieved by the addition of further sunscreen agents alone, but also by the addition of a thickening agent. Therefore in a preferred embodiment the present invention relates to a composition wherein said composition comprises no more than 5 sunscreen agents and wherein the sun protection factor is at least 15, such as at least 16, at least 17, at least 18 , at least 19, such at least 20, at least 21 at least 22 at least 23 at least 24 at least 25. at least 26, at least 27, at least 28, at least 29, at least 30, at least 32, at least 34, at least 36, at least 38, at least 40, at least 42, at least 44, at least 46, at least 48, such as at least 50. Preferably a composition wherein said composition comprises no more than 4 sunscreen agents and wherein the sun protection factor is at least 15, such as at least 16, at least 17, at least 18 , at least 19, such at least 20, at least 21 at least 22 at least 23 at least 24 at least 25. at least 26, at least 27, at least 28, at least 29, at least 30, at least 32, at least 34, at least 36, at least 38, at least 40, at least 42, at least 44, at least 46, at least 48, such as at least 50.
Alternatively a composition is preferred wherein said composition comprises no more than 6 sunscreen agents and wherein the sun protection factor is at least 30, such as at least 32, at least 34, at least 36, at least 38, at least 40, at least 42, at least 44, at least 46, at least 48, such as at least 50.
A highly preferred embodiment of the present invention is to provide a sunscreen composition with a high SPF value. Therefore in a preferred embodiment the present invention relates to a sunscreen composition wherein the sunscreen protection factor of said composition is at least 20, such as at least 22, such as at least 24, such as at least 26, such as at least 28, such as at least 30, such as at least 32, such as at least 34, such as at least 36, such as at least 38, such as at least 40, such as at least 42, at least 44, at least 46, at least 48, at least 50, at least 51, at least 52, at least 53, at least 54, such as at least 55. A sunscreen composition is preferably provided that achieves a high SPF value and a high water resistance while using a minimal amount of sunscreen agents. Thus, in preferred embodiment the composition comprises no more than 7 sunscreen agents and wherein the sun protection factor is at ieast 30, such as at least 32, at least 34, at least 36, at least 38, at least 40, at least 42, at least 44, at least 46, at least 48, at least 50, at least 52, at least 53, at least 54, such as at least 55, such as no more than 6 sunscreen agents and wherein the sun protection factor is at least 30, such as at least 32, at ieast 34, at ieast 36, at least 38, at least 40, at least 42, at least 44, at least 46, at least 48, at least 50, at least 52, at least 53, at least 54, such as at least 55.
The present sunscreen composition has the ability to achieve higher SPF values by the addition of a thickening agent. Therefore, a preferred embodiment is a sunscreen composition wherein the sun protection factor is increased by at ieast 5 SPF units, such as at ieast 6 units, 8 units, 10 units, 11 units, 12 units, 13 units when a thickening agent is comprised as compared to a composition comprising the same overall weight percentage in %(w/w) of sunscreen agents and no thickening agent. An even more preferred embodiment is a composition wherein the sun protection factor is increased by at least 5 SPF units, such as at ieast 6 units, 8 units, 10 units, 11 units, 12 units, 13 units when a thickening agent is comprised as compared to an essentially identical composition not comprising a thickening agent. Preferably the essentially identical composition not comprising thickening agent is the identical composition, wherein the thickening agent has been replaced by solvent.
It is desirable to provide a composition which delivers a high protection against the particularly harmful UVA radiation, UVA protection may either be expressed via the so-called COLIPA ratio or via the Boots star rating system, the guidelines for both of these rating systems being described in the below examples. Thus, the present sunscreen compositions may preferably have a COLIPA ratio below 3, such as below 2, below 1.5, such as below 1.2, preferably below 1,1, Preferably the present sunscreen composition has a boots star rating of at least 4 stars, such as preferably at least 5 stars.
The overall stability and particularly the photo-stability of sunscreen compositions must preferably be high in order to provide prolonged protection against UV radiation without the need for excessive and repeated topical administration during exposure to the sun. Therefore a preferred embodiment of the present invention is a sunscreen composition wherein the SPF value of said composition 10 hours after application in vivo is at least 60%, such as at least 65%, at least 70%, at least 75%, such as at least 78% of the SPF value of said sunscreen composition 15 minutes after application in vivo. Preferably said SPF value is the static SPF value.
In another embodiment of the invention a sunscreen composition according to the invention is a composition comprising or essentially consisting of Ethanol Denatured, Hydroxypropyiceilulose, Acrylates/Octylacrylamide Copolymer, PPG-15 Stearyl ether, C12-15 Alkyl Benzoate, Octocrylene, Homosalate, Butyl Methoxydibenzoylmethane and Dietbyiamino Hydroxybenzoyl Fiexyl Benzoate.
In a further embodiment of the invention a sunscreen composition according to the invention is a composition comprising or essentially consisting of Ethanol Denatured, Hydroxypropyiceilulose, Acrylates/Octylacrylamide Copolymer, PPG-15 Stearyl ether, C12-15 Alkyl Benzoate, Dibutyl Adipate, Octocrylene, Homosalate, Ethyihexyl Salicylate, Butyl Methoxydibenzoylmethane and Dietbyiamino Hydroxybenzoyl Hexyl Benzoate,
In an even further embodiment of the invention a sunscreen composition according to the invention is a composition comprising or essentially consisting of Ethanol Denatured, Hydroxypropyiceilulose, Acrylates/Octylacrylamide Copolymer, PPG-15 Stearyl ether, 02-15 Alkyl Benzoate, Cydopentasiloxane, Octocrylene, Homosaiate, Diethylhexyl Butamido Triazone, Butyl Methoxydibenzoyimethane and Dlethylamino Hydroxybenzoyl Hexyl Benzoate.
Use of thickening agent for Increasing SPF
A second aspect of the present invention is the use of a thickening agent for increasing the sun protection factor of a sunscreen composition comprising at least one sunscreen agent, at least one film forming polymer, and at least one solvent. Preferably said thickening agent is present in an amount in the range of Q,01“Q,5Q%(w/w). Preferably said film forming polymer is present in an amount of less that 2.0%(w/w).
Preferably the thickening agent is a polysaccharide thickening agent, such as a cellulosic material or cellulose derivative. Even more preferably said polysaccharide thickening agent is selected from the group consisting of cellulose, carboxymethyl hydroxyethyiceliuiose, hydroxypropyl methyiceliuiose, methyl hydroxyethylcellulose, microcrystalline cellulose, sodium celiuiose suiphate, hydroxyethyiceliuiose, hydroxypropylcellulose, and mixtures thereof. The thickening agent may preferably be hydroxyethyiceliuiose or hydroxypropylcellulose, such as preferably hydroxypropylcellulose.
Preferably the film forming polymer is selected from the group consisting of polyvinylpyrrolidone (PVP), acrylates, acrylamides, and any copolymers thereof or any combination thereof or more preferably, said film forming polymer is selected from the group consisting of acrylate/octylacrylamide copolymer, acrylates copolymer, acrylates/G?.-?.?. alkyl methacrylate copolymer, butylated PVP), VA/butyl maleate/isobornyl acrylate copolymer vinyl caprolactam/VP/dimethylaminoethyi methacrylate copolymer, most preferably acrylate/octylacrylamide copolymer.
A preferred embodiment is the use of a thickening agent for increasing the sun protection factor of a sunscreen composition wherein the sun protection factor is increased by at least 5 SPF units, such as at least 6 units, 8 units, 10 units, 11 units, 12 units, 13 units when a thickening agent is comprised as compared to a composition comprising the same overail weight percentage %(w/w) of sunscreen agents and no thickening agent. Another preferred use is a use wherein the sun protection factor is increased by at ieast 5 SPF units, such as at least 6 units, 8 units, 10 units, 11 units, 12 units, 13 units when a thickening agent is comprised as compared to an essentially identical composition not comprising a thickening agent. The essentially identical composition not comprising thickening agent may be the identical composition, wherein the thickening agent has been replaced by solvent.
In a preferred embodiment the use of a thickening agent described for the present invention is applied to a sunscreen composition which is sprayabie and/or a sunscreen composition which is formulated as a lotion. Preferably the sunscreen composition is a sprayabie lotion and anhydrous. It may preferably be formulated as a spray, and also it may preferable have a viscosity as described in the previous section.
All the embodiments described for the aspect relating to a sunscreen composition may naturally also apply to the sunscreen composition described for the present use of a thickening agent.
Method of manufacturing a sunscreen composition A third aspect of the present invention is a process for the manufacture of a sunscreen composition comprising the steps of i) providing at least one solvent, at least one thickening agent in an amount in the range of 0.01-0.50 %(w/w), at ieast one film forming polymer in an amount of less than 2.0 %(w/w), and at least one sunscreen agent, ii) admixing the components of step i) to provide a sunscreen composition.
Generally heating is used when manufacturing sunscreen compositions, however for the present invention the inventors surprisingly found that heating was unnecessary, and all the components dissolves to a satisfactory level without applying heat, beyond the heat generated during solvation and stirring. Therefore, preferably the mixture or composition is not heated during the process and the temperature is in the range of 0-60 °C, such as in the range of 5-55 °C, 15-50 °C, 20-50 °C, 30-45 °C, such as about 40 °C. Preferably, no wafer is added to the composition during said process, and even more preferably the components provided in step i) are admixed in the order provided in step i). Further additives as described herein may be added in step i). Each component added is dissolved under stirring before the next component is added. Stirring time may vary from 1-25 minutes.
AH the embodiments described for the aspect relating to a sunscreen composition may naturally also apply to the sunscreen composition described for the present method of manufacturing.
It should be noted that embodiments and features described in the context of one of the aspects of the present invention also apply to the other aspects of the invention. All patent and non-patent references cited in the present application, are hereby incorporated by reference in their entirety.
The invention will now be described in further details in the following non-limiting examples.
Examples
Example 1 - Sunscreen compositions and manufacture thereof Sunscreen compositions were prepared according to the tables shown below for compositions A1/A2, B1/B2 and C1/C2. The B1/B2 compositions are comparable but comprise higher amounts of sunscreen agents than the A1/A2 compositions (also comparable) to achieve higher SPF values. Also the C1/C2 compositions are comparable but comprise higher amounts of sunscreen agents than the A1/A2 compositions to achieve higher SPF values. The amount of thickening agent is varied in A! vs A2, Bl vs B2 and Cl vs C2 to elucidate the effect of said thickening agent. The amount of film former is the same in the various compositions.
Table 2: Sunscreen composition Å1 and Å2 (reduced film former) and low amounts of thickening agent
Figure DK201570891A1D00261
Composition A2 has several alterations as compared to Al, but comprises the same overall amount %(w/w) of sunscreen agents as Al. Importantly, A2 comprises more thickening agent than Al.
Table 3: Sunscreen composition Bl and B2 (reduced film former) and low amounts of thickening agent
Figure DK201570891A1D00271
Composition B2 has several alterations as compared to Bl, but comprises the same overall amount %(w/w) of sunscreen agents as Bl. Importantly, B2 comprises more thickening agent than Bl.
Table 4: Sunscreen composition Cl and C2 (reduced film former) and low amounts of thickening agent
Figure DK201570891A1D00281
Composition C2 has several alterations as compared to Cl, but comprises the same overall amount %(w/w) of sunscreen agents as Cl. Importantly, C2 comprises more thickening agent than Cl.
The compositions A1/A2, B1/B2 and C1/C2 were manufactured by addition of the listed components in the order they are listed under stirring using a Silverson L4RT high shear mixer. Stirring time in between additions of components is variable between 1-25 minutes. No heating of the solution was performed. The temperature of the mixture was between 20 °C and 40 °C at all times.
Example 2 - Effect of thickening agent on Sun Protection Factor
The present example will demonstrate that the addition of a thickening agent could enhance the SPF value of the present sunscreen compositions.
The test will be based on the International-Sun Protection Factor-Test Method (SPF) as defined in 2006 by COLIPA - CTFA SA - JCIA- CTFA US, as well as on the international standard ISO 24444, Cosmetics - Sun protection test methods - in vivo determination of the sun protection factor (SPF), ISO 24444:2010 (E); First edition 2010-11-15.
Based on the European Commission Recommendation from September 2006 as well as COLIPA statement (26.09.2006), basis of labeling should be the mean SPF obtained in application of the I-SPF-TM 2006 / ISO 24444:2010(E). The efficacy of sunscreen products should be indicated on the label by reference to categories.
The category of sunscreen products should be indicated on the label at least as prominently as the SPF. The variety of numbers used on labels for indicating the SPF is restricted to those and only those shown in the following Table. The range of SPF's for each category and the respective labeling is defined as follows:
Table 5: Protection categories according to EC recommendations
Figure DK201570891A1D00291
The minimum degree of protection provided by a sunscreen product is an SPF of 6. SPF values and SPF label values in the present examples are to be understood within the framework of the European recommendations and the SPF values are determined and/or calculated as described in the detailed description. In the present example 2 mg/cm2 sunscreen composition will be applied to test subjects as provided by the guidelines.
Sunscreen compositions A1/A2, B1/B2 and C1/C2 were prepared according to example 1 and will be subjected to in vivo SPF determination as prescribed by the above mentioned guidelines. The tests will be performed by Institute Dr. Schrader Hautphysiologie, Holzminden, Germany. The data in Table 5 below have not been generated yet.
Table 6 - Comparative in vivo measurements of SPF dependence on thickening agent for compositions A1/A2, B1/B2 and C1/C2
Figure DK201570891A1D00301
* mean value of in vivo measurements to be performed on 6 individual test subjects
The above experiment will demonstrate that the sun protection factor of the composition with thickening agent (in this case hydroxypropyiceilulose) will become significantly larger than that of the product with reduced amounts of thickening agent. This will lead to a higher attainable label SPF and label category without the addition of further sunscreen agents.
Example 3 - Effect of thickening agent on SPF kinetics
The effect of thickening agent on the kinetics, i.e. SPF performance over time will be measured in vivo in separate experiments. Sunscreen compositions A1/A2, B1/B2 arid C1/C2 were prepared according to example 1 and will be subjected to in vivo SPF determination as prescribed by the above mentioned guidelines.
The tests will be performed by Institute Dr. Schrader Hautphysiologie,
Holzminden, Germany. The data in Table 6 below have not been generated yet.
Table 7 - Comparative in vivo measurements of SPF kinetics and dependence on thickening agent for compositions A1/A2, BI/B2 and C1/C2.
Figure DK201570891A1D00311
* mean value of in vivo measurements on twelve individual test subjects,
The measurements will show that the improvements achieved when adding thickening agent are maintained over time, so that after 10 hours, the compositions with increased amounts of thickening agent (A2, B2, C2) will still be superior to those with less thickening agent (Al, Blf Cl),
Example 4 - Water resistance of sunscreen compositions
The effect of thickening agent and reduced amounts of film forming polymer on the water resistance of the compositions of the present invention was measured in vivo, Sunscreen compositions A1/A2, B1/B2 and C1/C2 were prepared according to example 1 and subjected to in vivo SPF determination as prescribed by the Guidelines for Evaluating Sun Product Water Resistance (COLIPA 2005).
The tests were performed by Institute Dr. Schrader Hautphysioiogie, Holzminden, Germany.
As described the wet SPF as measured in vivo is the SPF value measured after application of sunscreen and subsequent immersion of the test individual in water for 80 minutes. The immersion in water for 80 minutes is divided into 4 immersions of 20 minutes with 15 minutes of drying time in air before first immersion, in between immersions, and after the fourth immersion.
The very water resistance value (in percentage) is calculated as: VWR = 100 x SPFw/SPFs where the lower limits of the confidence intervals (95% Cl) is used for SPFw and SPFs based on statistics performed on the data from 12 test subjects,
Table 8 -in vivo measurements of SPF water resistance for sunscreen compositions Alf B1 and Cl
Figure DK201570891A1D00321
* Based on SPF (static and wet) measurements In vivo on 12 individuals, respectively ** Affirmative data on B1 is being generated and is expected to demonstrate water resistance of 50% or more. Strong preliminary data highly support this expectation.
The tests show that the compositions of the present invention retain a very high water resistance even with very low levels of thickening agent and low levels of film forming polymer present, which justifies the label "very water resistant" according to the recommendations in the abovementioned guidelines. The requirement for this label is a water resistance of 50% or more.
Example 5 - UVA protection and Boots star rating of Sunscreen compositions The protection against UVA radiation may be determined by the COLIPA ratio as defined in the COLIPA guideline (In vitro method for the determination of the UVA protection factor and "critical wavelength" values of sunscreen products". Guideline, COLIPA, March 2011). The COLIPA ratio is calculated as
COLIPA Ratio - SPFiabei/UVA-PF
where UVA-PF is the actual "SPF" obtained for UVA irradiation measured in vitro according to the guidelines. The present composition AI was tested and displayed a COLIPA ratio of 0.9 (Ai), which fulfils the recommendation from COLIPA which is a ratio below 3. Also, present compositions B1 and Cl will be tested and are expected to provide a COLIPA ratio of 1.2/1.3 (Bl/Cl) respectively, which will fulfil the recommendation from COLIPA which is a ratio below 3.
The UVA protection was also determined by the Boots star rating system (Measurement of UVA:UVB ratios according to the boots star rating system [2001 revision]; the Boots company PLC, Nottingham NG2 3AA, UK, September 2011), which is based on the ratio between UVA and UVB protection before and after exposing the sample to UV irradiation. The best Boots star rating of five stars (*****) requires a UVA: UVB ratio above 0.9 before UV exposure and above 0.86 after UV exposure. Composition A1 fulfils these criteria as demonstrated in the below table. Regarding composition B1 and Cl, strong preliminary data support the expectation that they too will obtain a five stars Boots star rating (*****) Le, that they will have a UVA: UVB ratio above 0.9 before UV exposure and above 0.86 after UV exposure.
Table 9: Boots star rating of composition A1 * mean product quantity - 1.3 mg/cm2
Figure DK201570891A1D00341
(after equilibration 0.8 mg/cm2), mean plate temp. = 26.9 °C.
Example 6 - Viscosity of sunscreen compositions
The viscosity of the present sunscreen compositions must be within certain limits for the compositions to remain sprayable and/or to remain suitable to be formulated as a lotion. Thus, the viscosity of composition A1 and Cl was investigated along with compositions having more thickening agent (solvent amounts being adjusted accordingly). The viscosities were measured at 25 °C at 60 rpm using a Brookfield LVDV-II + P viscometer with a small sample adapter and Spindle S18.
Table 10 - Viscosity of composition A1/A2 and C1/C2
Figure DK201570891A1D00342
HPC = hydroxyprOpyiceiiulo.se • Affirmative data on C1/C2 is being generated and is expected to demonstrate viscosity of about 90-150 cP, Preliminary data support this expectation.
The tests show that at 0.20%(w/w) HPC (compositions AI and Cl) or 0.40%(w/w) HPC (composition A2 and €2) the viscosity remains ideal for sunscreen compositions that are formulated as lotions. In fact, this viscosity will also allow the composition to form an aerosol upon dispensing it as a spray, either as a pump-spray or as a continuous spray, and it would be dispensable in a volume, which allows for sufficient coverage of the skin.
References ® WO 2009/016537 • WO 2004/110366 • WO 2011/100275 ® Commission Recommendation of 22 September 2006 on the efficacy of sunscreen products and the claims made relating thereto (notified under document number C(2006) 4089) (Text with EEA relevance) (2006/647/EC); Official Journal of the European Union, L 265/3 • WO 2014/015879 • WO2014/015880

Claims (11)

1. A sunscreen composition comprising at least one sunscreen agent, at least one solvent, at least one thickening agent, and at least one tlim forming polymer, and wherein said thickening agent is present in an amount in the range of 0.01-0.50 %(w/w), and wherein said film forming polymer is present in an amount of less than 2.0 %(w/w).
2. A sunscreen composition according to claim 1, wherein said composition is formulated as a lotion and/or wherein said composition is a sprayable sunscreen composition.
3. A sunscreen composition according to any of claims 1-2, wherein said thickening agent is a polysaccharide thickening agent.
4. A sunscreen composition according to any of claims 1-3, wherein said film forming polymer is selected from the group consisting of polyvinylpyrrolidone (PVP), acrylates, acrylamides, and any copolymers thereof or any combination thereof.
5. A sunscreen composition according to any of claims 1 -4, wherein said sunscreen agent is selected from the group consisting of Avobenzone, Cinoxate, Dioxybenzone, Homosalate, Menthyl anthranilate, Octocrylene, Ocfyl methoxycinnamate, Octyl salicylate, Oxybenzone, Padimaie O, Phenyibenzimidazole sulfonic acid, Sulisobenzone, Titanium dioxide, Trolamine salicylate, Zinc oxide, Benzophenone-3, Ethylhexyl Methoxycinnamate, Octocrylene, Butyl Methoxydibenzoyimethane (BMBM), Diethylamino hydroxybenzoyl Hexyl Benzoate, Diethylhexyl Butamido Triazone, PABA, camphor benzalkonium methosulfate, phenyibenzimidazole sulfonic acid, terephthalidene dicamphor sulfonic acid, benzylidene camphor sulfonic acid, poiyacryiamidomethyi benzylidene camphor, PEG-25 PABA, isoamyl p-methoxycinnamate, ethylhexyl triazone, drometrizole trielioxane, 4-methylbenzylidene camphor, 3-benz.ylidene camphor, ethylhexyl salicylate, ethylhexyl dimethyl PABA, benzophenone-4, methylene bis-benztriazolyl tetramethyibuiyiphenol, disodium phenyi dibenzimidazole ieirasulfonaie, his-efbylhexyioxypbenol methoxyphenol triazine, methylene bisbenzotriazolyl tetramethylbutylphenol, bisetbylhexyloxyphenol metboxyphenyl triazine and any combination thereof.
6. A sunscreen composition according to any of claims 1 -5, wherein fhe composition having a static sun protection factor after the composition has been applied to the skin of a human, the wet sun protection factor of the composition is at least 60% of the static sun protection factor, such as at least 65%, 70%, 75%, 80%, 85%, 90%, 95%, 100%, 105%, 110%, 115%, such as at least 120% when the composition is contacted with water.
7. A sunscreen composition according to any of claims 1 -6, wherein the composition having a static sun protection factor after fhe composition has been applied to the skin of a human, the sun protection factor of the composition is capable of being increased to a higher wet sun protection factor when the composition is contacted with water.
8. A sunscreen composition according to any of claims 1 -7, wherein the wet sun protection factor is increased by at least 5% relative to the static sun protection factor, such as increased by at least 10% relative to the static sun protection factor, e.g. increased by at least 15% relative to the static sun protection factor, such as increased by at least 20% relative to the static sun protection factor, e.g. increased by at least 25% relative to the static sun protection factor.
9. A sunscreen composition according to any of claims 1-8, wherein the Very Water Resistance value of said composition is above 50, such as above 60, above 70, above 80, such as above 85, above 90, above 95, above 100, above 105, above 110, such as above 115.
10. Use of a thickening agent for increasing the sun protection factor of a sunscreen composition comprising at least one sunscreen agent, at least one solvent, and at least one film forming polymer.
11. A process for the manufacture of a sunscreen composition comprising fhe steps of i) providing af least one solvent, af least one thickening agent in an amount in the range of 0.01-0.50 %(w/w), at least one film forming polymer in an amount of less than 2.0 %(w/w), and at least one sunscreen agent, ii) admixing the components of step i) to provide a sunscreen composition.
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