AU2006227561B2 - Sunscreen aerosol spray - Google Patents

Description

WO 2006/099687 PCT/AU2006/000405 - 1 SUNSCREEN AEROSOL SPRAY FIELD OF THE INVENTION 5 The present invention relates to sunscreen compositions containing at least one active sunscreen agent or UV radiation filter for providing protection for parts of the body against damage and/or injury caused by the sun. Embodiments of the present invention relate to 10 sunscreen compositions containing a sunscreen agent or UV radiation filter dispensed from a container in the form of an aerosol and/or dispensed from an aerosol container for application to the skin of a person. Even more particularly, the present invention relates to sunscreen 15 compositions containing a sunscreen agent that is active against the damaging effects of the sun in which the sunscreen compositions are dispensed from the container in either the form of an aerosol spray or from an aerosol container, such as a can, in the form of a spray, 20 particularly a spray of a fine mist or similar. The present invention finds particular application as a sunscreen composition containing one or more active sunscreen agents incorporated into an emulsion that can be dispensed from an aerosol container in the form of a fine 25 spray or mist, particularly a substantially consistent droplet size mist or spray so as to deliver the active sunscreen agent or agents to a person or animal in the form of a substantially even film containing the sunscreen agent or agents on to the skin of the person or animal so 30 as to provide a substantially uniform coverage of the sunscreen agent or agents over the surface of the skin to which the sunscreen is applied thereby protecting the skin against damage from the sun. The present invention relates not only to aerosol sunscreen compositions having 35 one or more active sunscreen agents and one or more propellants in the form of an emulsion but also to aerosol containers containing the sunscreen emulsion compositions, WO 2006/099687 PCT/AU2006/000405 -2 to methods of dispensing the sunscreen compositions from the aerosol container and to methods of applying the sunscreen agent or agents to parts of the body, such as to the skin, hair or the like. 5 Although the present invention will be described with particular reference to one form of the aerosol sunscreen composition, it is to be noted that the scope of the present invention is not limited to the described 10 embodiments, but rather the scope of the present invention is broader by including other components of the composition, variations of the composition, other containers, other methods and forms of dispensing the formulations and compositions from the various containers 15 and variations in methods of applying the different compositions to the various parts of the body of a person or animal and the like. Also, even though the present invention is 20 described primarily with reference to sunscreen formulations or compositions for applying to the skin of a person to provide protection against the harmful effects of the sun, it is to be noted that such sunscreen formulations or compositions can be applied to other parts 25 of the body, such as, for example, to the hair, and the like. Also, the sunscreens can be used on humans and animals to provide protection against the harmful effects of the sun. Thus, the use of terms such as 'skin', 'person' and the like are meant to be non-limiting in 30 scope and such terms are used for the sake of clarity and ease of expression rather than to delimit the scope of the invention. It is to be noted that the word "sunscreen agent" 35 is used in the specification for clarity of understanding and ease of expression. Its use is not meant to be limiting but its scope includes materials variously WO 2006/099687 PCT/AU2006/000405 -3 described as sunscreen agents, actives, UV filters, sun blocking agents, block out agents, sun protection agents and the like. 5 BACKGROUND OF THE INVENTION Sunscreen compositions are applied to the skin of a person to protect the skin from the harmful effect of the sun's rays so as to reduce or prevent the effects of 10 sunburn and the like, particularly from harmful ultraviolet radiation, such as short wavelength UV-B radiation of from about 290 - 320 nm and from longer wavelength UV-A radiation of from about 320 - 400 n= wavelength, both of which are damaging to the skin. 15 Exposure to the sun can cause reddening of the skin, sunburn and other temporary discomfort and can lead to long term damage to the skin. Excessive or prolonged exposure to sunlight, particularly to high intensity radiation from the sun, can lead to the development of 20 skin disorders including serious conditions such as melanoma, basal cell carcinoma, and squamous cell carcinoma, local and systemic immune suppression, and the like. Conditions such as solar keratoses, sunburn, erythema, or redness of the skin are also manifestations 25 of the.effects of both short term and long term exposure to UV radiation, and with high exposure doses the skin will become painful and edematous and blistering may occur. Excessive exposure may also promote photosensitization or phototoxicity caused by endogenous 30 factors, or by exposure to endogenous factors, such as certain plants, chemicals and the like. Even if excessive exposure to sunlight does not cause any medical condition, prolonged exposure results in photo-damage which is associated with premature ageing of the skin and ~is 35 characterised by wrinkled, cracked or dry skin, such as for example skin having the characteristic appearance of "crocodile skin", sagging, loss of elasticity, mottled WO 2006/099687 PCT/AU2006/000405 -4 pigmentation or aged lines and the like. Even if such conditions are not harmful, they are unsightly. The major causes of premature aging of the skin, appear to include cumulative lifetime exposure to UV radiation having 5 wavelengths in the region of from about 290 to 400 nm. Accordingly, sunscreen compositions have been developed to provide protection for the skin of animals and humans against long term damage from the sun and as a preventative against the conditions mentioned above. 10 One problem associated with some forms of existing sunscreen compositions is the unevenness of distribution of the sunscreen actives. Sunscreen formulations are usually applied topically as a relatively 15 viscous lotion, cream or similar which must be spread over the entire surface of the skin, such as by rubbing or the like in order to spread the active sunscreen agent present in the composition over the skin to form a thin film or coating over the skin to provide protection. Rubbing the 20 lotion or cream onto and over the skin in this manner results in an uneven distribution of the active sunscreen agent or agents in that there are some areas of high coverage with relatively greater film thickness having more sunscreen than is required and other areas of low 25 coverage of relatively lower film thickness in which there is insufficient sunscreen agent applied to satisfactorily protect the skin. If the layer is too thick, it is wasteful of the sunscreen since such a thick layer is not necessary to provide adequate protection and if the layer 30 is too thin, insufficient protection is provided to the underlying skin resulting in damage to the skin. As the coverage of the sunscreen over the surface is variable, the protection afforded by the sunscreen to the underlying skin is variable and the coverage is patchy which can 35 result in skin located beneath the relatively thin coverage of sunscreen lotion being burnt and damaged as evidenced by the reddening appearance of the skin. Thus, WO 2006/099687 PCT/AU2006/000405 -5 with existing formulations, it is difficult to provide a consistent coverage of sunscreen agent. Therefore, there is a need to provide a sunscreen composition in a form that can be applied more evenly and for a method of 5 applying the sunscreen to provide more uniform coverage of sunscreen on the skin of a person to provide the required protection. Another problem associated with existing 10 sunscreen formulations relates to the spreadability of the formulation, particularly to its ease of spreadability. Many existing formulations are difficult to apply, particularly in order to provide consistent protection for the entire surface of the skin. Reasons for the lack of 15 spreadability include the physical form in which the sunscreen formulation is manufactured, such as for example, in the form of a lotion, cream, paste or similar high viscosity formulation, which is difficult to apply and spread evenly over the surface of the skin. 20 Formulations at the other end of this viscosity spectrum, being very thin liquid such as for example, liquids having almost the viscosity of water, do not have sufficient "cling" properties to adhere to the skin but rather have a tendency to "run off" the surface of the skin before the 25 formulation can be spread evenly over the surface of the skin. This run off leads to wastage of the sunscreen and to reduced or uneven protection of the skin. Accordingly, it is an object of the present 30 invention to provide a sunscreen composition in a form that can be dispensed more readily from a container to deliver a substantially uniform film or to provide a substantially uniform coverage of the sunscreen agent on the surface of the skin in order to provide more 35 consistent protection for the skin. In one embodiment, this object is achieved by incorporating the sunscreen agent or agents into a suitable composition or formulation - 6 contained in an aerosol container and dispensing the sunscreen aerosol spray composition from the container in the form of a fine mist, spray or similar to provide a uniform coverage of the composition thereby providing 5 uniform protection. SUMMARY OF THE INVENTION According to the present invention, there is 10 provided a sunscreen composition for providing protection against the effects of the sun on the skin of a person to whom the composition is applied, said composition comprising an intimate mixture of at least one sunscreen agent and at least on propellant, said intimate mixture 15 forming an emulsion, said at least one sunscreen agent for providing protection to the skin against the harmful effects of the sun, and said at least one propellant for facilitating dispensing the intimate mixture from a container containing the intimate mixture, said intimate 20 mixture being capable of being dispensed from the container in the form of an aerosol, spray, mist, or fog by action of the propellant to produce the spray, mist or fog, wherein as the intimate mixture is sprayed from the container, the sunscreen agent is applied directly onto 25 the skin of the person to apply a substantially uniform film of the at least one sunscreen agent to the skin of the person thereby providing uniform protection against the damaging effects of the sun on the skin to which the sunscreen agent has been applied. 30 According to another aspect of the present invention, there is provided a method of applying to a person a sunscreen composition for providing protection against the effects of the sun on the skin of a person to 35 whom the composition is applied, said composition comprising an intimate mixture of at least one sunscreen agent and at least on propellant, said intimate mixture 2259583_1 (GHMatters) 16/11/10 -7 forming an emulsion, said at least one sunscreen agent for providing protection to the skin against the harmful effects of the sun, and said at least one propellant for facilitating dispensing the intimate mixture from a 5 container containing the intimate mixture, said intimate mixture being capable of being dispensed from the container in the form of an aerosol, spray, mist, or fog by action of the propellant to produce the spray, mist or fog, wherein as the intimate is sprayed from the 10 container, the sunscreen agent is applied directly onto the skin of the person to form a substantially uniform film of the at least one sunscreen agent on the skin of the person thereby providing uniform protection against the damaging effects of the sun for the skin to which the 15 sunscreen agent has been applied, comprising the steps of dispensing the sunscreen composition from an aerosol container using the propellant in response to operation of a dispensing valve provided on the container, the sunscreen being in the form of a spray, mist or fog for 20 applying a substantially uniform film containing the sunscreen agent to the skin of a person so as to produce a substantially uniform coverage of the skin by the sunscreen agent thereby protecting the skin against the harmful effects of the sun. 25 According to another aspect of the present invention, there is provided an aerosol container having a dispensing valve for containing a sunscreen composition in the form of an intimate mixture of at least one sunscreen 30 agent and at least one propellant in the form of an emulsion wherein the propellant dispenses the mixture from the container in response to activation of the dispensing valve in the form of a spray, mist, fog, contacting the skin of a person with the mixture and forming a 35 substantially uniform film of the sunscreen agent on the skin of the person so as to provide substantially even coverage of sunscreen composition to provide consistent 2259583_1 (GHMatters) 16/11/10 - 8 protection against the sun. It is to be noted that the use of the term 'person' in the present specification is not limited to 5 humans but includes animals as well. DETAILED DESCRIPTION OF THE INVENTION Typically, the spray of sunscreen composition has 10 a cooling effect on the skin. More typically, the cooling effect is enhanced by evaporation of one or more components of the sunscreen formulation or composition. Even more typically, the components that evaporate are at least some of the non-sunscreen agents in the composition 15 so that the sunscreen agents or filters remain on the skin after evaporation. Even more typically, the one or more propellants of the emulsion evaporate or boil on discharge from the container to provide the cooling effect on the skin. Even more typically, the boiling of the propellant 20 droplets or particles causes other components of the composition to break up i.e. disintegrate thereby facilitating more even distribution of droplets of the composition in the form of a fine mist or spray. 25 Typically, the sunscreen composition contains one or more, and preferably many components for a variety of purposes. More typically, the sunscreen composition includes at least one sunscreen agent, an emulsifier, a stabilizer, a neutraliser, and a propellant base, 30 including at least one propellant. More typically the sunscreen composition further comprises an emollient, a humectant, a preservative, an antioxidant, water and the like. Other additives may be added to the sunscreen composition as required or desired. Additionally, two or 35 more of each type of additive may be added to the composition such as for example, two or more emulsifiers and the like. 2259583_1 (GHMatters) 16/11/10 -9 Typically, the composition includes a sunscreen base mixture that contains the at least one sunscreen agent. More typically, the amount of sunscreen base 5 mixture in the total of the composition is in the range of about 1% to about 90%, preferably in the range from about 20% to 80%, more preferably in the range from about 40% to about 70% and most preferably in the range from about 50% to 65% of the weight of the total composition. 10 Typically, the container is a container capable of containing one or more propellants. More typically, the container is a pressurized container. Even more typically, the container is an aerosol container. 15 Typically, the aerosol container dispenses a spray, typically an aerosol spray made up of a composition of active ingredients and additives. Typically, the additives include excipients or other vehicles or the like 20 in the form of an emulsion and a propellant or blend of propellants. Typically the sunscreen formulation is an emulsion or an emulsion/suspension, or an emulsion and 25 suspended particles. Even more typically, the emulsion is a relatively simple emulsion, much as an oil-in-water emulsion or a water-in-oil emulsion or a complex emulsion having multiple phases forming the emulsion system such as an oil in water in oil emulsion or a water in oil in water 30 emulsion or the like. More typically, the non-aqueous phase of the emulsion is a solvent, typically, an organic solvent, or any other hydrophobic material and includes materials such as oils, waxes, waterproofers, film formers, emollients and the like. Typical examples of the 35 hydrophobic material include esters, silicones, oils, synthetic or natural waxes and the like. 2259583_1 (GHMatters) 16/11/10 - 10 Typically, the emulsion includes intimate contact between the sunscreen agent or agents and the propellant or propellants. 5 Typically, the sunscreen composition of the present invention is one phase, two phases or multiphase. Typically, compositions of the present invention can have any viscosity from about 10 cps to about 500,000 10 cps, preferably from about 100 cps to about 10,000 cps, more preferably from about 300 cps to about 5,000 cps, all measured at 21 0 C. The state of the composition can be from being almost gelatinous to being extremely thin. 15 Typically, the propellant is a liquefied propellant under pressure. More typically the liquefied propellant is responsible for and/or produces a fine, even and consistent spray, particularly on being discharged from the container. More typically, the propellant 20 converts into a gaseous phase on leaving the container at the point of discharge from the container. Typically, the propellant aids in distribution of the sunscreen agent or agents in the mist or spray. 25 Typically, the propellant is a volatile material, such as a material having a low boiling point that causes it to evaporate quickly. More typically, the propellant has a high volatility, particularly at room temperatures. Typically, the boiling points of the propellants vary from 30 about -50 0 C to about 50 0 C. Typically, the spray is in the form of a fine particle size or fine droplet size mist, fog, aerosol, spray or the like. More typically, the spray has a 35 particle size or droplet size of from about 0.1 micron to 2259583_1 (GHMatterS) 16/11/10 WO 2006/099687 PCT/AU2006/000405 -11 about 5000 micron, preferably from about 0.2 micron to about 1000 micron, more preferably from about 1.0 micron to about 500 micron. 5 Typically the spray or mist delivers a fine even coverage of a film of the sunscreen composition to skin surfaces. More typically, the film of sunscreen is a film of the sunscreen agent or active. Even more typically, the sunscreen agent or active is mixed with excipients to 10 form the sunscreen composition. Typically the sunscreen base mixture is an emulsion. More typically the sunscreen base mixture includes sunscreen agents, emulsifiers, water proofing 15 agent or agents, film formers, solvents, inorganic material, esters, perfumes', antioxidants, preservative materials or the like. Even more typically the sunscreen base includes a propellant base to be included in the emulsion system which, when packaged in an aerosol 20 container, with a suitable valve dispensing system, will deliver a consistent and even spray pattern of sunscreen for application to the skin. Typically the present invention relates to the 25 combination of the sunscreen composition with propellant and an aerosol container in which the aerosol container has a dispensing valve. More typically, the dispensing valve is a customised tailored aerosol valve to dispense the composition in the form of a substantially uniform 30 spray. Typically, the container has a valve. More typicallyl, the valve allows upright use, inverted use, or use in any direction or orientation. Typically, the valve includes a cup in which the cup of the valve can be of any suitable form and can be of different configurations. 35 Typically, the mounting cup can be aluminium, coated aluminium, steel, coated or laminated steel or the like. Typically, the container has an actuator. The actuator WO 2006/099687 PCT/AU2006/000405 -12 can be one of many different possible configurations, types, orifice size, spray patterns or the like. Typically, the dispensing valve actuator has a standard dispensing orifice or a reverse taper orifice or the like. 5 The valve and its components are selected to produce a suitable spray pattern of selected droplet size when spraying the intimate mixture of the sunscreen agents and propellants in direct contact with one another as the emulsion is sprayed from the aerosol container. The 10 present invention also relates to a method of applying the sunscreen composition to the skin, particularly over a defined area of the skin so as to leave a substantially uniform film of sunscreen over the skin. 15 Typically, the container is a conventional aerosol container, or is a container made from one or more materials, such as for example, aluminium, steel, plastic, glass or the container can be lined with a different material from which the body of the container is made 20 including combinations of different materials. The container is available in a number of different sizes, types, configurations, shapes or the like. SUNSCREEN AGENTS 25 Typically the sunscreen agents that can be used in the sunscreen composition of the present invention are capable of absorbing or blocking the harmful effects of the sun, particularly the ultra-violet radiation from the 30 sun. More typically, blocking and/or absorbing radiation in the 290 to 400 nm wavelength region. More typically, the sunscreen agents are all agents that have been approved for use in sunscreen formulations by one or more regulatory authority. Suitable sunscreen agents include, 35 for example, Para-aminobenzoic Acid (PABA), Benzophenone 1, Benzophenone-2, Benzophenone-3, Benzophenone-4, Benzophenone-5, Benzophenone-6, Benzophenone-8, WO 2006/099687 PCT/AU2006/000405 -13 Benzophenone-9, Benzophenone-12, Ethyl Dihydroxypropyl PABA, Glyceryl PABA, Homosalate, Methyl Anthranilate, Octocrylene, Octyl Dimethyl PABA, Octyl Methoxycinnamate, Octyl Salicylate, 2-Phenylbenzimidazole-5-sulphonic acid, 5 Triethanolamine Salicylate, 4-Methylbenzylidene Camphor, Red Petrolatum, and mixtures thereof. More typically the sunscreen agents are Octyl Methoxycinnamate,Ethylhexyl Methoxycinnamate, Isoamyl p-Methoxycinnamate, Cinoxate, Dioxybenzone, Homosalate, Ethylhexyl Salicylate, Para 10 aminobenzoic acid (PABA), Ethylhexyl Dimethyl PABA, PEG-25 PABA, Benzylidene camphor sulfonic acid, 3-Benzylidene camphor, 4-Methyl Benzylidene camphor, terephtalylidene dicamphor sulfonic acid, polyacrylamidomethyl benzylidene, phenylbenzimidazole sulfonic acid, 2-Hyroxy-4 15 Methoxybenzophenone, octocrylene, menthyl anthranilate, ethylhexyl triazone, diethylhexyl butamido triazone, butyl methoxydibenzoylmethane, camphor benzalkonium methosulfate, methylene bis-benzotriazolyl tetramethyl butylphenol, monosodium salt of 2,2 bis-(1,4-phenylene) 20 1H-benzimidazole-4,6-disulfonic acid, (1,3,5)-Triazine 2,4-bis-((4-(2-ethyihexyloxy)-2-hydroxy)-phenyl)-6-(4 methoxyphenyl), polysilicone 15, DEA methoxycinnamate, digaloyl trioleate, glyceryl PABA, isopropylbenzyl salicylate, triethanolamine salicylate, glyceryl 25 ethylhexanoate di-methoxycinnamate, methyl diisopropyl cinnamate,isopropyl methoxy cinnamate diisopropyl cinnamate esters mixture, benzophenone-9, trolamine salicylate, ethylene glycol salicylate, dipropylene glycol salicylate, methyl salicylate, phenyl salicylate, ethyl 30 PABA (benzocaine), glyceryl PABA, amyl dimethyl PABA, butyl methoxy PABA, phenylbenzimidazole sulfonic acid, terephthalylidene dicamphor sulfonic acid, drometrizole trisiloxane silatrizole, camphor benzalkonium methosulphate, Hososalate, Phenylbenz-imidazole sulphonic 35 acid, Terephthalylidene dicamphor sulphonic acid, Butyl methoxydibenzoy 1 methane, Benzylidene camphor sulfonic acid and salts, Octorylene, Polyacrilamido-methyl WO 2006/099687 PCT/AU2006/000405 -14 benzylidene camphor, Octyl methoxy-cinnamate, PEG-25-PABA, Isoamyl p methoxy-cinnamate, Octyltriazone, Drometrizole trisiloxane, Dioctyl butamido triazone, 4-methylbenzylide ne camphor, 3-Benzylidene camphor, Octyl Salicylate, Octyl 5 dimenthyl PABA, Benzophenone 4, Benzophenone 5, Methylene bix-benzotriazolyl tetramethyl butylphenol, Bisymidazylate, Anisotriazine, Polysilicone-15, Titanium dioxide including mixtures thereof. 10 The sunscreen agents included in the sunscreen composition of the present invention are present in an amount of about from 1 wt.% to about 40 wt.% of the total weight of the composition of the invention. It is to be noted that the amount of sunscreen agent in the 15 composition will be in accordance with the required sun protection factor (SPF) and/or UV filtering required of the sunscreen composition. Usually, the higher the SPF, and UV filtering, the greater the amount of sunscreen agents incorporated into the sunscreen formulation. 20 Preferably, the amount of sunscreen agent or agents (UV filters) included in the sunscreen composition including propellant is from about 0 wt.% to about 30 wt. depending upon the SPF required and also to achieve the necessary level of UVA protection. 25 Typically, the sunscreen composition has any SPF factor, such as for example from about 2 to 100, more typically about 10 to 40 or the like as required in accordance with the regulations in force in the country in 30 which the composition is to be used. Typically, the sunscreen agents or active agents used in the present invention include a wide variety of different types of sunscreen agents, such as, sunscreen 35 agents functioning by reflecting, blocking, absorbing or scattering UV radiation or other mechanism of filtering or a combination of these effects.

WO 2006/099687 PCT/AU2006/000405 -15 One type of active agent includes chemical absorbers. With this type of chemical compound the sunscreen agent or active is excited to a higher energy 5 state from its ground state by absorbing UV radiation. As the excited molecule in the higher energy level returns to the ground state energy is emitted. The emitted energy is lower in magnitude and longer in wavelength than the energy that initially caused the excitation of the 10 molecule. The wavelength of the emitted radiation is in the infrared region of the electromagnetic spectrum. However, the shift in wavelength to the infrared region and the lessening in intensity result in there being little or no damage to the skin caused by the sun and 15 hence chemical absorbers act as good sunscreening agents. Other types of sunscreen agents include combinations of both physical and chemical filters. Some embodiments of the sunscreen formulation of the present invention may contain one or more individual sunscreen agents such as 20 combinations of one, two, three, four, five, six or more individual sunscreen agents or types of sunscreen agents functioning in different ways. In one embodiment there may be three different sunscreen agents whilst in still others there may be four or five different sunscreen 25 agents to provide consistent protection over almost all of the UV spectrum since individual suncreeen agents have maximum protection at different points in the entire spectrum of radiation and have effective sunscreen protection over different ranges within the spectrum. As 30 an example, one sunscreen agent may provide maximum protection at one end of the UV region whilst another may provide maximum protection at the other end of the spectrum, whilst a third or fourth will provide maximum protection at different regions within the ends of the 35 spectrum of the ultra violet region so that all the sunscreen agents contribute to providing a broad spread of protection over the entire region required even though - 16 individual sunscreen agents may provide protection for a small range within the overall spectrum only. Also, some agents may provide effective protection over a narrow band width whereas others provide protection over a wide band 5 width within the overall spectrum. By mixing and matching the protection characteristics, it is possible to formulate a sunscreen formulation with acceptable protection over a broad UV spectrum. 10 PROPELLANTS The propellant used in the present invention is of any suitable type. The propellants are preferably in intimate contact with the sunscreen agent or agents in the 15 emulsion and are not located separately from the emulsion containing the sunscreen agent. Typically, the propellant is a pressurised liquid or mixture of liquids. Typical examples include propane, dimethylether, isobutane, n butane, vinyl-chloride, or blends or combinations of two 20 or more such propellants or the like. A particularly useful propellant is Dimethyl Ether. Liquefied gas propellants include hydrocarbons, chlorinated or fluorinated hydrocarbons or similar particularly halogenated methanes, ethanes, butanes or the like. Other 25 suitable propellants or mixture of propellants can also be used. These are contained in the system at pressures between 5 and 200 psig, more specifically between 20 and 100 psig and most specifically between 30 and 80 psig. 30 EMULSIFIERS The sunscreen composition of the present invention is in the form of an emulsion. Typically, the emulsion can be made using emulsifiers or can be 35 emulsifier-free by being made without using emulsifiers. 2259583_1 (CHMatters) 16/11/10 WO 2006/099687 PCT/AU2006/000405 -17 Typically, the emulsion is an oil in water emulsion, a water in oil emulsion or is a multiple component or multi system emulsion having a number of separate and/or discrete phases, such as for example, an oil-in-water-in 5 oil emulsion or a water-in-oil-in-water emulsion. Other combinations of the oil and water phases are possible. Additionally, the emulsion can be a standard emulsion, a nano-emulsion or a micro-emulsion. More typically, the emulsion of whichever type has a particle size of from 10 about .001 to 1000t, preferably from about 0.5 to 1000p depending upon the type of emulsion. Typically, the emulsion includes an emulsifier to promote the formation of the emulsion. More particularly 15 the emulsifier assists in stabilization of the emulsion and of the sunscreen composition. The emulsifiers that can be used in the present invention include any suitable emulsifier, such as for example, sorbitan oleate, sorbitan sesquioleate, sorbitan isostearate, sorbitan trioleate, 20 polyglyceryl-3-diisostearate, polyglycerol esters of oleic/isostearic acid, polyglyceryl-6 hexaricinolate, polyglyceryl-4-oleate, polygylceryl-4 oleate/PEG-8 propylene-glycol cocoate, oleamide DEA, sodium glyceryl oleate phosphate, hydrogenated vegetable glycerides 25 phosphate PEG-20 stearate, PEG-30 dipolyhydroxystearate, PEG-40 hydrogenated castor oil, PEG-60 hydrogenated castor oil, PEG-40 stearate, polyglyceryl-3 methylglucose di stearate, polysorbate 20, polysorbate 60, polysorbate 80, potassium cetyl phosphate, DEA cetyl phosphate, ethomeen, 30 dimethicone PEG-7 phosphate, and mixtures thereof. It is to be noted that emulsifiers other than those listed above can be used in the present invention either alone or in combination with other emulsifiers 35 depending upon requirements. Typical amounts of emulsifiers included in the WO 2006/099687 PCT/AU2006/000405 -18 emulsion and/or in any one of the phases of the emulsion include the following: from about 0.10% to 20.0%, preferably from about 0.5% to 10.0% and more preferably from about 1.0% to 5.0% of the total weight of the 5 composition. Stable emulsion can also be manufactured under certain conditions without containing emulsifiers. 10 FILM FORMERS Typically, film formers are included in the sunscreen composition to assist in forming a film when the sunscreen is in contact with the skin. More typically the 15 film forming materials in the sunscreen formulation form a substantially continuous film. Even more typically the substantially continuous film is substantially uniform in thickness providing a substantially uniform coverage of the skin without significant variation in the thickness of 20 the film thereby avoiding patches or blotches of sun damaged skin owing to too little coverage of the sunscreen composition over the skin. Typically the film formers included in the composition are water proofers, waxes and silicones. Typically, examples of waterproofers or film 25 formers include the following: polyethylene polymers, beeswax, butylenes/ethylene/styrene copolymers, stearates, silicones, paraffinium liquidum, PVP/hexadecane copolymer, tricontanyl PVP, dimethicone, cyclomethycones, dimethicone copolyol, or the like, including combinations or two or 30 more. Typically, the film formers are present in an amount of from 0.10% to 20.0%, preferably 0.5% to 5.0% of the total weight of the composition. 35

NEUTRALISERS

WO 2006/099687 PCT/AU2006/000405 -19 Neutralisers are in the composition of the present invention to neutralize components such as the thickeners, emulsifiers and other additives of the sunscreen composition. Typical examples of neutralizers 5 include hydroxides, amines, EDTA salts and the like. Other neutralizers include triethanolamine, sodium hydroxide, potassium hydroxide, ethomeen (PEG-15 cocamine), or the like including combinations or two or more. 10 More typically, further examples of the neutralizers include sodium hydroxide, potassium hydroxide, diethanolamine, triethanolamine, aminomethyl propanol, trisodium ethylenediaminetetraacetic acid, and 15 mixtures thereof. A particularly preferred neutralizer is triethanolamine. Typically the neutraliser or neutralisers are present in an amount of from about 0.1 wt.% to about 8 20 wt.% of the weighty of the sunscreen composition of the present invention. More typically, the neutralizer(s) are present in amount from about 1 wt.% to about 5 wt.% preferably from about 0.10% to about 2.0% of the total weight of the composition. 25 THICKENERS Thickeners are a typical example of additives added to the sunscreen composition. Examples of 30 thickeners include carbomers, xanthan gum, celluloses, acrylates/cross polymers or the like, including combinations or two or more. It is to be noted that the thickener is included 35 to adjust the viscosity of the'sunscreen formulation to assist in providing a fine mist of spray and/or forming a uniform coverage of the sunscreen formulation on the skin.

WO 2006/099687 PCT/AU2006/000405 -20 The amount of thickener added to the compositions include from about 0.01% to 20.0%, preferably from about 0.01% to 10.0% of the total weight of the composition. 5 EMOLLIENTS The present composition may additionally contain one or more emollients. An emollient provides a softening 10 or soothing effect on the surface of the skin and is generally regarded as being non-toxic and hence is considered safe for topical use, particularly topical use in the form of a uniform film of sunscreen. Emollients also help control the rate of evaporation and the 15 tackiness of the composition. Typical examples of emollients include mineral oils, esters, natural oils, lanolin derivatives and the like. Examples of emollients include: glycerine, sorbitol, propylene glycol, isopropyl myristate, isopropyl palmitate, butylene glycol, caprys 20 caprylic triglyceride, coco-caprylate/caprate, cocoglycerides, or the like including combinations of two or more. More typically the emollients include mineral 25 oil, lanolin oil, coconut oil, cocoa butter, olive oil, aloe extracts, jojoba oils, castor oil, fatty acids such as oleic and stearic, fatty alcohols such as cetyl and hexadecyl, diisopropyl adipate, hydroxybenzoate esters, benzoic acid esters, particularly C1O-C16 alcohols, 30 isononyl iso-nonanoate, alkanes such as mineral oil, silicones such as dimethyl polysiloxane, ethers such as polyoxypropylene butyl ethers and polyoxypropylene cetyl ethers, and C12-C15 alkyl benzoates including mixtures of two or more of the above. 35 Typically the emollient is present in an amount of from about 0.1 % to about 20.0% of the total weight of WO 2006/099687 PCT/AU2006/000405 -21 the sunscreen composition. The preferred amount of emollient is from about 0.1% to 20.0%, more preferably from about 1.0% to 10.0% of the total weight of the composition. 5 PRESERVATIVES Additives including preservatives, antioxidants and similar materials can be incorporated into the 10 sunscreen composition of the present invention. Typical examples of such preservatives or antioxidants include the parabens. Other examples include the following: vitamin E, vitamin E acetate, vitamin C, butylated hydroxytoluene, methylparaben and mixtures thereof. One or more 15 preservatives/antioxidants may be present in an amount of about 0.01 wt% to about 2 wt.% of the total weight of the present invention. Preferably, one or more preservatives/antioxidants are present in an amount about 0.1 wt.% to about 1 wt.%. 20 Typically, preservatives are added to the sunscreen formulation of the present invention in order to preserve the formulation against deterioration and/or degradation including microbial growth or the like. 25 Examples of preservatives include: BHA, BHT, phenoxyethanol, methyldibromo glutaro-nitrile, potassium sorbate, propylparaben, methylparraben, butylparraben, ethylparraben, imidazolidinyl urea, and others including 30 mixtures of two or more. HUMECTANTS A moistening agent, such as a humectant, may be 35 incorporated into the composition of the present invention. Suitable humectants include glycerin, polyethylene glycol, polypropylene glycol, sorbitol WO 2006/099687 PCT/AU2006/000405 -22 including mixtures thereof. RHEOLOGICAL ADDITIVES 5 The sunscreen compositions of the present invention can include a rheological additive, such as for example magnesium aluminium silicate, hydroxypropyl cellulose, carboxymethyl cellulose, carbomer, or the like. 10 BRIEF DESCRIPTION OF METHODS OF MANUFACTURE The process used to manufacture the sunscreen composition of the present invention includes the following steps. 15 Typically the sunscreen composition is introduced into the aerosol container. More typically, the aerosol sunscreen composition is added to the aerosol can and then the can is pressurised with the desired amount of 20 propellant. The sunscreen formulation of the present invention may be prepared by using techniques and methods well known to persons skilled in these arts. And the 25 aerosol container can be made and filled with the sunscreen composition in accordance with well known methods for filling such containers. Sunscreen compositions of the invention can be 30 made by the following process or modifications of this process. Other methods for making sunscreen compositions of the invention are also possible. A first phase comprising the hydrophobic components including such components as emollients, dispersing agents, emulsifiers, 35 and, optionally, antioxidants, and other additives, are combined together by stirring and heating at temperature of from about 10 0 C to about 90 0 C, preferably from about WO 2006/099687 PCT/AU2006/000405 -23 55 0 C to about 90 0 C, and most preferably from about 70 0 C to 85*C, until all of the solid material of the components is dissolved. The sunscreen agent can be added to this mixture as it is being prepared or it can be added after 5 the mixture is formed. A second phase comprising water, thickening agents, and other hydrophilic ingredients including, for example, humectants, emulsifiers, and preservatives can be formed by combining the individual compounds of this phase whilst stirring and heating at a 10 temperature of from about 10 0 C to about 90 0 C, preferably from about 55 0 C to about 90 0 C, and most preferably at about 70 0 C to 85 0 C. After forming, the second phase is then slowly added to the first phase while stirring at high speed. The mixture of the first and second phases is then 15 gently homogenized until the temperature of the mixture is between about 35 0 C to 40 0 C so as to form an emulsion. Preservatives are added, and the emulsion is then stirred, preferably with an anchor mixer, and allowed to reach 25 30 0 C before packaging. 20 It is to be noted that the emulsion may be emulsifier free or it can be made cold with or without homogenization or without excessive energy input. The emulsion can be made in any other suitable alternative 25 manner to achieve stability and variable particle size, including nano- and micro-emulsion. Typically the aerosol container is made from tin plate with appropriate internal lining. Alternatively the 30 container may be aluminum with appropriate internal lining or a composite of different materials, including plastics, PET, polystyrene and other suitable materials. It is to be noted that filling and pressurizing 35 of the container can be done in any suitable manner including pressure filling or under the cup filling or the like.

WO 2006/099687 PCT/AU2006/000405 -24 The containers can be cold filled, use pressure filling, rotary pressure filled, or undercap filled. The compositions of the present invention may be 5 applied with any device having an aerosol spraying means, such as an aerosol container. DETAILED DESCRIPTION OF EMBODIMENTS OF THE INVENTION 10 The present invention will now be described by way of example with reference to the following non limiting example which illustrates the typical formulation of one embodiment of the present invention. It is to be noted that the ranges of the individual components listed 15 in Column X of Table 1 illustrate typical ranges of values of the amounts by weight of the components that can be selected for incorporation into compositions in accordance with the present invention. Further, it is to be noted that the ranges of values of amounts indicated in Column Y 20 of Table 1 illustrate more specific prepared.amounts of the components that can be used in preparing formulations in accordance with the present invention. In one embodiment, the composition of the present 25 invention is a sunscreen composition containing one or more sunscreen agents. In another embodiment the sunscreen composition includes one or more moisturizing agents or is a moisturizing composition containing one or more sunscreen agents. 30 In other embodiments, the sunscreen composition includes one or more artificial tanning actives or accelerators, such as for example, dihydroxy acetone (DHA) or is a tanning composition containing one or more 35 sunscreen agents. In another embodiment, the composition includes one or more moisturizing agents with one or more tanning actives or accelerators as well as one or more WO 2006/099687 PCT/AU2006/000405 -25 sunscreen agents. In other embodiments, the sunscreen composition includes one or more skin whitening agents or is a skin 5 whitening agent with one or more sunscreen agents. In other embodiments, the composition may be a combination of all of the above compositions or agents. 10 In other embodiments, the compositions may have water resistance or may not have water resistance.

WO 2006/099687 PCT/AU2006/000405 -26 COLUMN X COLUMN Y PART A (Oil Phase) %w/w More specifically % w/w 0 - 30 Solvent 5 - 20 0 - 10 Film former 0.5 - 10 0 - 10 Fatty acid 1.0 - 8.0 0 - 10 Emulsifier 0.1 - 3.0 0 - 20 Waterproofer 0.1 - 5.0 0 - 30 UV Filters 5.0 - 20.0 0 - 5 Antioxidant 0.01 - 0.5 0 - 10 Wax 1.0 - 8.0 0 - 2 Preservative 0.1 - 1.5 PART B (Water Phase) %w/w More specifically % w/w 0 - 90 Water 20 - 70 0 - 40 Humectant 5 - 20 0 - 15 Thickener 0.1 - 5.0 0 - 15 Neutraliser 0.1 - 2.0 0 - 10 Emulsifier 0.1 - 5.0 0 - 5 Sequestering agent 0.01 - 2.0 5 Part C (Preservatives) 0 - 10 Preservatives 0.1 - 2.0 Part D (Fragrance) 0 - 5 Fragrance 0.05 - 2.0 10 Part E (Propellants) 0 - 60 Propellants 2.0 - 50.0 TABLE 1 WO 2006/099687 PCT/AU2006/000405 -27 ADVANTAGES OF THE INVENTION It is to be noted that an integral part of the composition and system of the present invention is that 5 the composition can be in the form of an emulsion which contains the sunscreen agent and propellant so that there is contact between the sunscreen agent and propellant, preferably intimate contact between the sunscreen agent and propellant in the emulsion in the container so that 10 the sunscreen agent and propellant are in direct contact with each other and are not separated from each other or are not stored in different directions within the container or in different compartments of the container. 15 The propellant being in direct contact with and being part of the emulsion system is responsible for the improved spray pattern and breakup of the composition as the composition is being discharged from the container. The improved spray pattern being more uniform and 20 consistent in both droplet size and distribution to form a fine mist or spray, results from the droplets of propellant effectively boiling upon being discharged from the container which in turn assists in disintegrating the droplets of the other components of the composition, 25 particularly the sunscreen agents, to provide improved distribution of fine droplets of the sunscreen agents in the form of a fine mist or spray of more uniform droplet size. This in turn allows a more even coverage of the skin by the sunscreen agents. 30 Additionally, the improved breakup of the composition caused by the boiling of the propellant in the emulsion promotes a cooling effect on the skin because of the more even distribution. 35 A further advantage of the present invention is that the container and contents are cheaper to manufacture WO 2006/099687 PCT/AU2006/000405 -28 since a single compartment container can be used for containing the emulsion containing the sunscreen agent and the propellant, rather than having to separately store the emulsion and propellant individually as required in many 5 other systems, such as for example, systems having the bag in can, bag on valve, piston in can or other systems requiring two or more separate compartments or storage areas for the emulsion and propellant. 10 A further advantage of the present invention includes that the container may be used in any orientation or direction since the propellant is contained within the emulsion along with the sunscreen agent. 15 In the claims which follow and in the preceding description of the invention, except where the context requires otherwise due to express language or necessary implication, the word "comprise" or variations such as "comprises" or "comprising" is used in an inclusive sense, 20 i.e. to specify the presence of the stated features but not to preclude the presence or addition of further features in various embodiments of the invention. It will be understood to persons skilled in the 25 art of the invention that many modifications may be made without departing from the spirit and scope of the invention.

Claims (30)

1. A sunscreen composition for providing protection against the effects of the sun on the skin of a 5 person to whom the composition is applied, said composition comprising an intimate mixture of at least one sunscreen agent and at least one liquid propellant, said intimate mixture forming an emulsion, said at least one sunscreen agent for 10 providing protection to the skin against the harmful effects of the sun, and said at least one liquid propellant for facilitating dispensing the intimate mixture from a container containing the intimate mixture, said intimate mixture being capable of being 15 dispensed from the container in the form of an aerosol, spray, mist, or fog by action of the liquid propellant to produce the spray, mist or fog, wherein as the intimate mixture is sprayed from the container, the sunscreen agent is applied directly 20 onto the skin of the person to apply a substantially uniform film of the at least one sunscreen agent to the skin of the person thereby providing uniform protection against the damaging effects of the sun on the skin to which the sunscreen agent has been 25 applied.

2. A sunscreen composition according to claim 1, further comprising an emulsifier or a neutraliser. 30

3. A sunscreen composition according to claim 1 or 2 in which the amount of sunscreen agent in the intimate mixture comprises 1% to 90-%.

4. A sunscreen composition according to claim 3 in which 35 the amount of sunscreen agent is 20% to 80%. 2593858_i (GHMatters) P56310.AU.1 - 30

5. A sunscreen composition according to claim 3 in which the amount of sunscreen agent is 40% to 70%.

6. A sunscreen composition according to claim 3 in which 5 the amount of sunscreen agent is 60% to 65% of the weight of the total composition.

7. A sunscreen composition according to any preceding 10 claim in which emulsion includes an emulsion/suspension or an emulsion and suspension of suspended particles.

8. A sunscreen composition according to any preceding is claim in which the emulsion is an oil in water emulsion, a water in oil emulsion, an oil in water in oil emulsion or a water in oil in water emulsion.

9. A sunscreen composition according to any preceding 20 claim in which the emulsion includes a non aqueous phase, wherein the non aqueous phase is a solvent, organic solvent, a hydrophobic material, an oil, a wax, a waterproof material, an emollient, an ester or a silicon. 25

10. A sunscreen composition according to any preceding claim in which the liquid propellant is liquefiable under pressure to form the liquid. 30

11. A sunscreen composition according to claim 9 in which the liquid propellant is a volatile material including a low boiling point liquid.

12. A sunscreen composition according to any preceding 35 claim in which the spray is in the form of a fine particle size or droplet size spray, mist, fog, or aerosol. 259385_1 (GHMatters) P56318.AU.I - 31

13. A sunscreen composition according to claim 11 in which the spray has a particle size or droplet size of from 0.01 micron to 5000 micron. 5

14. A sunscreen composition according to claim 11 in which the spray has a particle size or droplet size of from .20 micron to 1000 micron. 10

15. A sunscreen composition according to claim 11 in which the spray has a particle size or droplet size of from 1 micron to 50 micron.

16. A sunscreen composition according to any preceding is claim further including emulsifiers, waterproofing agents, film formers, solvents, inorganic materials, esters, perfumes, antioxidants, or preservative materials. . 20

17. A sunscreen composition according to any preceding claim in which the sunscreen agent is Para aminobenzoic Acid (PABA), Benzophenone-1, Benzophenone-2, Benzophenone-3, Benzophenone-4, Benzophenone-5, Benzophenone-6, Benzophenone-8, 25 Benzophenone-9, Benzophenone-12, Ethyl Dihydroxypropyl-PABA, Glyceryl PABA, Homosalate, Methyl Anthranilate, Octocrylene, Octyl Dimethyl PABA, Octyl Methoxycinnamate, Octyl Salicylate, 2 Phenylbenzimidazole-5-sulphonic acid, Triethanolamine 30 Salicylate, 4-Methylbenzylidene Camphor, Red Petrolatum, Octyl Methoxycinnamate,Ethylhexyl Methoxycinnamate, Isoamyl p-Methoxycinnamate, Cinoxate, Dioxybenzone, Homosalate, Ethylhexyl Salicylate, Para-aminobenzoic acid (PABA), Ethylhexyl 35 Dimethyl PABA, PEG-25 PABA, Benzylidene camphor sulfonic acid, 3-Benzylidene camphor, 4-Methyl Benzylidene camphor, terephtalylidene dicamphor 1204/11 25935M_.1 (GHMatters) P58318 AU I - 32 sulfonic acid, polyacrylamidomethyl benzylidene, phenylbenzimidazole sulfonic acid, 2-Hyroxy-4 Methoxybenzophenone, octocrylene, menthyl anthranilate, ethylhexyl triazone, diethylhexyl s butamido triazone, butyl methoxydibenzoylmethane, camphor benzalkonium methosulfate, methylene bis benzotriazolyl tetramethyl butylphenol, monosodium salt of 2,2 bis-(1,4-phenylene) 1H-benzimidazole-4,6 disulfonic acid, (1,3,5)-Triazine-2,4-bis-((4-(2 10 ethylhexyloxy)-2-hydroxy)-phenyl)-6-(4 methoxyphenyl), polysilicone 15, DEA methoxycinnamate, digaloyl trioleate, glyceryl PABA, isopropylbenzyl salicylate, triethanolamine salicylate, glyceryl ethylhexanoate di 15 methoxycinnamate, methyl diisopropyl cinnamate,isopropyl methoxy cinnamate diisopropyl cinnamate esters mixture, benzophenone-9, trolamine salicylate, ethylene glycol salicylate, dipropylene glycol salicylate, methyl salicylate, phenyl 20 salicylate, ethyl PABA (benzocaine), glyceryl PABA, amyl dimethyl PABA, butyl methoxy PABA, phenylbenzimidazole sulfonic acid, terephthalylidene dicamphor sulfonic acid, drometrizole trisiloxane silatrizole, camphor benzalkonium methosulphate, 25 Hososalate, Phenylbenz-imidazole sulphonic acid, Terephthalylidene dicamphor sulphonic acid, Butyl methoxydibenzoy 1 methane, Benzylidene camphor sulfonic acid and salts, Octorylene, Polyacrilamido methyl benzylidene camphor, Octyl methoxy-cinnamate, 30 PEG-25-PABA, Isoamyl p methoxy-cinnamate, Octyltriazone, Drometrizole trisiloxane, Dioctyl butamido triazone, 4-methylbenzylide ne camphor, 3 Benzylidene camphor, Octyl Salicylate, Octyl dimenthyl PABA, Benzophenone 4, Benzophenone 5, 35 Methylene bix-benzotriazolyl tetramethyl butylphenol, Bisymidazylate, Anisotriazine, Polysilicone-15, or mixtures of two or more thereof. 1204311 2503685I (GHMatters) P58318.AUAi - 33

18. A sunscreen composition according to any preceding claim in which the sunscreen agent is present in the mixture in an amount from 1 wt.% to 40 wt.% of the 5 total weight of the mixture.

19. A sunscreen composition according to any preceding claim in which the sunscreen agent has an SPF factor of from 2 to 100. 10

20. A sunscreen composition according to claim 18 in which the sunscreen agent has an SPF factor of from 10 to 40. is

21. A sunscreen composition according to any preceding claim having a range of different sunscreen agents for providing protection over the infra-red radiation spectrum. 20

22. A sunscreen composition according to any preceding claim in which the propellant is propane, dimethylether, isobutane, n-butane, vinyl chloride or blends or combinations of two or more such propellants. 25

23. A sunscreen composition according to any preceding claim in which the amount of emulsifier in the emulsion is from 0.1% to 20% by weight of the total weight of the mixture. 30

24. A sunscreen composition according to claim 22 in which the amount of emulsifier in the emulsion is from 0.5% to 10% by weight of the total weight of the mixture. 35 1/04/11

259388.1 (GHMatters) PS6316 AU.1 - 34

25. A sunscreen composition according to claim 22 in which the amount of emulsifier in the emulsion is from 1 to 5% of the total weight of the mixture. s

26. A sunscreen composition according to claim 1 having a formulation of components in amounts as provided in Column X of Table 1.

27. A sunscreen composition according to claim 1 having a 10 formulation of components as provided in Column Y of Table 1.

28. A method of applying to a person a sunscreen composition according to any one of claims 1 to 27. 15

29. An aerosol container containing a sunscreen composition according to any one of claims 1 to 27.

30. A sunscreen composition for providing protection 20 against the effects of the sun on the skin of a person to whom the composition is applied according to claim 1, substantially as herein described with reference to the accompanying examples. 19105/11 25938M_1 (GHMatters) P56318.AU.1