Sunscreen formulation

Abstract

The present disclosure relates to sunscreen compositions having a high SPF and comprising a combination UV filters and film forming agents.

Description

Sunscreen formulationCross-reference to related application(s)

[0001] The present application claims priority from Australian Provisional Patent Application No. 2024903290 filed on 11 October 2024, the entire contents of which is incorporated herein by reference.Field of the invention

[0002] The present disclosure relates to sunscreen formulations, methods of making sunscreen formulations and methods of using sunscreen formulations.Background of the invention

[0003] It is well known that ultraviolet radiation / light (UVR) is harmful to human skin. Exposure to UV radiation causes different types of skin damage including sunburn, hyperpigmentation, photoaging, skin photosensitization, and skin cancer.

[0004] To protect skin from UV radiation exposure it is desirable to apply a sunscreen to the skin to reduce the amount of UV radiation reaching the skin. Typically, sunscreens are formulations comprising UV filters which are able to absorb or reflect UV radiation. UV filters are typically classified into organic filters which can absorb UVR and mineral filters which can reflect and scatter the UVR.

[0005] The use of sunscreen, particularly a high SPF (Sun Protection Factor) sunscreen is known to reduce or prevent skin damage associated with UVR exposure. To obtain a higher SPF, high amounts of UV filters are included in the sunscreen formulations. However, high concentrations of organic UV filters may also have detrimental effects such as photo instability, environmental impacts, and potential toxicity.

[0006] High concentrations of mineral UV filters create opaque sunscreen formulations which leave a visible white cast on the skin which makes them less desirable to use. This may be particularly undesirable for people with darker skin tones.

[0007] There is a need for novel sunscreen formulations with reduced concentrations of UV filters that are still able to provide a high SPF protection.1006203396

[0008] Water resistance is also an important aspect of a sunscreen formulation. There is a need for sunscreens which provide a high level of protection and water resistance.

[0009] Furthermore, use of sunscreen is most effective when it is applied to exposed skin every day. It is therefore desirable to have a sunscreen formulation with appealing sensory and visual properties when applied to the skin.

[0010] Reference to any prior art in the specification is not an acknowledgment or suggestion that this prior art forms part of the common general knowledge in any jurisdiction or that this prior art could reasonably be expected to be understood, regarded as relevant, and / or combined with other pieces of prior art by a skilled person in the art.Summary of the invention

[0011] Surprisingly the inventors of the present disclosure have found that the inclusion of a film forming polymer in the sunscreen formulation has a synergistic relationship with the UV filters such that the amount of UV filter required to achieve a certain level of SPF.

[0012] In one aspect, the disclosure provides a sunscreen composition including: from about 5% to about 20% w / w of one or more UV filters; from about 0.5% to about 5% w / w of film forming polymer; one or more emollients, solvents, dispersants, or combinations thereof; one or more emulsifier; and water.

[0013] In another aspect, the disclosure provides a sunscreen composition including: from about 5% to about 14% w / w of one or more UV filters; from about 0.5% to about 5% w / w of film forming polymer; one or more emollients, solvents, dispersants, or combinations thereof; one or more emulsifier; and1006203396water.

[0014] In a further aspect, the disclosure provides a sunscreen composition including: from about 5% to about 20% w / w of one or more UV filters; from about 0.5% to about 5% w / w of film forming polymer; one or more emollients, solvents, dispersants, or combinations thereof; one or more emulsifier; and water, wherein the sunscreen composition is water resistant for at least 4 hours.In some embodiments, the water resistance is tested according to the ISO 16217:2020 standard.

[0015] In one aspect, the disclosure provides a sunscreen composition including: from about 5% to about 20% w / w of one or more UV filters; from about 0.5% to about 5% w / w of film forming polymer; one or more emollients, solvents, dispersants, or combinations thereof; one or more emulsifier; and water, wherein the film forming polymer is selected from triacontanyl PVP, polyester-7 or a combination thereof.

[0016] Optionally, the one or more UV filters comprise organic UV filters and mineral UV filters. Optionally, the one or more UV filters comprising UVA and UVB filters. The one or more UV filters may be selected from bis-ethylhexyloxyphenol methoxyphenyl triazine, diethylamino hydroxybenzoyl hexyl benzoate, ethylhexyl methoxycinnamate, ethylhexyl triazone, and titanium dioxide. Optionally, the one or more UV filters are included from about 7% to about 12% or about 8% to about 10% w / w of the sunscreen composition. Optionally, the UV filters are included from about 7% to about 10% w / w,1006203396about 7 to about 9% w / w of the sunscreen composition. Optionally, the UV filters are included from about 10% to about 20% w / w, about 15% to about 20% w / w, about 14% w / w, about 10 to about 13% w / w, about 10 to about 12% w / w, about 11 to about 13% w / w, or about 11 to about 12% w / w of the sunscreen composition.

[0017] The film forming polymer may be selected from polyester-7, VP / eicosane copolymer, Triacontanyl PVP or Trimethylpentanediol / adipic acid / glycerin crosspolymer. Optionally, the film forming is selected from polyester-7 and Triacontanyl PVP.Optionally, the film forming polymer is polyester-7. Optionally, the film forming polymer is included from about 0.5% to about 2% or about 1 .0% to about 1 .5% w / w of the sunscreen composition. Optionally, the film forming polymer is included from about 1% to about 2% or about 0.5% to about 1 .5% w / w of the sunscreen composition Optionally, the film forming polymer is included in the sunscreen composition at an amount that results in an application to the skin of about 1 to about 3 mg / cm2, about 1 .5 to about 2.5 mg / cm2or about 2mg / cm2.

[0018] Optionally, the emulsifier is PEG-30 dipolyhydroxystearate.

[0019] The sunscreen composition may further comprise one or more of: one or more emulsion stabilisers or thickeners; one or more humectants; one or more emollients; one or more dispersants; one or more chelating agents; one or more sensory ingredients; and one or more non-water solvents.

[0020] The sunscreen composition optionally further comprises one or more functional vitamins and / or one or more preservatives.

[0021] The sunscreen composition may have an SPF rating of 50+ according to the AS / NZS 2604:2021 standard. In some embodiments, the sunscreen composition has an1006203396SPF yield of at least 5. Optionally, the sunscreen composition is water resistant for at least 4 hours according to the ISO 16217:2020 standard. In some embodiments, the sunscreen composition may have a measured SPF value of at least 70.

[0022] The sunscreen composition may optionally have an SPF rating of 50+ according to the AS / NZS 2604:2021 standard after 4 hours of water immersion. Optionally, the water resistance standard requires 100% maintenance of the SPF following immersion (Australian standard). Alternatively, the water resistance standard requires 49% maintenance of the SPF following immersion (European standard).

[0023] In one aspect, the present invention provides a sunscreen composition including: from about 5% to about 20% w / w of one or more UV filters; from 0.5% to about 5% w / w of film forming polymer; from about 2 wt% to about 7 wt% of at one or more emollients; from about 0.5 wt% to about 5 wt% of at least one emulsifier; optionally additional formulation components; and about 20% to about 92% w / w aqueous solvent.

[0024] The optionally additional formulation components may be selected from one or more of: from about 1 wt% to about 5 wt% of one or more non water solvents; from about 1 wt% to about 10 wt% of one or more dispersants; from about 1 wt% to about 5 wt% of an emulsion stabilisers or thickeners; from about 0.5 wt% to about 3 wt% of one or more sensory ingredients; from about 3 wt% to about 6 wt% of one or more humectant; from about 0.5 wt% to about 3 wt% of one or more functional vitamins; from about 0.05wt% to about 0.3 wt% one or more chelating agents; and1006203396from about 0.25wt% to about 2.5 wt% of one or more preservatives.

[0025] In some embodiments, the UV filters are included from about 10% to about 20% w / w, about 15% to about 20% w / w, about 14% w / w, about 10 to about 13% w / w, about 10 to about 12% w / w, about 11 to about 13% w / w, or about 11 to about 12% w / w of the sunscreen composition.

[0026] Optionally, the one or more UV filters comprise organic UV filters and mineral UV filters. Optionally, the one or more UV filters comprising UVA and UVB filters. The one or more UV filters may be selected from bis-ethylhexyloxyphenol methoxyphenyl triazine, diethylamino hydroxybenzoyl hexyl benzoate, ethylhexyl methoxycinnamate, ethylhexyl triazone, and titanium dioxide. Optionally, the one or more UV filters are included from about 7% to about 12% or about 8% to about 10% w / w of the sunscreen composition. Optionally, the UV filters are included from about 7% to about 10% w / w, about 7 to about 9% w / w of the sunscreen composition. Optionally, the UV filters are included from about 10% to about 20% w / w, about 15% to about 20% w / w, about 14% w / w, about 10 to about 13% w / w, about 10 to about 12% w / w, about 11 to about 13% w / w, or about 11 to about 12% w / w of the sunscreen composition.

[0027] The film forming polymer may be selected from polyester-7, VP / eicosane copolymer, Triacontanyl PVP or Trimethylpentanediol / adipic acid / glycerin crosspolymer. Optionally, the film forming is selected from polyester-7 and Triacontanyl PVP.Optionally, the film forming polymer is polyester-7. Optionally, the film forming polymer is included from about 0.5% to about 2% or about 1 .0% to about 1 .5% w / w of the sunscreen composition. Optionally, the film forming polymer is included from about 1 % to about 2% or about 0.5% to about 1 .5% w / w of the sunscreen composition Optionally, the film forming polymer is included in the sunscreen composition at an amount that results in an application to the skin of about 1 to about 3 mg / cm2, about 1 .5 to about 2.5 mg / cm2 or about 2mg / cm2.

[0028] Optionally, the emulsifier is PEG-30 dipolyhydroxystearate.

[0029] The sunscreen composition may have an SPF rating of 50+ according to the AS / NZS 2604:2021 standard. In some embodiments, the sunscreen composition has an SPF yield of at least 5. Optionally, the sunscreen composition is water resistant for at1006203396least 4 hours according to the ISO 16217:2020 standard. In some embodiments, the sunscreen composition may have a measured SPF value of at least 70.

[0030] The sunscreen composition may optionally have an SPF rating of 50+ according to the AS / NZS 2604:2021 standard after 4 hours of water immersion. Optionally, the water resistance standard requires 100% maintenance of the SPF following immersion (Australian standard). Alternatively, the water resistance standard requires 49% maintenance of the SPF following immersion (European standard).

[0031] In one aspect, the present invention provides a method of protecting skin from sun damage or sunburn comprising application of the sunscreen formulation of this disclosure to the skin. Optionally, the method results in the application to the skin of about 1 to about 3 mg / cm2, about 1.5 to about 2.5 mg / cm2, or about 2mg / cm2of film forming polymer to the skin. The skin may be human skin.

[0032] Further aspects of the present invention and further embodiments of the aspects described in the preceding paragraphs will become apparent from the following description, given by way of example and with reference to the accompanying drawings.Brief description of the drawings

[0033] Figure 1 compares the percentage UV filter concentration present in the claimed formulation with that of commercially available sunscreens that are listed on the ARTG.

[0034] Figure 2 compares the SPF yields amongst SPF 50+ four hour water resistant sunscreens.Detailed description of the embodiments

[0035] The inventors of the present invention have surprisingly discovered that combinations of film forming polymers and UV filters having a higher SPF compared to sunscreen formulations comprising only UV filters. Additionally and advantageously, the inventors have found that certain combinations of film forming polymers and UV filters are able to have a high SPF and water resistance for up to 4 hours with lower concentrations of UV filters compared to sunscreen formulations comprising only UV filters. The synergistic impact of film forming polymers on UV filter yield is surprising and expected to be of significant impact in the sunscreen industry allowing more efficient1006203396sunscreen protection, potentially higher protection than previously, or high protection with relatively easy to apply product due to the lower UV filter content.

[0036] Reference will now be made in detail to certain embodiments of the invention. While the invention will be described in conjunction with the embodiments, it will be understood that the intention is not to limit the invention to those embodiments. On the contrary, the invention is intended to coverall alternatives, modifications, and equivalents, which may be included within the scope of the present invention as defined by the claims.

[0037] One skilled in the art will recognize other methods and materials similar or equivalent to those described herein, which could be used in the practice of the present invention. The present invention is in no way limited to the methods and materials described. It will be understood that the invention disclosed and defined in this specification extends to all alternative combinations of two or more of the individual features mentioned or evident from the text. All of these different combinations constitute various alternative aspects of the invention.Definitions

[0038] As used herein, except where the context requires otherwise, the term "comprise" and variations of the term, such as "comprising", "comprises" and "comprised", are not intended to exclude further additives, components, integers, or steps.

[0039] It must be noted that as used herein and in the appended claims, the singular forms “a”, “an” and “the” include plural reference unless the context clearly dictates otherwise.

[0040] The term “(s)” following a noun contemplates the singular or plural form, or both. For purposes of interpreting this specification, terms used in the singular will also include the plural and vice versa.

[0041] As used herein, the term "effective amount" means that amount of an active ingredient that will elicit the biological or medical response of a tissue, system, or animal that is being sought, for example, effective to prevent burning or other sun damage. The term "therapeutically effective amount" means any amount which, as compared to a1006203396corresponding subject who has not received such amount, results in improved treatment, healing, prevention, or amelioration of a disease, disorder, or side effect, or a decrease in the rate of advancement of a disease or disorder. The term also includes within its scope amounts effective to enhance normal physiological function.

[0042] The term “and / or” can mean “and” or “or”.

[0043] The degree of sun protection a sunscreen product offers is quantified by SPF testing. In Australia, testing is conducted according to the AS / NZS 2604:2021 standard (The Australia and New Zealand 2021 Sunscreen Standard). This standard has one test method for products without water resistance and another for products wishing to claim water resistance. A copy of the standard is incorporated by reference.

[0044] According to the AS / NZS 2604:2021 , a SPF 50+ label claim requires testing results demonstrating an SPF 60 or higher; and for a water resistant claim, the product must maintain SPF 50+ protection after immersion in water for the claimed duration of water resistance.

[0045] The degree of sun protection the sunscreen product offers depends on the combination, amount and the ratio of the UV filters used. In addition, the degree of sun protection depends on the quality of the applied product film on the skin surface. This in turn is related to the product formulation, which when formulated well, takes advantage of synergies between ingredients. Theoretically, a good quality film encompasses good skin adhesion, adequate film thickness, uniformity, and cohesion to act as the ‘UV barrier’ for the skin.

[0046] Without wishing to be bound by theory it is proposed that one factor affecting the quality and uniformity of the applied product film on the surface of the skin is the nature and concentration of film forming ingredients present in the sunscreen formulation. An additional factor may be the combination of film forming ingredient and one or more emulsifiers in the sunscreen. It is thought that the unexpected efficiency of this system results from the high uniformity of the film, which disperses relatively low levels of actives so uniformly that the SPF remains high, such as above 60.

[0047] For improved wear and I or water resistance, the product film needs to remain on the skin surface even when exposed to moisture and / or water.1006203396

[0048] In embodiments of the invention, the composition when applied to the skin retains water resistance for two hours or four hours.

[0049] Water resistance can be tested in accordance with the ISO 16217:2020 Cosmetics — Sun protection test methods — Water immersion procedure for determining water resistance published in 2020. A copy of which is incorporated by reference.

[0050] In embodiments of the invention, the composition may have an SPF rating of 50+ according to the AS / NZS 2604:2021 standard after 4 hours of water immersion. Appendix B of AS / NZS 2604:2021 describes the method for determining the water resistance of sunscreen products and is set out below:Determination of SPF where water resistance is claimedFor products where water resistance performance is to be measured, the water immersion procedure as described in ISO 16217 shall apply and is set out below:Simulated swim test device designThe device shall be of a design that permits efficient maintenance and sanitization.The device shall be capable of maintaining water temperature within the limits defined below.The dimensions of the device shall be such that the test areas are immersed in water and shall accommodate test subjects in such a way that the test areas on the subject’s back cannot be touched by the device or other subjects.The dimensions shall be such that the test areas are not in the direct path of the jets.It is recommended that the device should be emptied and refilled every day during testing activity.The linear flow rate of the simulated swim rest device shall be 0,02 m / s to 0,05 m / s when measured at the point where the test subject’s back is intended to be located during the test but without the test subject in the device. The flow rate1006203396shall be measured with a flow meter with appropriate sensitivity and of a type which is waterproof.Standardized water requirementsGenerally, the water to be used starts as potable water. The water used for each immersion test shall conform to this annex. All measurements should be conducted before the test volunteer(s) enter(s) the water.Conductivity shall be equal to or higher than 500 microSiemens (mS).Conductivity may be increased by the addition of sodium chloride.Water pH shall fall between pH 6,5 to 7,5 citric acid. If necessary, sodium hydrogen sulfate shall be used to adjust the pH downward and sodium bicarbonate shall be used to adjust the pH upward.Local health and safety requirements can apply to the quality of the water. Water hardness may be determined using data supplied by water authorities or by analytical determination.TemperatureThe temperature of the swim immersion room shall be maintained in the range of 20 °C to 26 °C.The temperature of the water shall be maintained at (30 ± 2) °C for the duration of the test period.Immersion sequencing cycleThe following sequence of immersion and a rest period shall be followed:• 20 minutes of immersion of the test subjects with water circulated for the full period;• 5 minutes to 20 minutes drying time with no towelling permitted between immersion periods.For 40 minutes water resistance, the sequence is repeated two times.1006203396For 80 minutes water resistance, the sequence is repeated four times.For extended water resistance time, the sequence is repeated as appropriate.At the conclusion of the final immersion period, allow the test subjects to dry in the air (with no towelling-off of the test sites) for at least 15 min. No water droplets shall be visible and additional drying time can be required prior to initiating any exposure.Positioning of test subjectsThe positioning of test subjects needs to take into account the various shapes of spa baths.The positioning of the subject in the water immersion device shall be such that it minimizes the possibility of the subject touching the test areas on the back with the spa sides or another test subject, and is comfortable for the subject.The subjects shall sit in a position such that waterjets cannot impinge directly on the test sites.The determination of SPF shall be as described in ISO 24444. ISO 16217:2020 Clause 4.1 describes the correct use of ISO 24444 and ISO 16217 together to complete the test. A copy of each of these ISO procedures are incorporated by reference.PrincipleThe mean SPF of the sunscreen product is determined after immersion of the test subject for not less than 40 minutes in a simulated swim test device.ResultsIf water resistance is to be claimed, the labelled SPF shall be calculated from the mean protection factor after immersion.The mean SPF of the product under test shall be calculated after immersion. Using the post-immersion mean SPF, the labelled be determined.1006203396

[0051] Determine of water resistance SPF (SPFiwr) as described in ISO 16217 is set out below: a. Calculation of the individual water resistance SPF (SPFjWr)Individual water resistance retention shall be calculated for each individual subject where concurrent static SPF data also exist. The procedure for the calculation of individual water resistance retention is set out in ISO 18861 .The SPFiwr of the reference sunscreen and the product under test for each subject is calculated as shown in Formula (1 ):MEDps MEDipi SPFiwr = - = -MEDup MEDiui whereMEDps is the MED on protected skin;MEDup is the MED on unprotected skin;MEDipi is the individual MED for the sunscreen-protected site after immersion;MEDiui is the individual MED for the unprotected site. b. Calculation of the water resistance SPF (SPFwr)The water resistance SPF (SPFwr) result for the test product and for the reference sunscreen formulation is calculated as the arithmetic mean of all valid individual SPFiwr values.The minimum number of valid SPFiwrvalues shall be 10 and the maximum number of valid SPFiwr values shall be 20. A maximum of 5 results may be excluded from the calculation of SPFwr, but each exclusion shall be justified. A sixth invalid result automatically invalidates the whole test for that test product and no SPFwr can be calculated for it.

[0052] Determination of SPF as described in ISO 24444 is set out below: a. Calculation of the individual SPF (SPFi)1006203396The SPFi of both the reference sunscreen and the product under test for each subject shall be calculated as shown in Formula (A) and expressed to one decimal place by truncation.ME DipSPFiMEDiu whereMEDip is the MED of the sunscreen protected skin for an individual;MEDiu is the MED of unprotected skin for an individual. b. Calculation of product SPFThe SPF result for test product and for the reference sunscreen formulation shall be calculated as the arithmetic mean of all valid individual SPFi values.The minimum number of valid SPFi values shall be ten and maximum number of valid SPFi values twenty. A maximum of five results may be excluded from the calculation of the mean SPFi,. A sixth invalid result automatically invalidates the whole test for the test product, and no SPF can be calculated for it.SPF shall be expressed to one decimal place by truncation. c. Statistical criterionThe statistical criterion for all SPF measurement is that the 95% confidence interval on the mean SPF measured shall comply with the ±17% of Cl criteria of the measured mean SPF. The applies to test products and reference sunscreen products.Consequently, the actual number of subjects tested shall be defined as the number (minimum ten) required to produce a mean test product SPF with a 95% confidence interval (Cl) which falls within a range of ±17% of the measured mean SPF for the tested product and a mean reference product SPF which has a 95% Cl which falls within the range of ±17% of the measured mean SPF for the reference sunscreen formulation.1006203396A minimum of ten valid results in only sufficient if the statistical criterion is fulfilled. If not, the number of subjects shall be increased from then until the statistical criterion is met up to a maximum of twenty valid results.

[0053] As outlined by the International Organization for Standardization (ISO), Australia has the strictest regulations for water resistance, as shown in the table below. In Australia, a product must retain 100% of its SPF after water immersion compared to its SPF before immersion to be considered water-resistant. In contrast, under the European standard, a product is regarded as water-resistant if less than 49% of its SPF is washed off. Furthermore, in Australia, the allowable maximum time to measure water resistance of a product is 4 hours. In other jurisdictions, for example Europe and the US, the maximum time is only 80 minutes.

[0054] The present invention uses UV filters to absorb or scatter and reflect UV light. UV filters may be organic UV filters which absorb UV light, or mineral UV filters that scatter and reflect UV light. Both types of UV filters are able to reduce the amount of UV light reaching the skin.1006203396

[0055] Organic UV filters, also known as chemical UV filters, chemical sunscreens or UV absorbers, may include UVA and UVB filters which refer to the different wave lengths of light absorbed by the filters. UVA filters are capable of filtering UVA light (having a wavelength of 315 - 400 nm) and UVB filters are capable of filtering UVB light (having a wavelength of 280-312 nm). Many sunscreen formulations comprises both UVA and UVB filters. Sunscreens which protect against UVA and UVB radiation may be called broad spectrum sunscreens when they comply with the regulations of the relevant jurisdiction. In Australia and New Zealand, that is AS / NZS 2604:2021 .

[0056] In embodiments of the invention the sunscreen is a broad-spectrum sunscreen. In embodiments the sunscreen comprises UVA and UVB filters.

[0057] UVA filters may be selected from butyl methoxy dibenzoylmethane, menthyl anthranilate, ecampsule, disodium phenyl dibenzimidazole tetrasulfonate, and diethylamino hydroxybenzoyl hexyl benzoate.

[0058] Some UV filters may be both UVA and UVB filters. These may be known as UVA + UVB filters. Non-limiting examples of UVA + UVB filters are benzophenone, benzophenone-2, dioxybenzone, oxybenzone, sulisobenzone, sulisobenzone sodium, bemotrizinol, methylene bis-benzotriazolyl tetramethyl butyl phenol, drometrizole trisiloxane, tris-biphenyl triazine, and octocrylene.

[0059] UVB filters may be selected from Isoamyl methoxycinnamate, octyl methoxycinnamate, cinoxate, aminobenzoic acid, padimate O, ethoxylated ethyl 4- amino benzoic acid, octyl salicylate, homosalate, isopropylbenzyl salicylate, Triethanolamine salicylate, Salicylic acid salts (potassium, sodium and triethanolamine), alpha-(2-oxoborn-3-ylidene)toluene-4-sulfonic acid and its salts, N,N,N-Trimethyl-4- (oxoborn-3-ylidenemethyl)anilinium methyl sulfate, 4-methylbenzylidene camphor, phenylbenzimidazole sulfonic acid, polysilicone-15, diethylhexyl butamido triazone, and octyl triazone.

[0060] Mineral UV filters, also known as physical UV filters, physical sunscreens, or UV reflectors may include Titanium dioxide or zinc oxide particles. Typically, the particle size is in the range of 10-100 nm, 15 -100 nm or 20-100 nm in diameter.

[0061] In embodiments of the invention the UV filters included in the composition are selected from bis-ethylhexyloxyphenol methoxyphenyl triazine, ethylhexyl1006203396methoxycinnamate, ethylhexyl triazone, titanium dioxide (and) silica (and) dimethicone and diethylamino hydroxybenzoyl hexyl benzoate and combinations thereof.

[0062] The amount of UV filter included in the formulation may be included in a range from a minimum to a maximum value. In embodiments the minimum value may be about 1 %, about 2%, about 3%, about 4%, about 5%, about 6%, about 7%, about 8%, about 9%, or about 10% w / w. In embodiments the maximum value may be about 20%, or about 19%, or about 18%, or about 17%, or about 16%, or about 15%, or about 14%, or about 13%, or about 12%, or about 11 % w / w. In embodiments of the invention the UV filter in included in a range from any of the listed minimums, to any of the listed maximums, for example from about 2% to about 18%, or from about 5% to about 12% w / w.

[0063] In embodiments of the invention the UV filters are included in the composition from about 5% to about 20%, preferably from about 7% to about 12%, even more preferably from about 9% to about 11 % w / w.

[0064] As used herein the term “film former” or “film forming agent” refers to an ingredient which is capable of forming a continuous covering over a surface when applied to that surface. In particular, in the context of the disclosure, film formers are capable of forming a continuous covering on the skin.

[0065] Film formers are typically polymers and include acrylate polymers, acrylamides, waxes, cellulose and derivatives, chitosan and derivatives, polyesters and derivatives thereof.

[0066] In embodiments of the invention the film forming polymer is VP / eicosense copolymer, trimethylpentanediol / adipic acid / glycerin cross polymer, Triacontanyl PVP, or Polyester-7.

[0067] In preferred embodiments of the invention the film forming polymer is a polyester or polyester derivative, more preferably polyester-7. The polyester-7 may be used as a mixture of polyester-7 and neopentyl glycol diheptanoate.

[0068] Ingredient synergies within a sunscreen product and UV filters can result in an efficient system that is characterized by a high ‘SPF yield’. The SPF yield is the SPF achieved for every percent of total UV filters included in the sunscreen product.1 The1006203396higher the SPF yield, the more efficient the sunscreen product is. Manufacturers of sunscreen actives expect SPF yields of one to two, while the majority of the products listed with the TGA (Therapeutic Goods Australia) have yields of two to three.

[0069] The amount of film former included in the formulation may be included in a range from a minimum to a maximum value. In embodiments the minimum value may be about 0.2%, about 0.3%, about 0.4%, about 0.5%, about 0.6%, about 0.7%, about 0.8%, about 0.9%, about 1%, or about 1.1 %. In embodiments the maximum value may be about 5%, or about 4.5%, or about 4%, or about 3.5%, or about 3%, or about 2.5%, or about 2.4%, or about 2.3%, or about 2.2%, or about 2.1 %, or about 2.0%, or about 1 .9%, or about 1 .8%, or about 1 .7%, or about 1 .6%, or about 1 .5%. In embodiments of the invention the film former is included in a range from any of the listed minimums, to any of the listed maximums, for example from about 0.5% to about 4%, or from about 1 .8% to about 2.4%.

[0070] In embodiments of the invention the UV filters are included in the composition from about 0.5% to about 5%, preferably from about 0.5% to about 2%, even more preferably from about 1 .0% to about 1 .5%.

[0071] Without wishing to be bound by theory it is proposed that there is a synergistic relationship between the UV filters and film forming agents of the composition such that the composition is able to provide a higher SPF factor with lower concentrations of UV filters, compared with compositions comprising only the UV filters and not the film forming agents. It is proposed that the addition of film forming agents to the sunscreen provides a uniform film of sunscreen when applied to the skin, enhancing the protection and improving the uniform dispersion of the UV filters in the film. If the residual film on the skin is efficiently formed, the UV filters become uniformly distributed in such film, therefore providing cohesive protection from the environmental UV radiation level.

[0072] The SPF yield of a product refers to the SPF rating of the product divided by the concentration (w / w%) of the UV filters in the product. If the product is labelled as a water resistant sunscreen, then the SPF yield is calculated using the actual SPF measured after immersion in water for the claimed duration of water resistance.

[0073] Typically, sunscreen formulations listed with the TGA (Therapeutic good Australia) achieve SPF yields of 2 to 3.1006203396

[0074] Compositions of the invention include film formers to improve the SPF yield through the synergism of the film former and UV filters in the compositions.

[0075] Both the type of film former, and quantity of film former used may have an effect on the SPF-yield.

[0076] As used herein the term emulsifier refers to an agent or ingredient in a composition which promotes blending of oil and water phases into an emulsion. Emulsifiers are typically surfactants and may be a non-ionic, cationic, anionic or zwitterionic emulsifier. The emulsifier may be an oil in water emulsifier or a water in oil emulsifier. The emulsifier may be used with a co-emulsifier to enhance stability of the emulsion.

[0077] The emulsifier is used in the composition to disperse solids, such as inorganic UV filters in the oil phase, as well as promote blending of the oil and water phases. Preferably the emulsifier has a HLB (hydrophilic-lipophilic balance) of from about 5 to about 6.

[0078] In some embodiments the emulsifier may be a polymeric emulsifier. The emulsifier may be a block co-polymer emulsifier. The block co-polymer emulsifier may have an A-B-A configuration, wherein ‘A’ represents a hydrophobic / lipophilic block of the emulsifier, and ‘B’ represents a hydrophilic block.

[0079] Non-limiting examples of emulsifiers include esters of glycerin, esters of propylene glycol, fatty acid esters of polyethylene glycol, fatty acid esters of polypropylene glycol, esters of sorbitol, esters of sorbitan anhydrides, carboxylic acid copolymers, esters and ethers of glucose, ethoxylated ethers, ethoxylated alcohols, alkyl phosphates, polyoxyethylene fatty ether phosphates, fatty acid amides, acyl lactylates, soaps, stearates, DEA oleth-3 phosphate, polyethylene glycol 20 sorbitan monolaurate (polysorbate 20), polyethylene glycol 5 soya sterol, steareth-2, steareth-20, steareth-21 , ceteareth-20, PPG-2 methyl glucose ether distearate, ceteth-10, polysorbate 80, cetyl phosphate, potassium cetyl phosphate, diethanolamine cetyl phosphate, polysorbate 60, glyceryl stearate, PEGylated stearates and derivatives thereof, lecithin, and mixtures thereof.

[0080] Optionally the emulsifier is PEG-30 dipolyhydroxystearate.1006203396

[0081] Compositions of the invention may include one or more emulsion stabilisers and / or thickeners.

[0082] The emulsion stabiliser may be selected from cetyl alcohol, copernicia cerifera wax, magnesium sulfate, or combinations thereof.

[0083] The sunscreen composition of the present invention may optionally further include one or more emulsion stabilisers, thickeners, humectants, emollients, chelating agents, or sensory ingredients.

[0084] As used herein the term emollient is an agent, or ingredient in a composition which can contribute to skin hydration. Emollients may also be known as barrier creams because they form a film on the skin’s outer layer which can help to prevent TEWL (trans epidermal water loss). Emollients also contribute to the sensory properties of the composition.

[0085] Common emollients are glycerin, lanolin, cocoates, laurates, synthetic esters, fatty acids, cocoa butter, cocoa oil, vegetable oils, mineral oil, and petroleum jelly.

[0086] In some embodiments the composition comprises hexyl laurate.

[0087] As used herein a humectant is an agent or ingredient that attracts water. Humectants are used in cosmetic formulations as they can help hydrate the skin, hair or nails.

[0088] Commonly used humectants are hyaluronic acid (or salts thereof), glycerin, betaine and alkyl glycols.

[0089] In some embodiments the composition comprises one or more humectants selected from alkyl glycol, an amino acid (betaine), glycerin or a combination thereof. In preferred embodiments the composition comprises 1 ,2 hexanediol, glycerin and betaine.

[0090] Some ingredients, for example glycerin, function as both an emollient and a humectant.

[0091] A chelating agent is a chemical compound which can tightly bind to metal ions. Chelating agents are optionally added to sunscreen formulations to bind metal ions preventing them from adhering the skin, and / or contaminating the formulation. Non1006203396limiting examples of chelating agents are ethylenediaminetetraacetic acid (EDTA) and salts thereof, tetrahydroxypropyl ethylenediamine and salts thereof, ascorbic acid and salts thereof, citric acid and salts thereof, trisodium ethlyenediameine disuccinate and sodium oxalate.

[0092] Preferably the chelating agent is disodium ethylenediaminetetraacetic acid.

[0093] Advantageously, addition of chelating agents to sunscreen formulations may have a protective effect against environmental stressors such as transition metals or boost the preservative system.

[0094] As used herein the term sensory ingredient refers to ingredients added to the composition or formulation which improve a sensory property, such as skin feel or odour. Sensory ingredients may be humectants, emollients, moisturisers, fragrances and or powders. A sensory ingredient may also be referred to as a feel enhancer.

[0095] Improvement of sensory properties of a sunscreen is beneficial as this can result in higher consumer daily use.

[0096] Non limiting examples of sensory ingredients include Talc, starch and modified starch powders, and / or silica. Preferably the sensory ingredient is Talc.

[0097] The composition may include one or more solvents and dispersants. The solvents and dispersants may improve the distribution of mineral sunscreen in the composition. The solvents and dispersants may be selected from C12-15 Alkyl benzoate, dicaprylyl carbonate, isostearic acid, isopropyl myristate, neopentyl glycol diheptanoate.

[0098] The composition of the invention may further include one or more functional vitamins, selected from niacinamide, cyanocobalamine, and tocopherol.

[0099] The composition of the invention may further include one or more functional vitamins, selected from dichlorobenzyl alcohol, methylparaben, phenoxyethanol, and propylparaben.

[0100] It will be understood that the invention disclosed and defined in this specification extends to all alternative combinations of two or more of the individual features1006203396mentioned or evident from the text or drawings. All of these different combinations constitute various alternative aspects of the invention.ExamplesMethodsExample 1 - Exemplary sunscreen formulations

[0101] Exemplary formulation of a sunscreen of the invention is shown in table E1 and E3 below.Table E1 Sunscreen formulation1006203396The formulation was made according to the method described with reference to table E2.Table E2 Ingredient parts for manufacturing10062033961 . The part B3 ingredients were combined and heated to 40°C with mixing to dissolve the solids.2. The Part B2 ingredients were combined and mixed to dissolve the solids.3. The Part C ingredients were combined and mixed to be incorporated.4. The Part A1 ingredients are combined and heated to 85°C with mixing. Once the solids had dissolved, Part A2 ingredients were added with mixing.5. Part A1 / A2 was then mixed with high shear.6. Part B1 Aqua was heated to 80°C with mixing. Then add the remaining Part B1 ingredients & continue mixing at temperature until all solids have dissolved.7. Add Parts B2 & B3 to Part B1 with mixing.8. At 80°C for both Part A1 / A2 and Part B1 / B2 / B3, add Part B to Part A with mixing.10062033969. Mix Part A / B with high shear.10. Cool product to 60°C with mixing.11 . At 60°C, mix product with high shear before cooling to 40°C with mixing.12. At 40°C, add Part C to the product with mixing.13. Mix the product with high shear.Table E3 Sunscreen formulation1006203396The formulation was made according to the method described with reference to table E4.Table E4 Ingredient parts for manufacturing10062033961 . Part B1 Aqua (preheated to 80°C) is added to the manufacturing vessel.2. The remaining Part B1 ingredients are added in order and with mixing.3. Part B1 is mixed at high shear for a set time at 80°C to dissolve the solids.4. Part B2 ingredients are added with mixing, and Part B1 / B2 is reheated to 80°C before being set aside and stored at temperature in the side vessel until required.5. Part A1 ingredients are added to the manufacturing vessel in order with mixing.6. Add Part A2 ingredients in order with mixing. Heat to 85°C with mixing.7. Mix with high shear at 85°C for a set time until solids have dissolved.8. Add Part A3 ingredients with mixing. At 80°C, mix with high shear for a set time.9. At 80°C for Part A and B, add Part B to Part A in three parts, mixing with high shear for a set time after each addition.10. Cool batch to 35°C with mixing.11 . Combine Part C ingredients and mix until uniform.100620339612. With the batch at 35°C, add Part C with mixing. Then mix with high shear to complete the batch.Table E5 SPF and broad spectrum results for the Sunscreen formulation of example 1.Example 2 - Sunscreen formulations of the invention with SPF 50+ resultsFurther formulations of the invention are shown in table E6 below.The titanium dioxide used in the formulations of the invention is coated with a layer of silica and dimethicone, and therefore comprised of 3 components that add up to 100% of the raw material - the titanium dioxide component makes up 80.5%w / w of the raw material used in F12 to F18. For F1 to F11 , titanium dioxide comprises 84.5%w / w of the raw material (ingredient); for the commercial product, the titanium dioxide component is 76.5%w / w of the raw material.To calculate the absolute amount of active content of UV filters in the overall formulation, the silica and dimethicone from the titanium dioxide raw material is excluded. Using F18 as an example, the amount of titanium dioxide only in the overall formulation = (% titanium dioxide in raw material - 100) x % titanium dioxide in raw material used in the end product i.e.. (80.5 - 100) x 2.384 = 1.919.To get the ‘total actives adjusted for TiO2 content’, 1 .919 is added to the other UV filters used in F18 to achieve 9.76%w / w. As such the ‘total actives’ row includes silica and dimethicone; the ‘total actives adjusted for TiO2 content’ does not include silica and diemthicone as they are not UV filters / actives.10062033961006203396Variations to a base formulation were made. The base formulation is given in table E7 below.Table E7 base formulation for sunscreen development studies:2.1 Film forming polymersFormulations of the invention were trialled using the base formulation of table E7 with different film forming ingredients as indicated in table E8 below.1006203396Table E8 The effect of the W / O emulsion and film former on post water immersion SPFWhile all the trialled film forming ingredients were able to produce a sunscreen with a high-yield SPF result after 4 hours of water immersion, there was a marked difference between the measured SPF of formulations with different film forming ingredients.2.2 Emulsifier choice and film forming polymerThe effect of emulsifier choice and film forming polymer was also tested. The results are shown in table E9 below.1006203396Table E9. The effect of film former levels and emulsifier on post water immersion SPF.Surprisingly formulations with lower levels of Triacontanyl PVP (1 .35 w / w%) had better SPF compared to formulations with higher levels (2.0 w / w%) suggesting there is an optimum amount of film forming polymer to create the synergistic / high yield effect with the UV filters.Example 3 - Formulations with reduced UV filter concentrationsThe effect of the UV filter concentration in sunscreen formulations with a film forming polymer on SPF was investigated. The amount of UV filter was reduced by 25% and the SPF of the formulation with the original amount of UV filter, and reduced amount of UV Filter.1006203396Table E10 The effect of a 25% reduction in LIV filters on post water immersion SPF amongst different film formers.Lastly the relationship between UV active concentration of SPF Yield was investigated in a formulation using Polyester-7 and neopentyl glycol diheptanoate as the film forming ingredient at 2.0%. The results are shown in table E11 below.Table E11 Comparison of concentration of UV filters versus post water immersion SPF and SPF yieldThe details of the tested formulations are in Table E12 below.1006203396Table E12 formulates tested in Table E1110062033961006203396A preliminary test is on 3 subjects and used to check formulation development. A full panel test is a 10 subject test and sufficient (assuming suitable results) to support regulatory approval in Australia. The same method is used for each test.Surprisingly it was shown that the amount of UV filter could be substantially reduced while still producing a sunscreen with high SPF and 4 hours water resistance.

[0102] Sunscreens without water resistance should have the same benefits. It is a well- known concept for experts in the field that water immersion will reduce the SPF value from the initial one. If the post immersion value is > 60, then the static SPF value will be >60.Example 4 - Comparison of formulation with low UV filter (actives) content compared with commercially available sunscreen products listed on the Australian Register of Therapeutic Goods (ARTG)Figure 1 compares the percentage UV filter concentration present in the claimed formulation with that of commercially available sunscreens that are listed on the ARTG. Overall, for the commercially available products, the higher the SPF claim, the higher the UV filter content of the products. UV filter content is also higher in the commercially available products offering water resistance when compared with products with the same SPF claim and no water resistance.SPF50+ four hour water resistant sunscreens1006203396Sunscreen products with water resistance typically contain more UV filters than non water resistance product to allow for some of the SPF to be washed off in the water without loss of SPF protection. The commercially available products with SPF rating of SPF50+ and water resistance contain an average of 24.2% UV filters. In contrast, the claimed formulation only contains 9.76% UV filters but also results in SPF 50+ four hours post water immersion.SPF 50+ products without water resistanceThe commercially available products average 20.70% UV filters and is comparably less than the 24.20% average present in the SPF 50+ four hour water resistant products. Accordingly, the claimed formulation still contains significantly less UV filters than the SPF 50+ non-water resistant sunscreens. Surprisingly, not only is the claimed formulation able to achieve SPF 50+ protection at low UV filter levels, but it is also able to maintain four hour wash resistance with low UV filter content.SPF 30+ products with no water resistanceThe commercially available products contain an average of 15.26% UV filters. It is not surprising that sunscreens with a lower SPF claim of 30 contains less UV filters than products claiming SPF 50+ protection with I without water resistance. However, the fact that the patent formulation contains only 9.76% UV filters while maintaining SPF 50+ protection with 4 hours water resistance in contrast to the 15.26% UV filters present in the SPF 30 products with no water resistance is significant and unexpected.Figure 2 compares the SPF yields amongst SPF 50+ four hour water resistant sunscreens. The SPF yield is a measure of sunscreen efficiency by dividing the actual SPF of a product by the total percentage UV filters it contains. For the purposes of product comparison, the SPF yield was calculated using a SPF of 60.To claim SPF 50+ protection after 4 hours water immersion in Australia, the product must maintain a minimum SPF of 60 after water immersion. The higher the SPF yield, the more efficient the sunscreen is.Surprisingly, despite the low concentration of UV filters, the claimed formulation has the highest SPF yield at 6.1 . That is, for every percentage point of UV filter present in the formulation, the product generates 6.1 SPF units of sun protection. In comparison, the1006203396other ten commercially available SPF 50+ four hour water resistant products have significantly lower SPF yields ranging from 1 .8 to 4.0 (average 2.6).Example 5 - Comparison of predicted and actual SPF of claimed formulationUsing the DSM Sunscreen Optimizer (or the equivalent BASF Sunscreen Simulator), the predicted and actual SPF results for the claimed formulation were compared to a market leader La Roche Posay Wetskin SPF 50+ (AUST L 300899) (Table E13). Both DSM Sunscreen Optimizer and BASF Sunscreen Simulator were developed by industry experts to help formulators select their sunscreen active combinations before proceeding with benchwork and SPF testing.The simulator programs to predict the SPF value of a formulations are available online at:• https: / / www.sunscreen-optimizer.com / index.html• https: / / care360.basf.com / global / en / industries / personal-care / digital-services / d-lite- — sunscreen-simulatorTable E13 Results of the predicted and actual SPF results for the claimed formulation and La Roche Posay Wetskin SPF 50+ (AUST L 300899)Surprisingly, the claimed formulation surpasses the predicted SPF. Furthermore, in contrast to La Roche Posay Wetskin SPF 50+ which has significantly higher content, the claimed formulation, achieves SPF comparable to predicted in the in silico tools.1006203396Example 6 - Sensory evaluation of sunscreen of the invention (SPF50+, 4 hour water resistant) and low SPF sunscreen formulation (SPF25, 4 hour water resistant)Three sunscreen formulations were subjected to a descriptive analysis to compare their sensory profiles. The sensory evaluation was carried out by trained panellists.Table E14 Formulations undergoing sensor evaluation1006203396100620339610062033961006203396The sensory evaluation design was as follows.• Sensory evaluation methodology at Croda uses a descriptive analysis method, which employs a trained and regularly calibrated sensory panel to objectively evaluate skin care products across 24 attributes, including greasiness and absorption. The panellists use Croda Reference Standards to calibrate the 0-100 scale.• Panel size: For descriptive analysis, a panel of 10 trained sensory panellists / subjects is sufficient to provide reliable and consistent results.• Sample quantity: Approximately 50 grams per sample in glass bottle.In general, the higher the active content (i.e. UV filters), the higher the oil loading needs to be, since many UV filters require oil-based solvents or dispersants to dissolve effectively and remain stable in the formulation. However, the total oil phase includes all oily components — some of which may be added for sensory, emolliency, or other formulation reasons, and are not necessarily needed for solubilizing or dispersing the1006203396UV filters. As such, the 'total solvent / dispersant & actives' more accurately reflects the portion of the oil phase that is functionally required for dissolving or dispersing the UV filters. Advantageously, as can be seen from Table E14, the 'total solvent / dispersant & actives' value for the sunscreen of the invention is comparable to that of the low-SPF formulation.The results of the sensory evaluation are shown below in Table E15. Typically, higher SPF sunscreens are thicker consistency with an oiler and sticker feel, which can be uncomfortable for the user and leave a white cast look. Surprisingly, the high-SPF (SPF 50+) sunscreen formulation of the invention was comparable to, or even better than, the low-SPF formulation in many skin-feel attributes during the play stage, immediately after application, and five minutes post-application. Further, the sunscreen formulation of the invention scored lower in glossiness, oiliness and whiteness in comparison to high-SPF sunscreen formulation.As such, the sunscreen of the invention addresses the long term industry wide challenge in developing SPF 50+ sunscreens with pleasant skin feel for improved user compliance and reduced incidences of UV induced skin cancer.Table E15 sensory evaluation results1006203396Example 5 - Formulations with different film formers and comparison to the measured SPF of the claimed formulationThe effect of different film formers and their concentration in sunscreen formulations was investigated (Table E19). The rest of the formulation was not changed (the full formulation is outlined in Table E20), including the UV filters.The study was set up using the StatEase Design Expert software (Version 23.1.3 64-bit) to investigate the effect of different film formers and their concentration in a water-in-oil sunscreen formulation designed to be SPF 50+ and have 4 hours water resistance as per the Australian standard AS / NZS 2604.For each product samples, four hour post water immersion SPF testing was conducted on three subjects (3 subject SPF 4hWR) and according to the AS / NZD 2604:2021 standard. The responses measured are shown below in Table E16.1006203396Table E16 Responses measuredAdditionally, since film formers also affect the feel and consistency of the sunscreen formulation, viscosity was measured using the Brookfield Viscometer DV-I Prime, spindle 4 at speed 6 rpm. Viscosity was measured at time 0 (viscosity tO).The study design was set up as shown in Table E17 below, with a total of 19 batches forming the study. These batches replaced the existing 2% polyester-7 (and) neopentyl glycol diheptanoate with different film formers at different levels.Table E17 Study design setup1006203396The two factors studied were (A) film former concentration, set at between 0% and 2%w / w and (B) film former type. Table E18 summarises the setup in the Design Expert software.Table E18 Factors studiedTable E19 Comparison of film former concentration and type versus post water immersion SPF and viscosity10062033961006203396Table E20 Complete formulationBased on the above results, the StateEase Design Expert predicted the SPF and viscosity of the formulation of Table E21 with 1 .54 % (entry A) and 2% (entry B) polyester-7 and neopentyl glycol diheptanoate film formers. Surprisingly, the claimed formulation surpasses the predicted SPF. Furthermore, the actual viscosity1006203396measurement for the claimed formulation is softer (entry C) in consistency than the predicted data (entry B).Table E21 Predicted StateEase Design Expert predicted the SPF and viscosity of the formulation (entries A and B) compared to the actual measured data for the claimed formulation (entry C).1006203396

Claims

CLAIMS1 . A sunscreen composition including: from about 5% to about 20% w / w of one or more UV filters; from about 0.5% to about 5% w / w of film forming polymer; one or more emollients, solvents, dispersants, or combinations thereof; one or more emulsifier; and water.

2. A sunscreen composition including: from about 5% to about 14% w / w of one or more UV filters; from about 0.5% to about 5% w / w of film forming polymer; one or more emollients, solvents, dispersants, or combinations thereof; one or more emulsifier; and water.

3. A sunscreen composition including: from about 5% to about 20% w / w of one or more UV filters; from about 0.5% to about 5% w / w of film forming polymer; one or more emollients, solvents, dispersants, or combinations thereof; one or more emulsifier; and water, wherein the sunscreen composition is water resistant for at least 4 hours according to the ISO 16217:2020 standard.

4. A sunscreen composition including:1006203396from about 5% to about 20% w / w of one or more UV filters; from about 0.5% to about 5% w / w of film forming polymer; one or more emollients, solvents, dispersants, or combinations thereof; one or more emulsifier; and water, wherein the film forming polymer is selected from triacontanyl PVP, polyester-7 or a combination thereof.

5. The sunscreen composition of any one of claims 1 to 4, wherein the one or more UV filters comprise organic UV filters and mineral UV filters.

6. The sunscreen composition of any one of claims 1 to 5, wherein the one or more UV filters comprising UVA and UVB filters.

7. The sunscreen composition of any one of claims 1 to 6, wherein the one or more UV filters are selected from bis-ethylhexyloxyphenol methoxyphenyl triazine, diethylamino hydroxybenzoyl hexyl benzoate, ethylhexyl methoxycinnamate, ethylhexyl triazone, and titanium dioxide.

8. The sunscreen composition of any one of claims 1 to 3 and 5 to 64, wherein the film forming polymer is polyester-7, VP / eicosane copolymer, Triacontanyl PVP or Trimethylpentanediol / adipic acid / glycerin crosspolymer.

9. The sunscreen composition of any one of claims 1 to 8, wherein the film forming polymer is polyester-7.

10. The sunscreen composition of any one of claims 1 to 9, wherein the emulsifier is PEG-30 dipolyhydroxystearate.11 . The sunscreen composition of any one of claims 1 to 10, wherein the one or more UV filters are included from about 7% to about 12% w / w of the sunscreen composition.100620339612. The sunscreen composition of any one of claims 1 to 11 , wherein the one or more UV filters are included from about 8% to about 10% w / w of the sunscreen composition.

13. The sunscreen composition of any one of claims 1 to 12, wherein the film forming polymer is included from about 0.5% to about 2% w / w of the sunscreen composition.

14. The sunscreen composition of any one of claims 1 to 13, wherein the film forming polymer is included form about 1 .0% to about 1 .5% w / w of the sunscreen composition.

15. The sunscreen composition of any one of claims 1 to 14, wherein the film forming polymer is included in the sunscreen composition at an amount that results in an application to the skin of about 1 to about 3 mg / cm2.

16. The sunscreen composition of claims 15, wherein the film forming polymer is included in the sunscreen composition at an amount that results in an application to the skin of about 1 .5 to about 2.5 mg / cm2.

17. The sunscreen composition of claims 15 or 16, wherein the film forming polymer is included in the sunscreen composition at an amount that results in an application to the skin of about 2mg / cm2.

18. The sunscreen composition of any one of claims 1 to 17, wherein the composition further comprises one or more of: one or more emulsion stabilisers or thickeners; one or more humectants; one or more emollients; one or more dispersants; one or more chelating agents; one or more preservatives; one or more sensory ingredients; and1006203396one or more non-water solvents.

19. The sunscreen composition of any one of claims 1 to 18, wherein the composition further comprises one or more functional vitamins and / or one or more preservatives.

20. The sunscreen composition of any one of claims 1 to 19, wherein the sunscreen composition has an SPF rating of 50+ according to the AS / NZS 2604:2021 standard.21 . The sunscreen composition of any one of claims 1 to 20, wherein the sunscreen composition has an SPF yield of at least 5.

22. The sunscreen composition of any one of claims 1 to 21 , wherein the sunscreen composition has a measured SPF value of at least 70.

23. The sunscreen composition of any one of claims 1 , 2 and 4 to 21 , wherein the sunscreen composition is water resistant for at least 4 hours according to the ISO 16217:2020 standard.

24. A sunscreen composition including: (waiting on confirmation for the values) from about 5% to about 20% w / w of one or more UV filters; from 0.5% to about 5% w / w of film forming polymer; from about 2 wt% to about 7 wt% of at one or more emollients; from about 0.5 wt% to about 5 wt% of at least one emulsifier; optionally additional formulation components; and about 20% to about 92% w / w aqueous solvent, optionally the one or more UV filters is included from about 5% to about 14% w / w of one or more UV filters.

25. The sunscreen composition of claim 24 wherein the optionally additional formulation include one or more of: from about 1 wt% to about 5 wt% of one or more non water solvents; from about 1 wt% to about 10 wt% of one or more dispersants;1006203396from about 1 wt% to about 5 wt% of an emulsion stabilisers or thickeners; from about 0.5 wt% to about 3 wt% of one or more sensory ingredients; from about 3 wt% to about 6 wt% of one or more humectant; from about 0.5 wt% to about 3 wt% of one or more functional vitamins; from about 0.05wt% to about 0.3 wt% one or more chelating agents; and from about 0.25wt% to about 2.5 wt% of one or more preservatives.26 The sunscreen composition of claim 24 or 25, wherein the one or more UV filters comprise organic UV filters and mineral UV filters.

27. The sunscreen composition of any one of claims 24 to 26, wherein the one or more UV filters comprising UVA and UVB filters.

28. The sunscreen composition of any one of claims 24 to 27, wherein the one or more UV filters are selected from bis-ethylhexyloxyphenol methoxyphenyl triazine, diethylamino hydroxybenzoyl hexyl benzoate, ethylhexyl methoxycinnamate, ethylhexyl triazone, and titanium dioxide.

29. The sunscreen composition of any one of claims 24 to 28, wherein the film forming polymer is polyester-7, VP / eicosane copolymer, Triacontanyl PVP or Trimethylpentanediol / adipic acid / glycerin crosspolymer.

30. The sunscreen composition of any one of claims 24 to 29, wherein the film forming polymer is polyester-7.31 . The sunscreen composition of any one of claims 24 to 30, wherein the emulsifier is PEG-30 dipolyhydroxystearate.

32. The sunscreen composition of any one of claims 24 to 31 , wherein the one or more UV filters are included from about 7% to about 12% w / w of the sunscreen composition.

33. The sunscreen composition of any one of claims 24 to 32, wherein the one or more UV filters are included from about 8% to about 10% w / w of the sunscreen composition.100620339634. The sunscreen composition of any one of claims 24 to 33, wherein the film forming polymer is included from about 0.5% to about 2% w / w of the sunscreen composition.

35. The sunscreen composition of any one of claims 24 to 34, wherein the film forming polymer is included form about 1 .0% to about 1 .5% w / w of the sunscreen composition.

36. The sunscreen composition of any one of claims 24 to 35, wherein the film forming polymer is included in the sunscreen composition at an amount that results in an application to the skin of about 1 to about 3 mg / cm237. The sunscreen composition of claims 36, wherein the film forming polymer is included in the sunscreen composition at an amount that results in an application to the skin of about 1 .5 to about 2.5 mg / cm2.

38. The sunscreen composition of claims 36 or 37, wherein the film forming polymer is included in the sunscreen composition at an amount that results in an application to the skin of about 2mg / cm2.

39. The sunscreen composition of any one of claims 23 to 38, wherein the sunscreen composition has an SPF rating of 50+ according to the AS / NZS 2604:2021 standard.

40. The sunscreen composition of any one of claims 24 to 39, wherein the sunscreen composition has an SPF yield of at least 5.41 . The sunscreen composition of any one of claims 24 to 41 , wherein the sunscreen composition has measure SPF of at least 70.

42. The sunscreen composition of any one of claims 24 to 41 , wherein the sunscreen composition is water resistant for at least 4 hours according to the ISO 16217:2020 standard.

43. A method of protecting skin from sun damage or sunburn comprising application of the sunscreen formulation of any one of claims 1 to 42 to the skin.

44. The method of claim 43, wherein the method results in the application to the skin of about 1 to about 3 mg / cm2of film forming polymer.100620339645. The method of claim 43 or 44, wherein the method results in the application to the skin of about 1 .5 to about 2.5 mg / cm2of film forming polymer.

46. The method of any one of claims 43 to 45, wherein the method results in the application to the skin of about 2mg / cm2of film forming polymer.

47. The method of any one of claims 43 to 46, wherein the skin is human skin.1006203396

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