A high SPF GEL composition comprising niacinamide

Abstract

The present invention relates to a photoprotective personal care composition. Particularly, the present invention relates to a personal care composition in the form of a gel that not only provides a high SPF but is also color stable.

Description

[0001] A HIGH SPF GEL COMPOSITION COMPRISING NIACINAMIDE

[0002] Field of the Invention

[0003] The present invention relates to a photoprotective personal care composition which provides high sun-protection factor (SPF). Particularly, the present invention relates to a personal care composition in gel form that provides high; and is color stable.

[0004] Background of the Invention

[0005] A co-pending application WO 2023 / 217920 (Unilever) of the present applicant disclosed a photoprotective personal care composition, which provides high sun-protection factor along with very good sensorial properties that the consumer expects when such a composition is applied on the skin. Particularly, it disclosed a gel composition that provided high SPF where the composition comprised a combination of an oil-soluble sunscreen, a water-soluble sunscreen, a water phase thickener, an oil phase thickener, a humectant; and a select sensory modifier.

[0006] However, it was found that vitamin B compounds e.g. niacinamide, which are water soluble ingredients, when added to such gel compositions in increased amounts, it tends to result in loss of color stability of the gel.

[0007] Therefore, there is need to overcome the drawbacks associated with the prior art and provide a gel composition that not only provides high SPF and good sensory properties which consumers expect (e.g. low oiliness and good spreadability), but also provide color stability.

[0008] It has now been found that when select antioxidants were incorporated in the gel composition of the present invention, it solved the problem faced and provided color stability. It was also found that the color stable gel reduced the reactive oxygen species that get generated due to external factors e.g. exposure to the sunlight and / or due to internal factors e.g. intracellular reactions.

[0009] Summary of the Invention

[0010] Accordingly, the present invention relates to a personal care composition comprising:

[0011] (i) 0.1 to 25 wt% oil-soluble sunscreen,

[0012] (ii) 0.1 to 5 wt% water-soluble sunscreen, (iii) 0.25 to 5 wt% of a water phase thickener selected from one or both of a polysaccharide gum and a synthetic polymer selected from ammoniumacryloyldimethyltaurate / VP copolymer, and ammonium acryloyldimethyltaurate / beheneth-25 methacrylate crosspolymer,

[0013] (iv) 0.5 to 10% of an oil phase thickener selected from one or more of an ester of C18 to C36 fatty acid, ester of C8 to C16 fatty acid; polymeric oil phase thickener; and particle selected from organically modified clays, hydrophobically modified fumed silica and aerogels,

[0014] (v) 0.5 to 15 wt% humectant selected from glycerol or a glycol,

[0015] (vi) 0.5 to 10 wt% of a sensory modifier selected from one or more of a modified starch, silica microsphere and a polymer of dimethicone / vinyldimethicone crosspolymer and silica,

[0016] (vii) 0.01 to 10 wt% a vitamin B3 compound; and

[0017] (viii) 0.01 to 10 wt% an antioxidant selected from dilauryl thiodipropionate (Tinogard DA), pentaerythrityl tetra di-t-butyl hydroxyhydrocinnamate (Tinogard TT), tris(tetramethylhydroxypiperidinol) citrate (Tinogard Q), vitamin C or a derivative thereof selected from sodium ascorbyl palmitate and sodium ascorbyl phosphate and mixtures thereof.

[0018] Further, the present invention also relates to a method of providing photoprotection with a Sun Protection Factor (SPF) of at least 30 comprising a step of applying a composition as claimed in any one of the preceding claims on to the desired skin surface.

[0019] Detailed Description of the Invention

[0020] These and other aspects, features and advantages will become apparent to those of ordinary skill in the art from a reading of the following detailed description and the appended claims. For the avoidance of doubt, any feature of one aspect of the present invention may be utilized in any other aspect of the invention. The word "comprising" is intended to mean "including" but not necessarily "consisting of" or "composed of." In other words, the listed steps or options need not be exhaustive. It is noted that the examples given in the description below are intended to clarify the invention and are not intended to limit the invention to those examples per se. Similarly, all percentages are weight / weight percentages unless otherwise indicated. Except in the operating and comparative examples, or where otherwise explicitly indicated, all numbers in this description and claims indicating amounts of material or conditions of reaction, physical properties of materials and / or use are to be understood as modified by the word "about". Numerical ranges expressed in the format "from x to y" are understood to include x and y. When for a specific feature multiple preferred ranges are described in the format "from x to y", it is understood that all ranges combining the different endpoints are also contemplated.

[0021] The photoprotective personal care composition of the invention is meant to be used for personal care or for cosmetic use and could also be referred to as a personal care composition or a cosmetic composition. By a “personal care composition” as used herein, is meant to include a composition for topical application to sun-exposed areas of the skin and / or hair of humans. Such a composition may be classified as leave-on or rinse off, and includes any product applied to a human body for improving appearance, cleansing, odour control or general aesthetics. The composition of the present invention (the composition) can be in the form of a liquid, or a gel, preferably in a gel format. Non-limiting examples of such sunscreen compositions include leave- on skin products like antiperspirants, deodorants, sunscreen gels and wash-off shampoos, conditioners, face wash and shower gels. The composition of the present invention is preferably a leave-on composition.

[0022] "Skin" as used herein is meant to include skin on the face and body (e.g., neck, chest, back, arms, underarms, hands, legs and scalp) and especially to the sun exposed parts thereof. Compositions of the invention is also of relevance to applications on any other keratinous substrates of the human body other than skin e.g., hair where products may be formulated with specific aim of improving photoprotection.

[0023] The compositions of the invention comprise 0.1 to 25 % by weight oil-soluble sunscreen. By oilsoluble is meant those organic sunscreens which have a solubility in water of less than 10 g / l, preferably less than 5 g / l, more preferably less than 2 g / l. Oil-soluble sunscreens could be of the UV-B type or of the IIV-A type. It is preferred that the composition in accordance with the invention comprises 0.1 to 20%, preferably 1 to 15% by weight of a UVB oil soluble sunscreen. It is further preferred that the composition of the invention comprises 0.1 to 5%, preferably 1 to 4% by weight of a UVA oil soluble sunscreen.

[0024] When an oil soluble UVB sunscreen is included, it is preferably one or more of octyl salicylate (Eusolex® OS), 3,3,5-trimethylclohexyl 2-hydroxybenzoate, ethylhexyl salicylate, 2-ethylhexyl 2- cyano-3,3-diphenyl-2-propenoate which is also known as octocrylene, 2-ethylhexyl-4- methoxycinnamate or octylmethoxycinnamate, ethylhexyl triazone, 3-benzylidene camphor, cinoxate, diethylhexyl butamido triazone, para amino benzoic acid (PABA), ethyl dihydroxypropyl PABA, ethylhexyl dimethoxy benzylidene dioxoimidazoline propionate, isoamyl p- methoxycinnamate, isopentyl trimethoxycinnamate trisiloxane, isopropyl benzyl salicylate, isopropyl methoxycinnamate, 4-methylbenzylidene camphor, PEG-25 PABA, and pentyl dimethyl PABA. More preferred oil-soluble UVB sunscreen is selected from one or more of octyl salicylate, 2-ethylhexyl 2-cyano-3,3-diphenyl-2-propenoate, and octylmethoxycinnamate.

[0025] Some of the well-known brands under which the above sunscreens are sold are Octisalate®, Homosalate®, Neo Heliopan®, Neo Heliopan® AV, Neo Heliopan® OS, Octocrylene® and Parsol® MCX. The oil-soluble IIV-B sunscreen has Amax from 280 to 320 nm.

[0026] Composition of the invention may comprise an organic oil-soluble UVA sunscreen. When included, it is selected from one or more of a dibenzoylmethane compound, diethylamino hydroxy benzoyl hexyl benzoate and methyl anthranilate. A dibenzoyl methane compound is most preferred for an oil-soluble UVA-sunscreen. Suitable dibenzoyl methane compounds are selected from one of more of t-butylmethoxy dibenzoylmethane, 2-methyldibenzoylmethane, 4- methyl-dibenzoyl-ethane, 4-isopropyldibenzoyl-methane, 4-tert-butyldibenzoylmethane, 2,4- dimethyldibenzoylmethane, 2,5-dimethyldibenzoylmethane, 4,4'-diisopropyl-dibenzoylmethane, 2-methyl-5-isopropyl-4'-methoxydibenzoylmethane, 2-methyl-5-tert-butyl-4'-methoxy-dibenzoyl methane, 2,4-dimethyl-4'-methoxy dibenzoylmethane and 2,6-dimethyl-4-tert-butyl-4'-methoxy- dibenzoylmethane. The most preferred dibenzoyl methane compound is t-butylmethoxy dibenzoylmethane commercially available as Parsol®1789.

[0027] Composition of the invention may comprise both an organic oil soluble UVB and an organic UVA sunscreen. Alternately, there are certain oil soluble sunscreens which have both a UVA and UVB screening efficacy. It is selected from one or more bis-ethylhexyloxyphenol methoxyphenyl triazine, drometrizole trisiloxane, benzophenone and its derivatives. The most preferred one is bis-ethylhexyloxyphenol methoxyphenyl triazine, commercially available as Tinosorb S.

[0028] The composition of the invention comprises 0.1 to 5 wt% of a water-soluble sunscreen. By water soluble sunscreen, whether of the UVA type, or of the UVB type, is meant that the solubility in water of the sunscreen is higher than 10 g / l preferably higher than 50 g / l at 25 °C.

[0029] The preferred water-soluble UVB sunscreen for use in the present invention is phenyl benzimidazole 5-sulphonic acid (PBSA), benzophenone-4 or benzylidene camphor sulfonic acid, preferably PBSA. PBSA also known as Ensulizole is commercially available as Eusolex 232 (from Merck KGaA). PBSA is also available under the brand names Neo Heliopan Hydro (from Symrise), Parsol HS (from DSM) and Sunsafe ES (from Uniproma). There are certain water- soluble sunscreens which have both a UVA screening efficacy as well as a UVB screening efficacy. Such sunscreens provide both UVA and UVB protection e.g. benzophenone-4 (sold as Sulisobenzone). However, for the purposes of the present invention benzophenone- 4 may be included as a water-soluble UV-B sunscreen.

[0030] The preferred UVA sunscreen for use in the present invention is one or more of disodium phenyl dibenzimidazole tetrasulfonate (Neoheliopan AP) or terephthalylidene dicamphor sulfonic acid (TDSA). Of these, di sodium phenyl dibenzimidazole tetra sulfonate is preferred which is also known as bisdisulizole disodium. This is commercially available as Neo heliopan AP (from Symrise Shanghai Ltd) or as Sunsafe DPDT (from Uniproma).

[0031] Terephthalylidene dicamphor sulfonic acid (TDSA) is also known as Ecamsule. This is commercially available as Mexoryl SX (US4585597) by L’ Oreal or Sunsafe TDSA (from Uniproma). It can be used as parent acid or its salts to deliver the desired benefit. The composition preferably comprises 0.1 to 5 wt%, more preferably 1 to 4 wt% water soluble sunscreen. It is preferred that the composition comprises both a UVA and a UVB water-soluble sunscreen. Most preferred is to include one or both of 2-phenylbenzimidazole-5-sulfonic acid and di sodium phenyl dibenzimidazole tetra sulfonate.

[0032] The water-soluble sunscreens for inclusion in the composition of the present invention are generally commercially available in the acid form. When included in the composition in the acid form (pre neutralized forms) i.e having sulphonic acid group (-SO3H) the composition additionally comprises a neutralising agent to convert the acid form into the salt form, in which form it is known to be active as a sunscreen with an exception to Mexoryl SX which can act as sunscreen with and without neutralization. When included, the neutralising agent is preferably in 0.05% to 4% more preferably 0.2% to 2% by weight of the composition. The neutralising agent is preferably an inorganic or an organic alkali. Organic alkali is preferably an amine such as triethanol amine or diethanol amine. The present inventors have observed that the inorganic alkali is especially preferred. Preferred are alkali metal hydroxides. Most preferred metal hydroxide for inclusion as neutralising agent in the composition of the invention are sodium hydroxide or potassium hydroxide. It is an especially challenging problem to stabilize the salt form of the water soluble sunscreen in a gel composition and yet get the desired enhancement of SPF and the desired tactile sensory properties. The present inventors have solved this by specifically selecting the claimed features (iii) to (vi) of the present invention viz. water phase thickener, oil phase thickener, the humectant and the sensory modifier.

[0033] The composition of the invention comprises a water phase thickener. The water phase thickener may be selected from one or more of (i) a polysaccharide gum and (ii) a synthetic polymer selected from (a) ammoniumacryloyldimethyltaurate / VP copolymer, and (b) ammonium acryloyldimethyltaurate / beheneth-25 methacrylate crosspolymer. Of the above a polysaccharide gum is most preferred. Preferred polysaccharide gums for inclusion in the composition of the invention are one or more of xanthan gum, guar gum, cellulose gum, tara gum, gellan gum, gum arabic, sclerotium gum, carrageenan gum, and locust bean gum. The most preferred polysaccharide gum is xanthan gum. Xanthan gum is commercially available as Keltrol CG-V from CP Kelco supplier. The synthetic polymers ammoniumacryloyldimethyltaurate / VP copolymer is commercially available as Aristoflex AVC and ammonium acryloyldimethyltaurate / beheneth-25 methacrylate crosspolymer as Aristoflex HMB. In an especially preferred aspect of the present invention both a polysaccharide gum e.g. xanthan gum and synthetic polymers Aristoflex AVC and Aristoflex HMB may be included. The water phase thickener is included in 0.25 to 5%, preferably 0.5 to 4%, most preferably 1 to 3% by weight of the composition.

[0034] The composition of the invention includes an oil phase thickener selected from one or more of an ester of C18 to C36 fatty acid, ester of C8 to C16 fatty acid; polymeric oil phase thickener and particle selected from organically modified clays, hydrophobically modified fumed silica and aerogels. Of these, an ester of C18 to C36 fatty acid is most preferred.

[0035] Suitable commercially available ester of C18 to C36 fatty acid are C18-36 Acid Triglyceride (Syncrowax HGLC), C18-36 Acid Glycol Ester (Syncrowax ERLC), Glyceryl tribehenate (Syncrowax HRC), Glyceryl hydroxystearate (Naturchem GMHS), Glyceryl tri(12- hydroxystearate) (Thixcin R), C16-18 triglyceride, C16-24 triglyceride (Cremeol HF-62- SPC). An especially preferred oil phase thickener for use in the composition of the invention is available as Syncrowax HGLC from Croda Personal Care. It has a melting point in the range of 60-70°C which also acts as a structure builder, crystallinity modifier and Emulsion stabilizer.

[0036] Example of esters of C8-C16 fatty acid is Hydrogenated cocoglycerides (Softisan 100). Polymeric oil thickeners which may be included are Sorbitol / Sebacic Acid Copolymer Behenate (Syncrowax ORM), Tribehenin (and) Sorbitol / Sebacic Acid Copolymer Behenate (Syncrowax OSW), Dextrin Palmitate (Dextrin Palmitate LDXP, HDXP and HDXP-KL), amide terminated polyamides (OleoCraft LP-20, MP-30, HP-31 , and MP-32), ester terminated polyamides (Uniclear 100VG and C75V), Stearoyl Inulin (Rheopearl ISK2), Poly C10-30 alkyl acrylate (Intellimer IPA 13-6 Polymer), poly C10-30 alkyl acrylate-MP 48C (Intellimer IPA 13-1 Polymer), and PVP (FlexiThix™ thickener).

[0037] Particles which act as oil phase thickeners could be selected from one or more of an organically modified clay such as cationic surfactant with a Sepiolite, Montmorillonite, Hectorite or Bentonite clay, fumed Silica, hydrophobically modified fumed Silica, and Aerogels such as Dow Corning VM-2270 Aerogel Fine particles, Aerosil® R 972 (Silica Silyate-Evonik).

[0038] The oil phase thickener is preferably included in 0.5 to 10%, more preferably from 0.8% to 5% and even more preferably from 1 % to about 3%, by weight of the composition. %

[0039] The composition of the invention comprises a humectant selected from a glycol or glycerol. The glycol is preferably selected from one or more of one of propylene glycol, butylene glycol, and caprylyl glycol. The humectant for use in the present invention is one or both of glycerol and caprylyl glycol. The composition comprises humectant at 0.5 to 15 %, preferably 1 to 10%, more preferably 1 to 8% by weight of the composition.

[0040] The composition comprises a sensory modifier selected from one or more of a modified starch, silica microsphere and a polymer of dimethicone / vinyldimethicone crosspolymer and silica.

[0041] Of these, one or both of silica microspheres and the polymer are most preferred to be included in the composition.

[0042] The polymer for use as a sensory modifier is preferably dimethicone / vinyldimethicone crosspolymer (and) silica. Dimethicone / Vinyl Dimethicone Crosspolymer (and) Silica is available as DOWSIL™9701 Cosmetic Powder from Dow Corning and is also known as DC 9701. Silica microsphere is available as MSS-500 / 3H from Kobo. Preferred modified starch is aluminium or sodium starch octenylsuccinate, more preferably aluminium starch octenylsuccinate. Aluminum Starch Octenylsuccinate is a chemically modified starch, in particular starches that have undergone esterification. Such aluminum starch Octenylsuccinate is commercially available from suppliers like Akzo Nobel or Nouryon under the names Dry Flo® Pure and Dry Flo® PC. A variety of other suppliers sell it under their own brand name. In cosmetics and personal care products, Aluminum Starch Octenylsuccinate is used in the formulation of lotions, powders, makeup and underarm deodorants. It is used as a thickener and binder, anticaking agent and oil absorbent. The composition may comprise aluminium starch octenylsuccinate which is further compounded with other ingredients to deliver other benefits, e.g. the ingredient having INCI name Aluminum Starch Octenylsuccinate (and) Acrylates Copolymer (and) Magnesium Carbonate may be included. It is available from Nouryon as NATRASORB® HFB. The natural content is 81% and the suggested applications include moisture resistant products, oil control products, anhydrous products, antiperspirant sticks, sunscreen, and dry shampoo for a variety of benefits including oil-absorption, mitigation of syneresis and fragrance-retention. The literature of the ingredient from Nouryon discloses that it is crosslinked aluminium starch octenyl succinate surface treated with acrylates copolymer and magnesium carbonate.

[0043] The sensory modifier is included in 0.5 to 10%, preferably 1 to 8%, more preferably 1 to 5% by weight of the composition. Of these, the polymer, when included is preferably at 0.2 to 3%, the silica microsphere when included is from 0.2 to 3% and the modified starch when included is from 0.5 to 4% by weight of the composition.

[0044] The composition comprises a vitamin B3 compound. Preferably, the vitamin B3 compound is selected from niacinamide, picolinamide, isonicotinamide, n-cyclopropyl niacinamide, n- cyclobutyl niacinamide, n-cyclopentyl niacinamide, n-cyclohexyl niacinamide and mixtures thereof. More preferably, the vitamin B3 compound is niacinamide, picolinamide, isonicotinamide and mixtures thereof. Even more preferably, the vitamin B3 compound is niacinamide.

[0045] The composition comprises a vitamin B3 compound in an amount from 0.01 to 10 wt%, preferably 0.1 to 9 wt%, preferably 0.5 to 8 wt%, preferably from 1 to 7 wt%, preferably from 2 to 6 wt%, preferably 3 to 5 wt% e.g. 4 wt%.

[0046] The composition further comprises an antioxidant selected from vitamin C or a derivative thereof such as sodium ascorbyl palmitate and sodium ascorbyl phosphate dilauryl thiodipropionate (Tinogard DA), pentaerythrityl tetra di-t-butyl hydroxyhydrocinnamate (Tinogard TT), tris(tetramethylhydroxypiperidinol) citrate (Tinogard Q) and mixtures thereof. More preferably, the antioxidant is selected from vitamin C or a derivative thereof such as sodium ascorbyl palmitate and sodium ascorbyl phosphate, dilauryl thiodipropionate and mixtures thereof. Even more preferably, the antioxidant selected is any one of sodium ascorbyl phosphate and dilauryl thiodipropionate or mixtures thereof.

[0047] The composition comprises 0.01 to 10 wt%, preferably 0.1 to 9 wt%, preferably 1 to 8 wt%, preferably 2 to 7 wt%, preferably 3 to 6 wt%, preferably 4 to 5 wt% of an antioxidant.

[0048] In the context of the gel composition of the present invention, ingredients like vitamin B3 compounds, due to water soluble nature, e.g. niacinamide (water solubility 1000 g / Liter at 20°C) are found in water phase of the composition. However, it was found that due to such highly water -soluble nature of such vitamin B3 compounds, the gel composition tended to develop coloration, i.e. it tended to result in loss of color stability, when such ingredients were incorporated in increased amounts in the gel disclosed in the prior art.

[0049] The present inventors found that when select antioxidants were added to the gel composition, it prevented the loos of color stability despite it contained water soluble compounds like vitamin B3 compounds viz. niacinamide, in increase amounts e.g. 3 wt%. It also resulted in providing reduction in reactive oxygen species that get generated due to external and / or internal factors like those mentioned earlier.

[0050] The composition of the invention is preferably substantially free of an emulsifier. Emulsifiers are generally surfactants or surface-active agents of anionic, nonionic, cationic and amphoteric type. A few examples include glyceryl stearate, glycol stearate and stearamide AMP. Accordingly, the composition is preferably substantially free of such emulsifiers. Preferably, by substantially free of an emulsifier is meant that the emulsifier is included in less than or equal to 2 wt%, more preferably less than 2 wt%, even more preferably less than 1.5 wt%, further more preferably less than 1 wt% and most preferably less than 0.5 wt%, ideally absent from the composition of the invention. Alternatively, the composition preferably comprises 0 to 2 wt%, more preferably from 0.1 to 1.5 wt%, even more preferably from 0.25 to 1 wt% and still more preferably from 0.5 to 0.75 wt% of an emulsifier.

[0051] It will be understood that the terms e.g. ‘substantially free of an emulsifier’ and ‘emulsifier free’ may be used interchangeably and they denote the same meaning. Accordingly, the composition is preferably an emulsifier-free gel composition comprising:

[0052] (i) 0.1 to 25 wt% oil-soluble sunscreen;

[0053] (ii) 0.1 to 5 wt% water-soluble sunscreen;

[0054] (iii) 0.25 to 5 wt% of a water phase thickener selected from one or both of a polysaccharide gum and a synthetic polymer selected from ammoniumacryloyldimethyltaurate / VP copolymer, and ammonium acryloyldimethyltaurate / beheneth-25 methacrylate crosspolymer;

[0055] (iv) 0.5 to 10% of an oil phase thickener selected from one or more of an ester of C18 to C36 fatty acid, ester of C8 to C16 fatty acid; polymeric oil phase thickener and particle selected from organically modified clay, hydrophobically modified fumed silica and aerogels,

[0056] (v) 0.5 to 15 wt% humectant selected from glycerol or a glycol; and

[0057] (vi) 0.5 to 10 wt% of a sensory modifier selected from one or more of a modified starch, silica microsphere and a polymer of dimethicone / vinyldimethicone crosspolymer and silica,

[0058] (vii) 0.01 to 10 wt% a vitamin B3 compound; and

[0059] (viii) 0.01 to 10 wt% an antioxidant selected from vitamin C or a derivative thereof such as sodium ascorbyl palmitate and sodium ascorbyl phosphate, dilauryl thiodipropionate and mixtures thereof.

[0060] Water is generally included in gel compositions as the cosmetically acceptable base. Water may be included in 10 to 70%, preferably 20 to 70%, furthermore preferably 20 to 65% by weight of the composition.

[0061] Preferably, the composition further comprises a moisturizing agent like hyaluronic acid. Hyaluronic acid may be added to the composition as sodium hyaluronate. Preferably hyaluronic acid may be added in amounts 0.1 to 10 wt%, preferably 1 to 8 wt%, preferably 2 to 6 wt%, preferably 3 to 5 wt%, in the composition of the present invention.

[0062] In addition to the ingredients disclosed earlier, the compositions, may and preferably do include other ingredients in order to perform one or more functions of this invention also include a cosmetically acceptable carrier. Emollient materials may serve as cosmetically acceptable carriers. These may be in the form of silicone oils, natural or synthetic esters, and hydrocarbons. Amounts of the emollients may range anywhere from 0.1 to 25 %, preferably between 1 and 10 % by weight of the composition. Silicone oils may be divided into the volatile and nonvolatile variety. The term "volatile" as used herein refers to those materials which have a measurable vapor pressure at ambient temperature. Volatile silicone oils are preferably chosen from cyclic (cyclomethicone) or linear polydimethylsiloxanes containing from 3 to 9, preferably from 5 to 6, silicon atoms.

[0063] Colorants, opacifiers and abrasives may also be included in compositions of the present invention. Each of these substances may range from 0.05 to 5 %, preferably between 0.1 and 3 % by weight of the composition.

[0064] The composition of the present invention provides in-vitro Sun Protection Factor (SPF) of preferably at least 30, more preferably at least 40 and even more preferably at least 50.

[0065] Further, the invention also relates to a method of providing photoprotection with a Sun Protection Factor (SPF) of at least 30 comprising a step of applying a composition of the invention on to the desired skin surface. Optionally, the method further comprises a step of washing off the composition applied in the previous step. If the method comprises the step of washing off the composition, then it is preferably carried out within 5 minutes, preferably within 4 minutes, preferably within 2 minutes, preferably within 1 minute e.g. 30 seconds, from the step of applying the composition.

[0066] The composition according to the invention is intended primarily as a product for topical application to human skin, especially as an agent for protecting from solar radiation, and preventing or reducing pigmentation, the appearance of wrinkled or aged skin, or age spots. Preferably, the method is cosmetic I non-therapeutic.

[0067] In use, a small quantity of the composition, for example from 1 to 5 ml, is applied to the skin, preferably to an area of the skin exposed to the sun or likely to get exposed to the sun, from a suitable container or applicator and, if necessary, it is then spread over and / or rubbed into the skin using the hand or fingers or a suitable device.

[0068] Accordingly, the present invention also relates to a use of the composition of the imnvention escribed hereinabove for providing photoprotection with a SPF of at least 30, preferably at least 40 and preferably at least 50. Preferably, the use is non-therapeutic I cosmetic.

[0069] While the above summarizes the present invention, it will become apparent to those skilled in the art that modifications, variations, and alterations may be made without deviating from the scope and spirit of the present invention as described and claimed herein. The invention will now be further illustrated in the following non-limiting examples.

[0070] Preparation of the control as well as those as per the present invention:

[0071] Briefly, the compositions shown in tables below were prepared as follows:

[0072] Glycerin, disodium EDTA, phenylbenzimidazole sulfonic acid (Ensulizole), sodium hydroxide (q.s. to pH 7), were added to water taken in a main vessel. The mixture was stirred until water phase become clear and heated to 70°C. Oil phase containing an oil phase thickener where applicable, caprylyl glycol, ethylhexyl salicylate, octocrylene, octyl methoxycinnamate (Parsol® MCX) and butyl methoxydibenzoylmethane (Parsol® 1789) were prepared in a separate beaker and heated to 70°C. Aristoflex AVC and Aristoflex HMB were added to the main vessel under homogenization. The water phase was allowed to become a clear gel. Thereafter, the oil phase was added to the main vessel under homogenization at 3500 rpm. The mixture was homogenized for 10 minutes followed by addition of xanthan gum which was pre-dispersed in 5 mL of water. DC 245 and where applicable MSS 500 / 3H were mixed and added into the main vessel and were mixed for 10 minutes. Where applicable, Dowsil 9701 was then added to the main vessel and mixing was continued. Once the main vessel reached below 40°C, ethyl alcohol, perfume, phenoxyethanol along with niacinamide and an antioxidant were added in the main vessel; and were mixed for 10 minutes. When the formulation attained room temperature and homogenous structure, it was removed from the homogenizer and stored in containers.

[0073] SPF measurements:

[0074] The invitro SPF and LIVAPF values for the samples shown in table 4 below were measured using the following procedure:

[0075] Thin film transmittance measurements were done using Labsphere’s Ultraviolet transmittance analyzer. In this study, 70 x 70 mm PMMA plate with ~6 pm roughness from Schonberg GmbH & Co were used. The percent transmittance of the various compositions was measured using a procedure as outlined below. 2 mg / cm2of sample was applied on PMMA plate, distributed uniformly using a syringe, and spread uniformly. The drying time for the PMMA plates was 30 minutes. After the drying time, sample plates were exposed to UV light and transmittance scan was recorded. This scan gives the transmittance as a function of wavelength (290 - 400 nm) for a given sample. For a single plate six to nine different spots were scanned. The same was repeated for 2 or 3 plates. The data reported is thus an average over 12 -18 readings. The reference transmittance scan was obtained using a blank plate, with no sample on the PMMA plates with glycerin spread on it. The transmittance values were used to arrive at the SPF values using the UV -2000s application provided with the instrument.

[0076] Percentage of transmittance (and therefore the SPF) was measured invitro SPF at zero time (line 0 min). Same plate was exposed to solar simulated light and % of transmittance measured at designated time intervals from 0 and 60 min. Average absorbance at 310 and 355 nm was recorded to measure % UVB & UVA photostability respectively. UV was generated using solar simulator (Atlas kW system) using irradiance of 550 W rrr2, at a distance of ~ 20 cm.

[0077] Color Stability:

[0078] The color stability was measured as follows:

[0079] Compositions in table 3 below were subjected to incubation at 45 to 50 °C using an incubator for a period ranging from 2 weeks to 3 months e.g. 1 month. Post desired incubation period, the color was measured using a chromameter and as presented by Hunter lab color space L*, a* and b* where, L* is black-white space, a* is green-red space, b* is blue-yellow space. The L*, a* and b* values of the compositions were also measured before the incubation. These values were used to calculate a change in color (denoted as Delta E (AE)). The lesser the AE, the more color stable is the composition.

[0080] Cell culture and exposure to UV light:

[0081] Keratinocytes (HaCaT cells) were seeded in 48-well plates at a density of 3.5 x 104cells / well and were maintained in the DMEM medium reconstituted as described above, for 24 to 48 h. The cells were exposed to UV light using a Solar simulator comprising a Xenon arc lamp, as required. Cells that were not exposed to UV, were used as control. Prior to exposure, compositions were applied evenly on PMMA plate (2 mg / cm2). Plates were incubated in 5% CC>2 / 37OC incubator for 6 h and post incubation, cells were harvested, and ROS levels were measured by DCFDA assay.

[0082] DCFDA assay:

[0083] Cells were exposed with and without UVA at 100 mJ / cm2and then incubated at 37°C in the CO2 incubator for 6 h. Post 6 h, cells were washed with 1X PBS and treated with media containing DCFDA reagent and incubated at 37°C in the CO2 incubator for 30 minutes. Then cells were washed with 1x PBS once followed by the addition of fresh PBS. The plates were then wrapped with aluminum foil and taken reading at an excitation wavelength of 485 nm and emission wavelength of 535 nm. The amount of ROS generated was calculated as percentage control after background subtraction.

[0084] The compositions as shown in table 1 were prepared as described earlier; and ROS generation was assessed as described earlier.

[0085] Table 1 : Control Compositions (example A and B), compositions as per the present invention (examples 1 and 2) and their ROS Data Further, additional compositions as shown in examples in table 2 below were prepared and their color stability was assessed as described earlier.

[0086] Table 2: Additional examples Table 3: Color stability

[0087] In vitro SPF obtained for compositions as shown in examples 1 to 6 was found to be in the range 75 to 85; and in-vitro ultraviolet A protection factor (LIVAPF) was found to be in the range 25 to 30 when measured as described earlier.

[0088] Table 4: Additional example

Claims

Claims1. A personal care composition comprising:(i) 0.1 to 25 wt% oil-soluble sunscreen,(ii) 0.1 to 5 wt% water-soluble sunscreen,(iii) 0.25 to 5 wt% of a water phase thickener selected from one or both of a polysaccharide gum and a synthetic polymer selected from ammoniumacryloyldimethyltaurate / VP copolymer, and ammonium acryloyldimethyltaurate / beheneth-25 methacrylate crosspolymer,(iv) 0.5 to 10% of an oil phase thickener selected from one or more of an ester of C18 to C36 fatty acid, ester of C8 to C16 fatty acid; polymeric oil phase thickener; and particle selected from organically modified clays, hydrophobically modified fumed silica and aerogels,(v) 0.5 to 15 wt% humectant selected from glycerol or a glycol,(vi) 0.5 to 10 wt% of a sensory modifier selected from one or more of a modified starch, silica microsphere and a polymer of dimethicone / vinyldimethicone crosspolymer and silica,(vii) 0.01 to 10 wt% a vitamin B3 compound; and(viii) 0.01 to 10 wt% an antioxidant selected from dilauryl thiodipropionate (Tinogard DA), pentaerythrityl tetra di-t-butyl hydroxyhydrocinnamate (Tinogard TT), tris(tetramethylhydroxypiperidinol) citrate (Tinogard Q), vitamin C or a derivative thereof selected from sodium ascorbyl palmitate and sodium ascorbyl phosphate and mixtures thereof.

2. A composition as claimed in claim 1 wherein said oil-soluble sunscreen is chosen from a UV-B sunscreen selected from one or more of octyl salicylate, 2-ethylhexyl 2-cyano-3,3- diphenyl-2-propenoate, and octylmethoxycinnamate; or a IIV-A sunscreen selected from a dibenzoylmethane compound.

3. A composition as claimed in claim 2 comprising 0.1 to 5 wt% oil-soluble UVA sunscreen.

4. A composition as claimed in claim 2 or 3 comprising 0.1 to 20 wt% oil-soluble UVB sunscreen.

5. A composition as claimed in any one of the preceding claims wherein said water-soluble sunscreen is chosen from one or both of 2-phenylbenzimidazole-5-sulfonic acid and di sodium phenyl dibenzimidazole tetra sulfonate.

6. A composition as claimed in any one of the preceding claims wherein the polysaccharide gum is xanthan gum.

7. A composition as claimed in any preceding claims wherein the glycol is selected from one or more of propylene glycol, butylene glycol and caprylyl glycol.

8. A composition as claimed in any one of the preceding claims wherein the sensory modifier is selected from one or both of silica microsphere and a polymer of dimethicone / vinyldimethicone crosspolymer and silica.

9. A composition as claimed in any one of the preceding claims comprising 10 to 70 wt% water.

10. A composition as claimed in any one of the preceding claims substantially free of an emulsifier.

11. A composition as claimed in any one of the preceding claims wherein the vitamin B3 compound is selected from 1 to 7 wt% niacinamide, picolinamide, isonicotinamide, n- cyclopropyl niacinamide, n-cyclobutyl niacinamide, n-cyclopentyl niacinamide, n- cyclohexyl niacinamide and mixture thereof.

12. A composition as claimed in any one of the preceding claims wherein the vitamin B3 compound selected is niacinamide.

13. A composition as claimed in any one of the preceding claims wherein the antioxidant is selected from vitamin C or a derivative thereof such as sodium ascorbyl palmitate and sodium ascorbyl phosphate, dilauryl thiodipropionate and mixtures thereof.

14. A composition as claimed in any one of the preceding claims wherein the composition further comprises hyaluronic acid or a salt thereof.

15. A method of providing photoprotection with a Sun Protection Factor (SPF) of at least 30 comprising a step of applying a composition as claimed in any one of the preceding claims on to the desired skin surface.

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