Label: STUDIO FIX FLUID SPF 15- octinoxate, titanium dioxide lotion
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Contains inactivated NDC Code(s)
NDC Code(s): 40046-0050-1, 40046-0050-2 - Packager: MAKEUP ART COSMETICS
- Category: HUMAN OTC DRUG LABEL
- DEA Schedule: None
- Marketing Status: OTC monograph not final
DISCLAIMER: Most OTC drugs are not reviewed and approved by FDA, however they may be marketed if they comply with applicable regulations and policies. FDA has not evaluated whether this product complies.
Drug Label Information
Updated August 26, 2011
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- ACTIVE INGREDIENT
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INACTIVE INGREDIENT
INACTIVE INGREDIENTS: WATER\AQUA\EAU [] CYCLOPENTASILOXANE [] PEG-10 DIMETHICONE [] BUTYLENE GLYCOL [] TRIMETHYLSILOXYSILICATE [] DIMETHICONE [] MAGNESIUM SULFATE [] LAMINARIA SACCHARINA EXTRACT [] ALGAE EXTRACT [] TOCOPHERYL ACETATE [] SODIUM HYALURONATE [] TOCOPHEROL [] LECITHIN [] HYDROGENATED LECITHIN [] XANTHAN GUM [] SORBITAN SESQUIOLEATE [] METHOXY AMODIMETHICONE/SILSESQUIOXANE COPOLYMER [] LAURETH-7 [] DIPROPYLENE GLYCOL [] DIMETHICONE/PEG-10/15 CROSSPOLYMER [] DIMETHICONE/PEG-10 CROSSPOLYMER [] PEG/PPG-18/18 DIMETHICONE [] DISTEARDIMONIUM HECTORITE [] SILICA [] DIMETHICONE CROSSPOLYMER [] TRIETHOXYCAPRYLYLSILANE [] PROPYLENE CARBONATE [] PENTAERYTHRITYL TETRA-DI-T-BUTYL HYDROXYHYDROCINNAMATE [] SORBIC ACID [] CHLOROXYLENOL [] PHENOXYETHANOL [] [+/- TITANIUM DIOXIDE (CI 77891) [] IRON OXIDES (CI 77491, CI 77492, CI 77499) [] CHROMIUM OXIDE GREENS (CI 77288)]
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INGREDIENTS AND APPEARANCE
STUDIO FIX FLUID SPF 15
octinoxate, titanium dioxide lotionProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:40046-0050 Route of Administration TOPICAL Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength OCTINOXATE (UNII: 4Y5P7MUD51) (OCTINOXATE - UNII:4Y5P7MUD51) OCTINOXATE 2.5 mL in 100 mL TITANIUM DIOXIDE (UNII: 15FIX9V2JP) (TITANIUM DIOXIDE - UNII:15FIX9V2JP) TITANIUM DIOXIDE 1 mL in 100 mL Inactive Ingredients Ingredient Name Strength WATER (UNII: 059QF0KO0R) CYCLOMETHICONE 5 (UNII: 0THT5PCI0R) BUTYLENE GLYCOL (UNII: 3XUS85K0RA) TRIMETHYLSILANE (UNII: 9L70DJH2K0) DIMETHICONE (UNII: 92RU3N3Y1O) MAGNESIUM SULFATE, UNSPECIFIED (UNII: DE08037SAB) SEAWEED (UNII: 477TV3P5UX) ALPHA-TOCOPHEROL ACETATE (UNII: 9E8X80D2L0) HYALURONATE SODIUM (UNII: YSE9PPT4TH) ALPHA-TOCOPHEROL (UNII: H4N855PNZ1) LECITHIN, SOYBEAN (UNII: 1DI56QDM62) HYDROGENATED SOYBEAN LECITHIN (UNII: H1109Z9J4N) XANTHAN GUM (UNII: TTV12P4NEE) SORBITAN SESQUIOLEATE (UNII: 0W8RRI5W5A) LAURETH-7 (UNII: Z95S6G8201) DIPROPYLENE GLYCOL (UNII: E107L85C40) SILICON DIOXIDE (UNII: ETJ7Z6XBU4) TRIETHOXYCAPRYLYLSILANE (UNII: LDC331P08E) PROPYLENE CARBONATE (UNII: 8D08K3S51E) PENTAERYTHRITOL TETRAKIS(3-(3,5-DI-TERT-BUTYL-4-HYDROXYPHENYL)PROPIONATE) (UNII: 255PIF62MS) SORBIC ACID (UNII: X045WJ989B) CHLOROXYLENOL (UNII: 0F32U78V2Q) PHENOXYETHANOL (UNII: HIE492ZZ3T) FERRIC OXIDE RED (UNII: 1K09F3G675) CHROMIC OXIDE (UNII: X5Z09SU859) Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:40046-0050-1 1 in 1 CARTON 1 NDC:40046-0050-2 30 mL in 1 BOTTLE Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date OTC monograph not final part352 12/01/2005 Labeler - MAKEUP ART COSMETICS (010597206) Establishment Name Address ID/FEI Business Operations ESTEE LAUDER COSMETICS, LTD 205952385 manufacture Establishment Name Address ID/FEI Business Operations ESTEE LAUDER N.V. 370151326 manufacture Establishment Name Address ID/FEI Business Operations Len-Ron Manufacturing Division of Aramis Inc. 809771152 manufacture Establishment Name Address ID/FEI Business Operations Aramis Inc. 042918826 manufacture Establishment Name Address ID/FEI Business Operations Northtec Bristol 949264774 manufacture, relabel, repack Establishment Name Address ID/FEI Business Operations Northtec Keystone 618107429 manufacture, relabel, repack Establishment Name Address ID/FEI Business Operations Estee Lauder Pennsylvania Distribution Center 2 828534516 manufacture, relabel, repack Establishment Name Address ID/FEI Business Operations Estee Lauder Cosmetics, Ltd. 255175580 manufacture Establishment Name Address ID/FEI Business Operations Estee Lauder Cosmetics, Ltd 253616536 manufacture Establishment Name Address ID/FEI Business Operations Estee Lauder Cosmetics Distribution Center 208579636 repack, relabel Establishment Name Address ID/FEI Business Operations Estee Lauder Kabushiki Kaisha 712808195 relabel, repack Establishment Name Address ID/FEI Business Operations Whitman Laboratories Ltd. 216866277 manufacture Establishment Name Address ID/FEI Business Operations Aveda Corporation 071352058 manufacture
