Label: STUDIO SCULPT SPF 15 FOUNDATION- octinoxate, titanium dioxide liquid
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Contains inactivated NDC Code(s)
NDC Code(s): 40046-0032-1, 40046-0032-2 - Packager: MAKE UP 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 February 28, 2010
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- ACTIVE INGREDIENT
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INACTIVE INGREDIENT
INACTIVE INGREDIENTS: WATER [] CYCLOPENTASILOXANE [] GLYCERIN [] BUTYLENE GLYCOL [] OCTYLDODECYL NEOPENTANOATE [] PEG/PPG-18/18 DIMETHICONE [] POLYMETHYLSILSESQUIOXANE [] ISOSTEARIC ACID [] C4-24 ALKYL DIMETHICONE/DIVINYLDIMETHICONE CROSSPOLYMER [] ISONONYL ISONONANOATE [] TAMARINDUS INDICA SEED EXTRACT [] TOCOPHEROL [] TOCOPHERYL ACETATE [] SODIUM HYALURONATE [] HABERLEA RHODOPENSIS LEAF EXTRACT [] BUTYROSPERMUM PARKII (SHEA BUTTER) [] YEAST EXTRACT\FAEX\EXTRAIT DE LEVURE [] QUERCUS SUBER BARK EXTRACT [] PHYTANTRIOL [] DEXTRIN PALMITATE [] DEXTRIN PALMITATE/ETHYLHEXANOATE [] CELLULOSE GUM [] TETRAHEXYLDECYL ASCORBATE [] XANTHAN GUM [] DIMETHICONE [] METHICONE [] PROPYLENE CARBONATE [] SODIUM CHLORIDE [] PALMITIC ACID [] POLYGLYCERYL-4 ISOSTEARATE [] CETYL PEG/PPG-10/1 DIMETHICONE [] HEXYL LAURATE [] POLYMETHYL METHACRYLATE [] OCTYLDODECYL PCA [] DISTEARDIMONIUM HECTORITE [] STEARIC ACID [] CAPRYLYL GLYCOL [] DIPROPYLENE GLYCOL [] PHENOXYETHANOL [] ALUMINUM STEARATE [] HEXYLENE GLYCOL [] [+/- MICA [] 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 SCULPT SPF 15 FOUNDATION
octinoxate, titanium dioxide liquidProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:40046-0032 Route of Administration TOPICAL Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength OCTINOXATE (UNII: 4Y5P7MUD51) (OCTINOXATE - UNII:4Y5P7MUD51) OCTINOXATE 7.0 mL in 100 mL TITANIUM DIOXIDE (UNII: 15FIX9V2JP) (TITANIUM DIOXIDE - UNII:15FIX9V2JP) TITANIUM DIOXIDE 2.0 mL in 100 mL Inactive Ingredients Ingredient Name Strength GLYCERIN (UNII: PDC6A3C0OX) CYCLOMETHICONE 5 (UNII: 0THT5PCI0R) WATER (UNII: 059QF0KO0R) BUTYLENE GLYCOL (UNII: 3XUS85K0RA) ISOSTEARIC ACID (UNII: X33R8U0062) TAMARINDUS INDICA SEED (UNII: 6AHP8A7OML) .ALPHA.-TOCOPHEROL ACETATE, DL- (UNII: WR1WPI7EW8) ALPHA-TOCOPHEROL, DL- (UNII: 7QWA1RIO01) HYALURONATE SODIUM (UNII: YSE9PPT4TH) SHEA BUTTER (UNII: K49155WL9Y) PHENOXYETHANOL (UNII: HIE492ZZ3T) FERRIC OXIDE RED (UNII: 1K09F3G675) FERRIC OXIDE YELLOW (UNII: EX438O2MRT) Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:40046-0032-1 1 in 1 CARTON 1 NDC:40046-0032-2 40 mL in 1 TUBE Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date OTC monograph not final part352 09/01/2008 Labeler - MAKE UP 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 Establishment Name Address ID/FEI Business Operations MANA COSMETICS INC 078870292 manufacture
