Label: STUDIO MOISTURE FIX SPF 15- zinc oxide, octinoxate lotion
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Contains inactivated NDC Code(s)
NDC Code(s): 40046-0046-1, 40046-0046-2 - 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 July 15, 2011
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- ACTIVE INGREDIENT
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INACTIVE INGREDIENT
INACTIVE INGREDIENTS: WATER [] DIMETHICONE [] C12-15 ALKYL BENZOATE [] BUTYLENE GLYCOL [] SILICA [] ISONONYL ISONONANOATE [] GLYCERIN [] TOCOPHERYL ACETATE [] CHOLESTEROL [] ASTROCARYUM MURUMURU BUTTER [] CAFFEINE [] SODIUM RNA [] SODIUM HYALURONATE [] PHYTOSPHINGOSINE [] HORDEUM VULGARE (BARLEY) EXTRACT\EXTRAIT D'ORGE [] PORIA COCOS SCLEROTIUM EXTRACT [] THERMUS THERMOPHILLUS FERMENT [] POLYGONUM CUSPIDATUM ROOT EXTRACT [] SACCHAROMYCES LYSATE EXTRACT [] YEAST EXTRACT\FAEX\EXTRAIT DE LEVURE [] TRITICUM VULGARE (WHEAT) GERM EXTRACT [] SUCROSE [] MAGNESIUM ASCORBYL PHOSPHATE [] POLYSORBATE 20 [] SQUALANE [] POLYSORBATE 80 [] GLYCERYL STEARATE [] PEG-100 STEARATE [] STEARETH-21 [] PVP [] SODIUM CITRATE [] CITRIC ACID [] DISTEARDIMONIUM HECTORITE [] CETYL ESTERS [] HEXYLENE GLYCOL [] POLYETHYLENE [] POLYHYDROXYSTEARIC ACID [] ACRYLAMIDE/SODIUM ACRYLOYLDIMETHYLTAURATE COPOLYMER [] AMMONIUM ACRYLOYLDIMETHYLTAURATE/VP COPOLYMER [] ISOHEXADECANE [] CAPRYLYL GLYCOL [] TRIETHOXYCAPRYLYLSILANE [] LINOLEIC ACID [] DISODIUM EDTA [] PROPYLENE GLYCOL DICAPRATE [] FRAGRANCE (PARFUM) [] BHT [] PHENOXYETHANOL [] CHLORPHENESIN
- WHEN USING
- WARNINGS
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INGREDIENTS AND APPEARANCE
STUDIO MOISTURE FIX SPF 15
zinc oxide, octinoxate lotionProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:40046-0046 Route of Administration TOPICAL Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength ZINC OXIDE (UNII: SOI2LOH54Z) (ZINC OXIDE - UNII:SOI2LOH54Z) ZINC OXIDE 6.7 mL in 100 mL OCTINOXATE (UNII: 4Y5P7MUD51) (OCTINOXATE - UNII:4Y5P7MUD51) OCTINOXATE 3.5 mL in 100 mL Inactive Ingredients Ingredient Name Strength WATER (UNII: 059QF0KO0R) DIMETHICONE (UNII: 92RU3N3Y1O) ALKYL (C12-15) BENZOATE (UNII: A9EJ3J61HQ) BUTYLENE GLYCOL (UNII: 3XUS85K0RA) SILICON DIOXIDE (UNII: ETJ7Z6XBU4) ISONONYL ISONONANOATE (UNII: S4V5BS6GCX) GLYCERIN (UNII: PDC6A3C0OX) ALPHA-TOCOPHEROL ACETATE (UNII: 9E8X80D2L0) CHOLESTEROL (UNII: 97C5T2UQ7J) ASTROCARYUM MURUMURU SEED BUTTER (UNII: 12V64UPU6R) CAFFEINE (UNII: 3G6A5W338E) HYALURONATE SODIUM (UNII: YSE9PPT4TH) BARLEY (UNII: 5PWM7YLI7R) FU LING (UNII: XH37TWY5O4) POLYGONUM CUSPIDATUM ROOT (UNII: 7TRV45YZF7) SACCHAROMYCES CEREVISIAE (UNII: 978D8U419H) YEAST (UNII: 3NY3SM6B8U) WHEAT GERM (UNII: YR3G369F5A) SUCROSE (UNII: C151H8M554) MAGNESIUM ASCORBYL PHOSPHATE (UNII: 0R822556M5) POLYSORBATE 20 (UNII: 7T1F30V5YH) SQUALANE (UNII: GW89575KF9) POLYSORBATE 80 (UNII: 6OZP39ZG8H) GLYCERYL MONOSTEARATE (UNII: 230OU9XXE4) PEG-100 STEARATE (UNII: YD01N1999R) STEARETH-21 (UNII: 53J3F32P58) POVIDONE K17 (UNII: C67P1734QJ) SODIUM CITRATE (UNII: 1Q73Q2JULR) CITRIC ACID MONOHYDRATE (UNII: 2968PHW8QP) CETYL ESTERS WAX (UNII: D072FFP9GU) HEXYLENE GLYCOL (UNII: KEH0A3F75J) POLYHYDROXYSTEARIC ACID (2300 MW) (UNII: YXH47AOU0F) ISOHEXADECANE (UNII: 918X1OUF1E) CAPRYLYL GLYCOL (UNII: 00YIU5438U) TRIETHOXYCAPRYLYLSILANE (UNII: LDC331P08E) LINOLEIC ACID (UNII: 9KJL21T0QJ) EDETATE DISODIUM (UNII: 7FLD91C86K) PROPYLENE GLYCOL DICAPRATE (UNII: U783H9JHWY) BUTYLATED HYDROXYTOLUENE (UNII: 1P9D0Z171K) PHENOXYETHANOL (UNII: HIE492ZZ3T) CHLORPHENESIN (UNII: I670DAL4SZ) Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:40046-0046-1 1 in 1 CARTON 1 NDC:40046-0046-2 50 mL in 1 BOTTLE Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date OTC monograph not final part352 09/01/2006 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
