Label: VITAMIN E DAY SPF 15- octisalate, avobenzone cream
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Contains inactivated NDC Code(s)
NDC Code(s): 62874-005-01 - Packager: JO MALONE LTD
- 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 1, 2011
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- ACTIVE INGREDIENT
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INACTIVE INGREDIENT
INGREDIENTS: WATER [] DIMETHICONE [] BUTYLOCTYL SALICYLATE [] BUTYLENE GLYCOL [] POLYESTER-8 [] CETYL RICINOLEATE [] STEARETH-21 [] STEARETH-2 [] DI-C12-15 ALKYL FUMARATE [] CAPRYLIC/CAPRIC/MYRISTIC/STEARIC TRIGLYCERIDE [] POLYSILICONE-11 [] GENTIANA LUTEA (GENTIAN) ROOT EXTRACT [] POLYGONUM CUSPIDATUM ROOT EXTRACT [] HORDEUM VULGARE (BARLEY) EXTRACT\EXTRAIT D'ORGE [] TRITICUM VULGARE (WHEAT) GERM EXTRACT [] LAMINARIA OCHROLEUCA EXTRACT [] HYDROLYZED RICE EXTRACT [] FUMARIA OFFICINALIS FLOWER/LEAF/STEM EXTRACT [] CITRUS MEDICA LIMONUM (LEMON) FRUIT EXTRACT [] HYDROLYZED RICE BRAN EXTRACT [] ROSMARINUS OFFICINALIS (ROSEMARY) LEAF EXTRACT [] VITIS VINIFERA (GRAPE) SEED EXTRACT [] ARTEMIA EXTRACT [] THERMUS THERMOPHILLUS FERMENT [] STEARYL ALCOHOL [] PENTYLENE GLYCOL [] POLYQUATERNIUM-51 [] LAURYL PEG-9 POLYDIMETHYLSILOXYETHYL DIMETHICONE [] BEHENYL ALCOHOL [] TRIACONTANYL PVP [] GLYCERIN [] LECITHIN [] C12-15 ALKYL BENZOATE [] LINOLEIC ACID [] CAFFEINE [] CHOLESTEROL [] SQUALANE [] SODIUM PCA [] ACRYLIC ACID/VP CROSSPOLYMER [] UREA [] 1,2-HEXANEDIOL [] CAPRYLIC/CAPRIC TRIGLYCERIDE [] DIPROPYLENE GLYCOL DIBENZOATE [] TOCOPHERYL ACETATE [] TETRAHEXYLDECYL ASCORBATE [] SODIUM HYALURONATE [] PPG-15 STEARYL ETHER BENZOATE [] GLYCYRRHETINIC ACID [] TREHALOSE [] HYDROGENATED LECITHIN [] FUMARIC ACID [] PALMITOYL HYDROXYPROPYLTRIMONIUM AMYLOPECTIN/GLYCERIN CROSSPOLYMER [] CYCLODEXTRIN [] NORDIHYDROGUAIARETIC ACID [] ASCORBYL TOCOPHERYL MALEATE [] CAPRYLYL GLYCOL [] ERGOTHIONEINE [] SODIUM CHLORIDE [] FRAGRANCE (PARFUM) [] SODIUM HYDROXIDE [] CITRIC ACID [] ETHYLBISIMINOMETHYLGUAIACOL MANGANESE CHLORIDE [] DISODIUM EDTA [] PENTAERYTHRITYL TETRA-DI-T-BUTYL HYDROXYHYDROCINNAMATE [] SODIUM DEHYDROACETATE [] PHENOXYETHANOL
- WARNINGS
- PRINCIPAL DISPLAY PANEL
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INGREDIENTS AND APPEARANCE
VITAMIN E DAY SPF 15
octisalate, avobenzone creamProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:62874-005 Route of Administration TOPICAL Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength OCTISALATE (UNII: 4X49Y0596W) (OCTISALATE - UNII:4X49Y0596W) OCTISALATE 5.0 mL in 100 mL AVOBENZONE (UNII: G63QQF2NOX) (AVOBENZONE - UNII:G63QQF2NOX) AVOBENZONE 3.0 mL in 100 mL Inactive Ingredients Ingredient Name Strength WATER (UNII: 059QF0KO0R) DIMETHICONE (UNII: 92RU3N3Y1O) BUTYLOCTYL SALICYLATE (UNII: 2EH13UN8D3) POLYESTER-10 (UNII: 212N9O2MMZ) MEDIUM-CHAIN TRIGLYCERIDES (UNII: C9H2L21V7U) GENTIANA LUTEA ROOT (UNII: S72O3284MS) BARLEY (UNII: 5PWM7YLI7R) WHEAT GERM (UNII: YR3G369F5A) LAMINARIA OCHROLEUCA (UNII: 4R2124HE76) FUMARIA OFFICINALIS FLOWERING TOP (UNII: VH659J61ZL) LEMON (UNII: 24RS0A988O) RICE BRAN (UNII: R60QEP13IC) ROSEMARY (UNII: IJ67X351P9) VITIS VINIFERA SEED (UNII: C34U15ICXA) STEARYL ALCOHOL (UNII: 2KR89I4H1Y) PENTYLENE GLYCOL (UNII: 50C1307PZG) DOCOSANOL (UNII: 9G1OE216XY) GLYCERIN (UNII: PDC6A3C0OX) LECITHIN, SOYBEAN (UNII: 1DI56QDM62) ALKYL (C12-15) BENZOATE (UNII: A9EJ3J61HQ) LINOLEIC ACID (UNII: 9KJL21T0QJ) CAFFEINE (UNII: 3G6A5W338E) CHOLESTEROL (UNII: 97C5T2UQ7J) SQUALANE (UNII: GW89575KF9) SODIUM PYRROLIDONE CARBOXYLATE (UNII: 469OTG57A2) 1,2-HEXANEDIOL (UNII: TR046Y3K1G) .ALPHA.-TOCOPHEROL ACETATE, D- (UNII: A7E6112E4N) TETRAHEXYLDECYL ASCORBATE (UNII: 9LBV3F07AZ) HYALURONATE SODIUM (UNII: YSE9PPT4TH) ENOXOLONE (UNII: P540XA09DR) TREHALOSE (UNII: B8WCK70T7I) HYDROGENATED SOYBEAN LECITHIN (UNII: H1109Z9J4N) MASOPROCOL (UNII: 7BO8G1BYQU) CAPRYLYL GLYCOL (UNII: 00YIU5438U) ERGOTHIONEINE (UNII: BDZ3DQM98W) SODIUM CHLORIDE (UNII: 451W47IQ8X) SODIUM HYDROXIDE (UNII: 55X04QC32I) CITRIC ACID MONOHYDRATE (UNII: 2968PHW8QP) EDETATE DISODIUM (UNII: 7FLD91C86K) PENTAERYTHRITOL TETRAKIS(3-(3,5-DI-TERT-BUTYL-4-HYDROXYPHENYL)PROPIONATE) (UNII: 255PIF62MS) SODIUM DEHYDROACETATE (UNII: 8W46YN971G) PHENOXYETHANOL (UNII: HIE492ZZ3T) Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:62874-005-01 50 mL in 1 JAR Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date OTC monograph not final part352 05/01/2011 Labeler - JO MALONE LTD (347366049) 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