Label: VITAMIN E DAY SPF 15- octisalate, avobenzone cream

  • 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

    ACTIVE INGREDIENTS: OCTISALATE 5.00% [] AVOBENZONE 3.00%

  • 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

    WARNING: KEEP OUT OF EYES. STOP USE IF IRRITATION OCCURS. KEEP OUT OF REACH OF CHILDREN.

  • PRINCIPAL DISPLAY PANEL

    PRINCIPAL DISPLAY PANEL:


    JO MALONE

    VITAMIN E DAY CREAM



    NET WT. 1.7 OZ/50ML



    DISTR JO MALONE LTD

    LONDON, ENGLAND W1K 3BQ



    labels

  • INGREDIENTS AND APPEARANCE
    VITAMIN E DAY  SPF 15
    octisalate, avobenzone cream
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:62874-005
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    OCTISALATE (UNII: 4X49Y0596W) (OCTISALATE - UNII:4X49Y0596W) OCTISALATE5.0 mL  in 100 mL
    AVOBENZONE (UNII: G63QQF2NOX) (AVOBENZONE - UNII:G63QQF2NOX) AVOBENZONE3.0 mL  in 100 mL
    Inactive Ingredients
    Ingredient NameStrength
    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 CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:62874-005-0150 mL in 1 JAR
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph not finalpart35205/01/2011
    Labeler - JO MALONE LTD (347366049)
    Establishment
    NameAddressID/FEIBusiness Operations
    ESTEE LAUDER COSMETICS, LTD205952385manufacture
    Establishment
    NameAddressID/FEIBusiness Operations
    ESTEE LAUDER N.V.370151326manufacture
    Establishment
    NameAddressID/FEIBusiness Operations
    Len-Ron Manufacturing Division of Aramis Inc.809771152manufacture
    Establishment
    NameAddressID/FEIBusiness Operations
    Aramis Inc.042918826manufacture
    Establishment
    NameAddressID/FEIBusiness Operations
    Northtec Bristol949264774manufacture, relabel, repack
    Establishment
    NameAddressID/FEIBusiness Operations
    Northtec Keystone618107429manufacture, relabel, repack
    Establishment
    NameAddressID/FEIBusiness Operations
    Estee Lauder Pennsylvania Distribution Center 2828534516manufacture, relabel, repack
    Establishment
    NameAddressID/FEIBusiness Operations
    Estee Lauder Cosmetics, Ltd.255175580manufacture
    Establishment
    NameAddressID/FEIBusiness Operations
    Estee Lauder Cosmetics, Ltd253616536manufacture
    Establishment
    NameAddressID/FEIBusiness Operations
    Estee Lauder Cosmetics Distribution Center208579636repack, relabel
    Establishment
    NameAddressID/FEIBusiness Operations
    Estee Lauder Kabushiki Kaisha712808195relabel, repack
    Establishment
    NameAddressID/FEIBusiness Operations
    Whitman Laboratories Ltd.216866277manufacture
    Establishment
    NameAddressID/FEIBusiness Operations
    Aveda Corporation071352058manufacture
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