Label: RESILIENCE LIFT FIRMING SCULPTING FACE AND NECK SPF15 FOR DRY SKIN- ocinoxate 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: OCTINOXATE 7.50%

  • INACTIVE INGREDIENT

    INACTIVE INGREDIENTS: WATER\AQUA\EAU [] OLEA EUROPAEA (OLIVE) FRUIT OIL [] DIMETHICONE [] CETYL RICINOLEATE [] BUTYROSPERMUM PARKII (SHEA BUTTER) [] BUTYLENE GLYCOL [] PPG-51/SMDI COPOLYMER [] CETYL ESTERS [] METHYL GLUCETH-20 [] GLYCERETH-26 [] GLYCERYL STEARATE [] PENTYLENE GLYCOL [] PEG-100 STEARATE [] BEHENYL ALCOHOL [] OLEA EUROPAEA (OLIVE) FRUIT EXTRACT [] TRITICUM VULGARE (WHEAT BRAN) EXTRACT [] PERSEA GRATISSIMA (AVOCADO) OIL [] YEAST EXTRACT\FAEX\EXTRAIT DE LEVURE [] CUCUMIS MELO (MELON) FRUIT EXTRACT [] ALGAE EXTRACT [] MIMOSA TENUIFLORA BARK EXTRACT [] PLANKTON EXTRACT [] AMINOPROPYL ASCORBYL PHOSPHATE [] OCTYLDODECYL NEOPENTANOATE [] ACETYL GLUCOSAMINE [] ACETYL HEXAPEPTIDE-8 [] DECARBOXY CARNOSINE HCL [] ETHYLHEXYLGLYCERIN [] LINOLEIC ACID [] SODIUM HYALURONATE [] WHEY PROTEIN\LACTIS PROTEIN\PROTEINE DU PETIT-LAIT [] CAFFEINE [] TOCOPHERYL ACETATE [] THERMUS THERMOPHILLUS FERMENT [] SACCHAROMYCES FERMENT LYSATE FILTRATE [] SODIUM HYDROXIDE [] ERGOTHIONEINE [] POLYMETHYL METHACRYLATE [] ZINC PCA [] CHOLESTEROL/POTASSIUM SULFATE [] TREHALOSE [] ETHYLHEXYL HYDROXYSTEARATE [] SORBITOL [] SILICA [] LAMINARIA DIGITATA EXTRACT [] ALUMINA [] SIMETHICONE [] ACRYLAMIDE/SODIUM ACRYLOYLDIMETHYLTAURATE COPOLYMER [] HYDROGENATED STARCH HYDROLYSATE [] GLYCERIN [] MALACHITE [] CARBOMER [] CITRIC ACID [] MALTODEXTRIN [] PROPYLENE GLYCOL DICAPRYLATE [] ARTEMIA EXTRACT [] ISOHEXADECANE [] PHYTOSTEROLS [] ACRYLATES/C10-30 ALKYL ACRYLATE CROSSPOLYMER [] HEXYLENE GLYCOL [] STEARIC ACID [] XANTHAN GUM [] POLYSORBATE 80 [] FRAGRANCE (PARFUM) [] CAPRYLYL GLYCOL [] PENTAERYTHRITYL TETRA-DI-T-BUTYL HYDROXYHYDROCINNAMATE [] BHT [] POTASSIUM SORBATE [] SODIUM DEHYDROACETATE [] PHENOXYETHANOL [] MICA [] IRON OXIDES (CI 77491, CI 77492, CI 77499) [] TITANIUM DIOXIDE (CI 77891)

  • WARNINGS

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

  • PRINCIPAL DISPLAY PANEL

    PRINCIPAL DISPLAY PANEL:


    ESTEE LAUDER

    RESILIENCE LIFT

    FIRMING/SCULPTING FACE AND NECK

    LOTION

    SPF15

    FOR

    DRY SKIN

    NET WT. 1.7 OZ /50 ML



    ESTEE LAUDER, DISTR

    NEW YORK, NY 10022

    FOLDING CARTON

     

  • INGREDIENTS AND APPEARANCE
    RESILIENCE LIFT  FIRMING SCULPTING FACE AND NECK SPF15 FOR DRY SKIN
    ocinoxate cream
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:11559-012
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    OCTINOXATE (UNII: 4Y5P7MUD51) (OCTINOXATE - UNII:4Y5P7MUD51) OCTINOXATE7.5 mL  in 100 mL
    Inactive Ingredients
    Ingredient NameStrength
    WATER (UNII: 059QF0KO0R)  
    CETYL ETHYLHEXANOATE (UNII: 134647WMX4)  
    BUTYLENE GLYCOL (UNII: 3XUS85K0RA)  
    GLYCERYL MONOSTEARATE (UNII: 230OU9XXE4)  
    PEG-100 STEARATE (UNII: YD01N1999R)  
    OCTYLDODECYL NEOPENTANOATE (UNII: X8725R883T)  
    GLYCERIN (UNII: PDC6A3C0OX)  
    HYDROGENATED SOYBEAN LECITHIN (UNII: H1109Z9J4N)  
    PENTYLENE GLYCOL (UNII: 50C1307PZG)  
    DOCOSANOL (UNII: 9G1OE216XY)  
    SODIUM ALGINATE (UNII: C269C4G2ZQ)  
    AVOCADO OIL (UNII: 6VNO72PFC1)  
    MUSKMELON (UNII: ZV095H5633)  
    POTASSIUM HYDROXIDE (UNII: WZH3C48M4T)  
    MIMOSA TENUIFLORA BARK (UNII: 515MQE449I)  
    YEAST (UNII: 3NY3SM6B8U)  
    SACCHAROMYCES CEREVISIAE (UNII: 978D8U419H)  
    CHOLESTEROL (UNII: 97C5T2UQ7J)  
    POTASSIUM SULFATE (UNII: 1K573LC5TV)  
    N-ACETYLGLUCOSAMINE (UNII: V956696549)  
    LINOLEIC ACID (UNII: 9KJL21T0QJ)  
    LECITHIN, SOYBEAN (UNII: 1DI56QDM62)  
    WHEY (UNII: 8617Z5FMF6)  
    ALPHA-TOCOPHEROL ACETATE (UNII: 9E8X80D2L0)  
    CAFFEINE (UNII: 3G6A5W338E)  
    ERGOTHIONEINE (UNII: BDZ3DQM98W)  
    HYALURONATE SODIUM (UNII: YSE9PPT4TH)  
    STEARIC ACID (UNII: 4ELV7Z65AP)  
    ZINC PIDOLATE (UNII: C32PQ86DH4)  
    TREHALOSE (UNII: B8WCK70T7I)  
    SORBITOL (UNII: 506T60A25R)  
    ACETYL HEXAPEPTIDE-3 (UNII: L4EL31FWIL)  
    CITRIC ACID MONOHYDRATE (UNII: 2968PHW8QP)  
    PROPYLENE GLYCOL DICAPRYLATE (UNII: 581437HWX2)  
    MEDIUM-CHAIN TRIGLYCERIDES (UNII: C9H2L21V7U)  
    MALTODEXTRIN (UNII: 7CVR7L4A2D)  
    HEXYLENE GLYCOL (UNII: KEH0A3F75J)  
    ETHYLHEXYLGLYCERIN (UNII: 147D247K3P)  
    CAPRYLYL GLYCOL (UNII: 00YIU5438U)  
    CARBOMER HOMOPOLYMER TYPE C (UNII: 4Q93RCW27E)  
    SILICON DIOXIDE (UNII: ETJ7Z6XBU4)  
    ALUMINUM OXIDE (UNII: LMI26O6933)  
    XANTHAN GUM (UNII: TTV12P4NEE)  
    EDETATE DISODIUM (UNII: 7FLD91C86K)  
    BUTYLATED HYDROXYTOLUENE (UNII: 1P9D0Z171K)  
    PHENOXYETHANOL (UNII: HIE492ZZ3T)  
    POTASSIUM SORBATE (UNII: 1VPU26JZZ4)  
    SODIUM DEHYDROACETATE (UNII: 8W46YN971G)  
    MICA (UNII: V8A1AW0880)  
    FERRIC OXIDE RED (UNII: 1K09F3G675)  
    OLIVE OIL (UNII: 6UYK2W1W1E)  
    DIMETHICONE (UNII: 92RU3N3Y1O)  
    SHEA BUTTER (UNII: K49155WL9Y)  
    CETYL ESTERS WAX (UNII: D072FFP9GU)  
    METHYL GLUCETH-20 (UNII: J3QD0LD11P)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:11559-012-011 in 1 CARTON
    1NDC:11559-012-0250 mL in 1 JAR
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph not finalpart35209/01/2010
    Labeler - ESTEE LAUDER INC (005914387)
    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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