Label: DAYWEAR ADVANCED MULTIPROTECTION ANTIOXIDANT CREME SPF 15 FOR NORMAL COMBINATION SKIN- octisalate and avobenzone cream

  • NDC Code(s): 11559-009-01, 11559-009-02
  • Packager: ESTEE LAUDER INC
  • Category: HUMAN OTC DRUG LABEL
  • DEA Schedule: None
  • Marketing Status: OTC monograph not final

NOTE: Most over the counter (OTC) are not reviewed and approved by the 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 04/11

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  • ACTIVE INGREDIENT

    ACTIVE INGREDIENTS: OCTISALATE 5.00% [] AVOBENZONE 3.00%

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  • INACTIVE INGREDIENT

    INACTIVE INGREDIENTS: WATER\AQUA\EAU [] 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 [] PSIDIUM GUAJAVA (GUAVA) FRUIT EXTRACT [] GENTIANA LUTEA (GENTIAN) ROOT EXTRACT [] POLYGONUM CUSPIDATUM ROOT EXTRACT [] STEARYL ALCOHOL [] HORDEUM VULGARE (BARLEY) EXTRACT\EXTRAIT D'ORGE [] LAMINARIA OCHROLEUCA EXTRACT [] ROSMARINUS OFFICINALIS (ROSEMARY) LEAF EXTRACT [] TRITICUM VULGARE (WHEAT) GERM EXTRACT [] ARTEMIA EXTRACT [] FUMARIA OFFICINALIS FLOWER/LEAF/STEM EXTRACT [] CAFFEINE [] PENTYLENE GLYCOL [] CITRUS MEDICA LIMONUM (LEMON) FRUIT EXTRACT [] HYDROLYZED RICE EXTRACT [] VITIS VINIFERA (GRAPE) SEED EXTRACT [] HYDROLYZED RICE BRAN EXTRACT [] LAURYL PEG-9 POLYDIMETHYLSILOXYETHYL DIMETHICONE [] THERMUS THERMOPHILLUS FERMENT [] BEHENYL ALCOHOL [] ACRYLIC ACID/VP CROSSPOLYMER [] TRIACONTANYL PVP [] GLYCERIN [] C12-15 ALKYL BENZOATE [] LINOLEIC ACID [] CHOLESTEROL [] SQUALANE [] SODIUM PCA [] 1,2-HEXANEDIOL [] UREA [] CAPRYLIC/CAPRIC TRIGLYCERIDE [] DIPROPYLENE GLYCOL DIBENZOATE [] TOCOPHERYL ACETATE [] TETRAHEXYLDECYL ASCORBATE [] SODIUM HYALURONATE [] ERGOTHIONEINE [] PPG-15 STEARYL ETHER BENZOATE [] GLYCYRRHETINIC ACID [] TREHALOSE [] POLYQUATERNIUM-51 [] LECITHIN [] HYDROGENATED LECITHIN [] FUMARIC ACID [] PALMITOYL HYDROXYPROPYLTRIMONIUM AMYLOPECTIN/GLYCERIN CROSSPOLYMER [] CAPRYLYL GLYCOL [] CYCLODEXTRIN [] SODIUM HYDROXIDE [] NORDIHYDROGUAIARETIC ACID [] SODIUM CHLORIDE [] ASCORBYL TOCOPHERYL MALEATE [] FRAGRANCE (PARFUM) [] CITRIC ACID [] ETHYLBISIMINOMETHYLGUAIACOL MANGANESE CHLORIDE [] PENTAERYTHRITYL TETRA-DI-T-BUTYL HYDROXYHYDROCINNAMATE [] DISODIUM EDTA [] SODIUM DEHYDROACETATE [] PHENOXYETHANOL [] BUTYLPHENYL METHYLPROPIONAL [] HYDROXYISOHEXYL 3-CYCLOHEXENE CARBOXALDEHYDE [] BENZYL SALICYLATE [] LINALOOL [] BLUE 1 (CI 42090) [] YELLOW 5 (CI 19140) [] CHROMIUM HYDROXIDE GREEN (CI 77289)

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  • WARNINGS


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

    KEEP OUT OF REACH OF CHILDREN.

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  • PRINCIPAL DISPLAY PANEL

    PRINCIPAL DISPLAY PANEL

    ESTEE LAUDER

    DAYWEAR

    ADVANCED MULTI-PROTECTION
    ANTIOXIDANT CREME
    SPF 15
    FOR NORMAL COMBINATION SKIN



    1.7  OZ /50 ML

    ESTEE LAUDER DISTR
    NEW YORK, NY 10022



    FOLDING CARTON



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  • INGREDIENTS AND APPEARANCE
    DAYWEAR  ADVANCED MULTIPROTECTION ANTIOXIDANT CREME SPF 15 FOR NORMAL COMBINATION SKIN
    octisalate, avobenzone cream
    Product Information
    Product Type HUMAN OTC DRUG LABEL Item Code (Source) NDC:11559-009
    Route of Administration TOPICAL DEA Schedule     
    Active Ingredient/Active Moiety
    Ingredient Name Basis of Strength Strength
    OCTISALATE (OCTISALATE) OCTISALATE 5.0 mL  in 100 mL
    AVOBENZONE (AVOBENZONE) AVOBENZONE 3.0 mL  in 100 mL
    Inactive Ingredients
    Ingredient Name Strength
    WATER  
    BUTYLENE GLYCOL  
    DIMETHICONE  
    GLYCERIN  
    CHOLESTEROL  
    SQUALANE  
    CITRIC ACID MONOHYDRATE  
    LECITHIN, SOYBEAN  
    BUTYLATED HYDROXYTOLUENE  
    PHENOXYETHANOL  
    Packaging
    # Item Code Package Description Marketing Start Date Marketing End Date
    1 NDC:11559-009-01 1 in 1 CARTON
    1 NDC:11559-009-02 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 09/01/2010
    Labeler - ESTEE LAUDER INC (005914387)
    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
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