Label: YOUTH FULL TINTED MOISTURIZER SPF 15- octinoxate, titanium dioxide liquid

  • 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 7, 2011

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  • ACTIVE INGREDIENT

    ACTIVE INGREDIENTS: OCTINOXATE 7.50% [] TITANIUM DIOXIDE 3.00%

  • INACTIVE INGREDIENT

    INGREDIENTS: WATER [] PHENYL TRIMETHICONE [] BUTYLENE GLYCOL [] PENTAERYTHRITYL TETRAETHYLHEXANOATE [] SIMMONDSIA CHINENSIS (JOJOBA) SEED OIL [] PETROLATUM [] BIOSACCHARIDE GUM - 1 [] STEARETH-21 [] GLYCERYL STEARATE [] SODIUM HYALURONATE [] TOCOPHERYL ACETATE [] POLYMETHYL METHACRYLATE [] MAGNESIUM ALUMINUM SILICATE [] ETHYLHEXYLGLYCERIN [] CAPRYLYL GLYCOL [] CETYL ALCOHOL [] ACRYLAMIDE/SODIUM ACRYLOYLDIMETHYLTAURATE COPOLYMER [] PEG-12 DIMETHICONE [] ISOHEXADECANE [] LECITHIN [] ALUMINA [] XANTHAN GUM [] STEARETH-2 [] POTASSIUM STEARATE [] CITRIC ACID [] FRAGRANCE (PARFUM) [] LIMONENE [] LINALOOL [] BENZYL SALICYLATE [] POLYSORBATE 80 [] DISODIUM EDTA [] PHENOXYETHANOL [] SORBIC ACID []  [+/- 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:

    AMERICAN
    BEAUTY

    YOUTH-FULL

    SHEER COLOR

    TINTED MOISTURIZER

     SPF 15

    NT WT 1.7 OZ./ 50 ML






    AMERICAN BEAUTY COSMETICS, DIST
    NEW YORK, NY 10022

    FOLDING CARTON

  • INGREDIENTS AND APPEARANCE
    YOUTH FULL TINTED MOISTURIZER  SPF 15
    octinoxate, titanium dioxide liquid
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:68759-003
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    OCTINOXATE (UNII: 4Y5P7MUD51) (OCTINOXATE - UNII:4Y5P7MUD51) OCTINOXATE7.5 mL  in 100 mL
    TITANIUM DIOXIDE (UNII: 15FIX9V2JP) (TITANIUM DIOXIDE - UNII:15FIX9V2JP) TITANIUM DIOXIDE3 mL  in 100 mL
    Inactive Ingredients
    Ingredient NameStrength
    WATER (UNII: 059QF0KO0R)  
    PHENYL TRIMETHICONE (UNII: DR0K5NOJ4R)  
    BUTYLENE GLYCOL (UNII: 3XUS85K0RA)  
    JOJOBA OIL (UNII: 724GKU717M)  
    PETROLATUM (UNII: 4T6H12BN9U)  
    BIOSACCHARIDE GUM-1 (UNII: BB4PU4V09H)  
    STEARETH-21 (UNII: 53J3F32P58)  
    GLYCERYL MONOSTEARATE (UNII: 230OU9XXE4)  
    HYALURONATE SODIUM (UNII: YSE9PPT4TH)  
    ALPHA-TOCOPHEROL ACETATE (UNII: 9E8X80D2L0)  
    MAGNESIUM ALUMINUM SILICATE (UNII: 6M3P64V0NC)  
    ETHYLHEXYLGLYCERIN (UNII: 147D247K3P)  
    CAPRYLYL GLYCOL (UNII: 00YIU5438U)  
    CETYL ALCOHOL (UNII: 936JST6JCN)  
    ISOHEXADECANE (UNII: 918X1OUF1E)  
    LECITHIN, SOYBEAN (UNII: 1DI56QDM62)  
    ALUMINUM OXIDE (UNII: LMI26O6933)  
    XANTHAN GUM (UNII: TTV12P4NEE)  
    STEARETH-2 (UNII: V56DFE46J5)  
    POTASSIUM STEARATE (UNII: 17V812XK50)  
    CITRIC ACID MONOHYDRATE (UNII: 2968PHW8QP)  
    POLYSORBATE 80 (UNII: 6OZP39ZG8H)  
    EDETATE DISODIUM (UNII: 7FLD91C86K)  
    PHENOXYETHANOL (UNII: HIE492ZZ3T)  
    SORBIC ACID (UNII: X045WJ989B)  
    FERRIC OXIDE RED (UNII: 1K09F3G675)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:68759-003-011 in 1 CARTON
    1NDC:68759-003-0250 mL in 1 TUBE
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph not finalpart35211/01/2010
    Labeler - AMERICAN BEAUTY COSMETICS (143367634)
    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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