YOUTH FULL TINTED MOISTURIZER SPF 15 (OCTINOXATE, TITANIUM DIOXIDE) LIQUID [AMERICAN BEAUTY COSMETICS]

YOUTH FULL TINTED MOISTURIZER SPF 15 (OCTINOXATE, TITANIUM DIOXIDE) LIQUID [AMERICAN BEAUTY COSMETICS]
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NDC 68759-003-01, 68759-003-02
Set ID 74d28465-56a5-49c6-a49a-1ea42f4addf3
Category HUMAN OTC DRUG LABEL
Packager AMERICAN BEAUTY COSMETICS
Generic Name
Product Class
Product Number
Application Number PART352
  • 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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