Label: MOISTURE RICH FOUNDATION SPF 15- octinoxate lipstick

  • 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 September 23, 2011

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  • ACTIVE INGREDIENT

    ACTIVE INGREDIENT: OCTINOXATE 2.2%

  • INACTIVE INGREDIENT


    INACTIVE INGREDIENTS: WATER\AQUA\EAU [] PHENYL TRIMETHICONE [] CAPRYLYL METHICONE [] DIMETHICONE [] BUTYLENE GLYCOL [] CAPRYLIC/CAPRIC TRIGLYCERIDE [] ISOCETYL ALCOHOL [] ISOHEXADECANE [] WHEAT GERM GLYCERIDES [] PEG/PPG-18/18 DIMETHICONE [] MAGNESIUM SULFATE [] PEG-10 DIMETHICONE [] PEG-10 DIMETHICONE CROSSPOLYMER [] TOCOPHERYL ACETATE [] DISTEARDIMONIUM HECTORITE [] CETYL PEG/PPG-10/1 DIMETHICONE [] SIMMONDSIA CHINENSIS (JOJOBA) SEED OIL [] SODIUM HYALURONATE [] ASCORBYL PALMITATE [] CHOLESTEROL [] LINOLEIC ACID [] HYDROGENATED LECITHIN [] LAVANDULA ANGUSTIFOLIA (LAVENDER) [] TRIETHYL CITRATE [] HDI/TRIMETHYLOL HEXYLLACTONE CROSSPOLYMER [] PROPYLENE CARBONATE [] SORBITAN STEARATE [] LAURETH-7 [] XANTHAN GUM [] TRIETHOXYCAPRYLYLSILANE [] LECITHIN [] SILICA [] LINALOOL [] PHENOXYETHANOL [] CHLOROXYLENOL []  [+/- TITANIUM DIOXIDE (CI 77891) [] IRON OXIDES (CI 77491, CI 77492, CI 77499) [] MICA]

  • WARNINGS

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

  • PRINCIPAL DISPLAY PANEL

    PRINCIPAL DISPLAY PANEL:


    BOBBI BROWN

    MOISTURE RICH FOUNDATION

    SPF 15



    30 ML/ 1 FL OZ LIQ



    DISTR BOBBI BROWN COSMETICS INC

    NEW YORK, NY 10022

    FOLDING CARTON


  • INGREDIENTS AND APPEARANCE
    MOISTURE RICH FOUNDATION  SPF 15
    octinoxate lipstick
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:64141-704
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    OCTINOXATE (UNII: 4Y5P7MUD51) (OCTINOXATE - UNII:4Y5P7MUD51) OCTINOXATE2.2 mL  in 100 mL
    Inactive Ingredients
    Ingredient NameStrength
    WATER (UNII: 059QF0KO0R)  
    PHENYL TRIMETHICONE (UNII: DR0K5NOJ4R)  
    DIMETHICONE (UNII: 92RU3N3Y1O)  
    BUTYLENE GLYCOL (UNII: 3XUS85K0RA)  
    MEDIUM-CHAIN TRIGLYCERIDES (UNII: C9H2L21V7U)  
    ISOCETYL ALCOHOL (UNII: 1800H64066)  
    ISOHEXADECANE (UNII: 918X1OUF1E)  
    WHEAT GERM (UNII: YR3G369F5A)  
    MAGNESIUM SULFATE, UNSPECIFIED (UNII: DE08037SAB)  
    ALPHA-TOCOPHEROL ACETATE (UNII: 9E8X80D2L0)  
    JOJOBA OIL (UNII: 724GKU717M)  
    HYALURONATE SODIUM (UNII: YSE9PPT4TH)  
    ASCORBYL PALMITATE (UNII: QN83US2B0N)  
    CHOLESTEROL (UNII: 97C5T2UQ7J)  
    LINOLEIC ACID (UNII: 9KJL21T0QJ)  
    HYDROGENATED SOYBEAN LECITHIN (UNII: H1109Z9J4N)  
    LAVANDULA ANGUSTIFOLIA FLOWER (UNII: 19AH1RAF4M)  
    TRIETHYL CITRATE (UNII: 8Z96QXD6UM)  
    PROPYLENE CARBONATE (UNII: 8D08K3S51E)  
    SORBITAN MONOSTEARATE (UNII: NVZ4I0H58X)  
    LAURETH-7 (UNII: Z95S6G8201)  
    XANTHAN GUM (UNII: TTV12P4NEE)  
    TRIETHOXYCAPRYLYLSILANE (UNII: LDC331P08E)  
    LECITHIN, SOYBEAN (UNII: 1DI56QDM62)  
    SILICON DIOXIDE (UNII: ETJ7Z6XBU4)  
    PHENOXYETHANOL (UNII: HIE492ZZ3T)  
    CHLOROXYLENOL (UNII: 0F32U78V2Q)  
    TITANIUM DIOXIDE (UNII: 15FIX9V2JP)  
    FERRIC OXIDE RED (UNII: 1K09F3G675)  
    MICA (UNII: V8A1AW0880)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:64141-704-011 in 1 CARTON
    1NDC:64141-704-0230 mL in 1 BOTTLE
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph not finalpart35210/01/2000
    Labeler - Bobbi Brown Professional Cosmetics Inc. (627131279)
    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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