Label: SELECT SPF 15 FOUNDATION- octinoxate 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 October 5, 2011

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  • ACTIVE INGREDIENT

    ACTIVE INGREDIENT: OCTINOXATE 7.50%

  • INACTIVE INGREDIENT

    INACTIVE INGREDIENTS: WATER [] DIMETHICONE [] PHENYL TRIMETHICONE [] TALC [] BUTYLENE GLYCOL [] POLYMETHYL METHACRYLATE [] POLYDECENE [] GLYCERYL DILAURATE [] CAPRYLYL GLYCOL [] TEA-ISOSTEARATE [] TEA-STEARATE [] KAOLIN [] TOCOPHERYL ACETATE [] ASCORBYL PALMITATE [] RETINYL PALMITATE [] HYDROGENATED LECITHIN [] PANTETHINE [] XANTHAN GUM [] CELLULOSE GUM [] TETRADIBUTYL PENTAERITHRITYL HYDROXYHYDROCINNAMATE [] HEXYLENE GLYCOL [] STEARETH-21 [] MAGNESIUM ALUMINUM SILICATE [] STEARETH-2 [] POLYPERFLUOROMETHYLISOPROPYL ETHER [] STEARYL ALCOHOL [] DISODIUM EDTA [] PHENOXYETHANOL []  [+/- TITANIUM DIOXIDE (CI 77891) [] IRON OXIDES (CI 77491, CI 77492, CI 77499) [] CHROMIUM OXIDE GREENS (CI 77288)]

  • WARNINGS

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

  • PRINCIPAL DISPLAY PANEL



    MAC

    SELECT

    SPF 15

    FOUNDATION



    1.0 FL/OZ/ 30 ML







    DISTR. MAKEUP ART COSMETICS
    ONTARIO, CANADA

    FOLDING CARTON

  • INGREDIENTS AND APPEARANCE
    SELECT  SPF 15 FOUNDATION
    octinoxate cream
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:40046-0052
    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)  
    DIMETHICONE (UNII: 92RU3N3Y1O)  
    PHENYL TRIMETHICONE (UNII: DR0K5NOJ4R)  
    TALC (UNII: 7SEV7J4R1U)  
    BUTYLENE GLYCOL (UNII: 3XUS85K0RA)  
    CAPRYLYL GLYCOL (UNII: 00YIU5438U)  
    TROLAMINE (UNII: 9O3K93S3TK)  
    STEARIC ACID (UNII: 4ELV7Z65AP)  
    KAOLIN (UNII: 24H4NWX5CO)  
    ALPHA-TOCOPHEROL ACETATE (UNII: 9E8X80D2L0)  
    ASCORBYL PALMITATE (UNII: QN83US2B0N)  
    VITAMIN A PALMITATE (UNII: 1D1K0N0VVC)  
    HYDROGENATED SOYBEAN LECITHIN (UNII: H1109Z9J4N)  
    PANTETHINE (UNII: 7K81IL792L)  
    XANTHAN GUM (UNII: TTV12P4NEE)  
    CARBOXYMETHYLCELLULOSE SODIUM (UNII: K679OBS311)  
    HEXYLENE GLYCOL (UNII: KEH0A3F75J)  
    STEARETH-21 (UNII: 53J3F32P58)  
    MAGNESIUM ALUMINUM SILICATE (UNII: 6M3P64V0NC)  
    STEARYL ALCOHOL (UNII: 2KR89I4H1Y)  
    EDETATE DISODIUM (UNII: 7FLD91C86K)  
    PHENOXYETHANOL (UNII: HIE492ZZ3T)  
    TITANIUM DIOXIDE (UNII: 15FIX9V2JP)  
    FERRIC OXIDE RED (UNII: 1K09F3G675)  
    CHROMIC OXIDE (UNII: X5Z09SU859)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:40046-0052-11 in 1 CARTON
    1NDC:40046-0052-230 mL in 1 BOTTLE
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph not finalpart35212/01/2001
    Labeler - MAKEUP ART COSMETICS (010597206)
    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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