Label: THE TREATMENT POWDER FOUNDATION SPF 15- titanium dioxide, octinoxate powder

  • 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 14, 2011

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  • ACTIVE INGREDIENT

    ACTIVE INGREDIENTS: TITANIUM DIOXIDE, 4.9% [] OCTINOXATE 4.5%

  • INACTIVE INGREDIENT

    INACTIVE INGREDIENTS: TALC [] DIMETHICONE [] SILICA [] BORON NITRIDE [] OCTYLDODECYL STEAROYL STEARATE [] NYLON-12 [] POLYMETHYL METHACRYLATE [] YEAST EXTRACT\FAEX\EXTRAIT DE LEVURE [] POLYGLYCERYL-3 DIISOSTEARATE [] POLYPERFLUOROMETHYLISOPROPYL ETHER [] METHICONE [] MALACHITE [] TOURMALINE [] ZEOLITE [] CAPRYLYL GLYCOL [] ORYZANOL [] TOCOPHERYL ACETATE [] CALCIUM CARBONATE [] PENTAERYTHRITYL TETRA-DI-T-BUTYL HYDROXYHYDROCINNAMATE [] HEXYLENE GLYCOL [] PHENOXYETHANOL [] SORBIC ACID []  [+/- MICA [] BISMUTH OXYCHLORIDE (CI 77163) [] TITANIUM DIOXIDE (CI 77891) [] ZINC OXIDE (CI 77947) [] IRON OXIDES (CI 77491, CI 77492, CI 77499)]

  • WARNINGS

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

  • PRINCIPAL DISPLAY PANEL

    PRINCIPAL DISPLAY PANEL:


    skin color de la mer

    LA MER

    the treatment powder foundation

    spf 15



    nt wt. 0.35 oz./10 g


    MAX HUBER RESEARCH LABS INC DISTR.

    NEW YORK, NY 10022

    FOLDING CARTON


  • INGREDIENTS AND APPEARANCE
    THE TREATMENT POWDER FOUNDATION  SPF 15
    titanium dioxide, octinoxate powder
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:65966-111
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    TITANIUM DIOXIDE (UNII: 15FIX9V2JP) (TITANIUM DIOXIDE - UNII:15FIX9V2JP) TITANIUM DIOXIDE4.9 g  in 100 g
    OCTINOXATE (UNII: 4Y5P7MUD51) (OCTINOXATE - UNII:4Y5P7MUD51) OCTINOXATE4.5 g  in 100 g
    Inactive Ingredients
    Ingredient NameStrength
    TALC (UNII: 7SEV7J4R1U)  
    DIMETHICONE (UNII: 92RU3N3Y1O)  
    SILICON DIOXIDE (UNII: ETJ7Z6XBU4)  
    BORON NITRIDE (UNII: 2U4T60A6YD)  
    OCTYLDODECYL STEAROYL STEARATE (UNII: 3D47Q6D93C)  
    YEAST (UNII: 3NY3SM6B8U)  
    CUPRIC CARBONATE (UNII: 9AOA5F11GJ)  
    CAPRYLYL GLYCOL (UNII: 00YIU5438U)  
    GAMMA ORYZANOL (UNII: SST9XCL51M)  
    ALPHA-TOCOPHEROL ACETATE (UNII: 9E8X80D2L0)  
    CALCIUM CARBONATE (UNII: H0G9379FGK)  
    PENTAERYTHRITOL TETRAKIS(3-(3,5-DI-TERT-BUTYL-4-HYDROXYPHENYL)PROPIONATE) (UNII: 255PIF62MS)  
    HEXYLENE GLYCOL (UNII: KEH0A3F75J)  
    PHENOXYETHANOL (UNII: HIE492ZZ3T)  
    SORBIC ACID (UNII: X045WJ989B)  
    BISMUTH OXYCHLORIDE (UNII: 4ZR792I587)  
    ZINC OXIDE (UNII: SOI2LOH54Z)  
    FERROSOFERRIC OXIDE (UNII: XM0M87F357)  
    FERRIC OXIDE YELLOW (UNII: EX438O2MRT)  
    FERRIC OXIDE RED (UNII: 1K09F3G675)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:65966-111-011 in 1 CARTON
    1NDC:65966-111-0210 g in 1 JAR
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph not finalpart35201/01/2008
    Labeler - MAX HUBER RESEARCH LAB INC (926708694)
    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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