Label: SUPERBALANCED MAKEUP SPF 15 MINERAL RICH FORMULA- titanium dioxide 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 September 13, 2011

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  • ACTIVE INGREDIENT

     active ingredient: titanium dioxide 6.30%

  • INACTIVE INGREDIENT

    inactive ingredients: talc [] mica [] octyldodecyl stearoyl stearate [] zinc stearate [] zinc laurate [] dimethicone [] bentonite [] hdi/trimethylol hexyllactone crosspolymer [] silica [] hydrolyzed soy protein [] glycerin [] lauroyl lysine [] astrocaryum murumuru seed butter [] squalane [] cetearyl dimethicone crosspolymer [] lecithin [] triethoxycaprylylsilane [] tocopheryl acetate [] tetrahexyldecyl ascorbate [] magnesium myristate [] coconut acid [] water\aqua\eau [] tetrasodium edta [] chlorphenesin [] potassium sorbate []  [+/- titanium dioxide (ci 77891) [] iron oxides (ci 77491, ci 77492, ci 77499) [] bismuth oxychloride (ci 77163)

  • WARNINGS AND PRECAUTIONS

    warning: keep out of eyes. stop use if irritation occurs. keep out of reach of children.

  • PRINCIPAL DISPLAY PANEL

    clinique

    superbalanced powder makeup
    spf 15

    mineral-rich formula




    net wt. 0.63 oz/ 18g


    clinique laboratories distr.
    new york, ny 10022

    folding carton

  • INGREDIENTS AND APPEARANCE
    SUPERBALANCED  MAKEUP SPF 15 MINERAL RICH FORMULA
    titanium dioxide powder
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:49527-746
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    TITANIUM DIOXIDE (UNII: 15FIX9V2JP) (TITANIUM DIOXIDE - UNII:15FIX9V2JP) TITANIUM DIOXIDE6.3 g  in 100 g
    Inactive Ingredients
    Ingredient NameStrength
    TALC (UNII: 7SEV7J4R1U)  
    MICA (UNII: V8A1AW0880)  
    OCTYLDODECYL STEAROYL STEARATE (UNII: 3D47Q6D93C)  
    ZINC STEARATE (UNII: H92E6QA4FV)  
    ZINC LAURATE (UNII: 4YOP58Y695)  
    DIMETHICONE (UNII: 92RU3N3Y1O)  
    BENTONITE (UNII: A3N5ZCN45C)  
    SILICON DIOXIDE (UNII: ETJ7Z6XBU4)  
    GLYCERIN (UNII: PDC6A3C0OX)  
    LAUROYL LYSINE (UNII: 113171Q70B)  
    ASTROCARYUM MURUMURU SEED BUTTER (UNII: 12V64UPU6R)  
    SQUALANE (UNII: GW89575KF9)  
    LECITHIN, SOYBEAN (UNII: 1DI56QDM62)  
    TRIETHOXYCAPRYLYLSILANE (UNII: LDC331P08E)  
    ALPHA-TOCOPHEROL ACETATE (UNII: 9E8X80D2L0)  
    TETRAHEXYLDECYL ASCORBATE (UNII: 9LBV3F07AZ)  
    MAGNESIUM MYRISTATE (UNII: Z1917F0578)  
    COCONUT ACID (UNII: 40U37V505D)  
    WATER (UNII: 059QF0KO0R)  
    EDETATE SODIUM (UNII: MP1J8420LU)  
    CHLORPHENESIN (UNII: I670DAL4SZ)  
    POTASSIUM SORBATE (UNII: 1VPU26JZZ4)  
    FERRIC OXIDE RED (UNII: 1K09F3G675)  
    BISMUTH OXYCHLORIDE (UNII: 4ZR792I587)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:49527-746-011 in 1 CARTON
    1NDC:49527-746-0218 g in 1 JAR
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph not finalpart35204/01/2010
    Labeler - CLINIQUE LABORATORIES INC. (173047747)
    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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