SUPERBALANCED MAKEUP SPF 15 MINERAL RICH FORMULA (TITANIUM DIOXIDE) POWDER [CLINIQUE LABORATORIES INC.]

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SUPERBALANCED MAKEUP SPF 15 MINERAL RICH FORMULA (TITANIUM DIOXIDE) POWDER [CLINIQUE LABORATORIES INC.]
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NDC 49527-746-01, 49527-746-02
Set ID b5ef5f9d-ef4f-4406-8f6e-b10e14ab6499
Category HUMAN OTC DRUG LABEL
Packager CLINIQUE LABORATORIES INC.
Generic Name
Product Class
Product Number
Application Number PART352
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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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