Label: COVER YOUR MOUTH SPF 8 LIP PROTECTOR- titanium dioxide lipstick

  • Category: HUMAN OTC DRUG LABEL

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Drug Label Information

Updated July 27, 2011

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  • ACTIVE INGREDIENT

    active ingredient: titanium dioxide 1.80%

  • INACTIVE INGREDIENT

    inactive ingredients: canola oil [] beeswax (cera alba) [] lecithin [] mentha piperita (peppermint) essential oil (olea) [] cocos nucifera (coconut) oil [] vanilla planifolia [] aloe barbadensis (aloe) leaf juice [] lauroyl lysine [] tocopherol (vitamin e) [] aluminum stearate [] stearic acid

  • WARNINGS

    warning: stop use if signs of irritation appear and check with doctor.

  • PRINCIPAL DISPLAY PANEL

    PRINCIPAL DISPLAY PANEL


    ORIGINS

    COVER YOUR MOUTH

    LIP PROTECTOR

    WITH SPF 8

    NT WT 0.15 OZ./ 4.5 G



    origins natural resources inc.
    new york, ny 10022


    FOLDING CARTON

  • INGREDIENTS AND APPEARANCE
    COVER YOUR MOUTH  SPF 8 LIP PROTECTOR
    titanium dioxide lipstick
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:59427-575
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    TITANIUM DIOXIDE (UNII: 15FIX9V2JP) (TITANIUM DIOXIDE - UNII:15FIX9V2JP) TITANIUM DIOXIDE1.8 g  in 100 g
    Inactive Ingredients
    Ingredient NameStrength
    CANOLA OIL (UNII: 331KBJ17RK)  
    WHITE WAX (UNII: 7G1J5DA97F)  
    LECITHIN, SOYBEAN (UNII: 1DI56QDM62)  
    PEPPERMINT OIL (UNII: AV092KU4JH)  
    COCONUT OIL (UNII: Q9L0O73W7L)  
    VANILLA (UNII: Q74T35078H)  
    LAUROYL LYSINE (UNII: 113171Q70B)  
    ALPHA-TOCOPHEROL (UNII: H4N855PNZ1)  
    ALUMINUM STEARATE (UNII: U6XF9NP8HM)  
    STEARIC ACID (UNII: 4ELV7Z65AP)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:59427-575-014.5 g in 1 CASE
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph not finalpart35204/01/1999
    Labeler - ORIGINS NATURAL RESOURCES INC. (611716283)
    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
    Establishment
    NameAddressID/FEIBusiness Operations
    PRIVALE LABEL SELECT LTD005415463manufacture