Label: NUDE AND IMPROVED BARE FACE MAKEUP SPF 15- titanium dioxide lotion

  • 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 28, 2011

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  • ACTIVE INGREDIENT

    active ingredient: titanium dioxide 7.60%

  • INACTIVE INGREDIENT

    inactive ingredients: water\aqua\eau; citrus aurantium amara (bitter orange) flower water [] cyclopentasiloxane [] octyldodecyl neopentanoate [] dimethicone [] ethylhexyl hydroxystearate [] butylene glycol [] glyceryl stearate [] polymethyl methacrylate [] silica [] talc [] polyglyceryl-2 sesquiisostearate [] quaternium-18 bentonite [] lauric acid [] ascorbyl palmitate [] tocopheryl acetate [] citrus medica limonum (lemon) peel oil*,  mentha viridis (spearmint) leaf oil*, citrus paradisi (grapefruit) fruit extract, limonene [] caprylyl glycol [] bisabolol [] glycine soja (soybean) sterols [] peg/ppg-18/18 dimethicone [] ethylhexylglycerin [] peg-10 dimethicone crosspolymer [] dimethiconol [] peg-12 distearate [] peg-10 dimethicone [] propylene carbonate [] polyglyceryl-4 isostearate [] hexyl laurate [] cetyl peg/ppg-10/1 dimethicone [] cellulose gum [] magnesium aluminum silicate [] barium sulfate [] alumina [] disodium edta [] bht [] phenoxyethanol []  [+/- mica [] titanium dioxide (ci 77891) [] 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:


    ORIGINS

    NUDE AND IMPROVED

    BARE-FACE MAKEUP

    WITH SPF 15

    SUNSCREEN


    1 fl oz liq/30 ml

    origins natural resources inc

    new york, ny 10022

    folding carton

  • INGREDIENTS AND APPEARANCE
    NUDE AND IMPROVED BARE FACE MAKEUP  SPF 15
    titanium dioxide lotion
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:59427-761
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    TITANIUM DIOXIDE (UNII: 15FIX9V2JP) (TITANIUM DIOXIDE - UNII:15FIX9V2JP) TITANIUM DIOXIDE7.6 mL  in 100 mL
    Inactive Ingredients
    Ingredient NameStrength
    WATER (UNII: 059QF0KO0R)  
    CYCLOMETHICONE 5 (UNII: 0THT5PCI0R)  
    OCTYLDODECYL NEOPENTANOATE (UNII: X8725R883T)  
    DIMETHICONE (UNII: 92RU3N3Y1O)  
    ETHYLHEXYL HYDROXYSTEARATE (UNII: B7I80BVV5E)  
    BUTYLENE GLYCOL (UNII: 3XUS85K0RA)  
    GLYCERYL MONOSTEARATE (UNII: 230OU9XXE4)  
    SILICON DIOXIDE (UNII: ETJ7Z6XBU4)  
    TALC (UNII: 7SEV7J4R1U)  
    LAURIC ACID (UNII: 1160N9NU9U)  
    ASCORBYL PALMITATE (UNII: QN83US2B0N)  
    CITRUS AURANTIUM FLOWER OIL (UNII: D4BGE91OXH)  
    CAPRYLYL GLYCOL (UNII: 00YIU5438U)  
    LEVOMENOL (UNII: 24WE03BX2T)  
    SOY STEROL (UNII: PL360EPO9J)  
    ETHYLHEXYLGLYCERIN (UNII: 147D247K3P)  
    DIMETHICONOL (250000 MW) (UNII: RKI3S914RT)  
    PEG-12 STEARATE (UNII: 9KU38O8CEK)  
    PROPYLENE CARBONATE (UNII: 8D08K3S51E)  
    POLYGLYCERYL-4 ISOSTEARATE (UNII: 820DPX33S7)  
    HEXYL LAURATE (UNII: 4CG9F9W01Q)  
    CARBOXYMETHYLCELLULOSE SODIUM (UNII: K679OBS311)  
    BARIUM SULFATE (UNII: 25BB7EKE2E)  
    ALUMINUM OXIDE (UNII: LMI26O6933)  
    EDETATE DISODIUM (UNII: 7FLD91C86K)  
    BUTYLATED HYDROXYTOLUENE (UNII: 1P9D0Z171K)  
    PHENOXYETHANOL (UNII: HIE492ZZ3T)  
    FERROUS OXIDE (UNII: G7036X8B5H)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:59427-761-021 in 1 CARTON
    1NDC:59427-761-0130 mL in 1 BOTTLE
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph not finalpart35201/01/2002
    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
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