Label: SMASH BOX STUDIO SKIN 15 HOUR WEAR HYDRATING FOUNDATION SPF10- titanium dioxide liquid

  • 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 June 24, 2011

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  • ACTIVE INGREDIENT

    ACTIVE INGREDIENT: TITANIUM DIOXIDE, 4.7%

  • INACTIVE INGREDIENT

    INACTIVE INGREDIENTS: WATER [] CYCLOPENTASILOXANE [] TRIMETHYLSILOXYSILICATE [] BUTYLENE GLYCOL [] TRIMETHYL PENTAPHENYL TRISILOXANE [] SILICA [] PHENYL TRIMETHICONE [] MAGNESIUM SULFATE [] POLYGLYCERYL-3 DIISOSTEARATE [] TRIBEHENIN [] PEG-10 DIMETHICONE [] BIS-PEG/PPG-14/14 DIMETHICONE [] TOCOPHERYL ACETATE [] SODIUM HYALURONATE [] GLYCERIN [] ETHYLHEXYLGLYCERIN [] POLYGLYCERYL-4 ISOSTEARATE [] CETYL PEG/PPG-10/1 DIMETHICONE [] METHICONE [] TETRAMETHYL HEXAPHENYL TETRASILOXANE [] PHENYL METHICONE [] DIMETHICONE [] LAURETH-7 [] POLYMETHYLSILSESQUIOXANE [] HEXYL LAURATE [] DISTEARDIMONIUM HECTORITE [] CELLULOSE GUM [] PROPYLENE CARBONATE [] ALUMINA [] XANTHAN GUM [] DIMETHICONE SILYLATE [] SORBIC ACID [] PHENOXYETHANOL [] CHLORPHENESIN []  [+/- IRON OXIDES (CI 77491, CI 77492, CI 77499) [] TITANIUM DIOXIDE (CI 77891)]

  • WHEN USING

    DIRECTIONS: APPLY BEFORE SUN EXPOSURE.

  • WARNINGS

    WARNING: KEEP OUT OF EYES. STOP USE IF IRRITATION OCCURS. IF IRRITATION PERSISTS, CONSULT A HEALTH PRACTITIONER. KEEP OUT OF REACH OF CHILDREN.

  • PRINCIPAL DISPLAY PANEL

    PRINCIPAL DISPLAY PANEL


    SMASHBOX

    STUDIO SKIN

    15 HOUR WEAR FOUNDATION

    SPF 10



    NET WT. 1 FL OZ/30 ML


    MAKEUP ART COSMETICS Dist.

    Smashbox Beauty Cosmetics Inc,

    Culver City, CA 90232

     FOLDING CARTON




  • INGREDIENTS AND APPEARANCE
    SMASH BOX STUDIO SKIN  15 HOUR WEAR HYDRATING FOUNDATION SPF10
    titanium dioxide liquid
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:40046-0044
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    TITANIUM DIOXIDE (UNII: 15FIX9V2JP) (TITANIUM DIOXIDE - UNII:15FIX9V2JP) TITANIUM DIOXIDE4.7 mL  in 100 mL
    Inactive Ingredients
    Ingredient NameStrength
    WATER (UNII: 059QF0KO0R)  
    CYCLOMETHICONE 5 (UNII: 0THT5PCI0R)  
    TRIMETHOXYCAPRYLYLSILANE (UNII: FZ07E4LW2M)  
    BUTYLENE GLYCOL (UNII: 3XUS85K0RA)  
    SILICON DIOXIDE (UNII: ETJ7Z6XBU4)  
    PHENYL TRIMETHICONE (UNII: DR0K5NOJ4R)  
    MAGNESIUM SULFATE, UNSPECIFIED (UNII: DE08037SAB)  
    TRIBEHENIN (UNII: 8OC9U7TQZ0)  
    ALPHA-TOCOPHEROL ACETATE (UNII: 9E8X80D2L0)  
    HYALURONATE SODIUM (UNII: YSE9PPT4TH)  
    GLYCERIN (UNII: PDC6A3C0OX)  
    ETHYLHEXYLGLYCERIN (UNII: 147D247K3P)  
    POLYGLYCERYL-4 ISOSTEARATE (UNII: 820DPX33S7)  
    DIMETHICONE (UNII: 92RU3N3Y1O)  
    LAURETH-7 (UNII: Z95S6G8201)  
    POLYMETHYLSILSESQUIOXANE (11 MICRONS) (UNII: Z570VEV8XK)  
    HEXYL LAURATE (UNII: 4CG9F9W01Q)  
    CARBOXYMETHYLCELLULOSE SODIUM (UNII: K679OBS311)  
    PROPYLENE CARBONATE (UNII: 8D08K3S51E)  
    ALUMINUM OXIDE (UNII: LMI26O6933)  
    XANTHAN GUM (UNII: TTV12P4NEE)  
    SORBIC ACID (UNII: X045WJ989B)  
    PHENOXYETHANOL (UNII: HIE492ZZ3T)  
    CHLORPHENESIN (UNII: I670DAL4SZ)  
    FERROSOFERRIC OXIDE (UNII: XM0M87F357)  
    FERRIC OXIDE RED (UNII: 1K09F3G675)  
    FERRIC OXIDE YELLOW (UNII: EX438O2MRT)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:40046-0044-11 in 1 CARTON
    1NDC:40046-0044-230 mL in 1 BOTTLE
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph not finalpart35201/01/2009
    Labeler - MAKEUP ART COSMETICS (010597206)
    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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