Label: TOM FORD TRACELESS FOUNDATION SPF 15- octinoxate 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 August 25, 2011

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  • ACTIVE INGREDIENT

    ACTIVE INGREDIENT: OCTINOXATE 2.20%

  • INACTIVE INGREDIENT

    INACTIVE INGREDIENTS: WATER\AQUA\EAU [] PHENYL TRIMETHICONE [] CAPRYLYL METHICONE [] DIMETHICONE [] BUTYLENE GLYCOL [] ISOHEXADECANE [] CAPRYLIC/CAPRIC TRIGLYCERIDE [] ISOCETYL ALCOHOL [] PEG/PPG-18/18 DIMETHICONE [] MAGNESIUM SULFATE [] PEG-10 DIMETHICONE [] WHEAT GERM GLYCERIDES [] SAPINDUS MUKUROSSI FRUIT EXTRACT [] MORINDA CITRIFOLIA FRUIT EXTRACT [] LAVANDULA ANGUSTIFOLIA (LAVENDER) [] CHOLESTEROL [] CAFFEINE [] GLYCERIN [] SIMMONDSIA CHINENSIS (JOJOBA) SEED OIL [] DISTEARDIMONIUM HECTORITE [] LINOLEIC ACID [] LECITHIN [] PEG-10 DIMETHICONE CROSSPOLYMER [] CETYL PEG/PPG-10/1 DIMETHICONE [] SODIUM HYALURONATE [] LAURETH-7 [] TOCOPHERYL ACETATE [] CAESALPINIA SPINOSA GUM [] SORBITAN STEARATE [] TRIETHYL CITRATE [] TRIETHOXYCAPRYLYLSILANE [] PENTAERYTHRITYL TETRA-DI-T-BUTYL HYDROXYHYDROCINNAMATE [] HYDROGENATED LECITHIN [] HDI/TRIMETHYLOL HEXYLLACTONE CROSSPOLYMER [] PROPYLENE CARBONATE [] XANTHAN GUM [] ASCORBYL PALMITATE [] SILICA [] LINALOOL [] CHLOROXYLENOL [] PHENOXYETHANOL []  [+/- TITANIUM DIOXIDE (CI 77891) [] IRON OXIDES (CI 77491, CI 77492, CI 77499) [] MICA]

  • WARNINGS

    WARNING: KEEP OUT OF EYES. DISCONTINUE USE IF IRRITATION OCCURS. KEEP OUT OF REACH OF CHILDREN.

  • PRINCIPAL DISPLAY PANEL

    PRINCIPAL DISPLAY  PANEL:


    TOM FORD

    TRACELESS FOUNDATION SPF 15





    1 FL OZ LIQ/30 ML



    TOM FORD BEAUTY DISTR.

    NEW YORK, NY 10022

    MADE IN BELGIUM

    CARTON

  • INGREDIENTS AND APPEARANCE
    TOM FORD TRACELESS FOUNDATION  SPF 15
    octinoxate liquid
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:62872-766
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    OCTINOXATE (UNII: 4Y5P7MUD51) (OCTINOXATE - UNII:4Y5P7MUD51) OCTINOXATE2.2 mL  in 100 mL
    Inactive Ingredients
    Ingredient NameStrength
    WATER (UNII: 059QF0KO0R)  
    PHENYL TRIMETHICONE (UNII: DR0K5NOJ4R)  
    DIMETHICONE (UNII: 92RU3N3Y1O)  
    BUTYLENE GLYCOL (UNII: 3XUS85K0RA)  
    ISOHEXADECANE (UNII: 918X1OUF1E)  
    MEDIUM-CHAIN TRIGLYCERIDES (UNII: C9H2L21V7U)  
    ISOCETYL ALCOHOL (UNII: 1800H64066)  
    MAGNESIUM SULFATE, UNSPECIFIED (UNII: DE08037SAB)  
    WHEAT GERM OIL (UNII: 14C97E680P)  
    SAPINDUS MUKOROSSI FRUIT (UNII: 66H9NW427Y)  
    MORINDA CITRIFOLIA FRUIT (UNII: 7829X3G2X5)  
    LAVANDULA ANGUSTIFOLIA FLOWER (UNII: 19AH1RAF4M)  
    CHOLESTEROL (UNII: 97C5T2UQ7J)  
    CAFFEINE (UNII: 3G6A5W338E)  
    GLYCERIN (UNII: PDC6A3C0OX)  
    JOJOBA OIL (UNII: 724GKU717M)  
    LINOLEIC ACID (UNII: 9KJL21T0QJ)  
    LECITHIN, SOYBEAN (UNII: 1DI56QDM62)  
    HYALURONATE SODIUM (UNII: YSE9PPT4TH)  
    LAURETH-7 (UNII: Z95S6G8201)  
    ALPHA-TOCOPHEROL ACETATE (UNII: 9E8X80D2L0)  
    CAESALPINIA SPINOSA RESIN (UNII: WL3883U2PO)  
    SORBITAN MONOSTEARATE (UNII: NVZ4I0H58X)  
    TRIETHYL CITRATE (UNII: 8Z96QXD6UM)  
    TRIETHOXYCAPRYLYLSILANE (UNII: LDC331P08E)  
    HYDROGENATED SOYBEAN LECITHIN (UNII: H1109Z9J4N)  
    PROPYLENE CARBONATE (UNII: 8D08K3S51E)  
    XANTHAN GUM (UNII: TTV12P4NEE)  
    ASCORBYL PALMITATE (UNII: QN83US2B0N)  
    SILICON DIOXIDE (UNII: ETJ7Z6XBU4)  
    CHLOROXYLENOL (UNII: 0F32U78V2Q)  
    PHENOXYETHANOL (UNII: HIE492ZZ3T)  
    TITANIUM DIOXIDE (UNII: 15FIX9V2JP)  
    MICA (UNII: V8A1AW0880)  
    FERRIC OXIDE RED (UNII: 1K09F3G675)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:62872-766-011 in 1 CARTON
    1NDC:62872-766-0230 mL in 1 BOTTLE
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph not finalpart35206/01/2011
    Labeler - ESTEE LAUDER N.V. (370151326)
    Establishment
    NameAddressID/FEIBusiness Operations
    ESTEE LAUDER N.V.370151326manufacture