Label: TOM FORD SOLEIL GLOW TINTED MOISTURIZER BROAD SPECTRUM SPF 15- octinoxate and titanium dioxide liquid

  • Category: HUMAN OTC DRUG LABEL
  • DEA Schedule: None

Drug Label Information

Updated December 21, 2023

If you are a consumer or patient please visit this version.

  • SPL UNCLASSIFIED SECTION

    Drug Facts

  • ACTIVE INGREDIENT

    Active IngredientsPurpose
    Octinoxate 7.5%Sunscreen
    Titanium Dioxide 2.9%Sunscreen
  • Use

    Helps prevent sunburn

  • Warnings

    For external use only

    Do not use on damaged or broken skin

    When using this product keep out of eyes. Rinse with water to remove.

    Stop use and ask a doctor if rash occurs

    Keep out of reach of children. If product is swallowed, get medical help or contact a Poison Control Center right away.

  • Directions

    For sunscreen use:

    • apply liberally and evenly 15 minutes before sun exposure
    • reapply at least every two hours
    • use a water resistant sunscreen if swimming or sweating
    • Sun Protection Measures. Spending time in the sun increases your risk of skin cancer and early skin aging. To decrease this risk, regularly use a sunscreen with a Broad Spectrum SPF value of 15 or higher and other sun protection measures including:
      • limit time in the sun, especially from 10 a.m. - 2 p.m.
      • wear long-sleeved shirts, pants hats and sunglasses
    • children under 6 months of age: ask a doctor
  • Inactive Ingredients

    water\aqua\eau • phenyl trimethicone • butylene glycol • pentaerythrityl tetraethylhexanoate • simmondsia chinensis (jojoba) seed oil • petrolatum • biosaccharide gum - 1 • steareth-21 • glyceryl stearate • tocopheryl acetate • sodium hyaluronate • ethylhexylglycerin • peg-12 dimethicone • isohexadecane • magnesium aluminum silicate • xanthan gum • lecithin • aluminum hydroxide • citric acid • steareth-2 • polymethyl methacrylate • cetyl alcohol • potassium stearate • acrylamide/sodium acryloyldimethyltaurate copolymer • polysorbate 80 • caprylyl glycol • lavandula angustifolia (lavender) oil • linalool • tocopherol • phenoxyethanol • bht • sorbic acid • disodium edta • [+/-titanium dioxide (ci 77891) • iron oxides (ci 77491) • iron oxides (ci 77492) • iron oxides (ci 77499)] <iln47202>

  • Other Information

    protect the product in this container from excessive heat and direct sun

  • PRINCIPAL DISPLAY PANEL - 50 ml Tube Carton

    TOM FORD
    SOLEIL

    GLOW TINTED MOISTURIZER
    BROAD SPECTRUM SPF 15

    1.7 FL. OZ./OZ. LIQ./50 ml e

    PRINCIPAL DISPLAY PANEL - 50 ml Tube Carton
  • INGREDIENTS AND APPEARANCE
    TOM FORD SOLEIL GLOW TINTED MOISTURIZER BROAD SPECTRUM SPF 15 
    octinoxate and titanium dioxide liquid
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:76398-012
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    OCTINOXATE (UNII: 4Y5P7MUD51) (OCTINOXATE - UNII:4Y5P7MUD51) OCTINOXATE75 mg  in 1 mL
    TITANIUM DIOXIDE (UNII: 15FIX9V2JP) (TITANIUM DIOXIDE - UNII:15FIX9V2JP) TITANIUM DIOXIDE29 mg  in 1 mL
    Inactive Ingredients
    Ingredient NameStrength
    WATER (UNII: 059QF0KO0R)  
    PHENYL TRIMETHICONE (UNII: DR0K5NOJ4R)  
    BUTYLENE GLYCOL (UNII: 3XUS85K0RA)  
    PENTAERYTHRITYL TETRAETHYLHEXANOATE (UNII: XJ7052W897)  
    JOJOBA OIL (UNII: 724GKU717M)  
    PETROLATUM (UNII: 4T6H12BN9U)  
    BIOSACCHARIDE GUM-1 (UNII: BB4PU4V09H)  
    STEARETH-21 (UNII: 53J3F32P58)  
    GLYCERYL MONOSTEARATE (UNII: 230OU9XXE4)  
    .ALPHA.-TOCOPHEROL ACETATE (UNII: 9E8X80D2L0)  
    HYALURONATE SODIUM (UNII: YSE9PPT4TH)  
    ETHYLHEXYLGLYCERIN (UNII: 147D247K3P)  
    PEG-12 DIMETHICONE (300 CST) (UNII: ZEL54N6W95)  
    ISOHEXADECANE (UNII: 918X1OUF1E)  
    MAGNESIUM ALUMINUM SILICATE (UNII: 6M3P64V0NC)  
    XANTHAN GUM (UNII: TTV12P4NEE)  
    ALUMINUM HYDROXIDE (UNII: 5QB0T2IUN0)  
    CITRIC ACID MONOHYDRATE (UNII: 2968PHW8QP)  
    STEARETH-2 (UNII: V56DFE46J5)  
    POLY(METHYL METHACRYLATE; 450000 MW) (UNII: Z47NNT4J11)  
    CETYL ALCOHOL (UNII: 936JST6JCN)  
    POTASSIUM STEARATE (UNII: 17V812XK50)  
    POLYSORBATE 80 (UNII: 6OZP39ZG8H)  
    CAPRYLYL GLYCOL (UNII: 00YIU5438U)  
    LAVENDER OIL (UNII: ZBP1YXW0H8)  
    LINALOOL, (+/-)- (UNII: D81QY6I88E)  
    TOCOPHEROL (UNII: R0ZB2556P8)  
    PHENOXYETHANOL (UNII: HIE492ZZ3T)  
    BUTYLATED HYDROXYTOLUENE (UNII: 1P9D0Z171K)  
    SORBIC ACID (UNII: X045WJ989B)  
    EDETATE DISODIUM ANHYDROUS (UNII: 8NLQ36F6MM)  
    FERRIC OXIDE RED (UNII: 1K09F3G675)  
    FERRIC OXIDE YELLOW (UNII: EX438O2MRT)  
    FERROSOFERRIC OXIDE (UNII: XM0M87F357)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:76398-012-011 in 1 CARTON02/21/2020
    150 mL in 1 TUBE; Type 0: Not a Combination Product
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC Monograph DrugM02002/21/2020
    Labeler - TOM FORD BEAUTY DIST (005914387)
    Registrant - Estee Lauder Companies Inc. (790802086)
    Establishment
    NameAddressID/FEIBusiness Operations
    Estee Lauder N.V.370151326manufacture(76398-012) , pack(76398-012) , label(76398-012)