Label: TOM FORD SHADE AND ILLUMINATE FOUNDATION BROAD SPECTRUM SPF 45 SOFT RADIANCE CUSHION COMPACT REFILL- octinoxate, titanium dioxide, and zinc oxide cream

  • 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 ingredients

    Octinoxate 7.0%
    Titanium Dioxide 7.6%
    Zinc Oxide 3.6%

  • Purpose

    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 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 • dimethicone • pentaerythrityl tetraisostearate • methyl trimethicone • propanediol • lauryl peg-9 polydimethylsiloxyethyl dimethicone • glycerin • silica • isohexadecane • sodium hyaluronate • tocopheryl acetate • acetyl hexapeptide-8 • caffeine • sapindus mukorossi fruit extract • tremella fuciformis sporocarp extract • hylocereus undatus fruit extract • caprylic/capric triglyceride • dimethicone/peg-10/15 crosspolymer • diisostearyl malate • caesalpinia spinosa gum • trehalose • dimethicone/vinyl dimethicone crosspolymer • cetyl peg/ppg-10/1 dimethicone • linoleic acid • methicone • triolein • jojoba esters • lactobacillus ferment • morinda citrifolia fruit extract • betaine • phytosteryl canola glycerides • oleic acid • hydrogenated coco-glycerides • alumina • dimethicone silylate • phospholipids • magnesium sulfate • trimethylsiloxysilicate • lavandula angustifolia (lavender) oil • triethoxycaprylylsilane • disteardimonium hectorite • propylene carbonate • polysilicone-11 • peg-75 • caprylyl glycol • polyglyceryl-2 triisostearate • hydroxethyl urea • stearyl alcohol • polymethylsilsesquioxane • cetearyl alcohol • dipropylene glycol • glyceryl stearate • behenyl alcohol • stearic acid • butylene glycol • dimethicone/divinyldimethicone silsesquioxane crosspolymer • palmitic acid • ammonium polyacryloyldimethyl taurate • linalool • tocopherol • bht • sodium citrate • disodium edta • phenoxyethanol • potassium sorbate • [+/- mica • titanium dioxide (ci 77891) • iron oxides (ci 77491) • iron oxides (ci 77492) • iron oxides (ci 77499)] <iln47200>

  • Other information

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

  • PRINCIPAL DISPLAY PANEL - 12 g Jar Carton

    TF

    TOM FORD

    SHADE AND ILLUMINATE FOUNDATION
    BROAD SPECTRUM SPF 45
    SOFT RADIANCE CUSHION COMPACT REFILL
    NET WT. .42 OZ./12 g e

    PRINCIPAL DISPLAY PANEL - 12 g Jar Carton
  • INGREDIENTS AND APPEARANCE
    TOM FORD SHADE AND ILLUMINATE FOUNDATION BROAD SPECTRUM SPF 45 SOFT RADIANCE CUSHION COMPACT REFILL 
    octinoxate, titanium dioxide, and zinc oxide cream
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:76398-011
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    OCTINOXATE (UNII: 4Y5P7MUD51) (OCTINOXATE - UNII:4Y5P7MUD51) OCTINOXATE7 g  in 100 g
    TITANIUM DIOXIDE (UNII: 15FIX9V2JP) (TITANIUM DIOXIDE - UNII:15FIX9V2JP) TITANIUM DIOXIDE7.6 g  in 100 g
    ZINC OXIDE (UNII: SOI2LOH54Z) (ZINC OXIDE - UNII:SOI2LOH54Z) ZINC OXIDE3.6 g  in 100 g
    Inactive Ingredients
    Ingredient NameStrength
    WATER (UNII: 059QF0KO0R)  
    PHENYL TRIMETHICONE (UNII: DR0K5NOJ4R)  
    DIMETHICONE (UNII: 92RU3N3Y1O)  
    PENTAERYTHRITYL TETRAISOSTEARATE (UNII: 9D7IK5483F)  
    METHYL TRIMETHICONE (UNII: S73ZQI0GXM)  
    PROPANEDIOL (UNII: 5965N8W85T)  
    LAURYL PEG-9 POLYDIMETHYLSILOXYETHYL DIMETHICONE (UNII: 25G622K2RA)  
    GLYCERIN (UNII: PDC6A3C0OX)  
    SILICON DIOXIDE (UNII: ETJ7Z6XBU4)  
    ISOHEXADECANE (UNII: 918X1OUF1E)  
    HYALURONATE SODIUM (UNII: YSE9PPT4TH)  
    .ALPHA.-TOCOPHEROL ACETATE (UNII: 9E8X80D2L0)  
    ACETYL HEXAPEPTIDE-8 (UNII: L4EL31FWIL)  
    CAFFEINE (UNII: 3G6A5W338E)  
    SAPINDUS MUKOROSSI FRUIT (UNII: 66H9NW427Y)  
    TREMELLA FUCIFORMIS FRUITING BODY (UNII: GG8N28393G)  
    SELENICEREUS UNDATUS FRUIT (UNII: WUG58TD53X)  
    MEDIUM-CHAIN TRIGLYCERIDES (UNII: C9H2L21V7U)  
    DIISOSTEARYL MALATE (UNII: QBS8A3XZGQ)  
    CAESALPINIA SPINOSA RESIN (UNII: WL3883U2PO)  
    TREHALOSE (UNII: B8WCK70T7I)  
    LINOLEIC ACID (UNII: 9KJL21T0QJ)  
    METHICONE (20 CST) (UNII: 6777U11MKT)  
    GLYCERYL TRIOLEATE (UNII: O05EC62663)  
    LIMOSILACTOBACILLUS REUTERI (UNII: 9913I24QEE)  
    NONI FRUIT (UNII: 7829X3G2X5)  
    BETAINE (UNII: 3SCV180C9W)  
    OLEIC ACID (UNII: 2UMI9U37CP)  
    HYDROGENATED COCO-GLYCERIDES (UNII: XDD37N2GPR)  
    ALUMINUM OXIDE (UNII: LMI26O6933)  
    LECITHIN, SOYBEAN (UNII: 1DI56QDM62)  
    MAGNESIUM SULFATE, UNSPECIFIED FORM (UNII: DE08037SAB)  
    LAVENDER OIL (UNII: ZBP1YXW0H8)  
    TRIETHOXYCAPRYLYLSILANE (UNII: LDC331P08E)  
    DISTEARDIMONIUM HECTORITE (UNII: X687XDK09L)  
    PROPYLENE CARBONATE (UNII: 8D08K3S51E)  
    DIMETHICONE/VINYL DIMETHICONE CROSSPOLYMER (SOFT PARTICLE) (UNII: 9E4CO0W6C5)  
    POLYETHYLENE GLYCOL 3350 (UNII: G2M7P15E5P)  
    CAPRYLYL GLYCOL (UNII: 00YIU5438U)  
    POLYGLYCERYL-2 TRIISOSTEARATE (UNII: 68DUY2D39A)  
    HYDROXYETHYL UREA (UNII: MBQ7DDQ7AR)  
    STEARYL ALCOHOL (UNII: 2KR89I4H1Y)  
    POLYMETHYLSILSESQUIOXANE (4.5 MICRONS) (UNII: 59Z907ZB69)  
    CETOSTEARYL ALCOHOL (UNII: 2DMT128M1S)  
    DIPROPYLENE GLYCOL (UNII: E107L85C40)  
    GLYCERYL MONOSTEARATE (UNII: 230OU9XXE4)  
    DOCOSANOL (UNII: 9G1OE216XY)  
    STEARIC ACID (UNII: 4ELV7Z65AP)  
    BUTYLENE GLYCOL (UNII: 3XUS85K0RA)  
    PALMITIC ACID (UNII: 2V16EO95H1)  
    AMMONIUM POLYACRYLOYLDIMETHYL TAURATE (55000 MPA.S) (UNII: F01RIY4371)  
    LINALOOL, (+/-)- (UNII: D81QY6I88E)  
    TOCOPHEROL (UNII: R0ZB2556P8)  
    BUTYLATED HYDROXYTOLUENE (UNII: 1P9D0Z171K)  
    SODIUM CITRATE, UNSPECIFIED FORM (UNII: 1Q73Q2JULR)  
    EDETATE DISODIUM ANHYDROUS (UNII: 8NLQ36F6MM)  
    PHENOXYETHANOL (UNII: HIE492ZZ3T)  
    POTASSIUM SORBATE (UNII: 1VPU26JZZ4)  
    MICA (UNII: V8A1AW0880)  
    FERRIC OXIDE RED (UNII: 1K09F3G675)  
    FERRIC OXIDE YELLOW (UNII: EX438O2MRT)  
    FERROSOFERRIC OXIDE (UNII: XM0M87F357)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:76398-011-011 in 1 CARTON11/15/2019
    112 g in 1 JAR; Type 0: Not a Combination Product
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC Monograph DrugM02011/15/2019
    Labeler - TOM FORD BEAUTY DIST (005914387)
    Registrant - Estee Lauder Companies Inc. (790802086)
    Establishment
    NameAddressID/FEIBusiness Operations
    Cosmax, Inc.689049693manufacture(76398-011)
    Establishment
    NameAddressID/FEIBusiness Operations
    Estee Lauder N.V.370151326manufacture(76398-011)