Label: TOM FORD SHADE AND ILLUMINATE FOUNDATION BROAD SPECTRUM SPF 45 SOFT RADIANCE CUSHION COMPACT REFILL- octinoxate, titanium dioxide, and zinc oxide cream
- NDC Code(s): 76398-011-01
- Packager: TOM FORD BEAUTY DIST
- Category: HUMAN OTC DRUG LABEL
- DEA Schedule: None
Drug Label Information
Updated December 21, 2023
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- SPL UNCLASSIFIED SECTION
- Active ingredients
- Purpose
- Use
- Warnings
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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
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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
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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
- PRINCIPAL DISPLAY PANEL - 12 g Jar Carton
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INGREDIENTS AND APPEARANCE
TOM FORD SHADE AND ILLUMINATE FOUNDATION BROAD SPECTRUM SPF 45 SOFT RADIANCE CUSHION COMPACT REFILL
octinoxate, titanium dioxide, and zinc oxide creamProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:76398-011 Route of Administration TOPICAL Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength OCTINOXATE (UNII: 4Y5P7MUD51) (OCTINOXATE - UNII:4Y5P7MUD51) OCTINOXATE 7 g in 100 g TITANIUM DIOXIDE (UNII: 15FIX9V2JP) (TITANIUM DIOXIDE - UNII:15FIX9V2JP) TITANIUM DIOXIDE 7.6 g in 100 g ZINC OXIDE (UNII: SOI2LOH54Z) (ZINC OXIDE - UNII:SOI2LOH54Z) ZINC OXIDE 3.6 g in 100 g Inactive Ingredients Ingredient Name Strength 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 Code Package Description Marketing Start Date Marketing End Date 1 NDC:76398-011-01 1 in 1 CARTON 11/15/2019 1 12 g in 1 JAR; Type 0: Not a Combination Product Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date OTC Monograph Drug M020 11/15/2019 Labeler - TOM FORD BEAUTY DIST (005914387) Registrant - Estee Lauder Companies Inc. (790802086) Establishment Name Address ID/FEI Business Operations Cosmax, Inc. 689049693 manufacture(76398-011) Establishment Name Address ID/FEI Business Operations Estee Lauder N.V. 370151326 manufacture(76398-011)