Label: TOM FORD SHADE AND ILLUMINATE SOFT RADIANCE FOUNDATION BROAD SPECTRUM SPF 50- ensulizole, octinoxate, octisalate, and zinc oxide liquid
- NDC Code(s): 76398-010-01
- Packager: TOM FORD BEAUTY DIST
- Category: HUMAN OTC DRUG LABEL
- DEA Schedule: None
Drug Label Information
Updated October 5, 2023
If you are a consumer or patient please visit this version.
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- Official Label (Printer Friendly)
- SPL UNCLASSIFIED SECTION
- ACTIVE INGREDIENT
- Use
- Warnings
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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
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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 • dimethicone • phenyl trimethicone • butylene glycol • glycerin • polymethylsilsesquioxane • lauryl peg-9 polydimethylsiloxyethyl dimethicone • hdi/ppg/polycaprolactone crosspolymer • trimethylsiloxysilicate/dimethiconol crosspolymer • tromethamine • polysilicone-11 • hexyl laurate • cetyl peg/ppg-10/1 dimethicone • neopentyl glycol diheptanoate • hydroxyethyl urea • tremella fuciformis sporocarp extract • hylocereus undatus fruit extract • euterpe oleracea fruit oil • carapa guaianensis seed oil • lavandula angustifolia (lavender) oil • sapindus mukorossi fruit extract • morinda citrifolia fruit extract • polyglyceryl-4 isostearate • copaifera officinalis (balsam copaiba) resin • triolein • caprylic/capric triglyceride • betaine • caffeine • acetyl hexapeptide-8 • tocopheryl acetate • trehalose • hydrogenated coco-glycerides • caesalpinia spinosa gum • trimethylsiloxysilicate • polyhydroxystearic acid • lecithin • glyceryl stearate • triethoxycaprylylsilane • laureth-7 • sodium chloride • disteardimonium hectorite • methicone • linoleic acid • phospholipids • stearyl alcohol • cetearyl alcohol • ammonium polyacryloyldimethyl taurate • sodium hyaluronate • tocopherol • triethyl citrate • palmitic acid • dimethicone/divinyldimethicone silsesquioxane crosspolymer • phytosteryl canola glycerides • stearic acid • oleic acid • polysorbate 80 • polysorbate 20 • behenyl alcohol • silica • linalool • disodium edta • bht • potassium sorbate • sodium dehydroacetate • phenoxyethanol • [+/- mica • titanium dioxide (ci 77891) • iron oxides (ci 77491) • iron oxides (ci 77492) • iron oxides (ci 77499)] <iln47071>
- Other Information
- PRINCIPAL DISPLAY PANEL - 30 mL Bottle Carton
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INGREDIENTS AND APPEARANCE
TOM FORD SHADE AND ILLUMINATE SOFT RADIANCE FOUNDATION BROAD SPECTRUM SPF 50
ensulizole, octinoxate, octisalate, and zinc oxide liquidProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:76398-010 Route of Administration TOPICAL Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength ENSULIZOLE (UNII: 9YQ9DI1W42) (ENSULIZOLE - UNII:9YQ9DI1W42) ENSULIZOLE 27 mg in 1 mL OCTINOXATE (UNII: 4Y5P7MUD51) (OCTINOXATE - UNII:4Y5P7MUD51) OCTINOXATE 67 mg in 1 mL OCTISALATE (UNII: 4X49Y0596W) (OCTISALATE - UNII:4X49Y0596W) OCTISALATE 45 mg in 1 mL ZINC OXIDE (UNII: SOI2LOH54Z) (ZINC OXIDE - UNII:SOI2LOH54Z) ZINC OXIDE 38 mg in 1 mL Inactive Ingredients Ingredient Name Strength WATER (UNII: 059QF0KO0R) DIMETHICONE (UNII: 92RU3N3Y1O) PHENYL TRIMETHICONE (UNII: DR0K5NOJ4R) BUTYLENE GLYCOL (UNII: 3XUS85K0RA) GLYCERIN (UNII: PDC6A3C0OX) POLYMETHYLSILSESQUIOXANE (4.5 MICRONS) (UNII: 59Z907ZB69) LAURYL PEG-9 POLYDIMETHYLSILOXYETHYL DIMETHICONE (UNII: 25G622K2RA) TROMETHAMINE (UNII: 023C2WHX2V) DIMETHICONE/VINYL DIMETHICONE CROSSPOLYMER (SOFT PARTICLE) (UNII: 9E4CO0W6C5) HEXYL LAURATE (UNII: 4CG9F9W01Q) NEOPENTYL GLYCOL DIHEPTANOATE (UNII: 5LKW3C543X) HYDROXYETHYL UREA (UNII: MBQ7DDQ7AR) TREMELLA FUCIFORMIS FRUITING BODY (UNII: GG8N28393G) SELENICEREUS UNDATUS FRUIT (UNII: WUG58TD53X) ACAI OIL (UNII: Z0W6766A2W) CARAPA GUIANENSIS SEED OIL (UNII: Y82418EH2I) LAVENDER OIL (UNII: ZBP1YXW0H8) SAPINDUS MUKOROSSI FRUIT (UNII: 66H9NW427Y) NONI FRUIT (UNII: 7829X3G2X5) POLYGLYCERYL-4 ISOSTEARATE (UNII: 820DPX33S7) COPAIFERA OFFICINALIS RESIN (UNII: 1VH544O5AT) GLYCERYL TRIOLEATE (UNII: O05EC62663) MEDIUM-CHAIN TRIGLYCERIDES (UNII: C9H2L21V7U) BETAINE (UNII: 3SCV180C9W) CAFFEINE (UNII: 3G6A5W338E) ACETYL HEXAPEPTIDE-8 (UNII: L4EL31FWIL) .ALPHA.-TOCOPHEROL ACETATE (UNII: 9E8X80D2L0) TREHALOSE (UNII: B8WCK70T7I) HYDROGENATED COCO-GLYCERIDES (UNII: XDD37N2GPR) CAESALPINIA SPINOSA RESIN (UNII: WL3883U2PO) GLYCERYL MONOSTEARATE (UNII: 230OU9XXE4) TRIETHOXYCAPRYLYLSILANE (UNII: LDC331P08E) LAURETH-7 (UNII: Z95S6G8201) SODIUM CHLORIDE (UNII: 451W47IQ8X) DISTEARDIMONIUM HECTORITE (UNII: X687XDK09L) METHICONE (20 CST) (UNII: 6777U11MKT) LINOLEIC ACID (UNII: 9KJL21T0QJ) LECITHIN, SOYBEAN (UNII: 1DI56QDM62) STEARYL ALCOHOL (UNII: 2KR89I4H1Y) CETOSTEARYL ALCOHOL (UNII: 2DMT128M1S) AMMONIUM POLYACRYLOYLDIMETHYL TAURATE (55000 MPA.S) (UNII: F01RIY4371) HYALURONATE SODIUM (UNII: YSE9PPT4TH) TOCOPHEROL (UNII: R0ZB2556P8) TRIETHYL CITRATE (UNII: 8Z96QXD6UM) PALMITIC ACID (UNII: 2V16EO95H1) STEARIC ACID (UNII: 4ELV7Z65AP) OLEIC ACID (UNII: 2UMI9U37CP) POLYSORBATE 80 (UNII: 6OZP39ZG8H) POLYSORBATE 20 (UNII: 7T1F30V5YH) DOCOSANOL (UNII: 9G1OE216XY) SILICON DIOXIDE (UNII: ETJ7Z6XBU4) LINALOOL, (+/-)- (UNII: D81QY6I88E) EDETATE DISODIUM ANHYDROUS (UNII: 8NLQ36F6MM) BUTYLATED HYDROXYTOLUENE (UNII: 1P9D0Z171K) POTASSIUM SORBATE (UNII: 1VPU26JZZ4) SODIUM DEHYDROACETATE (UNII: 8W46YN971G) PHENOXYETHANOL (UNII: HIE492ZZ3T) MICA (UNII: V8A1AW0880) TITANIUM DIOXIDE (UNII: 15FIX9V2JP) 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:76398-010-01 1 in 1 CARTON 10/10/2019 1 30 mL in 1 BOTTLE; 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 10/10/2019 Labeler - TOM FORD BEAUTY DIST (005914387) Registrant - Estee Lauder Companies Inc. (790802086) Establishment Name Address ID/FEI Business Operations Estee Lauder Cosmetics Ltd. 204132062 manufacture(76398-010) , label(76398-010) , pack(76398-010) Establishment Name Address ID/FEI Business Operations Estee Lauder Cosmetics Ltd 202952982 manufacture(76398-010)
