SHADE AND ILLUMINATE SOFT RAD PRMR SPF- octinoxate,octisalate,zinc oxide cream 
TOM FORD BEAUTY DIST

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SHADE AND ILLUMINATE SOFT RAD PRMR SPF

Active Ingredients

Octinoxate 6.7%

Octisalate 4.5%

Zinc Oxide 10.0%

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 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 [] DIMETHICONE [] BUTYLENE GLYCOL [] PHENYL TRIMETHICONE [] NIACINAMIDE [] GLYCERIN [] TRAMETES VERSICOLOR EXTRACT [] SYNTHETIC FLUORPHLOGOPITE [] VP/EICOSENE COPOLYMER [] ASCORBYL GLUCOSIDE [] LAURYL PEG-9 POLYDIMETHYLSILOXYETHYL DIMETHICONE [] HDI/PPG/POLYCAPROLACTONE CROSSPOLYMER [] HEXYL LAURATE [] CETYL PEG/PPG-10/1 DIMETHICONE [] PASSIFLORA EDULIS SEED OIL [] WHEY PROTEIN\LACTIS PROTEIN\PROTEINE DU PETIT-LAIT [] LAVANDULA ANGUSTIFOLIA (LAVENDER) OIL [] ZINGIBER OFFICINALE (GINGER) ROOT EXTRACT [] HORDEUM DISTICHON (BARLEY) EXTRACT\EXTRAIT D'ORGE A DEUX RANGS [] TRITICUM VULGARE (WHEAT) GERM EXTRACT [] MORINGA OLEIFERA SEED OIL [] SAPINDUS MUKOROSSI FRUIT EXTRACT [] CAESALPINIA SPINOSA GUM [] MORINDA CITRIFOLIA FRUIT EXTRACT [] TOCOPHEROL [] SQUALANE [] POLYGLYCERYL-4 ISOSTEARATE [] PHYTOSTERYL CANOLA GLYCERIDES [] CAPRYLIC/CAPRIC TRIGLYCERIDE [] TREHALOSE [] HYDROGENATED COCO-GLYCERIDES [] CAFFEINE [] CHOLESTEROL [] TRIETHYL CITRATE [] SODIUM HYALURONATE [] LINOLEIC ACID [] PHOSPHOLIPIDS [] CAPRYLYL GLYCOL [] TRIOLEIN [] HYDROXYETHYL UREA [] POLYMETHYLSILSESQUIOXANE [] DIMETHICONE/DIVINYLDIMETHICONE/SILSESQUIOXANE CROSSPOLYMER [] SILICA [] DISTEARDIMONIUM HECTORITE [] POLYHYDROXYSTEARIC ACID [] DISODIUM EDTA [] BHT [] LAURETH-7 [] STEARYL ALCOHOL [] HYDROXYAPATITE [] POLYSILICONE-11 [] CETEARYL ALCOHOL [] TROMETHAMINE [] SODIUM CHLORIDE [] LECITHIN [] GLYCERYL STEARATE [] AMMONIUM POLYACRYLOYLDIMETHYL TAURATE [] PALMITIC ACID [] STEARIC ACID [] POLYSORBATE 80 [] OLEIC ACID [] POLYSORBATE 20 [] BEHENYL ALCOHOL [] LINALOOL [] TOCOPHERYL ACETATE [] PHENOXYETHANOL [] SODIUM DEHYDROACETATE [] POTASSIUM SORBATE [] [+/- MICA [] TITANIUM DIOXIDE (CI 77891) [] IRON OXIDES (CI 77491) [] IRON OXIDES (CI 77492) [] BISMUTH OXYCHLORIDE (CI 77163) [] IRON OXIDES (CI 77499)] <ILN51397>

Other Information

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

PRINCIPAL DISPLAY PANEL

Principal Display PanelTOM FORD

SHADE AND ILLUMINATE
SOFT RADIANCE PRIMER
BROAD SPECTRUM SPF 25
1 FL. OZ./OZ. LIQ./30 ml ℮

SHADE AND ILLUMINATE SOFT RAD PRMR SPF 
octinoxate,octisalate,zinc oxide cream
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:76398-013
Route of AdministrationTOPICAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
ZINC OXIDE (UNII: SOI2LOH54Z) (ZINC OXIDE - UNII:SOI2LOH54Z) ZINC OXIDE100 mg  in 1 mL
OCTINOXATE (UNII: 4Y5P7MUD51) (OCTINOXATE - UNII:4Y5P7MUD51) OCTINOXATE67 mg  in 1 mL
OCTISALATE (UNII: 4X49Y0596W) (OCTISALATE - UNII:4X49Y0596W) OCTISALATE45 mg  in 1 mL
Inactive Ingredients
Ingredient NameStrength
TREHALOSE (UNII: B8WCK70T7I)  
CAFFEINE (UNII: 3G6A5W338E)  
CHOLESTEROL (UNII: 97C5T2UQ7J)  
MORINGA OLEIFERA SEED OIL (UNII: REM6A5QMC0)  
SAPINDUS MUKOROSSI FRUIT (UNII: 66H9NW427Y)  
CAESALPINIA SPINOSA RESIN (UNII: WL3883U2PO)  
MORINDA CITRIFOLIA FRUIT (UNII: 7829X3G2X5)  
POLYGLYCERYL-4 ISOSTEARATE (UNII: 820DPX33S7)  
TRAMETES VERSICOLOR FRUITING BODY (UNII: 4C900477MT)  
LAURYL PEG-9 POLYDIMETHYLSILOXYETHYL DIMETHICONE (UNII: 25G622K2RA)  
OLEIC ACID (UNII: 2UMI9U37CP)  
POLYSORBATE 20 (UNII: 7T1F30V5YH)  
.ALPHA.-TOCOPHEROL ACETATE (UNII: 9E8X80D2L0)  
MICA (UNII: V8A1AW0880)  
FERROSOFERRIC OXIDE (UNII: XM0M87F357)  
LECITHIN, SOYBEAN (UNII: 1DI56QDM62)  
LAVENDER OIL (UNII: ZBP1YXW0H8)  
LINOLEIC ACID (UNII: 9KJL21T0QJ)  
STEARYL ALCOHOL (UNII: 2KR89I4H1Y)  
PHENOXYETHANOL (UNII: HIE492ZZ3T)  
POTASSIUM SORBATE (UNII: 1VPU26JZZ4)  
HEXYL LAURATE (UNII: 4CG9F9W01Q)  
GINGER (UNII: C5529G5JPQ)  
MEDIUM-CHAIN TRIGLYCERIDES (UNII: C9H2L21V7U)  
HYDROGENATED COCO-GLYCERIDES (UNII: XDD37N2GPR)  
TRIETHYL CITRATE (UNII: 8Z96QXD6UM)  
SILICON DIOXIDE (UNII: ETJ7Z6XBU4)  
POLYHYDROXYSTEARIC ACID (2300 MW) (UNII: YXH47AOU0F)  
BUTYLATED HYDROXYTOLUENE (UNII: 1P9D0Z171K)  
CETOSTEARYL ALCOHOL (UNII: 2DMT128M1S)  
MAGNESIUM POTASSIUM ALUMINOSILICATE FLUORIDE (UNII: YK3DC63Y5M)  
TITANIUM DIOXIDE (UNII: 15FIX9V2JP)  
SQUALANE (UNII: GW89575KF9)  
HYALURONATE SODIUM (UNII: YSE9PPT4TH)  
DISTEARDIMONIUM HECTORITE (UNII: X687XDK09L)  
SODIUM DEHYDROACETATE (UNII: 8W46YN971G)  
BISMUTH OXYCHLORIDE (UNII: 4ZR792I587)  
WATER (UNII: 059QF0KO0R)  
DIMETHICONE (UNII: 92RU3N3Y1O)  
CETYL PEG/PPG-10/1 DIMETHICONE (HLB 5) (UNII: 035JKJ76MT)  
PASSIFLORA EDULIS SEED OIL (UNII: F3VOA31UHQ)  
WHEY (UNII: 8617Z5FMF6)  
BARLEY (UNII: 5PWM7YLI7R)  
WHEAT GERM (UNII: YR3G369F5A)  
TOCOPHEROL (UNII: R0ZB2556P8)  
FERRIC OXIDE RED (UNII: 1K09F3G675)  
FERRIC OXIDE YELLOW (UNII: EX438O2MRT)  
CAPRYLYL GLYCOL (UNII: 00YIU5438U)  
GLYCERYL TRIOLEATE (UNII: O05EC62663)  
HYDROXYETHYL UREA (UNII: MBQ7DDQ7AR)  
POLYMETHYLSILSESQUIOXANE (4.5 MICRONS) (UNII: 59Z907ZB69)  
DIMETHICONE/DIVINYLDIMETHICONE/SILSESQUIOXANE CROSSPOLYMER (UNII: T3064TZ75A)  
EDETATE DISODIUM ANHYDROUS (UNII: 8NLQ36F6MM)  
LAURETH-7 (UNII: Z95S6G8201)  
TRIBASIC CALCIUM PHOSPHATE (UNII: 91D9GV0Z28)  
DIMETHICONE/VINYL DIMETHICONE CROSSPOLYMER (SOFT PARTICLE) (UNII: 9E4CO0W6C5)  
TROMETHAMINE (UNII: 023C2WHX2V)  
SODIUM CHLORIDE (UNII: 451W47IQ8X)  
GLYCERYL MONOSTEARATE (UNII: 230OU9XXE4)  
AMMONIUM POLYACRYLOYLDIMETHYL TAURATE (55000 MPA.S) (UNII: F01RIY4371)  
PALMITIC ACID (UNII: 2V16EO95H1)  
STEARIC ACID (UNII: 4ELV7Z65AP)  
POLYSORBATE 80 (UNII: 6OZP39ZG8H)  
DOCOSANOL (UNII: 9G1OE216XY)  
LINALOOL, (+/-)- (UNII: D81QY6I88E)  
BUTYLENE GLYCOL (UNII: 3XUS85K0RA)  
PHENYL TRIMETHICONE (UNII: DR0K5NOJ4R)  
NIACINAMIDE (UNII: 25X51I8RD4)  
GLYCERIN (UNII: PDC6A3C0OX)  
EICOSYL POVIDONE (UNII: XQQ9MKE2BJ)  
ASCORBYL GLUCOSIDE (UNII: 2V52R0NHXW)  
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:76398-013-011 in 1 CARTON10/14/2022
130 mL in 1 BOTTLE; Type 0: Not a Combination Product
2NDC:76398-013-021 in 1 CARTON10/14/202211/30/2023
23.6 mL in 1 BOTTLE; Type 0: Not a Combination Product
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC Monograph DrugM02010/14/2022
Labeler - TOM FORD BEAUTY DIST (005914387)
Registrant - Estee Lauder Companies Inc. (790802086)
Establishment
NameAddressID/FEIBusiness Operations
Estee Lauder Cosmetics Ltd.202952982manufacture(76398-013)
Establishment
NameAddressID/FEIBusiness Operations
Estee Lauder Cosmetics Ltd.204132062pack(76398-013) , label(76398-013)

Revised: 12/2023
Document Id: 0b782b71-11a2-56d4-e063-6394a90a7676
Set id: eac7d416-c243-4647-e053-2a95a90abcb7
Version: 4
Effective Time: 20231201
 
TOM FORD BEAUTY DIST