SHADE AND ILLUMINATE SOFT RAD PRMR SPF- octinoxate,octisalate,zinc oxide cream

SHADE and ILLUMINATE SOFT RAD PRMR SPF by

Drug Labeling and Warnings

SHADE and ILLUMINATE SOFT RAD PRMR SPF by is a Otc medication manufactured, distributed, or labeled by TOM FORD BEAUTY DIST, Estee Lauder Companies Inc., PALC, Estee Lauder Cosmetics Ltd., Whitman Laboratories Ltd., Estee Lauder N.V., The Estee Lauder Inc, NORTHTEC INC, PADC 1. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

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

TOM FORD

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

INGREDIENTS AND APPEARANCE

SHADE AND ILLUMINATE SOFT RAD PRMR SPF 
octinoxate,octisalate,zinc oxide cream

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 76398-013
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
ZINC OXIDE (UNII: SOI2LOH54Z) (ZINC OXIDE - UNII:SOI2LOH54Z)	ZINC OXIDE	100 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

Inactive Ingredients
Ingredient Name	Strength
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 Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 76398-013-01	1 in 1 CARTON	10/14/2022
1		30 mL in 1 BOTTLE; Type 0: Not a Combination Product
2	NDC: 76398-013-02	1 in 1 CARTON	10/14/2022	11/30/2023
2		3.6 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	10/14/2022

Labeler - TOM FORD BEAUTY DIST (005914387)

Registrant - Estee Lauder Companies Inc. (790802086)

Establishment
Name	Address	ID/FEI	Business Operations
Estee Lauder Cosmetics Ltd.		202952982	manufacture(76398-013)

Establishment
Name	Address	ID/FEI	Business Operations
Estee Lauder Cosmetics Ltd.		204132062	pack(76398-013) , label(76398-013)