TOM FORD ARCHITECTURE RADIANCE HYDRATING FOUNDATION BROAD SPECTRUM SPF 50- ensulizole, octinoxate, octisalate, and zinc oxide emulsion

TOM FORD ARCHITECTURE RADIANCE HYDRATING FOUNDATION BROAD SPECTRUM SPF 50 by

Drug Labeling and Warnings

TOM FORD ARCHITECTURE RADIANCE HYDRATING FOUNDATION BROAD SPECTRUM SPF 50 by is a Otc medication manufactured, distributed, or labeled by TOM FORD BEAUTY DIST, Estee Lauder Companies Inc., Estee Lauder Cosmetics Ltd. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

Active Ingredients

ENSULIZOLE 2.7%
OCTINOXATE 6.5%
OCTISALATE 3%
ZINC OXIDE 5.3%

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,DIMETHICONE,PHENYL TRIMETHICONE,BUTYLENE GLYCOL,GLYCERIN,NIACINAMIDE,TROMETHAMINE,POLYMETHYLSILSESQUIOXANE,ASCORBYL GLUCOSIDE,LAURYL PEG-9 POLYDIMETHYLSILOXYETHYL DIMETHICONE,HDI/PPG/POLYCAPROLACTONE CROSSPOLYMER,TRIMETHYLSILOXYSILICATE/DIMETHICONOL CROSSPOLYMER,POLYSILICONE-11,CETYL PEG/PPG-10/1 DIMETHICONE,HEXYL LAURATE,ZINC PCA,NEOPENTYL GLYCOL DIHEPTANOATE,TOCOPHEROL,SODIUM HYALURONATE,SQUALANE,ZINGIBER OFFICINALE (GINGER) ROOT EXTRACT,HORDEUM DISTICHON (BARLEY) EXTRACT\EXTRAIT D'ORGE À DEUX RANGS,TRITICUM VULGARE (WHEAT) GERM EXTRACT,CEREUS GRANDIFLORUS (CACTUS) FLOWER EXTRACT,GERANIUM ROBERTIANUM EXTRACT,SAPINDUS MUKOROSSI FRUIT EXTRACT,MORINDA CITRIFOLIA FRUIT EXTRACT,PASSIFLORA EDULIS SEED OIL,MORINGA OLEIFERA SEED OIL,HYDROGENATED COCO-GLYCERIDES,PHOSPHOLIPIDS,PHYTOSTERYL CANOLA GLYCERIDES,WHEY PROTEIN\LACTIS PROTEIN\PROTÉINE DU PETIT-LAIT,CAFFEINE,POLYGLYCERYL-4 ISOSTEARATE,CAPRYLIC/CAPRIC TRIGLYCERIDE,TREHALOSE,TRIETHYL CITRATE,CHOLESTEROL,LINOLEIC ACID,METHICONE,TRIOLEIN,CAESALPINIA SPINOSA GUM,ACETYL HEXAPEPTIDE-8,DIMETHICONE/DIVINYLDIMETHICONE/SILSESQUIOXANE CROSSPOLYMER,SILICA,DISTEARDIMONIUM HECTORITE,POLYHYDROXYSTEARIC ACID,HYDROXYETHYL UREA,GLYCERYL STEARATE,OLEIC ACID,STEARIC ACID,POLYSORBATE 80,POLYSORBATE 20,LECITHIN,LAURETH-7,PALMITIC ACID,CETEARYL ALCOHOL,AMMONIUM POLYACRYLOYLDIMETHYL TAURATE,STEARYL ALCOHOL,BEHENYL ALCOHOL,TRIETHOXYCAPRYLYLSILANE,FRAGRANCE (PARFUM),LIMONENE,LINALOOL,TOCOPHERYL ACETATE,BHT,TETRASODIUM EDTA,DISODIUM EDTA,PHENOXYETHANOL,SODIUM DEHYDROACETATE,POTASSIUM SORBATE, [+/- MICA,TITANIUM DIOXIDE (CI 77891),IRON OXIDES (CI 77491),IRON OXIDES (CI 77492),IRON OXIDES (CI 77499)] <ILN53465>

Other information

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

PDP

TOM FORD

ARCHITECTURE

RADIANCE HYDRATING

FOUNDATION

BROAD SPECTRUM SPF 50+

1 FL.OZ/OZ. LIQ/30ml e

INGREDIENTS AND APPEARANCE

TOM FORD ARCHITECTURE RADIANCE HYDRATING FOUNDATION BROAD SPECTRUM SPF 50 
ensulizole, octinoxate, octisalate, and zinc oxide emulsion

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 76398-015
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
OCTINOXATE (UNII: 4Y5P7MUD51) (OCTINOXATE - UNII:4Y5P7MUD51)	OCTINOXATE	65 mg  in 1 mL
OCTISALATE (UNII: 4X49Y0596W) (OCTISALATE - UNII:4X49Y0596W)	OCTISALATE	30 mg  in 1 mL
ZINC OXIDE (UNII: SOI2LOH54Z) (ZINC OXIDE - UNII:SOI2LOH54Z)	ZINC OXIDE	53 mg  in 1 mL
ENSULIZOLE (UNII: 9YQ9DI1W42) (ENSULIZOLE - UNII:9YQ9DI1W42)	ENSULIZOLE	27 mg  in 1 mL

Inactive Ingredients
Ingredient Name	Strength
ZINGIBER OFFICINALE (GINGER) ROOT EXTRACT (UNII: C5529G5JPQ)
CAFFEINE (UNII: 3G6A5W338E)
OLEIC ACID (UNII: 2UMI9U37CP)
LIMONENE, (+)- (UNII: GFD7C86Q1W)
TETRASODIUM EDTA (UNII: MP1J8420LU)
PHENOXYETHANOL (UNII: HIE492ZZ3T)
CI 77492 (UNII: EX438O2MRT)
BUTYLENE GLYCOL (UNII: 3XUS85K0RA)
DIMETHICONE/VINYL DIMETHICONE CROSSPOLYMER (SOFT PARTICLE) (UNII: 9E4CO0W6C5)
TOCOPHEROL (UNII: R0ZB2556P8)
SQUALANE (UNII: GW89575KF9)
WHEY (UNII: 8617Z5FMF6)
TREHALOSE (UNII: B8WCK70T7I)
GLYCERYL STEARATE (UNII: 230OU9XXE4)
POLYSORBATE 80 (UNII: 6OZP39ZG8H)
LAURETH-7 (UNII: Z95S6G8201)
CI 77499 (UNII: XM0M87F357)
NEOPENTYL GLYCOL DIHEPTANOATE (UNII: 5LKW3C543X)
PASSIFLORA EDULIS SEED OIL (UNII: F3VOA31UHQ)
MORINGA OLEIFERA SEED OIL (UNII: REM6A5QMC0)
CAPRYLIC/CAPRIC TRIGLYCERIDE (UNII: C9H2L21V7U)
CAESALPINIA SPINOSA GUM (UNII: WL3883U2PO)
POLYSORBATE 20 (UNII: 7T1F30V5YH)
GLYCERIN (UNII: PDC6A3C0OX)
HEXYL LAURATE (UNII: 4CG9F9W01Q)
ZINC PCA (UNII: C32PQ86DH4)
SODIUM HYALURONATE (UNII: YSE9PPT4TH)
GERANIUM ROBERTIANUM EXTRACT (UNII: R5I1HK0UBL)
METHICONE (20 CST) (UNII: 6777U11MKT)
DIMETHICONE/DIVINYLDIMETHICONE/SILSESQUIOXANE CROSSPOLYMER (UNII: T3064TZ75A)
HYDROXYETHYL UREA (UNII: MBQ7DDQ7AR)
ALPHA-TOCOPHEROL ACETATE (UNII: 9E8X80D2L0)
EDETATE DISODIUM ANHYDROUS (UNII: 8NLQ36F6MM)
SODIUM DEHYDROACETATE (UNII: 8W46YN971G)
MICA (UNII: V8A1AW0880)
SAPINDUS MUKOROSSI FRUIT (UNII: 66H9NW427Y)
CETEARYL ALCOHOL (UNII: 2DMT128M1S)
WATER (UNII: 059QF0KO0R)
PHENYL TRIMETHICONE (UNII: DR0K5NOJ4R)
ASCORBYL GLUCOSIDE (UNII: 2V52R0NHXW)
LAURYL PEG-9 POLYDIMETHYLSILOXYETHYL DIMETHICONE (UNII: 25G622K2RA)
SELENICEREUS GRANDIFLORUS FLOWER (UNII: II877K4UNR)
MORINDA CITRIFOLIA FRUIT (UNII: 7829X3G2X5)
HYDROGENATED COCO-GLYCERIDES (UNII: XDD37N2GPR)
TRIETHYL CITRATE (UNII: 8Z96QXD6UM)
SILICA (UNII: ETJ7Z6XBU4)
PALMITIC ACID (UNII: 2V16EO95H1)
BEHENYL ALCOHOL (UNII: 9G1OE216XY)
SOYBEAN LECITHIN (UNII: 1DI56QDM62)
POLYGLYCERYL-4 ISOSTEARATE (UNII: 820DPX33S7)
CHOLESTEROL (UNII: 97C5T2UQ7J)
LINOLEIC ACID (UNII: 9KJL21T0QJ)
TRIOLEIN (UNII: O05EC62663)
ACETYL HEXAPEPTIDE-8 (UNII: L4EL31FWIL)
TRIETHOXYCAPRYLYLSILANE (UNII: LDC331P08E)
LINALOOL (UNII: D81QY6I88E)
BHT (UNII: 1P9D0Z171K)
POTASSIUM SORBATE (UNII: 1VPU26JZZ4)
CI 77891 (UNII: 15FIX9V2JP)
POLYMETHYLSILSESQUIOXANE (UNII: 59Z907ZB69)
DIMETHICONE (UNII: 92RU3N3Y1O)
NIACINAMIDE (UNII: 25X51I8RD4)
TROMETHAMINE (UNII: 023C2WHX2V)
CETYL PEG/PPG-10/1 DIMETHICONE (HLB 5) (UNII: 035JKJ76MT)
HORDEUM DISTICHON (BARLEY) EXTRACT (UNII: 5PWM7YLI7R)
TRITICUM VULGARE (WHEAT) GERM (UNII: YR3G369F5A)
DISTEARDIMONIUM HECTORITE (UNII: X687XDK09L)
POLYHYDROXYSTEARIC ACID (2300 MW) (UNII: YXH47AOU0F)
STEARIC ACID (UNII: 4ELV7Z65AP)
AMMONIUM POLYACRYLOYLDIMETHYL TAURATE (UNII: F01RIY4371)
STEARYL ALCOHOL (UNII: 2KR89I4H1Y)
CI 77491 (UNII: 1K09F3G675)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 76398-015-01	1 in 1 CARTON	12/06/2024
1		30 mL in 1 BOTTLE, PUMP; 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	12/06/2024

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(76398-015)

Establishment
Name	Address	ID/FEI	Business Operations
Estee Lauder Cosmetics Ltd		204132062	label(76398-015) , pack(76398-015) , manufacture(76398-015)