ensulizole, octinoxate, octisalate, and zinc oxide

Manufacturer
TOM FORD BEAUTY DIST | Estee Lauder Companies Inc. | Estee Lauder Cosmetics Ltd
Effective date
2024-12-02
Label type
HUMAN OTC DRUG LABEL
Version
1
Source
legacy-cache
Hydrated at
2026-08-01 20:47:54

Label at a glance#

Productensulizole, octinoxate, octisalate, and zinc oxide
Active ingredientOCTINOXATE, OCTISALATE, ZINC OXIDE, ENSULIZOLE
Label structure8 sections

Dosage and administration

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...

Storage and handling

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

Label contents#

Full prescribing information#

Active Ingredients

OTC - ACTIVE INGREDIENT SECTION

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

Purpose

OTC - PURPOSE SECTION

Sunscreen

USE

INDICATIONS & USAGE SECTION

helps prevent sunburn

Warnings

WARNINGS SECTION

For external use only

Do not use

OTC - DO NOT USE SECTION

on damaged or broken skin

When using this product

OTC - WHEN USING SECTION

keep out of eyes. Rinse with water to remove.

Stop use and ask a doctor if

OTC - STOP USE SECTION

rash occurs

Keep out of reach of children.

OTC - KEEP OUT OF REACH OF CHILDREN SECTION

If product is swallowed, get medical help or contact a Poison Control Center right away.

Directions

DOSAGE & ADMINISTRATION SECTION

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

INACTIVE INGREDIENT SECTION

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

STORAGE AND HANDLING SECTION

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

PDP

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

TOM FORD

ARCHITECTURE

RADIANCE HYDRATING

FOUNDATION

BROAD SPECTRUM SPF 50+

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

PDPPDP

Products#

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NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
76398-01476398-014-01

Ingredients#

Every source-derived ingredient row is available through these pages.

DailyMed ingredient rows page 1 of 2 · 76 matching rows.

Source Document#

Source XML

openFDA label cross-check#

OpenFDA label data provides additional search and identifier links. DailyMed’s Structured Product Label is the canonical label on FDA.report. Matching records are deduplicated before they are shown below.

Matched openFDA labels page 1 of 1 · 1 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
3583732b-874d-b36c-e063-6394a90a7ec528500ecb-efbe-e84b-e063-6394a90ac4d22025-05-19WarningsExact identifier
spl set id: 28500ecb-efbe-e84b-e063-6394a90ac4d2

Reported adverse events (FAERS/openFDA)#

Adverse event summaries are temporarily unavailable. Other product information remains available.