SHADE and ILLUMINATE SOFT RAD PRMR SPF

Manufacturer
TOM FORD BEAUTY DIST | Estee Lauder Companies Inc. | Estee Lauder Cosmetics Ltd.
Effective date
2023-12-01
Label type
HUMAN OTC DRUG LABEL
Version
4
Source
full-release
Hydrated at
2026-06-01 00:03:12

Label at a glance#

ProductSHADE and ILLUMINATE SOFT RAD PRMR SPF
Active ingredientZINC OXIDE, OCTINOXATE, OCTISALATE
Label structure8 sections

Dosage and administration

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 inclu...

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

Octinoxate 6.7%

Octisalate 4.5%

Zinc Oxide 10.0%

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 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

INACTIVE INGREDIENT SECTION

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

STORAGE AND HANDLING SECTION

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

PRINCIPAL DISPLAY PANEL

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

Principal Display PanelPrincipal Display PanelTOM FORD

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

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
77dc03a4-fbfc-e6a3-fe95-285bbae40d75Product name220250814
7dea7767-9f52-b60a-5435-33cb9cc28baeProduct name420250124
6338270f-96cb-0ecb-6fbb-0a9bc78001f4Product name720250116
0ca83774-3f79-b837-5d6f-c210102f3bc8Product name620250114
41b814f3-0166-1c53-c9ef-a0794c7daf9dProduct name320221110
a590be26-846c-8659-a5a1-fb25907965dcProduct name220221110
2dc76302-91c0-4c35-ad78-99adfb049c4bProduct name120200603
e6065d4b-5ae1-476f-a40e-f2851cbb5d2bProduct name220180221
f212291f-05fe-9603-fc7e-bd73e38ce1e6Product name220161129
182f9ab4-4ab5-c449-200f-87ce2ce8e550Product name220151105
332e86c3-7875-ca6e-f934-2206d2b31996Product name120140508
56625fcc-aa34-9d30-d0e9-1c1beb37ea21Product name120140508
7dfac40f-a405-cd2e-7c06-3059ec0e1092Product name120140508
96c2be53-8e44-452d-56a2-d255b2f1af2dProduct name120140508
bf8bd5f7-495f-4022-2780-7ded7ea7ea44Product name120140508
d223c173-c39b-d764-47d4-d671d3088815Product name120140508
e01133ad-4dcd-c7f3-454b-2ff569ee160aProduct name120140508

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
76398-013-01SHADE and ILLUMINATE SOFT RAD PRMR SPF1 in 1 CARTONCREAM14
76398-013-01SHADE and ILLUMINATE SOFT RAD PRMR SPF30 mL in 1 BOTTLECREAM304
76398-013-02SHADE and ILLUMINATE SOFT RAD PRMR SPF3.6 mL in 1 BOTTLECREAM3.64
76398-013-02SHADE and ILLUMINATE SOFT RAD PRMR SPF1 in 1 CARTONCREAM14

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
76398-013SHADE AND ILLUMINATE SOFT RAD PRMR SPF (OCTINOXATE,OCTISALATE,ZINC OXIDE) CREAM [TOM FORD BEAUTY DIST]4Current NDC, Legacy NDC, 4 package rows20231202_eac7d416-c243-4647-e053-2a95a90abcb7.zip

Products#

Every source-derived product name is available through these pages.

DailyMed product names page 1 of 2 · 76 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
76398-01376398-013-01, 76398-013-02

Ingredients#

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

DailyMed ingredient rows page 1 of 2 · 74 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
SHADE and ILLUMINATE SOFT RAD PRMR SPFOCTINOXATE,OCTISALATE,ZINC OXIDETOM FORD BEAUTY DISTeac7d416-c243-4647-e053-2a95a90abcb72023-12-01WarningsExact identifier
ndc (package): 76398-013-02
ndc (package): 76398-013-01
ndc (product): 76398-013
ndc11 (package): 76398001301
ndc11 (package): 76398001302
spl id: 0b782b71-11a2-56d4-e063-6394a90a7676
spl set id: eac7d416-c243-4647-e053-2a95a90abcb7

Reported adverse events (FAERS/openFDA)#

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