Shade And Illuminate Soft Rad Prmr Spf

Shade And Illuminate Soft Rad Prmr Spf
SPL v4
SPL
SPL Set ID eac7d416-c243-4647-e053-2a95a90abcb7
Route
TOPICAL
Published
Effective Date 2022-10-27
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients
Zinc Oxide (100 mg) Octinoxate (67 mg) Octisalate (45 mg)
Inactive Ingredients
Trehalose Caffeine Cholesterol Moringa Oleifera Seed Oil Sapindus Mukorossi Fruit Caesalpinia Spinosa Resin Morinda Citrifolia Fruit Polyglyceryl-4 Isostearate Trametes Versicolor Fruiting Body Lauryl Peg-9 Polydimethylsiloxyethyl Dimethicone Oleic Acid Polysorbate 20 .alpha.-tocopherol Acetate Mica Ferrosoferric Oxide Lecithin, Soybean Lavender Oil Linoleic Acid Stearyl Alcohol Phenoxyethanol Potassium Sorbate Hexyl Laurate Ginger Medium-chain Triglycerides Hydrogenated Coco-glycerides Triethyl Citrate Silicon Dioxide Polyhydroxystearic Acid (2300 Mw) Butylated Hydroxytoluene Cetostearyl Alcohol Magnesium Potassium Aluminosilicate Fluoride Titanium Dioxide Squalane Hyaluronate Sodium Disteardimonium Hectorite Sodium Dehydroacetate Bismuth Oxychloride Water Dimethicone Cetyl Peg/ppg-10/1 Dimethicone (hlb 5) Passiflora Edulis Seed Oil Whey Barley Wheat Germ Tocopherol Ferric Oxide Red Ferric Oxide Yellow Caprylyl Glycol Glyceryl Trioleate Hydroxyethyl Urea Polymethylsilsesquioxane (4.5 Microns) Dimethicone/divinyldimethicone/silsesquioxane Crosspolymer Edetate Disodium Anhydrous Laureth-7 Tribasic Calcium Phosphate Dimethicone/vinyl Dimethicone Crosspolymer (soft Particle) Tromethamine Sodium Chloride Glyceryl Monostearate Ammonium Polyacryloyldimethyl Taurate (55000 Mpa.s) Palmitic Acid Stearic Acid Polysorbate 80 Docosanol Linalool, (+/-)- Butylene Glycol Phenyl Trimethicone Niacinamide Glycerin Eicosyl Povidone Ascorbyl Glucoside

Identifiers & Packaging

Marketing Status
OTC MONOGRAPH DRUG Active Since 2022-10-14 Until 2023-11-30

Description

Octinoxate 6.7% Octisalate 4.5% Zinc Oxide 10.0%

Purpose

Sunscreen


Medication Information

Purpose

Sunscreen

Description

Octinoxate 6.7% Octisalate 4.5% Zinc Oxide 10.0%

Use

Helps prevent sunburn

Warnings

For external use only

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

Do Not Use

on damaged or broken skin

Other Information

protect the product in this container

from excessive heat and direct sun

Active Ingredients

Octinoxate 6.7%

Octisalate 4.5%

Zinc Oxide 10.0%

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>

Principal Display Panel

TOM FORD

SHADE AND ILLUMINATE

SOFT RADIANCE PRIMER

BROAD SPECTRUM SPF 25

1 FL. OZ./OZ. LIQ./30 ml ℮

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.


Structured Label Content

Use (USE)

Helps prevent sunburn

Purpose

Sunscreen

Warnings

For external use only

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

Do Not Use (Do not use)

on damaged or broken skin

Other Information

protect the product in this container

from excessive heat and direct sun

Active Ingredients

Octinoxate 6.7%

Octisalate 4.5%

Zinc Oxide 10.0%

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>

Principal Display Panel (PRINCIPAL DISPLAY PANEL)

TOM FORD

SHADE AND ILLUMINATE

SOFT RADIANCE PRIMER

BROAD SPECTRUM SPF 25

1 FL. OZ./OZ. LIQ./30 ml ℮

When Using This Product (When using this product)

keep out of eyes. Rinse with water to remove

Stop Use and Ask A Doctor If (Stop use and ask a doctor if)

rash occurs

Keep Out of Reach of Children (Keep out of reach of children)

If product is swallowed, get medical

help or contact a Poison Control

Center right away.


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