85176-001

85176-001
SPL v1
SPL
SPL Set ID 2d604579-7883-e4cb-e063-6394a90a7d92
Route
TRANSDERMAL
Published
Effective Date 2025-02-05
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients
Ethylhexyl Methoxycinnamate (8.49405 g) Titanium Dioxide (3.9 g) Aluminum Hydroxide (0.6 g) Ethylhexyl Salicylate (4 g) Phenylbenzimidazole Sulfonic Acid (1 g) Zinc Oxide (10.45 g)
Inactive Ingredients
Silica Disteardimonium Hectorite Bis-ethylhexyloxyphenol Methoxyphenyl Triazine Trimethylsiloxysilicate (m/q 0.8-1.0) Phenoxyethanol Stearic Acid Water Cyclopentasiloxane Triethoxycaprylylsilane Dimethicone Polymethylsilsesquioxane Sodium Chloride Glycerin Trolamine Salicylate Bht Lauryl Peg-9 Polydimethylsiloxyethyl Dimethicone Ethylhexylglycerin Isododecane Butylene Glycol Phenyl Trimethicone Dextrin Palmitate (corn; 20000 Mw) Propylene Carbonate Diethylamino Hydroxybenzoyl Hexyl Benzoate

Identifiers & Packaging

Marketing Status
OTC MONOGRAPH DRUG Active Since 2025-02-05

Description

ZINC OXIDE 10.45% ETHYLHEXYL METHOXYCINNAMATE 8.49405% TITANIUM DIOXIDE 3.9% ALUMINUM HYDROXIDE 0.6% ETHYLHEXYL SALICYLATE 4% PHENYLBENZIMIDAZOLE SULFONIC ACID 1%

Purpose

Sunscreen


Medication Information

Purpose

Sunscreen

Description

ZINC OXIDE 10.45% ETHYLHEXYL METHOXYCINNAMATE 8.49405% TITANIUM DIOXIDE 3.9% ALUMINUM HYDROXIDE 0.6% ETHYLHEXYL SALICYLATE 4% PHENYLBENZIMIDAZOLE SULFONIC ACID 1%

Use

helps prevent sunburn. if used as directed with other sun protection measures (see Directions).

decreases the risk of skin cancer and early skin aging caused by the sun.

Section 50565-1

Keep out of reach of children. If product is swallowed, get medical help or contact a Posion Control Center right away.

May stain some fabrics.

Section 50566-9

Stop use and ask a doctor if rash occurs.

Section 50567-7

When using this product

keep out of eyes. Rinse with water to remove.

Warnings

For external use only.

Directions

1. Clean the face

2. Moisturizing and hydrating

3. Apply sunscreen

Do Not Use

Do not use on damaged or broken skin.

Other Information

Other information protect this product from excessive heat and direct sun

Active Ingredient(s)

ZINC OXIDE 10.45%

ETHYLHEXYL METHOXYCINNAMATE 8.49405%

TITANIUM DIOXIDE 3.9%

ALUMINUM HYDROXIDE 0.6%

ETHYLHEXYL SALICYLATE 4%

PHENYLBENZIMIDAZOLE SULFONIC ACID 1%

Inactive Ingredients

WATER, CYCLOPENTASILOXANE, TRIETHOXYCAPRYLYLSILANE, DIMETHICONE, GLYCERIN, SODIUM CHLORIDE,

TRIETHANOLAMINE, BHT, ISODODECANE, STEARIC ACID, PHENYL TRIMETHICONE, POLYMETHYLSILSESQUIOXANE,

BUTYLENE GLYCOL, DIETHYLAMINO HYDROXYBENZOYL HEXYL BENZOATE, LAURYL PEG-9 POLYDIMETHYLSILOXYETHYL DIMETHICONE, SILICA, BIS-ETHYLHEXYLOXYPHENOL METHOXYPHENYL TRIAZINE, TRIMETHYLSILOXYSILICATE,

PHENOXYETHANOL, DISTEARDIMONIUM HECTORITE, DEXTRIN PALMITATE, PROPYLENE CARBONATE,

ETHYLHEXYLGLYCERIN

Package Label Principal Display Panel


Structured Label Content

Use

helps prevent sunburn. if used as directed with other sun protection measures (see Directions).

decreases the risk of skin cancer and early skin aging caused by the sun.

Section 50565-1 (50565-1)

Keep out of reach of children. If product is swallowed, get medical help or contact a Posion Control Center right away.

May stain some fabrics.

Section 50566-9 (50566-9)

Stop use and ask a doctor if rash occurs.

Section 50567-7 (50567-7)

When using this product

keep out of eyes. Rinse with water to remove.

Purpose

Sunscreen

Warnings

For external use only.

Directions

1. Clean the face

2. Moisturizing and hydrating

3. Apply sunscreen

Do Not Use (Do not use)

Do not use on damaged or broken skin.

Other Information (Other information)

Other information protect this product from excessive heat and direct sun

Active Ingredient(s)

ZINC OXIDE 10.45%

ETHYLHEXYL METHOXYCINNAMATE 8.49405%

TITANIUM DIOXIDE 3.9%

ALUMINUM HYDROXIDE 0.6%

ETHYLHEXYL SALICYLATE 4%

PHENYLBENZIMIDAZOLE SULFONIC ACID 1%

Inactive Ingredients (Inactive ingredients)

WATER, CYCLOPENTASILOXANE, TRIETHOXYCAPRYLYLSILANE, DIMETHICONE, GLYCERIN, SODIUM CHLORIDE,

TRIETHANOLAMINE, BHT, ISODODECANE, STEARIC ACID, PHENYL TRIMETHICONE, POLYMETHYLSILSESQUIOXANE,

BUTYLENE GLYCOL, DIETHYLAMINO HYDROXYBENZOYL HEXYL BENZOATE, LAURYL PEG-9 POLYDIMETHYLSILOXYETHYL DIMETHICONE, SILICA, BIS-ETHYLHEXYLOXYPHENOL METHOXYPHENYL TRIAZINE, TRIMETHYLSILOXYSILICATE,

PHENOXYETHANOL, DISTEARDIMONIUM HECTORITE, DEXTRIN PALMITATE, PROPYLENE CARBONATE,

ETHYLHEXYLGLYCERIN

Package Label Principal Display Panel (Package Label - Principal Display Panel)


Advanced Ingredient Data


Raw Label Data

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