83447-014

83447-014
SPL v1
SPL
SPL Set ID 4567d413-d8cc-677b-e063-6294a90a1a42
Route
CUTANEOUS
Published
Effective Date 2025-12-08
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients
Ethylhexyl Methoxycinnamate (5.994 g) Butyl Methoxydibenzoylmethane (1.5 g) Homosalate (2 g) Ethylhexyl Salicylate (3.5 g)
Inactive Ingredients
Caprylyl Glycol Niacinamide Polyacrylamide (1500 Mw) Titanium Dioxide C13-14 Isoparaffin Phenoxyethanol Peg-20 Stearate Hydroxyacetophenone Carbomer 1,2-hexanediol Glyceryl Stearate Potassium Hydroxide Polysorbate 20 Bht Panthenol Ethylhexylglycerin Xylitol Laureth-7 Water Glycerin Caprylic/capric Triglyceride Cetearyl Alcohol Palmitic Acid Stearic Acid Lauric/myristic/palmitic/stearic Glycerides Alpha-tocopherol Acetate Butylene Glycol Sodium Hyaluronate Benzyl Alcohol Dimethiconol (2000 Cst) Benzoic Acid Polymethylsilsesquioxane (4.5 Microns) Anhydroxylitol Palmitoyl Pentapeptide-4 Polyacrylic Acid (8000 Mw) Xylitylglucoside Edetate Disodium Dimethicone

Identifiers & Packaging

Marketing Status
OTC MONOGRAPH DRUG Active Since 2025-12-08

Description

Ethylhexyl Methoxycinnamate 5.994% Ethylhexyl Salicylate 3.5% Homosalate 2% Butyl Methoxydibenzoylmethane 1.5%

Purpose

Sunscreen


Medication Information

Purpose

Sunscreen

Description

Ethylhexyl Methoxycinnamate 5.994% Ethylhexyl Salicylate 3.5% Homosalate 2% Butyl Methoxydibenzoylmethane 1.5%

Uses

Helps prevent sunburn, decreases the risk of skin cancer and early skin

aging if used as directed.

Section 51945-4

Stop Use

Stop use and ask a doctor if rash occurs.

Warnings

For external use only

Directions

Apply evenly to clean, dry skin before sun exposure. Apply once-daily. In the

event of prolonged sun exposure, apply standard sunscreen as-needed

throughout day

Do Not Use

Do not use on damaged or broken skin

Keep Out Of

Keep out of reach of children. In case of ingestion, get medical help or

contact a Poison Control Center right away.

Other Information

Protect this product from excessive heat and direct sun

Active Ingredients

Ethylhexyl Methoxycinnamate 5.994%

Ethylhexyl Salicylate 3.5%

Homosalate 2%

Butyl Methoxydibenzoylmethane 1.5%

Inactive Ingredients

Water, Glycerin, Caprylic/Capric Triglyceride, Cetearyl Alcohol, Dimethicone,

Niacinamide, Panthenol, Palmitic Acid, Polymethylsilsesquioxane,PEG-20

Stearate, Stearic Acid, Lauric/Myristic/Palmitic/Stearic Glycerides,

Hydroxyacetophenone,1,2-Hexanediol, Tocopheryl Acetate, Dimethiconol,

Glyceryl Stearate, Polyacrylamide, Titanium Dioxide, Polyacrylic Acid,

Xylitylglucoside, Butylene Glycol, C13-14 Isoparaffin, Anhydroxylitol, Sodium

Hyaluronate, Potassium Hydroxide, Benzyl Alcohol, Laureth-7, Disodium EDTA,

Xylitol, Polysorbate20, Phenoxyethanol, Caprylyl Glycol, Carbomer,BHT,

Ethylhexylglycerin, Benzoic Acid, Palmitoyl Pentapeptide-4

When Using This Product

When using this product, keep out of eyes. Rinse with water to remove.


Structured Label Content

Uses

Helps prevent sunburn, decreases the risk of skin cancer and early skin

aging if used as directed.

Section 51945-4 (51945-4)

Purpose

Sunscreen

Stop Use (Stop use)

Stop use and ask a doctor if rash occurs.

Warnings

For external use only

Directions

Apply evenly to clean, dry skin before sun exposure. Apply once-daily. In the

event of prolonged sun exposure, apply standard sunscreen as-needed

throughout day

Do Not Use (Do not use)

Do not use on damaged or broken skin

Keep Out Of (Keep out of)

Keep out of reach of children. In case of ingestion, get medical help or

contact a Poison Control Center right away.

Other Information (Other information)

Protect this product from excessive heat and direct sun

Active Ingredients (Active ingredients)

Ethylhexyl Methoxycinnamate 5.994%

Ethylhexyl Salicylate 3.5%

Homosalate 2%

Butyl Methoxydibenzoylmethane 1.5%

Inactive Ingredients (Inactive ingredients)

Water, Glycerin, Caprylic/Capric Triglyceride, Cetearyl Alcohol, Dimethicone,

Niacinamide, Panthenol, Palmitic Acid, Polymethylsilsesquioxane,PEG-20

Stearate, Stearic Acid, Lauric/Myristic/Palmitic/Stearic Glycerides,

Hydroxyacetophenone,1,2-Hexanediol, Tocopheryl Acetate, Dimethiconol,

Glyceryl Stearate, Polyacrylamide, Titanium Dioxide, Polyacrylic Acid,

Xylitylglucoside, Butylene Glycol, C13-14 Isoparaffin, Anhydroxylitol, Sodium

Hyaluronate, Potassium Hydroxide, Benzyl Alcohol, Laureth-7, Disodium EDTA,

Xylitol, Polysorbate20, Phenoxyethanol, Caprylyl Glycol, Carbomer,BHT,

Ethylhexylglycerin, Benzoic Acid, Palmitoyl Pentapeptide-4

When Using This Product (When using this product)

When using this product, keep out of eyes. Rinse with water to remove.


Advanced Ingredient Data


Raw Label Data

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