SPL v1
SPL
SPL Set ID 4000a5b9-e7a3-b5d3-e063-6294a90a2506
Route
TOPICAL
Published
Effective Date 2025-09-30
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients
Ethylhexyl Methoxycinnamate (2 g) Homosalate (2.5 g) Octocrylene (4 g)
Inactive Ingredients
Cyclopentasiloxane Microcrystalline Wax Dicaprylyl Carbonate Polymethylsilsesquioxane (11 Microns) Phenoxyethanol Ethylhexyl Palmitate Polyglyceryl-2 Triisostearate Parfumidine Beeswax Ceramide Np Cyclohexasiloxane Silicon Dioxide Tocopherol Bisabolol Theobroma Cacao (cocoa) Seed Butter

Identifiers & Packaging

Marketing Status
OTC MONOGRAPH DRUG Active Since 2025-09-30
Description

OCTOCRYLENE 4% HOMOSALATE 2.5% ETHYLHEXYL METHOXYCINNAMATE 2%

Purpose

SUNSCREEN

Medication Information

Purpose

SUNSCREEN

Description

OCTOCRYLENE 4% HOMOSALATE 2.5% ETHYLHEXYL METHOXYCINNAMATE 2%

Uses

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 51945-4

Stop Use

Rinse with wate to remove.

Stop use and ask doctor if rash occurs.

Warnings

For external use only

Do Not Use

Do not use on damaged or broken skin.

When Using

When using this product keep out of eyes.

Active Ingredients

OCTOCRYLENE 4%

HOMOSALATE 2.5%

ETHYLHEXYL METHOXYCINNAMATE 2%

Inactive Ingredients

CYCLOPENTASILOXANE 15%

CYCLOHEXASILOXANE 7.5%

ETHYLHEXYL PALMITATE 6%

OZOKERITE 2.5%

MICROCRYSTALLINE WAX 2.5%

DICAPRYLYL CARBONATE 3%

THEOBROMA CACAO (COCOA) SEED BUTTER 2%

SILICA 1%

POLYMETHYLSILSESQUIOXANE 3%

CERAMIDE NP 0.5%

POLYGLYCERYL-2 TRIISOSTEARATE 1%

BISABOLOL 0.1%

TOCOPHEROL 0.2%

PHENOXYETHANOL 0.35%

AROMA 0.3%

Dosage & Administration

Squeeze out an appropriate amount of Sunscreen and spread evenly on skin.

Keep Out of Reach of Children

Keep Out Of Reach Of Children

Structured Label Content

Uses

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 51945-4 (51945-4)

Purpose

SUNSCREEN

Stop Use

Rinse with wate to remove.

Stop use and ask doctor if rash occurs.

Warnings

For external use only

Do Not Use

Do not use on damaged or broken skin.

When Using

When using this product keep out of eyes.

Active Ingredients

OCTOCRYLENE 4%

HOMOSALATE 2.5%

ETHYLHEXYL METHOXYCINNAMATE 2%

Inactive Ingredients (Inactive ingredients)

CYCLOPENTASILOXANE 15%

CYCLOHEXASILOXANE 7.5%

ETHYLHEXYL PALMITATE 6%

OZOKERITE 2.5%

MICROCRYSTALLINE WAX 2.5%

DICAPRYLYL CARBONATE 3%

THEOBROMA CACAO (COCOA) SEED BUTTER 2%

SILICA 1%

POLYMETHYLSILSESQUIOXANE 3%

CERAMIDE NP 0.5%

POLYGLYCERYL-2 TRIISOSTEARATE 1%

BISABOLOL 0.1%

TOCOPHEROL 0.2%

PHENOXYETHANOL 0.35%

AROMA 0.3%

Dosage & Administration (Dosage & administration)

Squeeze out an appropriate amount of Sunscreen and spread evenly on skin.

Keep Out of Reach of Children (Keep Out Of Reach Of Children)

Keep Out Of Reach Of Children

Advanced Ingredient Data

Raw Label Data

All Sections (JSON)

Additional Information

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Source: dailymed · Ingested: 2026-02-15T12:07:07.756439 · Updated: 2026-03-14T23:10:21.394156