4000a5b9-e7a3-b5d3-e063-6294a90a2506

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

Purpose

SUNSCREEN

Description

OCTOCRYLENE 4% HOMOSALATE 2.5% ETHYLHEXYL METHOXYCINNAMATE 2%

Medication Information

Warnings

For external use only

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.

Purpose

SUNSCREEN

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%

Description

OCTOCRYLENE 4% HOMOSALATE 2.5% ETHYLHEXYL METHOXYCINNAMATE 2%

Section 51945-4

Stop Use

Rinse with wate to remove.

Stop use and ask doctor if rash occurs.

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%

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

Warnings

For external use only

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.

Purpose

SUNSCREEN

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%

Section 51945-4 (51945-4)

Stop Use

Rinse with wate to remove.

Stop use and ask doctor if rash occurs.

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%

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

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Raw Label Data

All Sections (JSON)

{"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.", "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": "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"}

Additional Information

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