SPL v1
SPL
SPL Set ID 4517ef95-8ea1-3de6-e063-6394a90a2c79
Route
TOPICAL
Published
Effective Date 2026-01-15
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients
Octocrylene (0.1 g) Octisalate (0.05 g) Homosalate (0.15 g) Avobenzone (0.03 g)
Inactive Ingredients
Bisabolol Simmondsia Chinensis (jojoba) Seed Oil Acrylates/octylacrylamide Copolymer (40000 Mw) Butyloctyl Salicylate Water Niacinamide Diethoxyethyl Succinate Fragrance 13576 Alcohol

Identifiers & Packaging

Pill Appearance
Shape: freeform Color: yellow
Marketing Status
OTC MONOGRAPH DRUG Active Since 2026-01-15
Description

Homosalate 15%, Octocrylene 10%, Octisalate 5% , Avobenzone 3%

Medication Information

Warnings and Precautions

For external use only.

Skin cancer/skin aging alert

Spending time in the sun increases your risk of skin cancer and early skin aging.

This product has been shown only to help prevent sunburn, not skin cancer or early skin aging.

Do not use . on damaged or broken skin.

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

Stop use and ask doctor if . rash occurs.

Keep out of reach of children.lf product is swallowed get medical help or contact a poison control center right away.

Indications and Usage

Helps prevent sunbumn.

Dosage and Administration

Directions

Apply generously and evenly 15 minutes before sun exposure.

Reapply at least every 2hours..

Use a water resistant sunscreen if swimming or sweating.

Children under 6 month: ask a doctor.

Description

Homosalate 15%, Octocrylene 10%, Octisalate 5% , Avobenzone 3%

Section 50565-1

Keep out of reach of children.

lf product is swallowed get medical help or contact a poison control center right away.

Section 51727-6

ALCOHOL DENAT. , BUTYLOCTYL SALICYLATE, DIETHOXYETHYL SUCCINATE,FRAGRANCE, ACRYLATES/OCTYLACRYLAMIDE COPOLYMER, BISABOLOL, SIMMONDSIA CHINENSIS (JOJOBA)SEED OIL, NIACINAMIDE , WATER

Section 51945-4

Section 53413-1

1-212-244-5170 | [email protected]

Section 55105-1

Sunscreen

Section 55106-9

Homosalate 15%, Octocrylene 10%, Octisalate 5% , Avobenzone 3%

Section 60561-8

Protect the product in this container from excessive heat and direct sun.

Structured Label Content

Indications and Usage (34067-9)

Helps prevent sunbumn.

Dosage and Administration (34068-7)

Directions

Apply generously and evenly 15 minutes before sun exposure.

Reapply at least every 2hours..

Use a water resistant sunscreen if swimming or sweating.

Children under 6 month: ask a doctor.

Warnings and Precautions (34071-1)

For external use only.

Skin cancer/skin aging alert

Spending time in the sun increases your risk of skin cancer and early skin aging.

This product has been shown only to help prevent sunburn, not skin cancer or early skin aging.

Do not use . on damaged or broken skin.

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

Stop use and ask doctor if . rash occurs.

Keep out of reach of children.lf product is swallowed get medical help or contact a poison control center right away.

Section 50565-1 (50565-1)

Keep out of reach of children.

lf product is swallowed get medical help or contact a poison control center right away.

Section 51727-6 (51727-6)

ALCOHOL DENAT. , BUTYLOCTYL SALICYLATE, DIETHOXYETHYL SUCCINATE,FRAGRANCE, ACRYLATES/OCTYLACRYLAMIDE COPOLYMER, BISABOLOL, SIMMONDSIA CHINENSIS (JOJOBA)SEED OIL, NIACINAMIDE , WATER

Section 51945-4 (51945-4)

Section 53413-1 (53413-1)

1-212-244-5170 | [email protected]

Section 55105-1 (55105-1)

Sunscreen

Section 55106-9 (55106-9)

Homosalate 15%, Octocrylene 10%, Octisalate 5% , Avobenzone 3%

Section 60561-8 (60561-8)

Protect the product in this container from excessive heat and direct sun.

Advanced Ingredient Data

Raw Label Data

All Sections (JSON)

Additional Information

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Source: dailymed · Ingested: 2026-02-15T12:08:14.628370 · Updated: 2026-03-14T23:12:24.385926