SPL v1
SPL
SPL Set ID 4517fd05-ea60-0492-e063-6294a90a28e9
Route
TOPICAL
Published
Effective Date 2026-01-15
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients
Homosalate (0.15 g) Avobenzone (0.03 g) Octisalate (0.05 g) Octocrylene (0.1 g)
Inactive Ingredients
Caprylic/capric Triglyceride Helianthus Annuus (sunflower) Seed Oil Butyrospermum Parkii (shea) Butter Fragrance 13576 Butyloctyl Salicylate Alcohol Citrus Aurantium Bergamia (bergamot) Fruit Oil Simmondsia Chinensis (jojoba) Seed Oil Cocos Nucifera (coconut) Oil Vitis Vinifera (grape) Seed Oil

Identifiers & Packaging

Pill Appearance
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

Warnings

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 sunbur, 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 chlldren. If product is swallowed get medical help or contact a poison control center right away.

Indications and Usage

For external use only.

Dosage and Administration

Directions .

Apply generously and evenly 15 minutes before sun exposure.

Reapply at least every 2 hours.

Use a water resistant sunscreen if swimming or sweating.

Chlldren under 6 month: ask a doctor.

Description

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

Section 50565-1

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

Section 51727-6

CAPRYLIC/CAPRIC TRIGLYCERIDE, ALCOHOL DENAT., BUTYLOCTYL SALICYLATE, FRAGRANCE, SIMMONDSIA CHINENSIS (JOJOBA) SEED OIL, VITIS VINIFERA (GRAPE) SEED OIL, HELIANTHUS ANNUUS (SUNFLOWER) SEED OIL, COCOS NUCIFERA (COCONUT) OIL, BUTYROSPERMUM PARKII (SHEA) BUTTER, CITRUS AURANTIUM BERGAMIA (BERGAMOT) FRUIT OIL

Section 51945-4

Section 53413-1

1-212-244-5170 l [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)

For external use only.

Dosage and Administration (34068-7)

Directions .

Apply generously and evenly 15 minutes before sun exposure.

Reapply at least every 2 hours.

Use a water resistant sunscreen if swimming or sweating.

Chlldren under 6 month: ask a doctor.

Warnings and Precautions (34071-1)

Warnings

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 sunbur, 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 chlldren. If product is swallowed get medical help or contact a poison control center right away.

Section 50565-1 (50565-1)

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

Section 51727-6 (51727-6)

CAPRYLIC/CAPRIC TRIGLYCERIDE, ALCOHOL DENAT., BUTYLOCTYL SALICYLATE, FRAGRANCE, SIMMONDSIA CHINENSIS (JOJOBA) SEED OIL, VITIS VINIFERA (GRAPE) SEED OIL, HELIANTHUS ANNUUS (SUNFLOWER) SEED OIL, COCOS NUCIFERA (COCONUT) OIL, BUTYROSPERMUM PARKII (SHEA) BUTTER, CITRUS AURANTIUM BERGAMIA (BERGAMOT) FRUIT OIL

Section 51945-4 (51945-4)

Section 53413-1 (53413-1)

1-212-244-5170 l [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

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