SPL v1
SPL
SPL Set ID 452b6e12-1bf9-8093-e063-6394a90a9e74
Route
TOPICAL
Published
Effective Date 2026-01-15
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients
Homosalate (0.05 g) Octocrylene (0.045 g) Avobenzone (0.03 g) Octisalate (0.04 g)
Inactive Ingredients
Aluminum Hydroxide Fragrance 13576 Polyisobutylene (1300 Mw) Hydrogenated Polyisobutene (450 Mw) Octyldodecanol Sodium Chloride Menthol Tocopherol Sodium Sulfate Ci 45410 Menthoxypropanediol Bht Water Vp/hexadecene Copolymer Glyceryl Caprylate

Identifiers & Packaging

Pill Appearance
Color: pink
Marketing Status
OTC MONOGRAPH DRUG Active Since 2026-01-15

Description

Homosalate 5%, Octocrylene 4.5%, Octisalate 4%, 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. If product is swallowed get medical help or contact a poison control center right away.



Indications and Usage

Helps prevent sunburn

Dosage and Administration

Apply generously and evenly 15 minutes before sun exposure.

Reapply at least every 2 hours.

Use a water resistant sunscreen if swimming or sweating.

Children under 6 month: ask a doctor.

Description

Homosalate 5%, Octocrylene 4.5%, Octisalate 4%, Avobenzone 3%

Section 50565-1

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

Section 51727-6

POLYISOBUTENE, HYDROGENATED POLYISOBUTENE, VP/HEXADECENE COPOLYMER, OCTYLDODECANOL, MENTHOL, FRAGRANCE, GLYCERYL CAPRYLATE, MENTHOXYPROPANEDIOL, BHT, ALUMINUM HYDROXIDE, WATER, TOCOPHEROL, SODIUM SULFATE, SODIUM CHLORIDE, D&C RED NO. 28 ALUMINUM LAKE(CI 45410)

Section 51945-4

Section 53413-1

1-212- 244-5170 [email protected]

Section 55105-1

Sunscreen

Section 55106-9

Homosalate 5%, Octocrylene 4.5%, Octisalate 4%, 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 sunburn

Dosage and Administration (34068-7)

Apply generously and evenly 15 minutes before sun exposure.

Reapply at least every 2 hours.

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. 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)

POLYISOBUTENE, HYDROGENATED POLYISOBUTENE, VP/HEXADECENE COPOLYMER, OCTYLDODECANOL, MENTHOL, FRAGRANCE, GLYCERYL CAPRYLATE, MENTHOXYPROPANEDIOL, BHT, ALUMINUM HYDROXIDE, WATER, TOCOPHEROL, SODIUM SULFATE, SODIUM CHLORIDE, D&C RED NO. 28 ALUMINUM LAKE(CI 45410)

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 5%, Octocrylene 4.5%, Octisalate 4%, 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)