SPL v1
SPL
SPL Set ID 452b5f2c-b61f-8915-e063-6294a90ac911
Route
TOPICAL
Published
Effective Date 2026-01-15
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients
Octocrylene (0.045 g) Avobenzone (0.03 g) Homosalate (0.05 g) Octisalate (0.04 g)
Inactive Ingredients
Aluminum Hydroxide Hydrogenated Polyisobutene (450 Mw) Polyisobutylene (1300 Mw) Water Menthol Fragrance 13576 Octyldodecanol Vp/hexadecene Copolymer Menthoxypropanediol Sodium Chloride Ci 42090 Bht Tocopherol Sodium Sulfate Glyceryl Caprylate

Identifiers & Packaging

Pill Appearance
Color: blue
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,FD&C BLUE 1 ALUMINUM LAKE(CI 42090).

Section 51945-4

Section 53413-1
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,FD&C BLUE 1 ALUMINUM LAKE(CI 42090).

Section 51945-4 (51945-4)

Section 53413-1 (53413-1)
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)