SPL v1
SPL
SPL Set ID 451ba227-7973-1378-e063-6294a90ae893
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) Ethylhexyl Salicylate (0.04 g) Avobenzone (0.03 g) Homosalate (0.05 g)
Inactive Ingredients
Polymethylsilsesquioxane (11 Microns) Hydrogenated Poly(c6-14 Olefin; 4 Cst) Butyloctyl Salicylate Calcium Aluminum Borosilicate Sorbitan Isostearate Sucrose Cocoate Ci 16035 Pentaerythrityl Tetra-di-t-butyl Hydroxyhydrocinnamate Silica Pentaerythrityl Tetraisostearate Styrene/isoprene Copolymer (28:72; 210000 Mw) Ci 45410 Sodium Chloride Synthetic Wax (540 Mw) Euphorbia Cerifera (candelilla) Wax Fragrance 13576 Sorbitan Stearate Water Aluminum Hydroxide Sodium Sulfate

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

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 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 a 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 sunburn.

Dosage and Administration

Apply generously and evenly15 minutes before sun exposure.

Reapply at least every 2hours, as needed, or after eating or drinking.

Use a water resistant sunscreen if swimming or sweating.

Children under 6 months: ask a doctor.

Description

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

Section 50565-1

Keep out of reach of children.

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

Section 51727-6

HYDROGENATED POLY(C6-14 OLEFIN),HYDROGENATED STYRENE/ISOPRENE COPOLYMER,POLYMETHYLSILSESQUIOXANE,BUTYLOCTYL SALICYLATE,PENTAERYTHRITYL TETRAISOSTEARATE,SILICA,SYNTHETIC WAX,EUPHORBIA CERIFERA (CANDELILLA) WAX,FRAGRANCE (PARFUM),CALCIUM ALUMINUM BOROSILICATE,SORBITAN ISOSTEARATE,SORBITAN STEARATE,ALUMINUM HYDROXIDE,SUCROSE COCOATE,PENTAERYTHRITYL TETRA-DI-T-BUTYL HYDROXYHYDROCINNAMATE,WATER,SODIUM SULFATE,SODIUM CHLORIDE, RED 40 LAKE(CI 16035), RED 28 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 evenly15 minutes before sun exposure.

Reapply at least every 2hours, as needed, or after eating or drinking.

Use a water resistant sunscreen if swimming or sweating.

Children under 6 months: 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 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 a 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.

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

Section 51727-6 (51727-6)

HYDROGENATED POLY(C6-14 OLEFIN),HYDROGENATED STYRENE/ISOPRENE COPOLYMER,POLYMETHYLSILSESQUIOXANE,BUTYLOCTYL SALICYLATE,PENTAERYTHRITYL TETRAISOSTEARATE,SILICA,SYNTHETIC WAX,EUPHORBIA CERIFERA (CANDELILLA) WAX,FRAGRANCE (PARFUM),CALCIUM ALUMINUM BOROSILICATE,SORBITAN ISOSTEARATE,SORBITAN STEARATE,ALUMINUM HYDROXIDE,SUCROSE COCOATE,PENTAERYTHRITYL TETRA-DI-T-BUTYL HYDROXYHYDROCINNAMATE,WATER,SODIUM SULFATE,SODIUM CHLORIDE, RED 40 LAKE(CI 16035), RED 28 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

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