SPL v1
SPL
SPL Set ID 451bb62e-b603-7663-e063-6294a90a46db
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) Avobenzone (0.03 g) Octocrylene (0.045 g) Octisalate (0.04 g)
Inactive Ingredients
Polymethylsilsesquioxane (11 Microns) Ci 19140 Synthetic Wax (540 Mw) Sorbitan Stearate Aluminum Hydroxide Silica Sorbitan Isostearate Water Ci 15985 Sucrose Cocoate Pentaerythrityl Tetraisostearate Fragrance 13576 Calcium Aluminum Borosilicate Styrene/isoprene Copolymer (28:72; 210000 Mw) Pentaerythrityl Tetra-di-t-butyl Hydroxyhydrocinnamate Hydrogenated Poly(c6-14 Olefin; 4 Cst) Butyloctyl Salicylate Euphorbia Cerifera (candelilla) Wax Sodium Sulfate Sodium Chloride

Identifiers & Packaging

Pill Appearance
Color: orange
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.

Chidren under 6 months. ask a doctor.

Description

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

Section 50565-1

lf 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, WATER, PENTAERYTHRITYL TETRA-DI-T-BUTYL HYDROXYHYDROCINNAMATE, SODIUM SULFATE, SODIUM CHLORIDE, YELLOW NO. 6 LAKE (CI 15985), YELLOW 5 LAKE(CI 19140)

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 tne product in this container from excessive heat and dlrect sunl


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.

Chidren 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)

lf 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, WATER, PENTAERYTHRITYL TETRA-DI-T-BUTYL HYDROXYHYDROCINNAMATE, SODIUM SULFATE, SODIUM CHLORIDE, YELLOW NO. 6 LAKE (CI 15985), YELLOW 5 LAKE(CI 19140)

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 tne product in this container from excessive heat and dlrect sunl


Advanced Ingredient Data


Raw Label Data

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