SPL v1
SPL
SPL Set ID 451ba704-6fbd-d5a0-e063-6394a90a2fbc
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) Ethylhexyl Salicylate (0.04 g)
Inactive Ingredients
Calcium Sulfate Sodium Chloride Menthoxypropanediol Silica Ci 15850 Pentaerythrityl Tetraisostearate Synthetic Wax (540 Mw) Aluminum Hydroxide Rosin Pentaerythrityl Tetra-di-t-butyl Hydroxyhydrocinnamate Sorbitan Stearate Styrene/isoprene Copolymer (28:72; 210000 Mw) Ci 45410 Sucrose Cocoate Sodium Sulfate Sorbitan Isostearate Water Menthol Butyloctyl Salicylate Euphorbia Cerifera (candelilla) Wax Hydrogenated Poly(c6-14 Olefin; 4 Cst) Fragrance 13576

Identifiers & Packaging

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

Description

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

Section 50565-1

Keep out of reach of children.

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, BUTYLOCTYL SALICYLATE, SILICA,PENTAERYTHRITYL TETRAISOSTEARATE,SYNTHETIC WAX, EUPHORBIA CERIFERA (CANDELILLA) WAX,MENTHOL,FRAGRANCE (PARFUM),MENTHOXYPROPANEDIOL,SORBITAN ISOSTEARATE,SORBITAN STEARATE,SUCROSE COCOATE,PENTAERYTHRITYL TETRA-DI-t-BUTYL HYDROXYHYDROCINNAMATE,ALUMINUM HYDROXIDE,ROSIN,CALCIUM SULFATE,WATER,SODIUM CHLORIDE,SODIUM SULFATE, RED 7 LAKE(C) 15850) , 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 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)

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)

Keep out of reach of children.

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, BUTYLOCTYL SALICYLATE, SILICA,PENTAERYTHRITYL TETRAISOSTEARATE,SYNTHETIC WAX, EUPHORBIA CERIFERA (CANDELILLA) WAX,MENTHOL,FRAGRANCE (PARFUM),MENTHOXYPROPANEDIOL,SORBITAN ISOSTEARATE,SORBITAN STEARATE,SUCROSE COCOATE,PENTAERYTHRITYL TETRA-DI-t-BUTYL HYDROXYHYDROCINNAMATE,ALUMINUM HYDROXIDE,ROSIN,CALCIUM SULFATE,WATER,SODIUM CHLORIDE,SODIUM SULFATE, RED 7 LAKE(C) 15850) , 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 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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