SPL v1
SPL
SPL Set ID 451b902d-892d-15f1-e063-6294a90a3024
Route
TOPICAL
Published
Effective Date 2026-01-25
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients
Octisalate (0.05 g) Avobenzone (0.03 g) Homosalate (0.1 g) Octocrylene (0.08 g) Octinoxate
Inactive Ingredients
Hydrogenated Poly(c6-14 Olefin; 4 Cst) Phenoxyethanol Dimethicone/vinyl Dimethicone Crosspolymer (soft Particle) Styrene/isoprene Copolymer (28:72; 210000 Mw) Silica Glyceryl Caprylate Bht Pentaerythrityl Tetra-di-t-butyl Hydroxyhydrocinnamate Trisiloxane

Identifiers & Packaging

Pill Appearance
Color: white
Marketing Status
OTC MONOGRAPH DRUG Active Since 2026-01-25

Description

Homosalate 10%, Octocrylene 8%, Octisalate 5% ,Octinoxate 5%, 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. 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 gererously 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 10%, Octocrylene 8%, Octisalate 5% ,Octinoxate 5%, 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), TRISILOXANE, DIMETHICONE/VINYL DIMETHICONE CROSSPOLYMER, SILICA, HYDROGENATED STYRENE/ISOPRENE COPOLYMER, PHENOXYETHANOL, GLYCERYL CAPRYLATE, BHT, PENTAERYTHRITYL TETRA-DI-t-BUTYL HYDROXYHYDROCINNAMATE

Section 51945-4

Section 53413-1

1-212-244-5170 [email protected]

Section 55105-1

Sunscreen

Section 55106-9

Homosalate 10%, Octocrylene 8%, Octisalate 5% ,Octinoxate 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 gererously 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. 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), TRISILOXANE, DIMETHICONE/VINYL DIMETHICONE CROSSPOLYMER, SILICA, HYDROGENATED STYRENE/ISOPRENE COPOLYMER, PHENOXYETHANOL, GLYCERYL CAPRYLATE, BHT, PENTAERYTHRITYL TETRA-DI-t-BUTYL HYDROXYHYDROCINNAMATE

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 10%, Octocrylene 8%, Octisalate 5% ,Octinoxate 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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