SPL v1
SPL
SPL Set ID 452b8dde-dd63-b585-e063-6394a90a3543
Route
TOPICAL
Published
Effective Date 2026-01-15
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients
Avobenzone (0.03 g) Homosalate (0.1 g) Octocrylene (0.06 g) Octisalate (0.05 g)
Inactive Ingredients
Fragrance 13576 Magnesium Potassium Aluminosilicate Fluoride Styrene/isoprene Copolymer (28:72; 210000 Mw) Squalane Tin Oxide Mineral Oil Simmondsia Chinensis (jojoba) Seed Oil Silica Dimethyl Silylate Olea Europaea (olive) Fruit Oil Ci 19140 Ci 16035 Pentaerythrityl Tetra-di-t-butyl Hydroxyhydrocinnamate Ci 77491 Mica Ci 77891 Macadamia Integrifolia Seed Oil Glyceryl Caprylate

Identifiers & Packaging

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

Description

Homosalate 10%, Octocrylene 6%, Octisalate 5%, Avobenzone 3%.


Medication Information

Warnings and Precautions

For external use only.

Spending time in the sun increases your risk of skin Skin cancer/skin aging alert 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 10%, Octocrylene 6%, Octisalate 5%, Avobenzone 3%.

Section 50565-1

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

Section 51727-6

MINERAL OIL(PARAFFINUM LIQUIDUM), HYDROGENATED STYRENE/ISOPRENE COPOLYMER, SILICA DIMETHYL SILYLATE, GLYCERYL CAPRYLATE, FRAGRANCE, SIMMONDSIA CHINENSIS (JOJOBA) SEED OIL, SQUALANE, MACADAMIA INTEGRIFOLIA SEED OIL, OLEA EUROPAEA (OLIVE) FRUIT OIL, PENTAERYTHRITYL TETRA-DI-t-BUTYL HYDROXYHYDROCINNAMATE, SYNTHETIC FLUORPHLOGOPITE, MICA, TIN OXIDE, IRON OXIDES(CI 77491), TITANIUM DIOXIDE(CI 77891), FD&C YELLOW NO. 5(CI 19140), FD&C RED NO. 40(CI 16035)

Section 51945-4

Section 53413-1

1-212- 244-5170 | [email protected]

Section 55105-1

Sunscreen

Section 55106-9

Homosalate 10%, Octocrylene 6%, 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 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.

Spending time in the sun increases your risk of skin Skin cancer/skin aging alert 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)

MINERAL OIL(PARAFFINUM LIQUIDUM), HYDROGENATED STYRENE/ISOPRENE COPOLYMER, SILICA DIMETHYL SILYLATE, GLYCERYL CAPRYLATE, FRAGRANCE, SIMMONDSIA CHINENSIS (JOJOBA) SEED OIL, SQUALANE, MACADAMIA INTEGRIFOLIA SEED OIL, OLEA EUROPAEA (OLIVE) FRUIT OIL, PENTAERYTHRITYL TETRA-DI-t-BUTYL HYDROXYHYDROCINNAMATE, SYNTHETIC FLUORPHLOGOPITE, MICA, TIN OXIDE, IRON OXIDES(CI 77491), TITANIUM DIOXIDE(CI 77891), FD&C YELLOW NO. 5(CI 19140), FD&C RED NO. 40(CI 16035)

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 6%, 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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