SPL v2
SPL
SPL Set ID 2eea94e1-2409-8ad6-e063-6294a90a5df8
Route
TOPICAL
Published
Effective Date 2025-03-10
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients
Octisalate (45 mg) Octocrylene (90 mg) Avobenzone (27 mg) Homosalate
Inactive Ingredients
Trisodium Edta Citrus Aurantium Bergamia (bergamot) Fruit Oil Lavandula Angustifolia (lavender) Oil Pelargonium Graveolens Flower Oil Panthenol Isododecane Glyceryl Stearate Cetearyl Olivate Asiaticoside Benzotriazolyl Dodecyl P-cresol Glyceryl Caprylate Sodium Polyacryloyldimethyl Taurate Citrus Aurantifolia (lime) Oil Phloretin Geraniol Citronellol Citral Potassium Cetyl Phosphate Acetic Acid Anthemis Nobilis Flower Oil Glycerin Tromethamine Xanthan Gum Inulin Lauryl Carbamate Sorbitan Olivate Dimethicone Magnesium Aluminum Silicate Limonene, (+)- Butyl Acrylate/methyl Methacrylate/trimethylsiloxymethacrylate Copolymer 1,2-hexanediol Cetearyl Alcohol Linalool Butylene Glycol Madecassic Acid 2,3-butanediol Asiatic Acid Water

Identifiers & Packaging

Marketing Status
OTC MONOGRAPH DRUG Active Since 2025-03-10
Description

Avobenzone 2.7% Homosalate 9% Octisalate 4.5% Octocrylene 9%

Purpose

Sunscreen

Medication Information

Purpose

Sunscreen

Dosage and Administration

If swallowed, get medical help or contact a Poison Control Center right away.

Description

Avobenzone 2.7% Homosalate 9% Octisalate 4.5% Octocrylene 9%

Uses

Helps prevent sunburn.

If used as directed with other sun protection measures (see Directions), decreases the risk of skin cancer and early skin aging caused by the sun.

Section 50565-1

Keep out of reach of children.

Section 50566-9

Stop use and ask a doctor if rash occurs.

Section 50567-7



When using this product keep out of eyes. Rinse with water to remove.

Section 50570-1

Do not use on damaged or broken skin.

Section 51945-4

Warnings

For external use only

Directions

Apply generously and evenly 15 minutes before sun exposure.

Reapply at least every 2 hours.

Use a water resistant sunscreen if swimming or sweating.

Sun Protection Measures: Spending time in the sun increases your risk of skin cancer and early skin aging. To decrease this risk, regularly use a sunscreen with a Broad Spectrum SPF value of 15 or higher and other sun protection measures including:

- Limit time in the sun, especially from 10 a.m. – 2 p.m.

- Wear long-sleeved shirts, pants, hats, and sunglasses.

Children under 6 months: Ask a doctor.

Questions?

1-866-993-4709

Other Information



Protect the product in this container from excessive heat and direct sun

Active Ingredients

Avobenzone 2.7%

Homosalate 9%

Octisalate 4.5%

Octocrylene 9%

Inactive Ingredients

WATER, GLYCERIN, DIMETHICONE, CETEARYL ALCOHOL, POTASSIUM CETYL PHOSPHATE, 1,2-HEXANEDIOL, BENZOTRIAZOLYL DODECYL P-CRESOL, PANTHENOL, GLYCERYL CAPRYLATE, ISODODECANE, GLYCERYL STEARATE, ACRYLATES/POLYTRIMETHYLSILOXYMETHACRYLATE COPOLYMER, CETEARYL OLIVATE, INULIN LAURYL CARBAMATE, SORBITAN OLIVATE, SODIUM POLYACRYLOYLDIMETHYL TAURATE, CITRUS AURANTIFOLIA (LIME) OIL, MAGNESIUM ALUMINUM SILICATE, TROMETHAMINE, XANTHAN GUM, CITRUS AURANTIUM BERGAMIA (BERGAMOT) FRUIT OIL, LAVANDULA ANGUSTIFOLIA (LAVENDER) OIL, PELARGONIUM GRAVEOLENS FLOWER OIL, TRISODIUM EDTA, VINEGAR, ANTHEMIS NOBILIS FLOWER OIL, BUTYLENE GLYCOL, ASIATICOSIDE, MADECASSIC ACID, ASIATIC ACID, PHLORETIN, 2,3-BUTANEDIOL, SACCHAROMYCES POLYPEPTIDES, LIMONENE, LINALOOL, CITRONELLOL, GERANIOL, CITRAL.

Structured Label Content

Uses

Helps prevent sunburn.

If used as directed with other sun protection measures (see Directions), decreases the risk of skin cancer and early skin aging caused by the sun.

Dosage and Administration (34068-7)

If swallowed, get medical help or contact a Poison Control Center right away.

Section 50565-1 (50565-1)

Keep out of reach of children.

Section 50566-9 (50566-9)

Stop use and ask a doctor if rash occurs.

Section 50567-7 (50567-7)



When using this product keep out of eyes. Rinse with water to remove.

Section 50570-1 (50570-1)

Do not use on damaged or broken skin.

Section 51945-4 (51945-4)

Purpose

Sunscreen

Warnings

For external use only

Directions

Apply generously and evenly 15 minutes before sun exposure.

Reapply at least every 2 hours.

Use a water resistant sunscreen if swimming or sweating.

Sun Protection Measures: Spending time in the sun increases your risk of skin cancer and early skin aging. To decrease this risk, regularly use a sunscreen with a Broad Spectrum SPF value of 15 or higher and other sun protection measures including:

- Limit time in the sun, especially from 10 a.m. – 2 p.m.

- Wear long-sleeved shirts, pants, hats, and sunglasses.

Children under 6 months: Ask a doctor.

Questions?

1-866-993-4709

Other Information



Protect the product in this container from excessive heat and direct sun

Active Ingredients

Avobenzone 2.7%

Homosalate 9%

Octisalate 4.5%

Octocrylene 9%

Inactive Ingredients

WATER, GLYCERIN, DIMETHICONE, CETEARYL ALCOHOL, POTASSIUM CETYL PHOSPHATE, 1,2-HEXANEDIOL, BENZOTRIAZOLYL DODECYL P-CRESOL, PANTHENOL, GLYCERYL CAPRYLATE, ISODODECANE, GLYCERYL STEARATE, ACRYLATES/POLYTRIMETHYLSILOXYMETHACRYLATE COPOLYMER, CETEARYL OLIVATE, INULIN LAURYL CARBAMATE, SORBITAN OLIVATE, SODIUM POLYACRYLOYLDIMETHYL TAURATE, CITRUS AURANTIFOLIA (LIME) OIL, MAGNESIUM ALUMINUM SILICATE, TROMETHAMINE, XANTHAN GUM, CITRUS AURANTIUM BERGAMIA (BERGAMOT) FRUIT OIL, LAVANDULA ANGUSTIFOLIA (LAVENDER) OIL, PELARGONIUM GRAVEOLENS FLOWER OIL, TRISODIUM EDTA, VINEGAR, ANTHEMIS NOBILIS FLOWER OIL, BUTYLENE GLYCOL, ASIATICOSIDE, MADECASSIC ACID, ASIATIC ACID, PHLORETIN, 2,3-BUTANEDIOL, SACCHAROMYCES POLYPEPTIDES, LIMONENE, LINALOOL, CITRONELLOL, GERANIOL, CITRAL.

Advanced Ingredient Data

Raw Label Data

All Sections (JSON)

Additional Information

Back to search View SPL set listing Open on DailyMed ↗

Source: dailymed · Ingested: 2026-02-15T12:05:45.994451 · Updated: 2026-03-14T23:08:02.764471