Drug Facts

Composition & Product

Active Ingredients

Avobenzone (415 meq) Homosalate (40 mg) Octisalate (30 mg) Octocrylene (90 mg)

Inactive Ingredients

Octyldodecanol Castor Oil

Identifiers & Packaging

Pill Appearance

Color: yellow

Marketing Status

OTC MONOGRAPH DRUG Active Since 2025-11-21

Medication Information

Purpose

Sunscreen

Description

Avobenzone 3.0%, Homosalate 9.0%, Octisalate 5.0%, Octocrylene 9.0%

Uses

Helps prevent sunburn.

Warnings

For external use only. Do not use on damaged or broken skin. When using this product: Keep out of eyes. Risnse with water to remove. Stop use and ask a doctor if ·rash occurs·

Questions

1-800-290-0577

Directions

Apply liberally 15 minutes before sun exposure. Reapply; after 80 minutes of swimming or sweating. Immediately after towel drying.at least every 2 hours. Sun Protection Measures: Spending time in the sun increases your risk of skin cancer and early skin aging. To decrease the risk, regularly use a sunscreen with a broad spectrum SPF 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 sleeve shirts, pants, hats, and sunglasses. Children under 6 months: Ask a doctor.

Active Ingredient

Avobenzone 3.0%, Homosalate 9.0%, Octisalate 5.0%, Octocrylene 9.0%

Inactive Ingredients

Brassica Campestris/Aleurites Fordi Oil Crosspolymer, C12-15 Alkyl Benzoate, Dibutyl Ethylhexanoyl Glutamide, Dibutyl Lauroyl Glutamide, Diisostearyl Malate, Euterpe Oleracea Fruit Oil, Flavor, Octyldodecanol, Octyldodecyl Neopentanoate, Phenethyl Benzoate, Ricinus Communis (Castor) Seed Oil, Saccharin, Silica Silylate, Tocopherol (Vitamin E)

Keep Out of Reach of Children

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

Package/label Principal Display Panel

Structured Label Content

Uses

Helps prevent sunburn.

Purpose

Sunscreen

Warnings

For external use only. Do not use on damaged or broken skin. When using this product: Keep out of eyes. Risnse with water to remove. Stop use and ask a doctor if ·rash occurs·

Questions

1-800-290-0577

Directions

Apply liberally 15 minutes before sun exposure. Reapply; after 80 minutes of swimming or sweating. Immediately after towel drying.at least every 2 hours. Sun Protection Measures: Spending time in the sun increases your risk of skin cancer and early skin aging. To decrease the risk, regularly use a sunscreen with a broad spectrum SPF 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 sleeve shirts, pants, hats, and sunglasses. Children under 6 months: Ask a doctor.

Active Ingredient (Active ingredient)

Avobenzone 3.0%, Homosalate 9.0%, Octisalate 5.0%, Octocrylene 9.0%

Inactive Ingredients

Brassica Campestris/Aleurites Fordi Oil Crosspolymer, C12-15 Alkyl Benzoate, Dibutyl Ethylhexanoyl Glutamide, Dibutyl Lauroyl Glutamide, Diisostearyl Malate, Euterpe Oleracea Fruit Oil, Flavor, Octyldodecanol, Octyldodecyl Neopentanoate, Phenethyl Benzoate, Ricinus Communis (Castor) Seed Oil, Saccharin, Silica Silylate, Tocopherol (Vitamin E)

Keep Out of Reach of Children

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

Package/label Principal Display Panel (Package/Label Principal Display Panel)

Advanced Ingredient Data

[{"name": "OCTYLDODECANOL", "unii": "461N1O614Y", "classCode": "IACT", "strengthNumerator": "415", "strengthDenominator": "1", "strengthNumeratorUnit": "meq", "strengthDenominatorUnit": "g"}, {"name": "CASTOR OIL", "unii": "D5340Y2I9G", "classCode": "IACT", "strengthNumerator": "40", "strengthDenominator": "1", "strengthNumeratorUnit": "mg", "strengthDenominatorUnit": "g"}, {"name": "AVOBENZONE", "unii": "G63QQF2NOX", "classCode": "ACTIB", "strengthNumerator": "30", "strengthDenominator": "1", "strengthNumeratorUnit": "mg", "strengthDenominatorUnit": "g"}, {"name": "HOMOSALATE", "unii": "V06SV4M95S", "classCode": "ACTIB", "strengthNumerator": "90", "strengthDenominator": "1", "strengthNumeratorUnit": "mg", "strengthDenominatorUnit": "g"}, {"name": "OCTISALATE", "unii": "4X49Y0596W", "classCode": "ACTIB", "strengthNumerator": "50", "strengthDenominator": "1", "strengthNumeratorUnit": "mg", "strengthDenominatorUnit": "g"}, {"name": "OCTOCRYLENE", "unii": "5A68WGF6WM", "classCode": "ACTIB", "strengthNumerator": "90", "strengthDenominator": "1", "strengthNumeratorUnit": "mg", "strengthDenominatorUnit": "g"}]

Raw Label Data

All Sections (JSON)

{"Uses": "Helps prevent sunburn.", "Purpose": "Sunscreen", "Warnings": "For external use only. Do not use on damaged or broken skin. When using this product: Keep out of eyes. Risnse with water to remove. Stop use and ask a doctor if ·rash occurs·", "Questions": "1-800-290-0577", "Directions": "Apply liberally 15 minutes before sun exposure. Reapply; after 80 minutes of swimming or sweating. Immediately after towel drying.at least every 2 hours. Sun Protection Measures : Spending time in the sun increases your risk of skin cancer and early skin aging. To decrease the risk, regularly use a sunscreen with a broad spectrum SPF 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 sleeve shirts, pants, hats, and sunglasses. Children under 6 months: Ask a doctor.", "Active ingredient": "Avobenzone 3.0%, Homosalate 9.0%, Octisalate 5.0%, Octocrylene 9.0%", "Inactive Ingredients": "Brassica Campestris/Aleurites Fordi Oil Crosspolymer, C12-15 Alkyl Benzoate, Dibutyl Ethylhexanoyl Glutamide, Dibutyl Lauroyl Glutamide, Diisostearyl Malate, Euterpe Oleracea Fruit Oil, Flavor, Octyldodecanol, Octyldodecyl Neopentanoate, Phenethyl Benzoate, Ricinus Communis (Castor) Seed Oil, Saccharin, Silica Silylate, Tocopherol (Vitamin E)", "Keep Out of Reach of Children": "If product is swallowed, get medical help or contact a Poison Control Center right away."}

Drug Facts

Drug Facts

Composition & Product

Identifiers & Packaging

Medication Information

Structured Label Content

Advanced Ingredient Data

Raw Label Data

Additional Information