Drug Facts

Composition & Product

Active Ingredients

Avobenzone (240 mg) Homosalate (200 mg) Octisalate (30 mg) Octocrylene (100 mg)

Inactive Ingredients

Paraffin Ethylhexyl Palmitate

Identifiers & Packaging

Pill Appearance

Color: white

Marketing Status

OTC MONOGRAPH DRUG Active Since 2025-12-08

Medication Information

Purpose

Sunscreen

Description

Avobenzone 3.0%, Homosalate 10.0%, Octisalate 5.0%, Octocrylene 10%................Sunscreen

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.

Warnings

For external use only: 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 or irritation develops and lasts.

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.

Active Ingredient

Avobenzone 3.0%, Homosalate 10.0%, Octisalate 5.0%, Octocrylene 10%................Sunscreen

Inactive Ingredients

Paraffin wax, octyl palmitate, ozokerite, euphorbia cerifera (candelilla) wax, beeswax, butyloctyl salicylate, fragrance, polyethylene, polycrylene, cetyl alcohol, tocopheryl acetate, ascorbyl palmitate

Keep Out of Reach of Children

If swallowed get medical help or contact a Poison Control Center immediately.

Package/label Principal Display Panel

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.

Purpose

Sunscreen

Warnings

For external use only: 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 or irritation develops and lasts.

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.

Active Ingredient (Active ingredient)

Avobenzone 3.0%, Homosalate 10.0%, Octisalate 5.0%, Octocrylene 10%................Sunscreen

Inactive Ingredients

Paraffin wax, octyl palmitate, ozokerite, euphorbia cerifera (candelilla) wax, beeswax, butyloctyl salicylate, fragrance, polyethylene, polycrylene, cetyl alcohol, tocopheryl acetate, ascorbyl palmitate

Keep Out of Reach of Children

If swallowed get medical help or contact a Poison Control Center immediately.

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

Advanced Ingredient Data

[{"name": "PARAFFIN", "unii": "I9O0E3H2ZE", "classCode": "IACT", "strengthNumerator": "240", "strengthDenominator": "1", "strengthNumeratorUnit": "mg", "strengthDenominatorUnit": "g"}, {"name": "ETHYLHEXYL PALMITATE", "unii": "2865993309", "classCode": "IACT", "strengthNumerator": "200", "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": "100", "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": "100", "strengthDenominator": "1", "strengthNumeratorUnit": "mg", "strengthDenominatorUnit": "g"}]

Raw Label Data

All Sections (JSON)

{"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.", "Purpose": "Sunscreen", "Warnings": "For external use only: 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 or irritation develops and lasts.", "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.", "Active ingredient": "Avobenzone 3.0%, Homosalate 10.0%, Octisalate 5.0%, Octocrylene 10%................Sunscreen", "Inactive Ingredients": "Paraffin wax, octyl palmitate, ozokerite, euphorbia cerifera (candelilla) wax, beeswax, butyloctyl salicylate, fragrance, polyethylene, polycrylene, cetyl alcohol, tocopheryl acetate, ascorbyl palmitate", "Keep Out of Reach of Children": "If swallowed get medical help or contact a Poison Control Center immediately."}

Drug Facts

Drug Facts

Composition & Product

Identifiers & Packaging

Medication Information

Structured Label Content

Advanced Ingredient Data

Raw Label Data

Additional Information