Drug Facts

Composition & Product

Active Ingredients

Octinoxate (304 mg) Oxybenzone (305 mg)

Inactive Ingredients

Sunflower Oil White Wax Acetylated Lanolin

Identifiers & Packaging

Pill Appearance

Color: white

Marketing Status

OTC MONOGRAPH DRUG Active Since 2017-10-09

Medication Information

Purpose

Sunscreen

Description

Octinoxate (2.0%), Oxybenzone (4.5%)

Uses

Prevents Sunburns

Warnings

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 prevent sunburn, not skin cancer or early aging.

For external use only: Stop use and ask a doctor: if rash or irritation develops and lasts.

Directions

Apply liberally before sun exposure and as needed. Children under 6 months of age: Ask a doctor before use.

Active Ingredient

Octinoxate (2.0%), Oxybenzone (4.5%)

Inactive Ingredients

Synthetic Beeswax, Helianthus Annuus (Sunflower) Seed Oil, Ricinus Communis (Castor) Seed Oil, Lanolin, Cocos Nucifera (Coconut) Oil, Flavor, Zea Mays (Corn) Oil, Tocopheryl Acetate, BHT, Melaleuca Alternifolia (Tea Tree) Leaf Oil

Keep Out of Reach of Children

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

Package/label Principal Display Panel

Structured Label Content

Uses

Prevents Sunburns

Purpose

Sunscreen

Warnings

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 prevent sunburn, not skin cancer or early aging.

For external use only: Stop use and ask a doctor: if rash or irritation develops and lasts.

Directions

Apply liberally before sun exposure and as needed. Children under 6 months of age: Ask a doctor before use.

Active Ingredient (Active ingredient)

Octinoxate (2.0%), Oxybenzone (4.5%)

Inactive Ingredients

Synthetic Beeswax, Helianthus Annuus (Sunflower) Seed Oil, Ricinus Communis (Castor) Seed Oil, Lanolin, Cocos Nucifera (Coconut) Oil, Flavor, Zea Mays (Corn) Oil, Tocopheryl Acetate, BHT, Melaleuca Alternifolia (Tea Tree) Leaf Oil

Keep Out of Reach of Children

If 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": "SUNFLOWER OIL", "unii": "3W1JG795YI", "classCode": "IACT", "strengthNumerator": "304", "strengthDenominator": "1", "strengthNumeratorUnit": "mg", "strengthDenominatorUnit": "g"}, {"name": "WHITE WAX", "unii": "7G1J5DA97F", "classCode": "IACT", "strengthNumerator": "305", "strengthDenominator": "1", "strengthNumeratorUnit": "mg", "strengthDenominatorUnit": "g"}, {"name": "ACETYLATED LANOLIN", "unii": "2X654GD19H", "classCode": "IACT", "strengthNumerator": "97", "strengthDenominator": "1", "strengthNumeratorUnit": "mg", "strengthDenominatorUnit": "g"}, {"name": "OCTINOXATE", "unii": "4Y5P7MUD51", "classCode": "ACTIB", "strengthNumerator": "20", "strengthDenominator": "1", "strengthNumeratorUnit": "mg", "strengthDenominatorUnit": "g"}, {"name": "OXYBENZONE", "unii": "95OOS7VE0Y", "classCode": "ACTIB", "strengthNumerator": "45", "strengthDenominator": "1", "strengthNumeratorUnit": "mg", "strengthDenominatorUnit": "g"}]

Raw Label Data

All Sections (JSON)

{"Uses": "Prevents Sunburns", "Purpose": "Sunscreen", "Warnings": "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 prevent sunburn, not skin cancer or early aging. For external use only: Stop use and ask a doctor: if rash or irritation develops and lasts.", "Directions": "Apply liberally before sun exposure and as needed. Children under 6 months of age: Ask a doctor before use.", "Active ingredient": "Octinoxate (2.0%), Oxybenzone (4.5%)", "Inactive Ingredients": "Synthetic Beeswax, Helianthus Annuus (Sunflower) Seed Oil, Ricinus Communis (Castor) Seed Oil, Lanolin, Cocos Nucifera (Coconut) Oil, Flavor, Zea Mays (Corn) Oil, Tocopheryl Acetate, BHT, Melaleuca Alternifolia (Tea Tree) Leaf Oil", "Keep Out of Reach of Children": "If 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