Drug Facts

Composition & Product

Active Ingredients

Octinoxate (13 mg) Oxybenzone (25 mg) Octocrylene (0.5 mg) Octisalate (27 mg)

Inactive Ingredients

Petrolatum Light Mineral Oil .alpha.-tocopherol Acetate Ceresin Microcrystalline Wax

Identifiers & Packaging

Pill Appearance

Color: white

Marketing Status

OTC MONOGRAPH DRUG Active Since 2017-10-09

Medication Information

Purpose

Sunscreen, Sunscreen, Sunscreen, Sunscreen

Description

Octinoxate (7.5%), Octocrylene (10.0%), Oxybenzone (5.0%), Octisalate (5.0%)

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 (7.5%), Octocrylene (10.0%), Oxybenzone (5.0%), Octisalate (5.0%)

Inactive Ingredients

Mineral Oil, Ozokerite, Petrolatum, Microcrystalline Wax, Ceresin, Flavor, Copernicia Cerifera (Carnauba) Wax, Caprylic/Capric Triglyceride, Titanium Dioxide (CI 77891), Stearic Acid, Tocopheryl Acetate, Aluminum Hydroxide.

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, Sunscreen, Sunscreen, 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 (7.5%), Octocrylene (10.0%), Oxybenzone (5.0%), Octisalate (5.0%)

Inactive Ingredients

Mineral Oil, Ozokerite, Petrolatum, Microcrystalline Wax, Ceresin, Flavor, Copernicia Cerifera (Carnauba) Wax, Caprylic/Capric Triglyceride, Titanium Dioxide (CI 77891), Stearic Acid, Tocopheryl Acetate, Aluminum Hydroxide.

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": "PETROLATUM", "unii": "4T6H12BN9U", "classCode": "IACT", "strengthNumerator": "13", "strengthDenominator": "1", "strengthNumeratorUnit": "mg", "strengthDenominatorUnit": "g"}, {"name": "LIGHT MINERAL OIL", "unii": "N6K5787QVP", "classCode": "IACT", "strengthNumerator": "25", "strengthDenominator": "1", "strengthNumeratorUnit": "mg", "strengthDenominatorUnit": "g"}, {"name": ".ALPHA.-TOCOPHEROL ACETATE", "unii": "9E8X80D2L0", "classCode": "IACT", "strengthNumerator": "0.5", "strengthDenominator": "1", "strengthNumeratorUnit": "mg", "strengthDenominatorUnit": "g"}, {"name": "CERESIN", "unii": "Q1LS2UJO3A", "classCode": "IACT", "strengthNumerator": "27", "strengthDenominator": "1", "strengthNumeratorUnit": "mg", "strengthDenominatorUnit": "g"}, {"name": "MICROCRYSTALLINE WAX", "unii": "XOF597Q3KY", "classCode": "IACT", "strengthNumerator": "4", "strengthDenominator": "1", "strengthNumeratorUnit": "mg", "strengthDenominatorUnit": "g"}, {"name": "OCTINOXATE", "unii": "4Y5P7MUD51", "classCode": "ACTIB", "strengthNumerator": "7.5", "strengthDenominator": "1", "strengthNumeratorUnit": "mg", "strengthDenominatorUnit": "g"}, {"name": "OXYBENZONE", "unii": "95OOS7VE0Y", "classCode": "ACTIB", "strengthNumerator": "5", "strengthDenominator": "1", "strengthNumeratorUnit": "mg", "strengthDenominatorUnit": "g"}, {"name": "OCTOCRYLENE", "unii": "5A68WGF6WM", "classCode": "ACTIB", "strengthNumerator": "10", "strengthDenominator": "1", "strengthNumeratorUnit": "mg", "strengthDenominatorUnit": "g"}, {"name": "OCTISALATE", "unii": "4X49Y0596W", "classCode": "ACTIB", "strengthNumerator": "5", "strengthDenominator": "1", "strengthNumeratorUnit": "mg", "strengthDenominatorUnit": "g"}]

Raw Label Data

All Sections (JSON)

{"Uses": "Prevents Sunburns", "Purpose": "Sunscreen, Sunscreen, Sunscreen, 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 (7.5%), Octocrylene (10.0%), Oxybenzone (5.0%), Octisalate (5.0%)", "Inactive Ingredients": "Mineral Oil, Ozokerite, Petrolatum, Microcrystalline Wax, Ceresin, Flavor, Copernicia Cerifera (Carnauba) Wax, Caprylic/Capric Triglyceride, Titanium Dioxide (CI 77891), Stearic Acid, Tocopheryl Acetate, Aluminum Hydroxide.", "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