Drug Facts

Composition & Product

Active Ingredients

Octisalate (165 mg) Avobenzone (23 mg) Petrolatum (5 mg) Homosalate (50 mg)

Inactive Ingredients

Ceresin Isocetyl Stearate .alpha.-tocopherol Acetate

Identifiers & Packaging

Pill Appearance

Color: white

Marketing Status

OTC MONOGRAPH DRUG Active Since 2024-08-01

Medication Information

Purpose

Sunscreen, Sunscreen, Skin Protectant

Description

Avobenzone (3.0%), Homosalate (8.0%), Octisalate (5.0%) Petrolatum (38.8%)

Uses

Helps prevent sunburn. Helps prevent and temporarily protect dry, chapped, or windburned lips.

Warnings

For external use only: 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 and as needed. Children under 6 months: Ask a doctor.

Active Ingredient

Avobenzone (3.0%), Homosalate (8.0%), Octisalate (5.0%)

Petrolatum (38.8%)

Inactive Ingredients

Aloe Barbadensis Leaf Juice, Caprylic/Capric Triglyceride, Cocos Nucifera (Coconut ) Oil, Ethylhexyl Methoxycrylene, Flavor, Helianthus Annuus (Sunflower) Seed Oil, Isocetyl Stearate, Melaleuca Alternifolia (Tea Tree) Leaf Oil, Microcrystalline Wax, Olea Europaea (Olive) Fruit Oil, Ozokerite, Saccharin, Stearyl Alcohol, Theobroma Cacao (Cocoa) Seed Butter, Tocopheryl Acetate.

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

Helps prevent sunburn. Helps prevent and temporarily protect dry, chapped, or windburned lips.

Purpose

Sunscreen, Sunscreen, Skin Protectant

Warnings

For external use only: 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 and as needed. Children under 6 months: Ask a doctor.

Active Ingredient (Active ingredient)

Avobenzone (3.0%), Homosalate (8.0%), Octisalate (5.0%)

Petrolatum (38.8%)

Inactive Ingredients

Aloe Barbadensis Leaf Juice, Caprylic/Capric Triglyceride, Cocos Nucifera (Coconut ) Oil, Ethylhexyl Methoxycrylene, Flavor, Helianthus Annuus (Sunflower) Seed Oil, Isocetyl Stearate, Melaleuca Alternifolia (Tea Tree) Leaf Oil, Microcrystalline Wax, Olea Europaea (Olive) Fruit Oil, Ozokerite, Saccharin, Stearyl Alcohol, Theobroma Cacao (Cocoa) Seed Butter, Tocopheryl Acetate.

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": "CERESIN", "unii": "Q1LS2UJO3A", "classCode": "IACT", "strengthNumerator": "165", "strengthDenominator": "1", "strengthNumeratorUnit": "mg", "strengthDenominatorUnit": "g"}, {"name": "ISOCETYL STEARATE", "unii": "3RJ7186O9W", "classCode": "IACT", "strengthNumerator": "23", "strengthDenominator": "1", "strengthNumeratorUnit": "mg", "strengthDenominatorUnit": "g"}, {"name": ".ALPHA.-TOCOPHEROL ACETATE", "unii": "9E8X80D2L0", "classCode": "IACT", "strengthNumerator": "5", "strengthDenominator": "1", "strengthNumeratorUnit": "mg", "strengthDenominatorUnit": "g"}, {"name": "OCTISALATE", "unii": "4X49Y0596W", "classCode": "ACTIB", "strengthNumerator": "50", "strengthDenominator": "1", "strengthNumeratorUnit": "mg", "strengthDenominatorUnit": "g"}, {"name": "AVOBENZONE", "unii": "G63QQF2NOX", "classCode": "ACTIB", "strengthNumerator": "30", "strengthDenominator": "1", "strengthNumeratorUnit": "mg", "strengthDenominatorUnit": "g"}, {"name": "PETROLATUM", "unii": "4T6H12BN9U", "classCode": "ACTIB", "strengthNumerator": "388", "strengthDenominator": "1", "strengthNumeratorUnit": "mg", "strengthDenominatorUnit": "g"}, {"name": "HOMOSALATE", "unii": "V06SV4M95S", "classCode": "ACTIB", "strengthNumerator": "80", "strengthDenominator": "1", "strengthNumeratorUnit": "mg", "strengthDenominatorUnit": "g"}]

Raw Label Data

All Sections (JSON)

{"Uses": "Helps prevent sunburn. Helps prevent and temporarily protect dry, chapped, or windburned lips.", "Purpose": "Sunscreen, Sunscreen, Skin Protectant", "Warnings": "For external use only: 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 and as needed. Children under 6 months: Ask a doctor.", "Active ingredient": "Avobenzone (3.0%), Homosalate (8.0%), Octisalate (5.0%) Petrolatum (38.8%)", "Inactive Ingredients": "Aloe Barbadensis Leaf Juice, Caprylic/Capric Triglyceride, Cocos Nucifera (Coconut ) Oil, Ethylhexyl Methoxycrylene, Flavor, Helianthus Annuus (Sunflower) Seed Oil, Isocetyl Stearate, Melaleuca Alternifolia (Tea Tree) Leaf Oil, Microcrystalline Wax, Olea Europaea (Olive) Fruit Oil, Ozokerite, Saccharin, Stearyl Alcohol, Theobroma Cacao (Cocoa) Seed Butter, Tocopheryl Acetate.", "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