Drug Facts

Composition & Product

Active Ingredients

Petrolatum (165 mg) Avobenzone (11 mg) Homosalate (396 mg) Octisalate (30 mg)

Inactive Ingredients

White Wax Microcrystalline Wax

Identifiers & Packaging

Pill Appearance

Color: white

Marketing Status

OTC MONOGRAPH DRUG Active Since 2025-11-21

Medication Information

Purpose

Sunscreen

Skin Protectant

Description

Avobenzone 3.0%, Homosalate 8.0%, Octisalate 5.0% Petrolatum, 39.6%

Uses

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

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 8.0%, Octisalate 5.0%

Petrolatum, 39.6%

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, Stearyl Alcohol, Theobroma Cacao (Cocoa) Seed Butter, Butyrospermum Parkii (Shea Butter), Tocopheryl Acetate.

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. Helps prevent and temporarily protects dry, chapped or windburned lips.

Purpose

Sunscreen

Skin Protectant

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 8.0%, Octisalate 5.0%

Petrolatum, 39.6%

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, Stearyl Alcohol, Theobroma Cacao (Cocoa) Seed Butter, Butyrospermum Parkii (Shea Butter), Tocopheryl Acetate.

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": "WHITE WAX", "unii": "7G1J5DA97F", "classCode": "IACT", "strengthNumerator": "165", "strengthDenominator": "1", "strengthNumeratorUnit": "mg", "strengthDenominatorUnit": "g"}, {"name": "MICROCRYSTALLINE WAX", "unii": "XOF597Q3KY", "classCode": "IACT", "strengthNumerator": "11", "strengthDenominator": "1", "strengthNumeratorUnit": "mg", "strengthDenominatorUnit": "g"}, {"name": "PETROLATUM", "unii": "4T6H12BN9U", "classCode": "ACTIB", "strengthNumerator": "396", "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": "80", "strengthDenominator": "1", "strengthNumeratorUnit": "mg", "strengthDenominatorUnit": "g"}, {"name": "OCTISALATE", "unii": "4X49Y0596W", "classCode": "ACTIB", "strengthNumerator": "50", "strengthDenominator": "1", "strengthNumeratorUnit": "mg", "strengthDenominatorUnit": "g"}]

Raw Label Data

All Sections (JSON)

{"Uses": "Helps prevent sunburn. Helps prevent and temporarily protects dry, chapped or windburned lips.", "Purpose": "Sunscreen Skin Protectant", "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 8.0%, Octisalate 5.0% Petrolatum, 39.6%", "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, Stearyl Alcohol, Theobroma Cacao (Cocoa) Seed Butter, Butyrospermum Parkii (Shea Butter), Tocopheryl Acetate.", "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