Drug Facts

Drug Facts
SPL v2
SPL
SPL Set ID c7094485-a19f-41b7-88b8-d6d472adbff1
Route
TOPICAL
Published
Effective Date 2025-04-22
Document Type 34390-5 HUMAN OTC DRUG LABEL

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 2022-08-01

Description

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

Purpose

Sunscreen, Sunscreen, Skin Protectant


Medication Information

Purpose

Sunscreen, Sunscreen, Skin Protectant

Description

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

Uses

Helps prevent sunburn. if used as directed with other sun protection measures (see Directions) decreases the risk of skin cancer and early aging caused by the sun. helps prevent and temporarily protects chafed, chapped or cracked lips. Helps prevent and protect from the drying effects of wind and cold weather

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 occurs

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. SunProtectionMeasures. 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. to 2 p.m. wear long-sleeve shirts, pants, hats and sunglasses. Children under 6 months: Ask a doctor.

Active Ingredient

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

Petrolatum (39.6%)

Inactive Ingredients

Aloe Barbadensis Leaf Extract, Beeswax, 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, Tocopheryl Acetate.

Keep Out of Reach of Children

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

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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 aging caused by the sun. helps prevent and temporarily protects chafed, chapped or cracked lips. Helps prevent and protect from the drying effects of wind and cold weather

Purpose

Sunscreen, Sunscreen, Skin Protectant

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 occurs

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. SunProtectionMeasures. 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. to 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%), Octisalate (5.0%), Homosalate (8.0%)

Petrolatum (39.6%)

Inactive Ingredients

Aloe Barbadensis Leaf Extract, Beeswax, 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, 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


Raw Label Data

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