drug facts

drug facts
SPL v1
SPL
SPL Set ID 92966c2d-b61a-4f8b-a5c1-8dfb6352c82f
Route
topical
Published
Effective Date 2025-01-25
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients
octinoxate (7 mg) oxybenzone (0.1 mg) petrolatum (16.8 mg) octocrylene (7.5 mg) octisalate (5 mg)
Inactive Ingredients
light mineral oil .alpha.-tocopherol acetate white wax cetyl alcohol methylparaben

Identifiers & Packaging

Pill Appearance
Color: white
Marketing Status
otc monograph drug active Since 2025-01-01

Purpose

Sunscreen, Sunscreen, Sunscreen, Sunscreen, Skin Protectant

Description

Octinoxate (7.5%), Octocrylene (7.0%), Oxybenzone (5.0%), Octisalate (5.0%), Petrolatum (30.0%)


Medication Information

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.

Uses

Prevents Sunburns

Purpose

Sunscreen, Sunscreen, Sunscreen, Sunscreen, Skin Protectant

Directions

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

Inactive Ingredients

Synthetic Beeswax, Cetyl Alcohol, Mineral Oil, Paraffin, Polyethylene, Flavor, Caprylic/Capric Triglyceride, Titanium Dioxide (CI 77891), Stearic Acid, Aluminum Hydroxide, Lanolin, Phenyl Trimethicone, Oleyl Alcohol, Isopropyl Lanolate, Isopropyl Myristate, BHT, Tocopheryl Acetate, Propyl paraben, Aloe Barbadensis Leaf Extract, Methylparaben, Sodium Saccharin.

Description

Octinoxate (7.5%), Octocrylene (7.0%), Oxybenzone (5.0%), Octisalate (5.0%), Petrolatum (30.0%)

Active Ingredient

Octinoxate (7.5%), Octocrylene (7.0%), Oxybenzone (5.0%), Octisalate (5.0%), Petrolatum (30.0%)

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

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.

Uses

Prevents Sunburns

Purpose

Sunscreen, Sunscreen, Sunscreen, Sunscreen, Skin Protectant

Directions

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

Inactive Ingredients

Synthetic Beeswax, Cetyl Alcohol, Mineral Oil, Paraffin, Polyethylene, Flavor, Caprylic/Capric Triglyceride, Titanium Dioxide (CI 77891), Stearic Acid, Aluminum Hydroxide, Lanolin, Phenyl Trimethicone, Oleyl Alcohol, Isopropyl Lanolate, Isopropyl Myristate, BHT, Tocopheryl Acetate, Propyl paraben, Aloe Barbadensis Leaf Extract, Methylparaben, Sodium Saccharin.

Active Ingredient (Active ingredient)

Octinoxate (7.5%), Octocrylene (7.0%), Oxybenzone (5.0%), Octisalate (5.0%), Petrolatum (30.0%)

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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