Drug Facts

Drug Facts
SPL v3
SPL
SPL Set ID 6dd76e6a-42b2-4539-abfe-fa600db693ca
Route
TOPICAL
Published
Effective Date 2015-01-02
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients
Octinoxate (7.5 mg) Oxybenzone (3.5 mg) Petrolatum (40.7 mg)
Inactive Ingredients
Ceresin Light Mineral Oil Isocetyl Stearate Microcrystalline Wax Lanolin .alpha.-tocopherol Acetate

Identifiers & Packaging

Pill Appearance
Color: white
Marketing Status
OTC MONOGRAPH NOT FINAL Active Since 2015-01-02

Description

Octinoxate (7.5%), Oxybenzone (3.5%) Petrolatum (40.7%)

Purpose

Sunscreen, Sunscreen, Skin Protectant


Medication Information

Purpose

Sunscreen, Sunscreen, Skin Protectant

Description

Octinoxate (7.5%), Oxybenzone (3.5%) Petrolatum (40.7%)

Uses

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

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

Do not use on broken or damaged skin

Stop use and ask a doctor: If rash or irritation develops and lasts for more than 7 days.

When using this product keep out of eyes. Rinse with water to remove.

Directions

Apply liberally 15 minutes before sun exposure. Reapply as needed.

Children under 6 months of age: Ask a doctor before use.

Active Ingredient

Octinoxate (7.5%), Oxybenzone (3.5%)

Petrolatum (40.7%)

Inactive Ingredients

Ozokerite, Mineral Oil, Isocetyl Stearate, Microcrystalline Wax, Isopropyl Lanolate, Lanolin, Copernicia Cerifera (Carnauba) Wax, Tocopheryl Acetate, Isopropyl Myristate, Aloe Barbadenis Leaf Extract, Paraffin, Cetyl Alcohol, Tocerpheryl Linoleate, Flavor, Methylparaben, Propylparaben.

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 protects dry, chapped or windburned lips.

Purpose

Sunscreen, Sunscreen, Skin Protectant

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

Do not use on broken or damaged skin

Stop use and ask a doctor: If rash or irritation develops and lasts for more than 7 days.

When using this product keep out of eyes. Rinse with water to remove.

Directions

Apply liberally 15 minutes before sun exposure. Reapply as needed.

Children under 6 months of age: Ask a doctor before use.

Active Ingredient (Active ingredient)

Octinoxate (7.5%), Oxybenzone (3.5%)

Petrolatum (40.7%)

Inactive Ingredients

Ozokerite, Mineral Oil, Isocetyl Stearate, Microcrystalline Wax, Isopropyl Lanolate, Lanolin, Copernicia Cerifera (Carnauba) Wax, Tocopheryl Acetate, Isopropyl Myristate, Aloe Barbadenis Leaf Extract, Paraffin, Cetyl Alcohol, Tocerpheryl Linoleate, Flavor, Methylparaben, Propylparaben.

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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