drug facts

drug facts
SPL v1
SPL
SPL Set ID 897c8709-e798-4bfd-80f0-1b8831682c13
Route
topical
Published
Effective Date 2013-04-29
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 2013-03-15
Purpose

Sunscreen, Sunscreen, Skin Protectant

Description

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

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

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

Purpose

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

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.

Description

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

Active Ingredient

Octinoxate (7.5%), Oxybenzone (3.5%)

Petrolatum (40.7%)

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

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

Purpose

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

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.

Active Ingredient (Active ingredient)

Octinoxate (7.5%), Oxybenzone (3.5%)

Petrolatum (40.7%)

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

All Sections (JSON)

Additional Information

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Source: dailymed · Ingested: 2026-02-15T11:55:37.796579 · Updated: 2026-03-14T22:53:29.712463