Drug Facts

Composition & Product

Active Ingredients

Petrolatum (44.0 mg) Padimate O (3.00 mg)

Inactive Ingredients

Microcrystalline Wax Lanolin Ceresin Carnauba Wax Isopropyl Myristate Light Mineral Oil

Identifiers & Packaging

Pill Appearance

Color: pink

Marketing Status

OTC MONOGRAPH NOT FINAL Active Since 2013-03-15

Medication Information

Purpose

Sunscreen, Skin Protectant

Description

Padimate O, Petrolatum

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

Stop use and ask a doctor: If rash or irritation develops and lasts.

Directions

Apply liberally before sun exposure and as needed.

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

Active Ingredient

Padimate O, Petrolatum

Inactive Ingredients

Mineral Oil, Ozokerite, Microcrystalline Wax, Phenyl Trimethicone, Lanolin, Copercicia (Carnauba) Wax, Isopropyl Myristate, Cetyl Alcohol, Euphorbia Cerifera (Candelilla) Wax, Flavor, Camphor, Methylparaben, Titanium Dioxide (CI 77891), Yellow 5 Lake (CI 19140), Red 6 Lake (CI 15850).

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, 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

Stop use and ask a doctor: If rash or irritation develops and lasts.

Directions

Apply liberally before sun exposure and as needed.

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

Active Ingredient (Active ingredient)

Padimate O, Petrolatum

Inactive Ingredients

Mineral Oil, Ozokerite, Microcrystalline Wax, Phenyl Trimethicone, Lanolin, Copercicia (Carnauba) Wax, Isopropyl Myristate, Cetyl Alcohol, Euphorbia Cerifera (Candelilla) Wax, Flavor, Camphor, Methylparaben, Titanium Dioxide (CI 77891), Yellow 5 Lake (CI 19140), Red 6 Lake (CI 15850).

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

[{"name": "PETROLATUM", "unii": "4T6H12BN9U", "classCode": "ACTIB", "strengthNumerator": "44.0", "strengthDenominator": "1", "strengthNumeratorUnit": "mg", "strengthDenominatorUnit": "g"}, {"name": "MICROCRYSTALLINE WAX", "unii": "XOF597Q3KY", "classCode": "IACT", "strengthNumerator": "3.00", "strengthDenominator": "1", "strengthNumeratorUnit": "mg", "strengthDenominatorUnit": "g"}, {"name": "LANOLIN", "unii": "7EV65EAW6H", "classCode": "IACT", "strengthNumerator": "1", "strengthDenominator": "1", "strengthNumeratorUnit": "mg", "strengthDenominatorUnit": "g"}, {"name": "PADIMATE O", "unii": "Z11006CMUZ", "classCode": "ACTIB", "strengthNumerator": "1.5", "strengthDenominator": "1", "strengthNumeratorUnit": "mg", "strengthDenominatorUnit": "g"}, {"name": "CERESIN", "unii": "Q1LS2UJO3A", "classCode": "IACT", "strengthNumerator": "17.30", "strengthDenominator": "1", "strengthNumeratorUnit": "mg", "strengthDenominatorUnit": "g"}, {"name": "CARNAUBA WAX", "unii": "R12CBM0EIZ", "classCode": "IACT", "strengthNumerator": "1", "strengthDenominator": "1", "strengthNumeratorUnit": "mg", "strengthDenominatorUnit": "g"}, {"name": "ISOPROPYL MYRISTATE", "unii": "0RE8K4LNJS", "classCode": "IACT", "strengthNumerator": "2.23", "strengthDenominator": "1", "strengthNumeratorUnit": "mg", "strengthDenominatorUnit": "g"}, {"name": "LIGHT MINERAL OIL", "unii": "N6K5787QVP", "classCode": "IACT", "strengthNumerator": "27.50", "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": "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.", "Directions": "Apply liberally before sun exposure and as needed. Children under 6 months of age: Ask a doctor before use.", "Active ingredient": "Padimate O, Petrolatum", "Inactive Ingredients": "Mineral Oil, Ozokerite, Microcrystalline Wax, Phenyl Trimethicone, Lanolin, Copercicia (Carnauba) Wax, Isopropyl Myristate, Cetyl Alcohol, Euphorbia Cerifera (Candelilla) Wax, Flavor, Camphor, Methylparaben, Titanium Dioxide (CI 77891), Yellow 5 Lake (CI 19140), Red 6 Lake (CI 15850).", "Keep Out of Reach of Children": "If 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