Drug Facts

Composition & Product

Active Ingredients

Zinc Oxide (205 mg)

Inactive Ingredients

Coconut Oil White Wax Almond Oil Castor Oil

Identifiers & Packaging

Pill Appearance

Color: white

Marketing Status

OTC MONOGRAPH DRUG Active Since 2023-06-06

Medication Information

Purpose

Sunscreen

Description

Zinc Oxide (10.0%)

Uses

Prevents Sunburns

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 to prevent sunburn, skin cancer and/or early aging.

For external use only: Stop use and ask a doctor: if rash or irritation develops and lasts.

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 • Sun

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

Active Ingredient

Zinc Oxide (10.0%)

Inactive Ingredients

Cocos Nucifera (Coconut) Oil, Ricinus Communis (Castor) Seed Oil, Prunus Amygdalus Dulcis (Sweet Almond) Oil, Behenyl Behenate, Polyhydroxystearic Acid, Helianthus Annuus (Sunflower) Seed Wax, Caprylic/CapricTriglyceride, Flavor, Euphorbia Cerifera (Candelilla) Wax, Persea Gratissima (Avocado) Oil, Copernicia Cerifera (Carnauba) Wax, Butyrospermum Parkii (Shea Butter),Simmondsia Chinensis (Jojoba) Seed Oil, Tocopherol (Vitamin E), Helianthus Annuus(Sunflower) Seed Oil, Terminalia Ferdinandiana (Kakadu Plum) Fruit Extract, Melaleuca

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

Prevents Sunburns

Purpose

Sunscreen

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 to prevent sunburn, skin cancer and/or early aging.

For external use only: Stop use and ask a doctor: if rash or irritation develops and lasts.

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 • Sun

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

Active Ingredient (Active ingredient)

Zinc Oxide (10.0%)

Inactive Ingredients

Cocos Nucifera (Coconut) Oil, Ricinus Communis (Castor) Seed Oil, Prunus Amygdalus Dulcis (Sweet Almond) Oil, Behenyl Behenate, Polyhydroxystearic Acid, Helianthus Annuus (Sunflower) Seed Wax, Caprylic/CapricTriglyceride, Flavor, Euphorbia Cerifera (Candelilla) Wax, Persea Gratissima (Avocado) Oil, Copernicia Cerifera (Carnauba) Wax, Butyrospermum Parkii (Shea Butter),Simmondsia Chinensis (Jojoba) Seed Oil, Tocopherol (Vitamin E), Helianthus Annuus(Sunflower) Seed Oil, Terminalia Ferdinandiana (Kakadu Plum) Fruit Extract, Melaleuca

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": "COCONUT OIL", "unii": "Q9L0O73W7L", "classCode": "IACT", "strengthNumerator": "205", "strengthDenominator": "1", "strengthNumeratorUnit": "mg", "strengthDenominatorUnit": "g"}, {"name": "WHITE WAX", "unii": "7G1J5DA97F", "classCode": "IACT", "strengthNumerator": "202", "strengthDenominator": "1", "strengthNumeratorUnit": "mg", "strengthDenominatorUnit": "g"}, {"name": "ALMOND OIL", "unii": "66YXD4DKO9", "classCode": "IACT", "strengthNumerator": "170", "strengthDenominator": "1", "strengthNumeratorUnit": "mg", "strengthDenominatorUnit": "g"}, {"name": "CASTOR OIL", "unii": "D5340Y2I9G", "classCode": "IACT", "strengthNumerator": "170", "strengthDenominator": "1", "strengthNumeratorUnit": "mg", "strengthDenominatorUnit": "g"}, {"name": "ZINC OXIDE", "unii": "SOI2LOH54Z", "classCode": "ACTIB", "strengthNumerator": "100", "strengthDenominator": "1", "strengthNumeratorUnit": "mg", "strengthDenominatorUnit": "g"}]

Raw Label Data

All Sections (JSON)

{"Uses": "Prevents Sunburns", "Purpose": "Sunscreen", "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 to prevent sunburn, skin cancer and/or early aging. For external use only: Stop use and ask a doctor: if rash or irritation develops and lasts.", "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 • Sun Protection Measures. 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. -2 p.m. • wear long-sleeve shirts, pants, hats and sunglasses. Children under 6 months: Ask a doctor.", "Active ingredient": "Zinc Oxide (10.0%)", "Inactive Ingredients": "Cocos Nucifera (Coconut) Oil, Ricinus Communis (Castor) Seed Oil, Prunus Amygdalus Dulcis (Sweet Almond) Oil, Behenyl Behenate, Polyhydroxystearic Acid, Helianthus Annuus (Sunflower) Seed Wax, Caprylic/CapricTriglyceride, Flavor, Euphorbia Cerifera (Candelilla) Wax, Persea Gratissima (Avocado) Oil, Copernicia Cerifera (Carnauba) Wax, Butyrospermum Parkii (Shea Butter),Simmondsia Chinensis (Jojoba) Seed Oil, Tocopherol (Vitamin E), Helianthus Annuus(Sunflower) Seed Oil, Terminalia Ferdinandiana (Kakadu Plum) Fruit Extract, Melaleuca", "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