Drug Facts

Composition & Product

Active Ingredients

Zinc Oxide (189 mg)

Inactive Ingredients

Plantago Lanceolata Leaf Ascorbyl Palmitate Sorbitan Monostearate Cetearyl Glucoside Cetyl Alcohol Ethylhexylglycerin Glycerin Porphyra Umbilicalis Carrageenan Water Stearyl Alcohol Polyhydroxystearic Acid Stearate Isostearic Acid Punica Granatum Root Bark Medium-chain Triglycerides Polysorbate 60 Stearic Acid Polyglyceryl-3 Ricinoleate Lecithin, Soybean Xanthan Gum

Identifiers & Packaging

Marketing Status

OTC MONOGRAPH DRUG Active Since 2017-12-04

Medication Information

Warnings and Precautions

Warnings: For external use only.

Indications and Usage

Uses:

Provide high protection against sunburn.
Provide broad spectrum (UVA and UVB) protection.
If used as directed with other sun protection measures, decreases the risk of skin cancer and early skin aging caused by the sun.

Dosage and Administration

Directions:

Apply liberally 15 minutes before sun exposure.
Reapply: after swimming or sweating. Immediately after towel drying. At least every 2 hours.
Children under 6 months: Ask a doctor.

Description

Active Ingredients: Zinc Oxide 18.9%

Section 50565-1

Keep out of reach of children.

Section 50566-9

Stop and ask a doctor if rash or irritation occurs.

Section 50567-7

Keep out of eyes. Rinse with water to remove.

Section 51727-6

Inactive Ingredients: Caprylic/Capric Triglyceride, Water (Aqua), Glycerin, Polysorbate 60, Stearic Acid, Cetyl Alcohol, Sorbitan Stearate, Cetearyl Glucoside, Stearyl Alcohol, Polyhydroxystearic Acid, Polyglyceryl-3 Ricinoleate, Isostearic Acid, Lecithin, Phenoxyethanol, Xanthan Gum, Carageenan, Helionori, Punica Granatum (Pomegranate) Extract, Plantago Lanceolate (Plantain) Leaf Extract, Ascorbyl Palmitate (Vitamin-C), Ethylhexylglycerin.

Section 51945-4

Sun Research LLC

Santa Cruz, CA

www.burnoutsun.com

Section 53413-1

Questions? Call toll free 1-800-798-7970

Section 55105-1

Purpose

Sunscreen

Section 55106-9

Active Ingredients:

Zinc Oxide 18.9%

Section 60561-8

High sun protection product.

Structured Label Content

Indications and Usage (34067-9)

Uses:

Provide high protection against sunburn.
Provide broad spectrum (UVA and UVB) protection.
If used as directed with other sun protection measures, decreases the risk of skin cancer and early skin aging caused by the sun.

Dosage and Administration (34068-7)

Directions:

Apply liberally 15 minutes before sun exposure.
Reapply: after swimming or sweating. Immediately after towel drying. At least every 2 hours.
Children under 6 months: Ask a doctor.

Warnings and Precautions (34071-1)

Warnings: For external use only.

Section 50565-1 (50565-1)

Keep out of reach of children.

Section 50566-9 (50566-9)

Stop and ask a doctor if rash or irritation occurs.

Section 50567-7 (50567-7)

Keep out of eyes. Rinse with water to remove.

Section 51727-6 (51727-6)

Inactive Ingredients: Caprylic/Capric Triglyceride, Water (Aqua), Glycerin, Polysorbate 60, Stearic Acid, Cetyl Alcohol, Sorbitan Stearate, Cetearyl Glucoside, Stearyl Alcohol, Polyhydroxystearic Acid, Polyglyceryl-3 Ricinoleate, Isostearic Acid, Lecithin, Phenoxyethanol, Xanthan Gum, Carageenan, Helionori, Punica Granatum (Pomegranate) Extract, Plantago Lanceolate (Plantain) Leaf Extract, Ascorbyl Palmitate (Vitamin-C), Ethylhexylglycerin.

Section 51945-4 (51945-4)

Sun Research LLC

Santa Cruz, CA

www.burnoutsun.com

Section 53413-1 (53413-1)

Questions? Call toll free 1-800-798-7970

Section 55105-1 (55105-1)

Purpose

Sunscreen

Section 55106-9 (55106-9)

Active Ingredients:

Zinc Oxide 18.9%

Section 60561-8 (60561-8)

High sun protection product.

Advanced Ingredient Data

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Raw Label Data

All Sections (JSON)

{"34067-9": "Uses: Provide high protection against sunburn. Provide broad spectrum (UVA and UVB) protection. If used as directed with other sun protection measures, decreases the risk of skin cancer and early skin aging caused by the sun.", "34068-7": "Directions: Apply liberally 15 minutes before sun exposure. Reapply: after swimming or sweating. Immediately after towel drying. At least every 2 hours. Children under 6 months: Ask a doctor.", "34071-1": "Warnings: For external use only.", "50565-1": "Keep out of reach of children.", "50566-9": "Stop and ask a doctor if rash or irritation occurs.", "50567-7": "Keep out of eyes. Rinse with water to remove.", "51727-6": "Inactive Ingredients: Caprylic/Capric Triglyceride, Water (Aqua), Glycerin, Polysorbate 60, Stearic Acid, Cetyl Alcohol, Sorbitan Stearate, Cetearyl Glucoside, Stearyl Alcohol, Polyhydroxystearic Acid, Polyglyceryl-3 Ricinoleate, Isostearic Acid, Lecithin, Phenoxyethanol, Xanthan Gum, Carageenan, Helionori, Punica Granatum (Pomegranate) Extract, Plantago Lanceolate (Plantain) Leaf Extract, Ascorbyl Palmitate (Vitamin-C), Ethylhexylglycerin.", "51945-4": "Sun Research LLC Santa Cruz, CA www.burnoutsun.com", "53413-1": "Questions? Call toll free 1-800-798-7970", "55105-1": "Purpose Sunscreen", "55106-9": "Active Ingredients: Zinc Oxide 18.9%", "60561-8": "High sun protection product."}

Drug Facts

Drug Facts

Composition & Product

Identifiers & Packaging

Medication Information

Structured Label Content

Advanced Ingredient Data

Raw Label Data

Additional Information