Drug Facts

Drug Facts
SPL v1
SPL
SPL Set ID 0c6ac094-cb5b-0f09-e063-6394a90a9eed
Route
TOPICAL
Published
Effective Date 2023-12-13
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients
Zinc Oxide (18.6 g)
Inactive Ingredients
Water Polyglyceryl-3 Polydimethylsiloxyethyl Dimethicone (4000 Mpa.s) Triethoxysilylethyl Polydimethylsiloxyethyl Hexyl Dimethicone Lecithin, Soybean Arabidopsis Thaliana Butylene Glycol Sorbitan Monostearate Dimethicone Medium-chain Triglycerides Ascorbyl Palmitate Cyclomethicone 6 Date Polygonum Aviculare Top Teprenone Polyacrylamide (crosslinked; 2 Mole Percent Bisacrylamide) Carbomer Homopolymer, Unspecified Type Polyethylene Glycol 400 Cetyl Alcohol Peg-100 Stearate Tocopherol .alpha.-tocopherol Acetate, Dl- Imperata Cylindrica Root Laureth-7 Citric Acid Monohydrate Sodium Lactate, L- Caprylyl Glycol Cyclomethicone 5 Glyceryl Monostearate Linoleic Acid Ethylhexylglycerin Edetate Disodium Anhydrous Glycyrrhizinate Dipotassium Micrococcus Luteus C13-14 Isoparaffin Phenoxyethanol Hexylene Glycol Xanthan Gum Glycerin Ascorbic Acid

Identifiers & Packaging

Marketing Status
OTC MONOGRAPH DRUG Active Since 2023-12-13
Description

Active Ingredients: Zinc Oxide 18.6%

Medication Information

Warnings and Precautions

Warnings For external use only

Indications and Usage

Uses • helps to prevent sunburn

• if used as directed with other sun protection measures (see Directions), 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.

• Children under 6 months: Ask a doctor

• Reapply: 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 this 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.

Description

Active Ingredients: Zinc Oxide 18.6%

Section 50565-1

Keep out of reach of children. If product is swallowed, get medical help, or contact a Poison Control Center right away.

Section 50566-9

Stop use and ask a doctor if rash occurs.

Section 50567-7

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

Section 50570-1

Do not use • on damaged or broken skin.

Section 51727-6

Inactive Ingredients:

Water (Aqua),Cyclopentasiloxane, Butylene Glycol, Glycerin, Glyceryl Stearate, PEG-100 Stearate, Cyclohexasiloxane, Polyglyceryl-3 Polydimethylsiloxyethyl Dimethicone, Sorbitan Stearate, Dimethicone,Ascorbic Acid, Plankton Extract, Tocopherol, caprylyl Glycol, Caprylic/Capric Triglyceride, Phoenix Dactylifera ( Date) Fruit Extract, Imperata Cylindrica Root Extract, Arabidopsis Thaliana Extract, Ascorbyl Palmitate, Polygonum Aviculare Extract,Tocopheryl Linoleate/Oleate, Teprenone, Xanthan Gum,Polyacrylamide, C13-14 Isoparaffin, Laureth-7, Phenoxyethanol, Ethylhexylglycerin, Hexylene Glycol, PEG-8, Carbomer, Triethoxysilylethyl Polydimethylsiloxyethyl Hexyl Dimethicone, Cetyl Alcohol, Lecithin, Citric Acid, Sodium Lactate, Disodium EDTA, Dipotassium Glycyrrhizate, Micrococcus Lysate.

Section 51945-4

Section 55105-1

Purpose: Sunscreen

Section 55106-9

Active Ingredients:

Zinc Oxide 18.6%

Section 60561-8

Other information • Protect this product from excessive heat or direct sun.

Structured Label Content

Indications and Usage (34067-9)

Uses • helps to prevent sunburn

• if used as directed with other sun protection measures (see Directions), 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.

• Children under 6 months: Ask a doctor

• Reapply: 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 this 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.

Warnings and Precautions (34071-1)

Warnings For external use only

Section 50565-1 (50565-1)

Keep out of reach of children. If product is swallowed, get medical help, or contact a Poison Control Center right away.

Section 50566-9 (50566-9)

Stop use and ask a doctor if rash occurs.

Section 50567-7 (50567-7)

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

Section 50570-1 (50570-1)

Do not use • on damaged or broken skin.

Section 51727-6 (51727-6)

Inactive Ingredients:

Water (Aqua),Cyclopentasiloxane, Butylene Glycol, Glycerin, Glyceryl Stearate, PEG-100 Stearate, Cyclohexasiloxane, Polyglyceryl-3 Polydimethylsiloxyethyl Dimethicone, Sorbitan Stearate, Dimethicone,Ascorbic Acid, Plankton Extract, Tocopherol, caprylyl Glycol, Caprylic/Capric Triglyceride, Phoenix Dactylifera ( Date) Fruit Extract, Imperata Cylindrica Root Extract, Arabidopsis Thaliana Extract, Ascorbyl Palmitate, Polygonum Aviculare Extract,Tocopheryl Linoleate/Oleate, Teprenone, Xanthan Gum,Polyacrylamide, C13-14 Isoparaffin, Laureth-7, Phenoxyethanol, Ethylhexylglycerin, Hexylene Glycol, PEG-8, Carbomer, Triethoxysilylethyl Polydimethylsiloxyethyl Hexyl Dimethicone, Cetyl Alcohol, Lecithin, Citric Acid, Sodium Lactate, Disodium EDTA, Dipotassium Glycyrrhizate, Micrococcus Lysate.

Section 51945-4 (51945-4)

Section 55105-1 (55105-1)

Purpose: Sunscreen

Section 55106-9 (55106-9)

Active Ingredients:

Zinc Oxide 18.6%

Section 60561-8 (60561-8)

Other information • Protect this product from excessive heat or direct sun.

Advanced Ingredient Data

Raw Label Data

All Sections (JSON)

Additional Information

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Source: dailymed · Ingested: 2026-02-15T12:02:30.211982 · Updated: 2026-03-14T23:02:05.629064