SPL v1
SPL
SPL Set ID 461910bd-1f74-f99e-e063-6394a90ae30e
Route
TOPICAL
Published
Effective Date 2025-07-03
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients
Zinc Oxide (200 mg)
Inactive Ingredients
Polysorbate 20 Sodium Chloride Alpha-tocopherol Acetate Peg-30 Dipolyhydroxystearate Polyhydroxystearic Acid (2300 Mw) Peg-10 Dimethicone (600 Cst) Bismuth Oxychloride Triethoxycaprylylsilane Caprylyl Glycol Cetyl Peg/ppg-10/1 Dimethicone (hlb 4) Cyclohexasiloxane Cyclopentasiloxane Dimethicone Dimethicone/vinyl Dimethicone Crosspolymer (soft Particle) Dimethiconol (2000 Cst) Edetate Disodium Anhydrous Glycerin Ci 77492 Ci 77499 Stearyl Dimethicone (400 Mpa.s At 50c) Ci 77491 Tetrahexyldecyl Ascorbate Polyglyceryl-4 Isostearate Caprylhydroxamic Acid Mica Dimethicone Crosspolymer Hydrogen Dimethicone (20 Cst) Microcrystalline Wax C12-15 Alkyl Benzoate Water Triethanolamine

Identifiers & Packaging

Marketing Status
OTC MONOGRAPH DRUG Active Since 2025-07-03

Description

ZINC OXIDE 20%

Purpose

SUNSCREEN


Medication Information

Purpose

SUNSCREEN

Description

ZINC OXIDE 20%

Uses



Helps 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.



Section 51945-4

Warning

KEEP OUT OF REACH OF CHILDREN

Warnings

For external use only. Do not use on broken or damaged skin. Stop use and ask a doctor if rash occurs. When using this product, keep out of eyes. Rinse with water to remove. Keep out of reach of children. If swallowed, get medical help or contact a poison control center right away.

Directions



Apply liberally 15 minutes before sun exposure. Use a water-resistant product if swimming or sweating. Reapply at least every 2 hours. Children under 6 months: Ask a doctor. 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 value 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-sleeved shirts, pants, hats and sunglasses.



Other Information

PROTECT THIS PRODUCT FROM EXCESSIVE HEAT AND DIRECT SUN

MAY STAIN SOME FABRICS

Active Ingredients

ZINC OXIDE 20%

Inactive Ingredients

Bismuth Oxychloride, C12-15 Alkyl Benzoate, Caprylhydroxamic Acid, Caprylyl Glycol, Cetyl PEG/PPG-10/1 Dimethicone, Cyclohexasiloxane, Cyclopentasiloxane, Dimethicone, Dimethicone Crosspolymer, Dimethicone/Vinyl Dimethicone Crosspolymer, Dimethiconol, Disodium EDTA, Glycerin, Hydrogen Dimethicone, Iron Oxides, Mica, Microcrystalline Wax, PEG-10 Dimethicone, PEG-30 Dipolyhydroxystearate, Polyglyceryl-4 Isostearate, Polyhydroxystearic Acid, Polysorbate 20, Sodium Chloride, Stearyl Dimethicone, Tetrahexyldecyl Ascorbate, Tocopheryl Acetate, Triethanolamine, Triethoxycaprylylsilane, Water


Structured Label Content

Uses (USES)



Helps 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.



Section 51945-4 (51945-4)

Purpose (PURPOSE)

SUNSCREEN

Warning (WARNING)

KEEP OUT OF REACH OF CHILDREN

Warnings (WARNINGS)

For external use only. Do not use on broken or damaged skin. Stop use and ask a doctor if rash occurs. When using this product, keep out of eyes. Rinse with water to remove. Keep out of reach of children. If swallowed, get medical help or contact a poison control center right away.

Directions (DIRECTIONS)



Apply liberally 15 minutes before sun exposure. Use a water-resistant product if swimming or sweating. Reapply at least every 2 hours. Children under 6 months: Ask a doctor. 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 value 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-sleeved shirts, pants, hats and sunglasses.



Other Information (OTHER INFORMATION)

PROTECT THIS PRODUCT FROM EXCESSIVE HEAT AND DIRECT SUN

MAY STAIN SOME FABRICS

Active Ingredients (ACTIVE INGREDIENTS)

ZINC OXIDE 20%

Inactive Ingredients (INACTIVE INGREDIENTS)

Bismuth Oxychloride, C12-15 Alkyl Benzoate, Caprylhydroxamic Acid, Caprylyl Glycol, Cetyl PEG/PPG-10/1 Dimethicone, Cyclohexasiloxane, Cyclopentasiloxane, Dimethicone, Dimethicone Crosspolymer, Dimethicone/Vinyl Dimethicone Crosspolymer, Dimethiconol, Disodium EDTA, Glycerin, Hydrogen Dimethicone, Iron Oxides, Mica, Microcrystalline Wax, PEG-10 Dimethicone, PEG-30 Dipolyhydroxystearate, Polyglyceryl-4 Isostearate, Polyhydroxystearic Acid, Polysorbate 20, Sodium Chloride, Stearyl Dimethicone, Tetrahexyldecyl Ascorbate, Tocopheryl Acetate, Triethanolamine, Triethoxycaprylylsilane, Water


Advanced Ingredient Data


Raw Label Data

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