Drug Facts
fc316b19-c1cf-4b5b-9f22-9672b7d0cbff
34390-5
HUMAN OTC DRUG LABEL
Drug Facts
Composition & Product
Identifiers & Packaging
Description
Active Ingredient: Zinc oxide - 18.6%
Medication Information
Warnings and Precautions
Warnings: For external use only. Do not use on damaged or broken skin.
Indications and Usage
Uses:
- Help prevent sunburn. Higher SPF gives more sunburn protection. Provide high protection against 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:
- For sunscreen use. Apply generously 15 minutes before sun exposure. Reapply at least every 2 hours. Use a water resistant sunscreen if swimming or sweating.
- 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 protection measures including: limit time in the sun, especially from 10 am - 2 pm. Wear long-sleeved shirts, pants, hats, and sunglasses. Children under 6 months of age: Ask a doctor.
Description
Active Ingredient: Zinc oxide - 18.6%
Section 44425-7
Store at controlled room temperature 59 F - 89 F (15 C - 30 C).
Section 50565-1
Keep out of reach of children. If swallowed, get medical help or contact a Poison Cpntrol center right away.
Section 50566-9
Stop use and ask a doctor if rash or irritation developes and lasts.
Section 50567-7
When using this product keep out of eyes. Rinse with water to remove.
Section 51727-6
Inactive Ingredients: Water (Aqua), Cyclopentasiloxane, Butylene glycol, glycerin, Propylene Glycol, Caprylic/Capric triglyceride, Glycerin Stearate, PEG-100 Stearate, Polyglyceryl-3 Polymethylsiloxyeethyl Dimethicon, Cyclohexasiloxane, Sorbitan Stearate, Dimethicone, Polyacrylamide, C13-14 Isoparaffin, Laureth-7,phenoxyethanol, Caprylyl Glycol, Ethylhexyglycerin, Hexylene glycol, Imperata Cylindrica Root Extract, PEG-8, Carbomer, triethoxysilylethyl Polydimethylsiloxyethyl Hexyl Dimethicone, Cetyl Alcohol, Lecithin, Tocopherol, Ascorbyl Palmitate, Ascorbic Acid, Citric Acid, Xanthan gum, Furfuryl Tetrahydropyranyladinine, tocopherol Linoleate/Oleate, Teprenone, Phoenix Dactylifera (Date) Fruit Extract, Sodium Lactate, Disodium EDTA, Dipotassium Glycyrrhizate, Arabidopsis Thaliana Extract, Plankton Extract and Micrococcus Lysate.
Section 51945-4
Developed, Distributed and Marketed by:
Pyratine LLC
2950 Main Street
Morro Bay, CA 93442
1-888-467-9728
www.pyratine.com
Section 53413-1
Call toll free 1-888-467-9728
Section 55105-1
Purpose: Sunscreen
Section 55106-9
Active Ingredient: Zinc oxide - 18.6%
Section 60561-8
protect this product from excessive heat and direct sun.
Structured Label Content
Indications and Usage (34067-9)
Uses:
- Help prevent sunburn. Higher SPF gives more sunburn protection. Provide high protection against 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:
- For sunscreen use. Apply generously 15 minutes before sun exposure. Reapply at least every 2 hours. Use a water resistant sunscreen if swimming or sweating.
- 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 protection measures including: limit time in the sun, especially from 10 am - 2 pm. Wear long-sleeved shirts, pants, hats, and sunglasses. Children under 6 months of age: Ask a doctor.
Warnings and Precautions (34071-1)
Warnings: For external use only. Do not use on damaged or broken skin.
Section 44425-7 (44425-7)
Store at controlled room temperature 59 F - 89 F (15 C - 30 C).
Section 50565-1 (50565-1)
Keep out of reach of children. If swallowed, get medical help or contact a Poison Cpntrol center right away.
Section 50566-9 (50566-9)
Stop use and ask a doctor if rash or irritation developes and lasts.
Section 50567-7 (50567-7)
When using this product keep out of eyes. Rinse with water to remove.
Section 51727-6 (51727-6)
Inactive Ingredients: Water (Aqua), Cyclopentasiloxane, Butylene glycol, glycerin, Propylene Glycol, Caprylic/Capric triglyceride, Glycerin Stearate, PEG-100 Stearate, Polyglyceryl-3 Polymethylsiloxyeethyl Dimethicon, Cyclohexasiloxane, Sorbitan Stearate, Dimethicone, Polyacrylamide, C13-14 Isoparaffin, Laureth-7,phenoxyethanol, Caprylyl Glycol, Ethylhexyglycerin, Hexylene glycol, Imperata Cylindrica Root Extract, PEG-8, Carbomer, triethoxysilylethyl Polydimethylsiloxyethyl Hexyl Dimethicone, Cetyl Alcohol, Lecithin, Tocopherol, Ascorbyl Palmitate, Ascorbic Acid, Citric Acid, Xanthan gum, Furfuryl Tetrahydropyranyladinine, tocopherol Linoleate/Oleate, Teprenone, Phoenix Dactylifera (Date) Fruit Extract, Sodium Lactate, Disodium EDTA, Dipotassium Glycyrrhizate, Arabidopsis Thaliana Extract, Plankton Extract and Micrococcus Lysate.
Section 51945-4 (51945-4)
Developed, Distributed and Marketed by:
Pyratine LLC
2950 Main Street
Morro Bay, CA 93442
1-888-467-9728
www.pyratine.com
Section 53413-1 (53413-1)
Call toll free 1-888-467-9728
Section 55105-1 (55105-1)
Purpose: Sunscreen
Section 55106-9 (55106-9)
Active Ingredient: Zinc oxide - 18.6%
Section 60561-8 (60561-8)
protect this product from excessive heat and direct sun.
Advanced Ingredient Data
Raw Label Data
All Sections (JSON)
Additional Information
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Source: dailymed · Ingested: 2026-02-15T11:56:27.276982 · Updated: 2026-03-14T22:54:56.160161