2d53071f-0275-d00c-e063-6294a90afcca

SPL v2
SPL
SPL Set ID 2d53071f-0275-d00c-e063-6294a90afcca
Route
topical
Published
Effective Date 2024-10-08
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients
zinc oxide (150 mg)
Inactive Ingredients
ci 77499 ci 77492 hydrogen dimethicone (20 cst) cyclohexasiloxane glycerin dimethicone isohexadecane dimethicone/vinyl dimethicone crosspolymer (soft particle) edetate disodium anhydrous polysorbate 20 stearyl dimethicone (400 mpa.s at 50c) silicon dioxide lauryl peg/ppg-18/18 methicone sodium hyaluronate tetrahexyldecyl ascorbate triethanolamine triethoxycaprylylsilane cetyl peg/ppg-10/1 dimethicone (hlb 4) dimethiconol (2000 cst) isododecane polyhydroxystearic acid (2300 mw) sodium chloride water microcrystalline wax alpha-tocopherol acetate titanium dioxide caprylyl glycol cyclopentasiloxane c12-15 alkyl benzoate caprylhydroxamic acid magnesium sulfate octadecene ci 77491 peg-10 dimethicone (600 cst) ceramide 3 dimethicone crosspolymer

Identifiers & Packaging

Marketing Status
otc monograph drug active Since 2024-10-08
Purpose

Sunscreen

Description

Zinc Oxide 15%

Medication Information

Purpose

Sunscreen

Description

Zinc Oxide 15%

Uses:

Helps prevents 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

Purpose:

Sunscreen

Warnings:

For external use only. Do not use on damaged or broken 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. Reapply At least every 2 hours. Use a water resistant product if swimming or sweating. 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

Active Ingredient:

Zinc Oxide 15%

Other Information:

Protect this product from excessive heat and direct sun. May stain some fabrics. Shake well before using.

Inactive Ingredients:

C 12-15 Alkyl Benzoate, Caprylhydroxamic Acid, Caprylyl Glycol, Ceramide 3, CetylPEG/PPG-10/1 Dimethicone, Cyclohexasiloxane, Cyclopentasiloxane, Dimethicone,Dimethicone Crosspolymer, Dimethicone/Vinyl Dimethicone Crosspolymer, Dimethiconol, Disodium EDTA, Glycerin, Hydrogen Dimethicone, Iron Oxides, Isododecane, Isohexadecane, Lauryl PEG/PPG-18/18 Methicone, Magnesium Sulfate, Microcrystalline Wax, Octadecene, PEG-10 Dimethicone, Polyhydroxystearic Acid, Polysorbate 20, Silica, Sodium Chloride, Sodium Hyaluronate, Stearyl Dimethicone, Tetrahexyldecyl Ascorbate, Titanium Dioxide,

Tocopheryl Acetate, Triethanolamine, Triethoxycaprylylsilane, Water

Structured Label Content

Uses:

Helps prevents 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:

Sunscreen

Warnings:

For external use only. Do not use on damaged or broken 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. Reapply At least every 2 hours. Use a water resistant product if swimming or sweating. 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

Active Ingredient:

Zinc Oxide 15%

Other Information:

Protect this product from excessive heat and direct sun. May stain some fabrics. Shake well before using.

Inactive Ingredients:

C 12-15 Alkyl Benzoate, Caprylhydroxamic Acid, Caprylyl Glycol, Ceramide 3, CetylPEG/PPG-10/1 Dimethicone, Cyclohexasiloxane, Cyclopentasiloxane, Dimethicone,Dimethicone Crosspolymer, Dimethicone/Vinyl Dimethicone Crosspolymer, Dimethiconol, Disodium EDTA, Glycerin, Hydrogen Dimethicone, Iron Oxides, Isododecane, Isohexadecane, Lauryl PEG/PPG-18/18 Methicone, Magnesium Sulfate, Microcrystalline Wax, Octadecene, PEG-10 Dimethicone, Polyhydroxystearic Acid, Polysorbate 20, Silica, Sodium Chloride, Sodium Hyaluronate, Stearyl Dimethicone, Tetrahexyldecyl Ascorbate, Titanium Dioxide,

Tocopheryl Acetate, Triethanolamine, Triethoxycaprylylsilane, Water

Advanced Ingredient Data

Raw Label Data

All Sections (JSON)

Additional Information

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Source: dailymed · Ingested: 2026-02-15T12:07:43.275663 · Updated: 2026-03-14T23:11:28.912883