3b138432-19e5-e757-e063-6294a90a4cbe

SPL v2
SPL
SPL Set ID 3b138432-19e5-e757-e063-6294a90a4cbe
Route
topical
Published
Effective Date 2023-10-27
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients
zinc oxide (200 mg)
Inactive Ingredients
dimethicone/vinyl dimethicone crosspolymer (soft particle) hydrogen dimethicone (20 cst) sodium chloride triethoxycaprylylsilane tetrahexyldecyl ascorbate polyglyceryl-4 isostearate peg-10 dimethicone (600 cst) dimethiconol (2000 cst) cyclopentasiloxane microcrystalline wax caprylyl glycol edetate disodium anhydrous stearyl dimethicone (400 mpa.s at 50c) glycerin polysorbate 20 peg-30 dipolyhydroxystearate polyhydroxystearic acid (2300 mw) triethanolamine cyclohexasiloxane dimethicone caprylhydroxamic acid dimethicone crosspolymer water c12-15 alkyl benzoate cetyl peg/ppg-10/1 dimethicone (hlb 4) alpha-tocopherol acetate

Identifiers & Packaging

Marketing Status
otc monograph drug active Since 2023-10-27

Purpose

Sunscreen

Description

Zinc Oxide 20%


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

Purpose:

Sunscreen

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.

Active Ingredint:

Zinc Oxide 20%

Other Information:
  • Protect this product from excessive heat and direct sun
  • May stain some fabrics
Inactive Ingredients:

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, 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:

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:

Sunscreen

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.

Active Ingredint:

Zinc Oxide 20%

Other Information:
  • Protect this product from excessive heat and direct sun
  • May stain some fabrics
Inactive Ingredients:

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, 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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