308c711d-4c3e-1208-e063-6394a90a9cc2

SPL v2
SPL
SPL Set ID 308c711d-4c3e-1208-e063-6394a90a9cc2
Route
topical
Published
Effective Date 2020-03-10
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

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

Identifiers & Packaging

Marketing Status
otc monograph drug active Since 2020-03-10

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 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: • After 40 minutes of swimming or sweating • Immediately after towel drying • 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 am- 2 pm • Wear long sleeve shirts and 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:

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 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: • After 40 minutes of swimming or sweating • Immediately after towel drying • 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 am- 2 pm • Wear long sleeve shirts and 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:

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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