SPL v2
SPL
SPL Set ID 2f9d087c-b2b3-5654-e063-6294a90a94e5
Route
TOPICAL
Published
Effective Date 2024-08-09
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

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

Identifiers & Packaging

Marketing Status
OTC MONOGRAPH DRUG Active Since 2024-08-09

Description

Zinc Oxide 20%

Purpose

Sunscreen


Medication Information

Purpose

Sunscreen

Description

Zinc Oxide 20%

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 the 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 • 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-sleeved shirts, pants, hats, and sunglasses

Active Ingredient:

Zinc Oxide 20%

Other Information:

Protect this product from excessive heat and direct sun.

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 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 the 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 • 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-sleeved shirts, pants, hats, and sunglasses

Active Ingredient:

Zinc Oxide 20%

Other Information:

Protect this product from excessive heat and direct sun.

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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