SPL v2
SPL
SPL Set ID 2d550967-25af-3e7a-e063-6394a90a2c79
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
Cetyl Peg/ppg-10/1 Dimethicone (hlb 4) Peg-10 Dimethicone (600 Cst) Polysorbate 20 Sodium Chloride Stearyl Dimethicone (400 Mpa.s At 50c) Alpha-tocopherol Acetate Water Edetate Disodium Anhydrous Glycerin Cyclohexasiloxane Dimethiconol (2000 Cst) Hydrogen Dimethicone (20 Cst) Cyclopentasiloxane Dimethicone Ci 77491 Lauryl Peg/ppg-18/18 Methicone Microcrystalline Wax Polyhydroxystearic Acid (2300 Mw) Silicon Dioxide Triethoxycaprylylsilane Magnesium Sulfate Caprylhydroxamic Acid Isohexadecane Tetrahexyldecyl Ascorbate C12-15 Alkyl Benzoate Isododecane Octadecene Caprylyl Glycol Ceramide 3 Titanium Dioxide Dimethicone Crosspolymer Dimethicone/vinyl Dimethicone Crosspolymer (soft Particle) Sodium Hyaluronate Triethanolamine Ci 77492 Ci 77499

Identifiers & Packaging

Marketing Status
OTC MONOGRAPH DRUG Active Since 2024-10-08

Description

Zinc Oxide 1%

Purpose

Sunscreen


Medication Information

Purpose

Sunscreen

Description

Zinc Oxide 1%

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. 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 Ingredient:

Zinc Oxide 1%

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. 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 Ingredient:

Zinc Oxide 1%

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

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