SPL v2
SPL
SPL Set ID 2d57790c-22cf-08aa-e063-6394a90aeac0
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 Caprylhydroxamic Acid Caprylyl Glycol Ceramide 3 Cetyl Peg/ppg-10/1 Dimethicone (hlb 4) Edetate Disodium Anhydrous C12-15 Alkyl Benzoate Hydrogen Dimethicone (20 Cst) Isohexadecane Peg-10 Dimethicone (600 Cst) Polyhydroxystearic Acid (2300 Mw) Alpha-tocopherol Acetate Dimethicone/vinyl Dimethicone Crosspolymer (soft Particle) Dimethiconol (2000 Cst) Polysorbate 20 Stearyl Dimethicone (400 Mpa.s At 50c) Silicon Dioxide Microcrystalline Wax Sodium Chloride Lauryl Peg/ppg-18/18 Methicone Magnesium Sulfate Sodium Hyaluronate Titanium Dioxide Triethanolamine Water Octadecene Tetrahexyldecyl Ascorbate Cyclopentasiloxane Glycerin Dimethicone Crosspolymer Dimethicone Triethoxycaprylylsilane Ci 77491 Cyclohexasiloxane Isododecane Ci 77492

Identifiers & Packaging

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

Description

Zinc Oxide 15%

Purpose

Sunscreen


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 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. 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

Other Information:

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

Active Inhgredients:

Zinc Oxide 15%

Inactive Ingredients:

C12-15 Alkyl Benzoate, Caprylhydroxamic Acid, Caprylyl Glycol, Ceramide 3, Cetyl PEG/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 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. 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

Other Information:

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

Active Inhgredients:

Zinc Oxide 15%

Inactive Ingredients:

C12-15 Alkyl Benzoate, Caprylhydroxamic Acid, Caprylyl Glycol, Ceramide 3, Cetyl PEG/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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