SPL v2
SPL
SPL Set ID 2d44158a-44b3-5a3d-e063-6294a90a1f16
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
Caprylyl Glycol Dimethicone Crosspolymer Ci 77491 Lauryl Peg/ppg-18/18 Methicone Tetrahexyldecyl Ascorbate Glycerin Caprylhydroxamic Acid Isododecane Isohexadecane Sodium Hyaluronate Cyclopentasiloxane Dimethicone/vinyl Dimethicone Crosspolymer (soft Particle) C12-15 Alkyl Benzoate Cyclohexasiloxane Ci 77499 Ci 77492 Octadecene Polysorbate 20 Water Hydrogen Dimethicone (20 Cst) Triethoxycaprylylsilane Microcrystalline Wax Peg-10 Dimethicone (600 Cst) Silicon Dioxide Sodium Chloride Polyhydroxystearic Acid (2300 Mw) Ceramide 3 Magnesium Sulfate Triethanolamine Alpha-tocopherol Acetate Cetyl Peg/ppg-10/1 Dimethicone (hlb 4) Dimethicone Dimethiconol (2000 Cst) Edetate Disodium Anhydrous Stearyl Dimethicone (400 Mpa.s At 50c) Titanium Dioxide

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 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 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

Active Ingredient:

Zinc Oxide 15%

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 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 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

Active Ingredient:

Zinc Oxide 15%

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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