Drug Facts

Drug Facts
SPL v1
SPL
SPL Set ID 00bf7331-c9dc-4a8a-9ff3-901e0d07eac6
Route
TOPICAL
Published
Effective Date 2025-01-15
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients
Zinc Cation (23 g)
Inactive Ingredients
Isododecane Cyclopentasiloxane Hexyl Laurate Cyclohexasiloxane Polysilicone-15 Polymethylsilsesquioxane Mica Bisabolol Water Triethoxycaprylylsilane Peg/ppg-20/15 Dimethicone Niacinamide Tetrahexyldecyl Ascorbate Glycerin Polyglyceryl-3 Diisostearate Phenoxyethanol Salicylic Acid Saccharide Isomerate Titanium Dioxide Iron Oxides

Identifiers & Packaging

Marketing Status
OTC MONOGRAPH DRUG Active Since 2025-01-15

Description

Zinc Oxide 23%

Purpose

Sunscreen


Medication Information

Purpose

Sunscreen

Description

Zinc Oxide 23%

Uses

• helps prevent 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

Warnings

For external use only

Do not use on damaged or broken skin

When using this product keep out of eyes. Rinse with water to remove.

Stop use and ask a docor if rash occurs

Keep out of reach of children. If swalled, get medical help or contact a Poison Control Center right away.

Packaging

Keep out of reach of children

Directions

• apply generously 15 minutes before sun exposure

• reapply at least every 2 hours

• use a water-resistant sunscreen if swimming or sweating

• 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

• children under 6 months of age: Ask a doctor

Other Information

• protect the product in this container from excessive

heat and direct sun

Active Ingredients

Zinc Oxide 23%

Inactive Ingredients

Isododecane, Cyclopentasiloxane, Hexyl Laurate, Cyclohexasiloxane, Polysilicone-11, Polymethylsilsesquioxane, Mica, Bisabolol, Water, Triethoxycaprylylsilane, PEG/PPG-20/15 Dimethicone, Niacinamide, Tetrahexyldecyl Ascorbate, Maris Aqua/Sea Water/Eau de Mer, Glycerin, Polyglyceryl-3 Diisostearate, Phenoxyethanol, Saccharide Isomerate, Salicylic Acid, Titanium Dioxide, Iron Oxides


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 skin aging caused by the sun

Purpose

Sunscreen

Warnings

For external use only

Do not use on damaged or broken skin

When using this product keep out of eyes. Rinse with water to remove.

Stop use and ask a docor if rash occurs

Keep out of reach of children. If swalled, get medical help or contact a Poison Control Center right away.

Packaging

Keep out of reach of children

Directions

• apply generously 15 minutes before sun exposure

• reapply at least every 2 hours

• use a water-resistant sunscreen if swimming or sweating

• 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

• children under 6 months of age: Ask a doctor

Other Information

• protect the product in this container from excessive

heat and direct sun

Active Ingredients

Zinc Oxide 23%

Inactive Ingredients (Inactive ingredients)

Isododecane, Cyclopentasiloxane, Hexyl Laurate, Cyclohexasiloxane, Polysilicone-11, Polymethylsilsesquioxane, Mica, Bisabolol, Water, Triethoxycaprylylsilane, PEG/PPG-20/15 Dimethicone, Niacinamide, Tetrahexyldecyl Ascorbate, Maris Aqua/Sea Water/Eau de Mer, Glycerin, Polyglyceryl-3 Diisostearate, Phenoxyethanol, Saccharide Isomerate, Salicylic Acid, Titanium Dioxide, Iron Oxides


Advanced Ingredient Data


Raw Label Data

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