75779-008

75779-008
SPL v1
SPL
SPL Set ID 2deea723-32a0-da33-e063-6294a90accdd
Route
TOPICAL
Published
Effective Date 2025-02-12
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients
Zinc Oxide (24.05 g)
Inactive Ingredients
Butylene Glycol Propylene Carbonate Stearyl Glycyrrhetinate Vinyl Dimethicone/methicone Silsesquioxane Crosspolymer Dimethicone Hydroxyacetophenone Centella Asiatica Root Polyglyceryl-4 Isostearate Isododecane Polyglyceryl-6 Polyricinoleate Pentylene Glycol Tocopherol Magnesium Sulfate Disteardimonium Hectorite Triethoxycaprylylsilane Glycerin Triethylhexanoin Aqua Diisopropyl Sebacate

Identifiers & Packaging

Marketing Status
OTC MONOGRAPH DRUG Active Since 2025-02-12

Description

Zinc Oxide 24.05%

Purpose

Sunscreen


Medication Information

Purpose

Sunscreen

Description

Zinc Oxide 24.05%

Use

Helps prevent sunburn

If used as directed with other sun protection measures(see Directions),decreases the risk of the skin cancer and early skin aging caused by the sun.

Stop Use

Stop use and ask a doctor if rashes occur

Warnings

For external use only

Questions

Contact Information:

[email protected]

Ask Doctor

Stop use and ask a doctor if rashes occur

For children under 6 months: Ask adoctor.

Directions

Adults, adolescents and children over 6 months of age. For children under 6 months: Ask a doctor.

Apply liberally 15 minutes before sun exposure

Reapply at least every 2 hours

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 of 15 or higher and other sun protection measures including:limit time in the sun,especially from 10a.m-2p.m; and wear long-sleeved shirts, pants, hats, and sunglasses.

Use a water resistant sunscreen if swimming or sweating

Do Not Use

Do not use on damaged or broken skin

Avoid prolonged sun exposure

When Using

When using this product keep out of eyes.

Rinse with water to remove.

Active Ingredient

Zinc Oxide 24.05%

Other Information

Protect this product from excess heat and direct sun.

Inactive Ingredients

Aqua,Dimethicone,Isododecane,Butylene Glycol,Diisopropyl Sebacate,Triethylhexanoin,Glycerin,Polyglyceryl-4 Isostearate,Polyglyceryl-6 Pentaoleate,Pentylene Glycol,Vinyl Dimethicone/Methicone Silsesquioxane Crosspolymer,Triethoxycaprylylsilane,Magnesium Sulfate,Disteardimonium Hectorite,Hydroxyacetophenone,Propylene Carbonate,Stearyl Glycyrrhetinate,Centella Asiatica Extract,Tocopherol

Principal Display Panel

Keep Oot of Reach of Children

Keep out of reach of children

If product is swallowed, get medical help or contact a Poison Control Center right away.


Structured Label Content

Use

Helps prevent sunburn

If used as directed with other sun protection measures(see Directions),decreases the risk of the skin cancer and early skin aging caused by the sun.

Purpose

Sunscreen

Stop Use

Stop use and ask a doctor if rashes occur

Warnings

For external use only

Questions

Contact Information:

[email protected]

Ask Doctor

Stop use and ask a doctor if rashes occur

For children under 6 months: Ask adoctor.

Directions

Adults, adolescents and children over 6 months of age. For children under 6 months: Ask a doctor.

Apply liberally 15 minutes before sun exposure

Reapply at least every 2 hours

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 of 15 or higher and other sun protection measures including:limit time in the sun,especially from 10a.m-2p.m; and wear long-sleeved shirts, pants, hats, and sunglasses.

Use a water resistant sunscreen if swimming or sweating

Do Not Use (Do not use)

Do not use on damaged or broken skin

Avoid prolonged sun exposure

When Using

When using this product keep out of eyes.

Rinse with water to remove.

Active Ingredient

Zinc Oxide 24.05%

Other Information (Other information)

Protect this product from excess heat and direct sun.

Inactive Ingredients (Inactive ingredients)

Aqua,Dimethicone,Isododecane,Butylene Glycol,Diisopropyl Sebacate,Triethylhexanoin,Glycerin,Polyglyceryl-4 Isostearate,Polyglyceryl-6 Pentaoleate,Pentylene Glycol,Vinyl Dimethicone/Methicone Silsesquioxane Crosspolymer,Triethoxycaprylylsilane,Magnesium Sulfate,Disteardimonium Hectorite,Hydroxyacetophenone,Propylene Carbonate,Stearyl Glycyrrhetinate,Centella Asiatica Extract,Tocopherol

Principal Display Panel (PRINCIPAL DISPLAY PANEL)

Keep Oot of Reach of Children (Keep Oot Of Reach Of Children)

Keep out of reach of children

If product is swallowed, get medical help or contact a Poison Control Center right away.


Advanced Ingredient Data


Raw Label Data

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