83447-001

83447-001
SPL v3
SPL
SPL Set ID fae8ecaf-7a9c-902b-e053-6394a90a5f31
Route
cutaneous
Published
Effective Date 2023-05-05
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients
zinc oxide (25 g)
Inactive Ingredients
silicon dioxide mica pyrophyllite

Identifiers & Packaging

Marketing Status
otc monograph drug active Since 2023-05-05

Purpose

Sunscreen

Description

Zinc Oxide 25%


Medication Information

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 immediately.

Uses

Helps prevent sunburn

Purpose

Sunscreen

Directions

Apply liberally to face at least 15 minutes before sun exposure.

Use a water resistant sunscreen if swimming or sweating.

Reapply at least every 2 hours.

Children under 6 months of age: Ask a doctor

Other Information

Protect this product from excessive heat and direct sun.

Inactive Ingredients

Sericite, Mica, and Silica.

Description

Zinc Oxide 25%

Section 51945-4

Stop Use

Stop use and ask a doctor if rash occurs.

Do Not Use

Do not use on damaged or broken skin.

Keep Out Of

Keep out of reach of children.

Active Ingredients

Zinc Oxide 25%

When Using This Product

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


Structured Label Content

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 immediately.

Uses

Helps prevent sunburn

Purpose

Sunscreen

Directions

Apply liberally to face at least 15 minutes before sun exposure.

Use a water resistant sunscreen if swimming or sweating.

Reapply at least every 2 hours.

Children under 6 months of age: Ask a doctor

Other Information (Other information)

Protect this product from excessive heat and direct sun.

Inactive Ingredients (Inactive ingredients)

Sericite, Mica, and Silica.

Section 51945-4 (51945-4)

Stop Use (Stop use)

Stop use and ask a doctor if rash occurs.

Do Not Use (Do not use)

Do not use on damaged or broken skin.

Keep Out Of (Keep out of)

Keep out of reach of children.

Active Ingredients (Active ingredients)

Zinc Oxide 25%

When Using This Product (When using this product)

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


Advanced Ingredient Data


Raw Label Data

All Sections (JSON)