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

Description

Zinc Oxide 25%

Purpose

Sunscreen


Medication Information

Purpose

Sunscreen

Description

Zinc Oxide 25%

Uses

Helps prevent sunburn

Section 51945-4

Stop Use

Stop use and ask a doctor if rash occurs.

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.

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

Do Not Use

Do not use on damaged or broken skin.

Keep Out Of

Keep out of reach of children.

Other Information

Protect this product from excessive heat and direct sun.

Active Ingredients

Zinc Oxide 25%

Inactive Ingredients

Sericite, Mica, and Silica.

When Using This Product

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


Structured Label Content

Uses

Helps prevent sunburn

Section 51945-4 (51945-4)

Purpose

Sunscreen

Stop Use (Stop use)

Stop use and ask a doctor if rash occurs.

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.

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

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.

Other Information (Other information)

Protect this product from excessive heat and direct sun.

Active Ingredients (Active ingredients)

Zinc Oxide 25%

Inactive Ingredients (Inactive ingredients)

Sericite, Mica, and Silica.

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)