85817-002

85817-002
SPL v1
SPL
SPL Set ID 37ead2b1-12d4-af92-e063-6394a90af0d6
Route
TOPICAL
Published
Effective Date 2025-06-19
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients
Zinc Oxide (15 g)
Inactive Ingredients
Raspberry Coconut Oil Tallow Jojoba Oil Beeswax Shea Butter Carrot Seed Oil

Identifiers & Packaging

Marketing Status
OTC MONOGRAPH DRUG Active Since 2025-06-19
Description

Zinc Oxide 15% (w/w)

Purpose

Sunscreen

Medication Information

Purpose

Sunscreen

Description

Zinc Oxide 15% (w/w)

Use

· 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

Stop Use

· rash occurs

Warnings

For external use only.

Ask Doctor

· rash occurs

Directions

·Apply liberally 15 minutes before sun exposure

·Reapply:

1.After 80 minutes of swimming or sweating

2.Immediately after towel drying

3.At least every 2 hours

Do Not Use

· on damaged or broken skin

When Using

· keep out of eyes. Rinse with water to remove.

Active Ingredient

Zinc Oxide 15% (w/w)

Other Information

· Protect this product from excessive heat and direct sun

· May stain some fabrics

Inactive Ingredients

Tallow, Beeswax, Red Raspberry Seed Oil, Carrot Seed Oil, Coconut Oil, Jojoba Oil, Shea Butter

Principal Display Panel

Keep Out of Reach of Children

If 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 skin cancer and early skin aging caused by the sun

Purpose

Sunscreen

Stop Use

· rash occurs

Warnings

For external use only.

Ask Doctor

· rash occurs

Directions

·Apply liberally 15 minutes before sun exposure

·Reapply:

1.After 80 minutes of swimming or sweating

2.Immediately after towel drying

3.At least every 2 hours

Do Not Use (Do not use)

· on damaged or broken skin

When Using

· keep out of eyes. Rinse with water to remove.

Active Ingredient

Zinc Oxide 15% (w/w)

Other Information (Other information)

· Protect this product from excessive heat and direct sun

· May stain some fabrics

Inactive Ingredients (Inactive ingredients)

Tallow, Beeswax, Red Raspberry Seed Oil, Carrot Seed Oil, Coconut Oil, Jojoba Oil, Shea Butter

Principal Display Panel (PRINCIPAL DISPLAY PANEL)

Keep Out of Reach of Children (Keep Out Of Reach Of Children)

If swallowed, get medical help or contact a poison control center right away.

Advanced Ingredient Data

Raw Label Data

All Sections (JSON)

Additional Information

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Source: dailymed · Ingested: 2026-02-15T12:06:20.918186 · Updated: 2026-03-14T23:09:05.302478