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
Purpose

Sunscreen

Description

Zinc Oxide 15% (w/w)

Medication Information

Warnings

For external use only.

Purpose

Sunscreen

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

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

Description

Zinc Oxide 15% (w/w)

Principal Display Panel

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

Ask Doctor

· rash occurs

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)

Keep Out of Reach of Children

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

Structured Label Content

Warnings

For external use only.

Purpose

Sunscreen

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

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)

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

Ask Doctor

· rash occurs

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)

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