35372859-8f40-5eb0-e063-6294a90a6a00

SPL v4
SPL
SPL Set ID 35372859-8f40-5eb0-e063-6294a90a6a00
Route
topical
Published
Effective Date 2025-06-03
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients
zinc cation (0.2 g)
Inactive Ingredients
beeswax silica sorbitan olivate prunus amygdalus dulcis (sweet almond) oil hydrolyzed jojoba esters mica tocopherol squalene prickly pear fruit candelilla wax polyhydroxystearic acid (2300 mw)

Identifiers & Packaging

Marketing Status
otc monograph drug active Since 2025-04-30

Description

On damaged or broken skin.


Medication Information

Warnings and Precautions

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

Indications and Usage

Uses:

Helps prevent sunburn

Dosage and Administration

Directions:

- Apply liberally 15 minutes before sun exposure.

- Reapply:

• After 80 minutes of swimming or sweating

• Immediately after towel drying

• At least every 2 hours

- For children under 6 months of age: ask a doctor

Description

On damaged or broken skin.

Section 50565-1

Keep out of reach of children.

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

Section 50566-9



if rash occurs.

Section 51727-6

Inactive Ingredients:

Candelilla Wax, Cera Alba (Beeswax), Extracts of Laminaria Saccharina (Sugar Kelp) in Coconut Oil and Opuntia Ficus-Indica (Prickly Pear Cactus) Seed, Jojoba Esters, Mica, Mixed Tocopherols (Vitamin E), Polyhydroxystearic Acid, Prunus Amygdalus Dulcis (Sweet Almond) Oil, Silica, Sorbitan Olivate, Squalane (Plant-Based)

*CERTIFIED ORGANIC INGREDIENTS

Section 51945-4

Section 55105-1

Purpose:

Sunscreen

Do Not Use

On damaged or broken skin.

Other Info

Protect product from excessive heat and sun.


Structured Label Content

Warnings and Precautions (34071-1)

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

Indications and Usage (34067-9)

Uses:

Helps prevent sunburn

Dosage and Administration (34068-7)

Directions:

- Apply liberally 15 minutes before sun exposure.

- Reapply:

• After 80 minutes of swimming or sweating

• Immediately after towel drying

• At least every 2 hours

- For children under 6 months of age: ask a doctor

Section 50565-1 (50565-1)

Keep out of reach of children.

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

Section 50566-9 (50566-9)



if rash occurs.

Section 51727-6 (51727-6)

Inactive Ingredients:

Candelilla Wax, Cera Alba (Beeswax), Extracts of Laminaria Saccharina (Sugar Kelp) in Coconut Oil and Opuntia Ficus-Indica (Prickly Pear Cactus) Seed, Jojoba Esters, Mica, Mixed Tocopherols (Vitamin E), Polyhydroxystearic Acid, Prunus Amygdalus Dulcis (Sweet Almond) Oil, Silica, Sorbitan Olivate, Squalane (Plant-Based)

*CERTIFIED ORGANIC INGREDIENTS

Section 51945-4 (51945-4)

Section 55105-1 (55105-1)

Purpose:

Sunscreen

Do Not Use (Do not Use)

On damaged or broken skin.

Other Info

Protect product from excessive heat and sun.


Advanced Ingredient Data


Raw Label Data

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