29928ab0-4467-57cb-e063-6394a90ac4d3

SPL v3
SPL
SPL Set ID 29928ab0-4467-57cb-e063-6394a90ac4d3
Route
topical
Published
Effective Date 2024-06-01
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients
zinc oxide (3.502 g)
Inactive Ingredients
olea europaea (olive) fruit oil copernicia cerifera (carnauba) wax euphorbia cerifera (candelilla) wax oryzanol helianthus annuus (sunflower) seed oil theobroma cacao (cocoa) seed butter butyloctyl salicylate bisabolol butyrospermum parkii (shea) butter cocos nucifera (coconut) oil tocopherol

Identifiers & Packaging

Marketing Status
otc monograph drug active Since 2024-06-01

Description

ACTIVE INGREDIENTS: Zinc Oxide – 20.6%


Medication Information

Warnings and Precautions

Warnings

• For external use only. Do not use

• On damaged or broken skin. When using this product

• Keep out of eyes.

• Rinse with water to remove.

Stop use and ask a doctor

if a rash occurs.

Keep out of reach of children

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

Active Ingredient

ACTIVE INGREDIENTS: Zinc Oxide – 20.6%

Indications and Usage

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.

Sun Protection Measures:

Spending time in the sun increases your risk of skin cancer and early skin aging. To decrease this risk, regularly use a sunscreen with a Broad Spectrum SPF value of 15 or higher and other sun protection measures including:

Limit time in the sun especially from 10 a.m.

2 p.m.

Wearlong-sleved shirts, pants, hats, and sunglasses.

• For external use only.

Do not use

• On damaged or broken skin.

When using this product

Keep out of eyes.

Rinse with water to remove.

Dosage and Administration





Apply liberally 15 minutes before sun exposure.



Reapply:

• After 80 minutes of swimming or sweating.

• Immediately after towel drying.

• At least every 2 hours.

• Children under 6 months: Ask a doctor.

Description

ACTIVE INGREDIENTS: Zinc Oxide – 20.6%

Section 50565-1

Keep Out of Reach of Children

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

Section 51727-6

Inactive Ingredients:

Bisabolol*

Butyloctyl Salicylate

Butyrospermum Parkii (Shea) Butter*

Cocos Nucifera (Coconut) Oil*

Copernicia Cerifera (Carnauba) Wax

Euphorbia Cerifera (Candelilla) Wax

Helianthus Annuus (Sunflower) Seed Oil

Olea Europaea (Olive) Fruit Oil

Oryzanol

Theobroma Cacao (Cocoa) Seed Butter

Tocopherol

*Certified Organic Ingredients

Section 55105-1

Zinc Oxide - 20.6% Sunscreen

Sr Active Face Stick

Package Label


Structured Label Content

Warnings and Precautions (34071-1)

Warnings

• For external use only. Do not use

• On damaged or broken skin. When using this product

• Keep out of eyes.

• Rinse with water to remove.

Stop use and ask a doctor

if a rash occurs.

Keep out of reach of children

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

Active Ingredient (55106-9)

ACTIVE INGREDIENTS: Zinc Oxide – 20.6%

Indications and Usage (34067-9)

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.

Sun Protection Measures:

Spending time in the sun increases your risk of skin cancer and early skin aging. To decrease this risk, regularly use a sunscreen with a Broad Spectrum SPF value of 15 or higher and other sun protection measures including:

Limit time in the sun especially from 10 a.m.

2 p.m.

Wearlong-sleved shirts, pants, hats, and sunglasses.

• For external use only.

Do not use

• On damaged or broken skin.

When using this product

Keep out of eyes.

Rinse with water to remove.

Dosage and Administration (34068-7)





Apply liberally 15 minutes before sun exposure.



Reapply:

• After 80 minutes of swimming or sweating.

• Immediately after towel drying.

• At least every 2 hours.

• Children under 6 months: Ask a doctor.

Section 50565-1 (50565-1)

Keep Out of Reach of Children

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

Section 51727-6 (51727-6)

Inactive Ingredients:

Bisabolol*

Butyloctyl Salicylate

Butyrospermum Parkii (Shea) Butter*

Cocos Nucifera (Coconut) Oil*

Copernicia Cerifera (Carnauba) Wax

Euphorbia Cerifera (Candelilla) Wax

Helianthus Annuus (Sunflower) Seed Oil

Olea Europaea (Olive) Fruit Oil

Oryzanol

Theobroma Cacao (Cocoa) Seed Butter

Tocopherol

*Certified Organic Ingredients

Section 55105-1 (55105-1)

Zinc Oxide - 20.6% Sunscreen

Sr Active Face Stick (SR Active Face Stick)

Package Label


Advanced Ingredient Data


Raw Label Data

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