83447-011

83447-011
SPL v1
SPL
SPL Set ID 2de9173b-fa02-8017-e063-6394a90ae0aa
Route
CUTANEOUS
Published
Effective Date 2025-02-12
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients
Zinc Oxide (25 g)
Inactive Ingredients
Aqua Olea Europaea (olive) Fruit Oil Tallow Butyrospermum Parkii (shea) Butter Lecithin, Soybean Cyproheptadine Silica Tocopherol Leuconostoc/radish Root Ferment Filtrate

Identifiers & Packaging

Marketing Status
OTC MONOGRAPH DRUG Active Since 2025-02-12

Description

Zinc Oxide 25%

Purpose

Sunscreen


Medication Information

Purpose

Sunscreen

Description

Zinc Oxide 25%

Uses

■ 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

Section 51945-4

Stop Use

Stop use and ask a doctor if rash occurs.

Warnings

For external use only.

Directions

1.shake well before use

2.apply liberally 15 minutes before sun exposure

3.reapply:●after 80 minutes of swimming or sweating ●immediately after towel drying●at least every 2 hours

4.children after 6 months of age: ask a doctor

5.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 of 15 or higher and other sun protection

measures including:

●limit time in the sun, especially from 10am-2pm

●wear long-sleeve shirts, pants, hats, and sunglasses

Do Not Use

Do not use on damaged or broken skin.

Keep Out Of

Keep out of reach of children . If product is swallowed . get medical help or contact a Poison Control Center right away.

Other Information

Protect the product in this container from excessive heat and direct sun.

Active Ingredients

Zinc Oxide 25%

Inactive Ingredients

Aqua (Water), Tllow, Olea Europaea (Olive) Oil, Butyrospermum Parki Butter (Shea Butter), Lecithin,

Cera Alba (Beeswax), Silica, Tocopherol (Vitamin E), Leuconostoc/Radish Root Ferment Filtrate

When Using This Product

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


Structured Label Content

Uses

■ 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

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.

Directions

1.shake well before use

2.apply liberally 15 minutes before sun exposure

3.reapply:●after 80 minutes of swimming or sweating ●immediately after towel drying●at least every 2 hours

4.children after 6 months of age: ask a doctor

5.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 of 15 or higher and other sun protection

measures including:

●limit time in the sun, especially from 10am-2pm

●wear long-sleeve shirts, pants, hats, and sunglasses

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

Other Information (Other information)

Protect the product in this container from excessive heat and direct sun.

Active Ingredients (Active ingredients)

Zinc Oxide 25%

Inactive Ingredients (Inactive ingredients)

Aqua (Water), Tllow, Olea Europaea (Olive) Oil, Butyrospermum Parki Butter (Shea Butter), Lecithin,

Cera Alba (Beeswax), Silica, Tocopherol (Vitamin E), Leuconostoc/Radish Root Ferment Filtrate

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

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