drug facts

drug facts
SPL v1
SPL
SPL Set ID 81c83ce9-3c21-47af-9392-24fd537cb7ca
Route
topical
Published
Effective Date 2022-02-26
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients
zinc oxide (18 g)
Inactive Ingredients
aloe vera leaf synthetic beeswax canola oil helianthus annuus seed wax olea europaea fruit volatile oil tocopherol

Identifiers & Packaging

Marketing Status
otc monograph final active Since 2022-02-26

Description

Zinc Oxide 18%


Medication Information

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 docor if rash occurs

Keep out of reach of children. If swalled, get medical help or contact a Poison Control Center right away.

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

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

• 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 10 a.m. – 2 p.m.

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

• children under 6 months: Ask a doctor

Other Information

• protect the product in this container from excessive

heat and direct sun

Inactive Ingredients

Aloe Barbadensis (Aloe Vera) Leaf Extract, Beeswax, Canola Oil, Helianthus Annuus (Sunflower) Seed Oil, Olea Europaea (Olive) Fruit Oil, Tocopherol

Description

Zinc Oxide 18%

Principal Display Panel

Active Ingredients

Zinc Oxide 18%


Structured Label Content

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 docor if rash occurs

Keep out of reach of children. If swalled, get medical help or contact a Poison Control Center right away.

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

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

• 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 10 a.m. – 2 p.m.

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

• children under 6 months: Ask a doctor

Other Information

• protect the product in this container from excessive

heat and direct sun

Inactive Ingredients (Inactive ingredients)

Aloe Barbadensis (Aloe Vera) Leaf Extract, Beeswax, Canola Oil, Helianthus Annuus (Sunflower) Seed Oil, Olea Europaea (Olive) Fruit Oil, Tocopherol

Principal Display Panel

Active Ingredients

Zinc Oxide 18%


Advanced Ingredient Data


Raw Label Data

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