SPL v3
SPL
SPL Set ID cc722ce1-0ded-19d5-e053-2995a90a7d03
Route
TOPICAL
Published
Effective Date 2021-09-20
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients
Zinc Oxide (15 g)
Inactive Ingredients
Sunflower Oil Sorbitan Olivate Cannabis Sativa Seed Oil Olive Oil Pumpkin Seed Oil Yellow Wax Lavender Oil Avocado Oil Mauritia Flexuosa Fruit Oil Tocopherol

Identifiers & Packaging

Marketing Status
OTC MONOGRAPH DRUG Active Since 2021-09-20

Description

Zinc Oxide 15%

Purpose

Sunscreen


Medication Information

Purpose

Sunscreen

Description

Zinc Oxide 15%

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.

Label

Warnings

For external use only.

Do not use on damaged or broken skin. When using this product keep out of eyes. Rinse eyes with water to remove.

Stop use and ask a doctor if rash occurs.

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
  • use a water resistant sunscreen if swimming or sweating

Sun protection measures: spending time in the sun increases your risk of skin cancer and early skin aging. To decrease risk, regularly use a sunscreen with broad spectrum SPF value of 15 or higher and other sun protection measure including:

  • limit time in the sun, especially from 10 am to 2 pm
  • wear long-sleeved shirts, pants, hats, and sunglasses.
  • Children under 6 months: ask a doctor.

Active Ingredients

Zinc Oxide 15%

Inactive Ingredients

Helianthus Annuus (Sunflower) Seed Oil*, Sorbitan Olivate, Cannabis Sativa Seed Oil*, Olea Europaea (Olive) Fruit Oil*, Cucurbita Pepo (Pumpkin) Seed Oil*, Beeswax*, Lavandula Angustifolia (Lavender) Oil, Persea Gratissima (Avocado) Oil*, Mauritia Flexuosa Fruit Oil, Tocopherol. *Organic

Keep Out of Reach of Children.

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


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.

Label

Purpose

Sunscreen

Warnings

For external use only.

Do not use on damaged or broken skin. When using this product keep out of eyes. Rinse eyes with water to remove.

Stop use and ask a doctor if rash occurs.

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
  • use a water resistant sunscreen if swimming or sweating

Sun protection measures: spending time in the sun increases your risk of skin cancer and early skin aging. To decrease risk, regularly use a sunscreen with broad spectrum SPF value of 15 or higher and other sun protection measure including:

  • limit time in the sun, especially from 10 am to 2 pm
  • wear long-sleeved shirts, pants, hats, and sunglasses.
  • Children under 6 months: ask a doctor.

Active Ingredients

Zinc Oxide 15%

Inactive Ingredients

Helianthus Annuus (Sunflower) Seed Oil*, Sorbitan Olivate, Cannabis Sativa Seed Oil*, Olea Europaea (Olive) Fruit Oil*, Cucurbita Pepo (Pumpkin) Seed Oil*, Beeswax*, Lavandula Angustifolia (Lavender) Oil, Persea Gratissima (Avocado) Oil*, Mauritia Flexuosa Fruit Oil, Tocopherol. *Organic

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

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