SPL v2
SPL
SPL Set ID e5820376-897f-4c77-aadc-7991137870b7
Route
TOPICAL
Published
Effective Date 2024-04-15
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients
Zinc Cation (18 g)
Inactive Ingredients
Olea Europaea (olive) Oil Unsaponifiables White Wax Jojoba Oil Cocoa Butter Shea Butter .alpha.-tocopherol Acetate

Identifiers & Packaging

Marketing Status
OTC MONOGRAPH DRUG Active Since 2023-04-10

Description

Zinc Oxide 18%

Purpose

Sunscreen


Medication Information

Purpose

Sunscreen

Description

Zinc Oxide 18%

Uses
  • helps prevent sunburn
Warnings

For external use only

Do not useon damaged or broken skin.

When using this productavoid contact with eyes. If contact occurs, rinse with water.

Stop use and ask a doctor ifrash occurs.

Keep out of reach of children. If swallowed, get medical help or contact a poison control center immediately.

Directions

Apply liberally 15 minutes before sun exposure

Reapply: after 8o minutes of swimming or sweating

  • immediately after towel drying 
  • at least every 2 hours
  • Children under 6 months, ask a doctor.

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 10am-2pm
  • wear long sleeved shirts, pants, hats and sunglasses.
Product Label

Active Ingredient

Zinc Oxide 18%

Other Information

Protect this product from excessive heat and direact sun

Inactive Ingredients

Olea Europaea (Olive) Oil, Beeswax, Simmondsia Chinensis (Jojoba) Seed Oil, Theobroma Cacoa (Cocoa) Seed Butter, Butyrospermum Parkii (Shea Butter), Flavor, Tocopheryl Acetate

Question Or Comments?

1-888-546-3797


Structured Label Content

Uses
  • helps prevent sunburn
Purpose

Sunscreen

Warnings

For external use only

Do not useon damaged or broken skin.

When using this productavoid contact with eyes. If contact occurs, rinse with water.

Stop use and ask a doctor ifrash occurs.

Keep out of reach of children. If swallowed, get medical help or contact a poison control center immediately.

Directions

Apply liberally 15 minutes before sun exposure

Reapply: after 8o minutes of swimming or sweating

  • immediately after towel drying 
  • at least every 2 hours
  • Children under 6 months, ask a doctor.

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 10am-2pm
  • wear long sleeved shirts, pants, hats and sunglasses.
Product Label (Product label)

Active Ingredient

Zinc Oxide 18%

Other Information

Protect this product from excessive heat and direact sun

Inactive Ingredients

Olea Europaea (Olive) Oil, Beeswax, Simmondsia Chinensis (Jojoba) Seed Oil, Theobroma Cacoa (Cocoa) Seed Butter, Butyrospermum Parkii (Shea Butter), Flavor, Tocopheryl Acetate

Question Or Comments? (Question or Comments?)

1-888-546-3797


Advanced Ingredient Data


Raw Label Data

All Sections (JSON)