49fcf429-332f-43b3-aab0-d2a5b95f4571

SPL v2
SPL
SPL Set ID 49fcf429-332f-43b3-aab0-d2a5b95f4571
Route
topical
Published
Effective Date 2025-04-03
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients
zinc cation (10 g)
Inactive Ingredients
water tallow simmondsia chinensis (jojoba) seed oil jojoba oil, randomized propolis wax yellow wax tocopherol sunflower seed rice bran salix alba bark xanthan gum glycerin gluconolactone sodium benzoate potassium sorbate

Identifiers & Packaging

Marketing Status
otc monograph drug active Since 2025-03-20

Description

Zinc Oxide 10%                                         sunscreen


Medication Information

Warnings
  • For external use only
  • Do not useon broken or damaged skin. 
  • When using this product keep out of eyes. Rinse with water to remove. 
  • Stop use and ask a doctor ifrash occurs.
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 generously and evenly 15 minutes before sun exposure
  • reapply at least every 2 hours 
  • use a water resistant sunscreen if swimming or sweating
  • children under 6 months of age: 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 10 a.m. - 2 p.m. 
  • wear long-sleeved shirts, pants, hats, and sunglasses.
Other Information
  • protect the product in this container from excessive heat and direct sun
  • Do not use if the seal is broken
Inactive Ingredients

Aqua (Water), Tallow, Simmondsia Chinensis (Jojoba) Oil Jojoba Esters, Organic Propolis, Organic Cera Alba (Beeswax), Tocopherol (Vitamin E), Helianthus Annuus (Sunflower) Extract, Oryza Sativa (Rice) Bran Extract, Salix Alba (Willow Bark) Extract, Xanthan Gum, Glycerin, Gluconolactone & Sodium Benzoate (Geogard Ultra), Potassium Sorbate.

Description

Zinc Oxide 10%                                         sunscreen

Questions?

Product Label

Active Ingredient       

Zinc Oxide 10%                                         sunscreen


Structured Label Content

Warnings
  • For external use only
  • Do not useon broken or damaged skin. 
  • When using this product keep out of eyes. Rinse with water to remove. 
  • Stop use and ask a doctor ifrash occurs.
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 generously and evenly 15 minutes before sun exposure
  • reapply at least every 2 hours 
  • use a water resistant sunscreen if swimming or sweating
  • children under 6 months of age: 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 10 a.m. - 2 p.m. 
  • wear long-sleeved shirts, pants, hats, and sunglasses.
Other Information
  • protect the product in this container from excessive heat and direct sun
  • Do not use if the seal is broken
Inactive Ingredients

Aqua (Water), Tallow, Simmondsia Chinensis (Jojoba) Oil Jojoba Esters, Organic Propolis, Organic Cera Alba (Beeswax), Tocopherol (Vitamin E), Helianthus Annuus (Sunflower) Extract, Oryza Sativa (Rice) Bran Extract, Salix Alba (Willow Bark) Extract, Xanthan Gum, Glycerin, Gluconolactone & Sodium Benzoate (Geogard Ultra), Potassium Sorbate.

Questions?

Product Label (Product label)

Active Ingredient       

Zinc Oxide 10%                                         sunscreen


Advanced Ingredient Data


Raw Label Data

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