Drug Facts

Drug Facts
SPL v2
SPL
SPL Set ID a1b1cdeb-e5fe-4ba1-8bb0-3c7a97dd93fe
Route
TOPICAL
Published
Effective Date 2023-03-28
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients
Zinc Cation (19 g)
Inactive Ingredients
Medium-chain Triglycerides Coconut Alkanes Polyhydroxystearic Acid Stearate Cocoyl Caprylocaprate Carnauba Wax Arachidyl Alcohol Docosanol Arachidyl Glucoside Candelilla Wax Meadowfoam Seed Oil Tocopherol Cetostearyl Alcohol Hydrogenated Castor Oil Glyceryl Monocaprylate Shea Butter

Identifiers & Packaging

Marketing Status
OTC MONOGRAPH DRUG Active Since 2023-03-28

Description

Zinc Oxide 19%

Purpose

Sunscreen


Medication Information

Purpose

Sunscreen

Description

Zinc Oxide 19%

Uses
  • Helps prevent sunburn. 
  • If used as directed with other other sun protection measures (see  Directions) , decreases the risk of skin cancer and early skin aging caused by the sun.
Section 50565-1

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 doctor if rash occurs
  • Keep out of reach of child. If product is swallowed, get medical help or contact a Poison Control Center right away.
Directions
  • Apply liberally 15min before sun exposure. Reapply after 80mins of swimming or sweating immediately after towel drying and at least every 2 hrs. For 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.

Questions?
Product Label

Baby Donna Mineral Sunscreen Sheer 35 SPF- NDC 69555-044-01 -0.5 oz/16 G Stick Label

Active Ingredient

Zinc Oxide 19%

Other Information

Protect this product from excessive heat and direct sun

Inactive Ingredients

Caprylic Capric Triglycerides, Coconut Alkanes (and) Coco-Caprylate/Caprate PolyhydroxystearicAcid, Coco caprylate/caprate, Butyrospermum Parkii (Shea) Butter Copernicia Cerifera (Carnauba) Wax, Arachidyl Alcohol (and) Behenyl Alcohol (and) Arachidyl Glucoside Candelilla Wax (Euphorbia Cerifera), Cetearyl Alcohol 50, Hydrogenated Castor Oil, Glyceryl Caprylate Meadowfoam Seed Oil,Mixed Tocopherols (Vitamin E)


Structured Label Content

Uses
  • Helps prevent sunburn. 
  • If used as directed with other other sun protection measures (see  Directions) , decreases the risk of skin cancer and early skin aging caused by the sun.
Section 50565-1 (50565-1)

Purpose

Sunscreen

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 doctor if rash occurs
  • Keep out of reach of child. If product is swallowed, get medical help or contact a Poison Control Center right away.
Directions
  • Apply liberally 15min before sun exposure. Reapply after 80mins of swimming or sweating immediately after towel drying and at least every 2 hrs. For 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.

Questions?
Product Label (Product label)

Baby Donna Mineral Sunscreen Sheer 35 SPF- NDC 69555-044-01 -0.5 oz/16 G Stick Label

Active Ingredient

Zinc Oxide 19%

Other Information

Protect this product from excessive heat and direct sun

Inactive Ingredients

Caprylic Capric Triglycerides, Coconut Alkanes (and) Coco-Caprylate/Caprate PolyhydroxystearicAcid, Coco caprylate/caprate, Butyrospermum Parkii (Shea) Butter Copernicia Cerifera (Carnauba) Wax, Arachidyl Alcohol (and) Behenyl Alcohol (and) Arachidyl Glucoside Candelilla Wax (Euphorbia Cerifera), Cetearyl Alcohol 50, Hydrogenated Castor Oil, Glyceryl Caprylate Meadowfoam Seed Oil,Mixed Tocopherols (Vitamin E)


Advanced Ingredient Data


Raw Label Data

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