Baby Donna Sheer Spf Sunscreen Stick
FDA Label NDC 83265-001

Full FDA labeling including Indications, Dosage, Usage, and Precautions

Structured Product Label

The following Structured Product Label (SPL) was submitted to the FDA by Babydonna Llc for the product Baby Donna Sheer Spf Sunscreen Stick (NDC 83265-001). This document serves as the official prescribing information, containing essential scientific data and clinical materials required for healthcare providers and patients.

This specific version of the label includes detailed information regarding active ingredient, purpose, uses, warnings, directions, other information, questions?, inactive ingredients, and other regulatory disclosures. Use the navigation below to review specific sections of the FDA submission.

Label Section Quick Index

Active Ingredient

Zinc Oxide 19%

Purpose

Sunscreen

Uses

  • Helps prevent sunburn. 
  • If used as directed with other other sun protection measures ( seedirections), decreases the risk of skin cancer and early skin aging caused by the sun.

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.

Other Information

  • Protect this product from excessive heat and direct sun

Inactive Ingredients

Caprylic Capric Triglycerides, Coconut Alkanes (and) Coco-Caprylate/Caprate Polyhydroxystearic Acid, 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)

Product Label

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