Active Ingredients
Zinc Oxide 25%
Sunscreen Powder
FDA Label NDC 83447-001
Full FDA labeling including Indications, Dosage, Usage, and Precautions
Structured Product Label
The following Structured Product Label (SPL) was submitted to the FDA by Guangzhou Fantesy Biotechnology Co.,ltd for the product Sunscreen Powder (NDC 83447-001). 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 ingredients, purpose, uses, warnings, do not use, when using this product, stop use, keep out of, and other regulatory disclosures. Use the navigation below to review specific sections of the FDA submission.
Label Section Quick Index
Purpose
Sunscreen
Uses
Helps prevent sunburn
Warnings
For external use only.
Do not use on damaged or broken skin.
Stop use and ask a doctor if rash occurs.
When using this product, keep out of eyes. Rinse with water to remove.
Keep out of reach of children.
If swallowed, get medical help or contact a Poison Control Center immediately.
Do Not Use
Do not use on damaged or broken skin.
When Using This Product
When using this product, keep out of eyes. Rinse with water to remove.
Stop Use
Stop use and ask a doctor if rash occurs.
Keep Out Of
Keep out of reach of children.
Directions
Apply liberally to face at least 15 minutes before sun exposure.
Use a water resistant sunscreen if swimming or sweating.
Reapply at least every 2 hours.
Children under 6 months of age: Ask a doctor
Other Information
Protect this product from excessive heat and direct sun.
Inactive Ingredients
Sericite, Mica, and Silica.
Package Label.Principal Display Panel
83447-001-01 (83447 001 01)
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