Otc - Active Ingredient
Active Ingredients:
Zinc Oxide (18%)
Fresh Skin Organics
FDA Label NDC 58418-425
Full FDA labeling including Indications, Dosage, Usage, and Precautions
Structured Product Label
The following Structured Product Label (SPL) was submitted to the FDA by Tropical Enterprises International, Inc. for the product Fresh Skin Organics (NDC 58418-425). 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 otc - active ingredient, otc - purpose, indications & usage, warnings, otc - when using, otc - stop use, otc - keep out of reach of children, otc - questions, and other regulatory disclosures. Use the navigation below to review specific sections of the FDA submission.
Label Section Quick Index
Otc - Purpose
Purpose: Sunscreen
Indications & Usage
Uses: Our SPF formulas provide both UVA and UVB
protection, and are infused with antioxidants and nutrients to help
prevent sun damage while keepingthe skin well-hydrated.
Warnings
WARNINGS:
For external use only.
Do not use on damaged or broken skin.
Otc - When Using
When using this product avoid contact with eyes.
If contact with eyes occurs, flush with water to remove.
Otc - Stop Use
Stop use and ask a doctor if irritation or rash develops
and persists.
Otc - Keep Out Of Reach Of Children
Keep out of reach of children. If product is swallowed,
seek immediate medical attention or contact a Poison Control Center
right away.
For use on children under 6 months: consult a physician.
Otc - Questions
Questions? Call 1-800-535-5053
* Please review the disclaimer below.
