Otc - Active Ingredient
Active Ingredients:
Titanium DIoxide 23.9%
Zinc Oxide 24.1 %
Purpose: Sunscreen
Spf 50 Mineral Powder Sunscreen Powder
FDA Label NDC 83369-001
Full FDA labeling including Indications, Dosage, Usage, and Precautions
Structured Product Label
The following Structured Product Label (SPL) was submitted to the FDA by Smalls Brand Llc Dba Roe Wellness for the product Spf 50 Mineral Powder Sunscreen (NDC 83369-001). 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 otc - active ingredient, otc - purpose, otc - keep out of reach of children, indications & usage, warnings, dosage & administration, inactive ingredient, package label.principal display panel, and other regulatory disclosures. Use the navigation below to review specific sections of the FDA submission.
Label Section Quick Index
Otc - Purpose
Uses:
- Helps prevent sunburn
Otc - Keep Out Of Reach Of Children
Keep out of reach of children. If product is swallowed, get medical help or contact a Poison Control Center right away.
Indications & Usage
Stop use and ask a doctor if rash occurs
Warnings
Warning:
- For external use only. Do not use on broken or damaged skin
- When using this product keep out of eyes. Rinse with water to remove.
Dosage & Administration
Directions:
- Apply liberally 15 minutes before sun or water exposure. Works best on moisturized skin. Reapply:
- After 80 minutes of swimming or sweating
- Immediately after towel drying
- At least every 2 hours
- Children under 6 months: Ask a doctor
Inactive Ingredient
Inactive ingredients: Silca, Mica, Polymethyl Methacrylate, Ascorbic Acid (Vitamin C), Ceramide EOP, Sodium Hyaluronate (Hyaluronic Acid), Tocopherol (Vitamin E), Camellia Sinensis Leaf Extract, CI 77492, CI 77491
Package Label.Principal Display Panel
roe wellness
spf 50 mineral powder
borad spectrum
0.21 oz 6g
* Please review the disclaimer below.
