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Drug Facts
Mineral Sunscreen Powder
FDA Label NDC 51326-125
Full FDA labeling including Indications, Dosage, Usage, and Precautions
Structured Product Label
The following Structured Product Label (SPL) was submitted to the FDA by Topiderm, Inc. for the product Mineral Sunscreen (NDC 51326-125). 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 other, otc - purpose, uses, warnings, otc - do not use, otc - when using, otc - stop use, otc - keep out of reach of children, and other regulatory disclosures. Use the navigation below to review specific sections of the FDA submission.
Label Section Quick Index
Otc - Purpose
| Active ingredients | Purpose |
|---|---|
| Zinc Oxide 24% | Sunscreen |
| Titanium Dioxide 22.5% | Sunscreen |
Uses
- Helps prevent sunburnIf used as directed with other sun protection measures (See Directions), decreases the risk of skin cancer and early skin aging caused by the sun.
Warnings
For external use only
Otc - Do Not Use
Do not use on damaged or broken skin.
Otc - When Using
When using this product keep out of eyes.
Rinse with water to remove.
Otc - Stop Use
Stop use and ask a doctor if rash occurs.
Otc - Keep Out Of Reach Of Children
Keeo out of reach of children.
If product is swallowed, get medical help or contact a Poison Control Center immediately.
Directions
- Apply liberally 15 minutes before sun exposure
- Reapply atleast every 2 hours
- Sun Protection Measures
- Limit time in the sun, especially from 10a.m.-2p.m.
- Wear long-sleeve shirts, pants, hats, & sunglasses
- Children under 6 months of age: Ask a doctor.
Spending time in the sun increases your risk of skin can cer and early skin aging. To decrease this risk, regularly use a sunscreen with a broa spectrum SPF of 15 or higher & other sunscreen measures including:
Other Information
Protect the product in this container from excessive heat and direct sun.
Inactive Ingredients
Mica, Silica, Caprrylic/Capric Triglyceride, Lauroyl Lusine, Potassium Sorbate, Sodium Benzoate, Undecylenoyl Glycine, Capryloyl Glyccine. Camellia Sinensis Polyphenols, Caffeine, Resveratrol, Tocpheryl Acetatte, Carthamus Tinctorius (Safflower) Seed Oil, Cam llia Sinesis Leaf Extract, Chammomilla Recutita (Matricaria) Flower Extract, Iron Oxides (CI 77489, CI 77492)
Principal Display Panel - 4 G Tube Carton
MINERAL POWDER
UVA/UVB
BROAD
SPECTRUM
SPF
50
SUN PROTECTION
+ OIL CONTROL
Protects against visible aging
Sets makeup and reduces shine
Translucent color blurs imperfections
BROAD SPECTRUM SPF 50
Net wt. 0.14 oz. (4 g)
Principal Display Panel (4 g Tube Carton)
* Please review the disclaimer below.
