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Drug Facts
Tinted Mineral Sunscreen Lotion
FDA Label NDC 51326-123
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 Tinted Mineral Sunscreen (NDC 51326-123). 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 - when using, otc - stop use, otc - keep out of reach of children, sun protection measures, and other regulatory disclosures. Use the navigation below to review specific sections of the FDA submission.
Label Section Quick Index
Otc - Purpose
| Active ingredient | Purpose |
|---|---|
| Zinc Oxide 11% | Sunscreen |
| Titanium Dioxide 7.5% | Sunscreen |
Uses
- Helps prevent sunburn
- If 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 - When Using
When using this product keep out of eyes, rinse with water to remove.
Otc - Stop Use
Stop use if signs of irritation or rash appear. If irritation or rash persists consult a doctor.
Otc - Keep Out Of Reach Of Children
Keep out of reach of children.
In case of accidental ingestion, seek professional assistance or contact a Poison Control Center immediately.
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 of 15 or higher and other sunscreen measures including:
- limit time in the sun, especially from 10 a.m.-2 p.m.
- wear long-sleeve shirts, pants, hats, and sunglasses
Directions
- Apply liberally to face and neck and spread evenly 15 minutes before sun exposure
- Re-apply after swimming, excessive perspiring, or anytime after towel drying
- Use a water resistant sunscreen if swimming or sweating
- Use on children under 6 months of age: consult a doctor.
Inactive Ingredients
Purified Water, Dimethicone, Methyl Trimethicone, Isononyl Isononanoate, Oleth-3 Phosphate, PEG-9 Polydimethylsiloxyethyl Dimethicone, Alumina, Butylene Glycol, Octyldodecyl Neopentanoate, VP/Eicosene Copolymer, Sodium Hyaluronate, Tocopheryl Acetate, Caffeine, Polyisobutene, Iron Oxides, Sucrose, Glycerin, Silicone, Isopropyl Titanium Triisostearate, Polysorbate 20, Polyacrylate-13, Panthenol, Cetearyl Alcohol, Dicetyl Phosphate, Ceteth-20 Phosphate, PEG-8 Methyl Ether Triethoxysilane, Hydrogen Dimethicone Polyglyceryl-6 Polyricinoleate, Xanthan Gum, Sodium Hydroxide, Phenoxyethanol, Disodium EDTA.
Principal Display Panel - 99 G Bottle Label
COMPLIMENTS OF
TOPIX
PHARMACEUTICALS, INC
MULTI-TASKING
Mineral
Lightly Tinted
Antioxidant
Sunscreen
SPF 50+
Broad Spectrum SPF 50+
Water Resistant 40 minutes
Net wt. 3.5 oz. (99 g)
Available
Custom Branded
800.445.2595
[email protected]
Principal Display Panel (99 g Bottle Label)
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