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Drug Facts
Reef Safe Unscented Spf 50 Mineral Sunscreen Cream
FDA Label NDC 82953-050
Full FDA labeling including Indications, Dosage, Usage, and Precautions
Structured Product Label
The following Structured Product Label (SPL) was submitted to the FDA by Cosmuses Cosmetics (ningbo) Co., Ltd. for the product Reef Safe Unscented Spf 50 Mineral Sunscreen (NDC 82953-050). 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, active ingredients, purpose, uses, warnings, indications & usage, do not use, when using this product, and other regulatory disclosures. Use the navigation below to review specific sections of the FDA submission.
Label Section Quick Index
Active Ingredients
Titanium Dioxide 3.2%
Zinc oxide 20%
Purpose
Sunscreen
Uses
- Helps prevent sunburn
- Higher SPF gives more sunburn protection.
Warnings
Skin Cancer/Skin Aging Alert: Spending time in the sun increases your risk of skin cancer and early skin aging.This product has been shown
Indications & Usage
For external use only.
Do Not Use
Do not use on damaged or broken skin.
When Using This Product
Keep out of eyes. Rinse with water to remove.
Otc - Stop Use
Stop use and ask a doctor: if rash or irritation develops and persists.
Otc - Keep Out Of Reach Of Children
Keep out of reach of children. If swallowed, get medical help or contact a Poison Control Center right away.
Directions
- Apply liberally 15 minutes before sun exposure as needed
- Children under 6 months of age: ask a doctor before use.
- Reapply at least every 2 hours.
- Use a water resistant sunscreen if swimming or sweating
- Limit time in the sun, especially from 10 a.m.-2 p.m.
- Wear long-sleeved shirts, pants, hats, and sunglasses
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 value of 15 or higher and other sun protection measures including:
Inactive Ingredients
Water, Dicaprylyl Ether, lsododecane, Propylene Glycol, Disiloxane, Polyglyceryl-4 Diisostearate/Polyhydroxystearate/Sebacate, Hdi/Trimethylol Hexyllactone Crosspolymer, Silica, Disteardimonium Hectorite, Polyglycery-3 Polydimethylsiloxyethyl Dimethicone, Sodium Chloride, Triethoxycaprylylsilane, Sorbitan lsostearate, Aluminum Hydroxide, Caprylyl Glycol, Dimethicone, Ethylhexylglycerin
Other Information
- Protect this product from excessive heat and direct sun.
Questions Or Comments?
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