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Drug Facts
Reef Safe Unscented Spf Mineral Sunscreen Cream
FDA Label NDC 82953-027
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 Mineral Sunscreen (NDC 82953-027). 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, skin cancer/skin aging alert:, otc - do not use, otc - when using, and other regulatory disclosures. Use the navigation below to review specific sections of the FDA submission.
Label Section Quick Index
Active Ingredients
Avobenzone 3%
Homosalate 10%
Octocrylene 10%
Octisalate 5%
Purpose
Sunscreen
Uses
- Helps prevent sunburn
- Higher SPF giwes more sunburn protection
Warnings
For external use only
For external use only
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 only to prevent sumburn, not skin cancer or early skin aging.
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 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 15minutes 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 10a.m.- 2p.m.
- wear long-sleeve shirts, pants, hats and sunglasses
Sun Protection Measures
Spending time in the sun increases your risk of skin cancer and early skin aging.
To decreases this risk, regularly use a sunscreen with a Broad Spectrum SPF value of 15 or higher and other sun protection measures including:
Inactive Ingredients
AQUA(WATER), ISONONYL ISONONANOATE, C12-15 ALKYL BENZOATE, DIMETHICONE, GLYCERIN, CETETH-25, CETEARYL ALCOHOL, SILICA, VP/HEXADECENE COPOLYMER, GLYCERYL STEARATE, PEG-100 STEARATE, PHENOXYETHANOL, TOCOPHEROL, XANTHAN GUM, PVP, ETHYLHEXYLGLYCERIN, GLYCINE MAX (SOYBEAN) OIL, DISODIUM EDTA, TRIETHOXYCAPRYLYLSILANE
Other Information
Protect this product from excessive heat and direct sun
* Please review the disclaimer below.
