Otc - Active Ingredient
Active Ingredients:
Zinc Oxide 18.6%
Sheer Mineral Sunscreen Broad Spectrum Spf 30 Cream
FDA Label NDC 62742-4242
Full FDA labeling including Indications, Dosage, Usage, and Precautions
Structured Product Label
The following Structured Product Label (SPL) was submitted to the FDA by Allure Labs for the product Sheer Mineral Sunscreen Broad Spectrum Spf 30 (NDC 62742-4242). 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, indications & usage, 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
Purpose: Sunscreen
Indications & Usage
Uses • helps to 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
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 warm water to remove.
Otc - Stop Use
Stop use and ask a doctor if rash occurs.
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.
Dosage & Administration
Directions • Apply liberally 15 minutes before sun exposure.
• Children under 6 months: Ask a doctor
• Reapply: at least every 2 hours
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 sun protection measures including: • limit time in the sun, especially from 10 a.m. – 2 p.m. • wear long-sleeve shirts, pants, hats, and sunglasses.
Other Safety Information
Other information • Protect this product from excessive heat or direct sun.
Inactive Ingredient
Inactive Ingredients:
Water (Aqua),Cyclopentasiloxane, Butylene Glycol, Glycerin, Glyceryl Stearate, PEG-100 Stearate, Cyclohexasiloxane, Polyglyceryl-3 Polydimethylsiloxyethyl Dimethicone, Sorbitan Stearate, Dimethicone,Ascorbic Acid, Plankton Extract, Tocopherol, caprylyl Glycol, Caprylic/Capric Triglyceride, Phoenix Dactylifera ( Date) Fruit Extract, Imperata Cylindrica Root Extract, Arabidopsis Thaliana Extract, Ascorbyl Palmitate, Polygonum Aviculare Extract,Tocopheryl Linoleate/Oleate, Teprenone, Xanthan Gum,Polyacrylamide, C13-14 Isoparaffin, Laureth-7, Phenoxyethanol, Ethylhexylglycerin, Hexylene Glycol, PEG-8, Carbomer, Triethoxysilylethyl Polydimethylsiloxyethyl Hexyl Dimethicone, Cetyl Alcohol, Lecithin, Citric Acid, Sodium Lactate, Disodium EDTA, Dipotassium Glycyrrhizate, Micrococcus Lysate.
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