Active Ingredients
Zinc Oxide 19.0%
Mineral Suscreen Spf 30
FDA Label NDC 63750-037
Full FDA labeling including Indications, Dosage, Usage, and Precautions
Structured Product Label
The following Structured Product Label (SPL) was submitted to the FDA by Vivant Pharmaceuticals, Llc for the product Mineral Suscreen Spf 30 (NDC 63750-037). 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 active ingredients, purpose, uses, warnings, do not use, when using this product, stop use and ask doctor, 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
Purpose
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.
Do Not Use
Do not use on damaged or broken skin.
.
When Using This Product
Keep out of eyes. Rinse with water to remove.
Stop Use And Ask Doctor
if rash occurs.
Keep Out Of Reach Of Children.
If product is swallowed, get medical help or contact a Poison Control Center right away
Directions
Apply liberally 15 minutes before sun exposure. Reapply at least every 2 hours.
Children under 6 months of age: ask a doctor. Sun protection measures. Spending time in the sun increases your risk of skin cancer and early skin again. To decrease the risk, regularly use a sunscreen with a Broad Spectrum SPF value 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-sleeved shirts, pants, hats and sunglasses.
Other Information:
Protect this product from excessive heat and direct sun.
Inactive Ingredients:
Water, Capric Caprylic Triglyceride, Lactic Acid, Mineral Oil, Isocetyl Stearoyl Stearate, Dicaprylyl Carbonate, Octyldodecanol, Glycerin, Carthamus Tinctorius (Safflower) Oleosomes, Grape Seed Oil, Glycereth 26, Sorbitan Sesquioleate, Propylene Glycol, Cetyl Alcohol, Emulsifying Wax NF, Glyceryl Stearate, PEG-100 Stearate, Polyacrylamide, C13-14 Isoparaffin, Laureth-7, Vitamin E Acetate, Saccharomyces/Zinc Ferment, Aloe Barbadensis Leaf Powder, Phenoxyethanol, Caprylyl Glycol, Potassium Sorbate, Hexylene Glycol, Sodium Acrylates Copolymer, Lecithin, Triethanolamine
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