Active Ingredients
Zinc Oxide 19.0%
Mineral Suscreen Spf 30 Cream
FDA Label NDC 63750-038
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 63750-038). 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, inactive ingredients:, 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.
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
rash or irritation develops and lasts
Inactive Ingredients:
aloe barbadensis leaf juice, C13-14 isoparaffin, caprylic/capric triglyceride, capryloyl glycerin/sebacic acid copolymer, caprylyl glycol, carthamus tinctorius (safflower) oleosomes, diheptyl succinate, emulsifying wax, glycerin, glyceryl stearate, hexylene glycol, laureth-7, PEG-100 stearate, phenoxyethanol, polyacrylamide, polyhydroxystearic acid, potassium sorbate, saccharomyces/zinc ferment, sorbitan sesquioleate, tocopheryl acetate, vitis vinifera (grape) seed oil, water
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. If pregnant or breastfeeding, ask a health professional before use.
Directions
Apply liberally 15 minutes before sun exposure. Reapply at least every 2 hours.
Children under 6 months of age: ask a doctor.
Use enough to cover your entire face and body (avoiding the eyes and mouth)
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.
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