Active Ingredients
Zinc Oxide 22%
Mineral Sunscreen Spf 50 Cream
FDA Label NDC 54136-351
Full FDA labeling including Indications, Dosage, Usage, and Precautions
Structured Product Label
The following Structured Product Label (SPL) was submitted to the FDA by Better Planet Brands Llc for the product Mineral Sunscreen Spf 50 (NDC 54136-351). 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, 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
Purpose
Sunscreen
Uses
• helps prevent sunburn
Warnings
• For external use
Otc - Do Not Use
• Do not use on damaged or broken skin.
Otc - When Using
• When using the product keep out of eyes. Rinse with 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.
Directions
Directions_• apply liberally 15 minutes before sun exposure
reapply at least every 2 hours
use a water-resistant sunscreen if swimming or sweating. • 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:
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.
May stain some
Inactive Ingredients
ALOE BARBADENSIS LEAF JUICE*, BUTYLOCTYL SALICYLATE, CAPRYLIC/CAPRIC TRIGLYCERIDE, POLYESTER-8, GLYCERIN, WATER, CETEARYL ALCOHOL, GLYCERYL STEARATE, SQUALANE, ISOAMYL LAURATE, SORBITAN SESQUIOLEATE, TOCOPHEROL, SIMMONDSIA CHINENSIS (JOJOBA) SEED OIL*, HELANTHUS ANNUUS (SUNFLOWER) SEED OIL, SODIUM HYALURONATE, HYDROLYZED JOJOBA ESTERS, BISABOLOL, PULLULAN, SCLEROTIUM GUM, XANTHAN GUM, GLYCOLIPIDS, GLYCERYL CAPRYLATE, SODIUM STEAROYL GLUTAMATE, POLYHYDROXYSTEARIC ACID, COCO-GLUCOSIDE, LYSOLECITHIN, SILICA, CAPRYLHYDROXAMIC ACID, CITRIC ACID
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