Active Ingredients
Zinc Oxide 20%
Radically Rejuvenating Spf Day Cream
FDA Label NDC 54136-152
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 Radically Rejuvenating Spf Day Cream (NDC 54136-152). 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 only.
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
• 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-sleeveshirts, pants, hats, and sunglasses
Other Information
• Protect this product from excessive heat and direct sun. • May stain some fabrics.
Inactive Ingredients
WATER, COCO-CAPRYLATE/CAPRATE, CETEARYL OLIVATE, SORBITAN OLIVATE, SODIUM ASCORBYL PHOSPHATE, PANTHENOL, CURCUMA LONGA (TURMERIC) ROOT EXTRACT, FERULIC ACID, LAUROYL LYSINE, GLYCERIN, LECITHIN, PULLULAN, SCLEROTIUM GUM, XANTHAN GUM, CETEARYL ALCOHOL, POLYHYDROXYSTEARIC ACID, SILICA, SODIUM PHYTATE, DEHYDROACETIC ACID, BENZYL ALCOHOL
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