Otc - Active Ingredient
Active Ingredients:
Zinc Oxide 19.0%
Purpose: Sunscreen
Spf 30 Mineral Sunscreen Cream
FDA Label NDC 83369-003
8 label sections · Submitted to the FDA by Smalls Brand Llc Dba Roe Wellness · Indications, Dosage, Usage, and Precautions
Structured Product Label
The following Structured Product Label (SPL) was submitted to the FDA by Smalls Brand Llc Dba Roe Wellness for the product Spf 30 Mineral Sunscreen (NDC 83369-003). 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, otc - keep out of reach of children, indications & usage, warnings, dosage & administration, inactive ingredient, package label.principal display panel, and other regulatory disclosures. Use the navigation below to review specific sections of the FDA submission.
Label Section Quick Index
Otc - Purpose
Uses:
Helps prevent sunburn. Higher SPF gives more sunburn protection.
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
Indications & Usage
Stop use and ask a doctor if rash occurs.
Warnings
Warning:
For external use only. Do not use on damaged or broken skin. When using this product, keep out of eyes. Rinse with water to remove.
Dosage & Administration
Directions:
- Apply liberally 5 minutes before sun or water exposure
- Immediately after towel drying
- At least every 2 hours
- Children under 6 months: Ask a doctor
Inactive Ingredient
Inactive Ingredients: Water, Ethylhexyl Olivate, Dimethicone, C9-12 Alkane, Cocoglycerides, Hydroxyethyl Dimethicone Laurate, Pentylene Glycol, Butyloctyl Salicylate, Glycerin, Jojoba Esters, Pyrus Malus (Apple) Fruit Extract, Polymethylsilsesquioxane, Squalane, Dipotassium glycyrrhizate, Beta Vulgaris (Beet) Root Extract. Fructooligosaccharides. Glycine Soja (Soybean) Seed Extract Diheptyl Succinate, Disteardimonium Hectorite, Phenoxyethanol, Sodium Chloride, Polyhydroxystearic Acid, Trihydroxystearin, Triethyl Citrate, Hydroxyacetophenone, Sodium Citrate, Tetrasodium Glutamate Diacetate, Sodium Dehydroacetate, Capryloyl Glycerin/Sebacic Acid Copolymer
Package Label.Principal Display Panel
SPF 30 Mineral Sunscreen
Net Wt 1.76 oz 50 g
* Please review the disclaimer below.
