Otc - Active Ingredient
Active Ingredient: Zinc Oxide
Purpose: Sunscreen
Wonderscreen Broad Spectrum Spf 30 Cream
FDA Label NDC 44717-062
Full FDA labeling including Indications, Dosage, Usage, and Precautions
Structured Product Label
The following Structured Product Label (SPL) was submitted to the FDA by Wasatch Product Development, Llc. for the product Wonderscreen Broad Spectrum Spf 30 (NDC 44717-062). 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 broken or damaged skin
Dosage & Administration
Directions:
- Apply liberally 15 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
DIME
Wonderscreen
Broad Spectrum SPF 30
50 G
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