Otc - Active Ingredient
Acitve ingredient:
Zinc Oxide 19.0%
Purpose: Sunscreen
Wonderscreen Tinted Broad Spectrum Spf 30 Shade 3 Cream
FDA Label NDC 82870-008
Full FDA labeling including Indications, Dosage, Usage, and Precautions
Structured Product Label
The following Structured Product Label (SPL) was submitted to the FDA by Dime Beauty Co, Llc for the product Wonderscreen Tinted Broad Spectrum Spf 30 Shade 3 (NDC 82870-008). 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
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. when using this product keep out of eyes. Rinse with water to remove
Dosage & Administration
Directions:
- Apply liberally 15 minutes before sun or water exposure
- Immediately after towel drying
- At least every 2 hours
- Children under 6 month: Ask a doctor
Inactive Ingredient
Inactive Ingredients: Water, Ethylhexyl Olivate, Dimethicone, C9-12 Alkane, Cocoglycerides, Caprylic/Capric Triglyceride, Hydroxyethyl Dimethicone Laurate, Pentylene Glycol, Iron Oxides (CI 77492), Butyloctyl Salicylate, Glycerin, Jojoba Esters, Pyrus Malus (Apple) Fruit Extract, Polymethylsilsesquioxane, Diheptyl Succinate, Disteardimonium Hectorite, Squalane, Phenoxyethanol, Sodium Chloride, Iron Oxides (CI 77499), Polyhydroxystearic Acid, Trihydroxystearin, Iron Oxides (CI 77491), Triethyl Citrate, Hydroxyacetophenone, Persea Gratissima (Avocado) Oil, Dipotassium Glycyrrhizate, Fructooligosaccharides, Sodium Citrate, Beta Vulgaris (Beet) Root Extract, Hydrogenated Vegetable Oil, Tetrasodium Glutamate Diacetate, Sodium Dehydroacetate, Capryloyl Glycerin/Sebacic acid Copolymer, Glycine Soja (Soybean) Seed Extract, Tocopherol
Package Label.Principal Display Panel
Dime
Wonderscreen
Tinted Broad Spectrum SPF 30
50 G
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