Active Ingredient
Zinc Oxide 17%
Radiant Shield Broad Spectrum Spf 40 Tinted Mineral Sunscreen Cream
FDA Label NDC 70060-1507
Full FDA labeling including Indications, Dosage, Usage, and Precautions
Structured Product Label
The following Structured Product Label (SPL) was submitted to the FDA by Cosmedical Technologies, Llc for the product Radiant Shield Broad Spectrum Spf 40 Tinted Mineral Sunscreen (NDC 70060-1507). 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 ingredient, purpose, uses, warnings, do not use, when using this product, stop use and ask a doctor if, 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.
Do Not Use
on damaged or broken skin.
When Using This Product
keep out of eyes. Rinse with water to remove.
Stop Use And Ask A Doctor If
rash occurs.
Keep Out Of Reach Of Children.
If swallowed, get medical help or contact a Poison Control Center right away.
Directions
• Apply liberally and evenly 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 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 • Children under 6 months of age: Ask a doctor.
Other Information
Protect the product in this container from excessive heat and direct sun.
Inactive Ingredients
Water (Aqua), Isododecane, Propanediol, Caprylic/Capric Triglyceride, Polyglyceryl-6 Polyricinoleate, C12-15 Alkyl Benzoate, Dimethicone, Polymethylsilsesquioxane/Trimethylsiloxysilicate, Coco-Caprylate/Caprate, Ethylhexyl Palmitate, Polymethylsilsesquioxane, Disteardimonium Hectorite, Polyglyceryl-10 Dioleate, Polyhydroxystearic Acid, Lecithin, Ectoin, Dimethylmethoxy Chromanol, Betula Alba (Birch) Bark Extract, Boswellia Serrata (Indian Frankincense) Extract, Polygonum Cuspidatum (Japanese Knotweed) Root Extract, Centella Asiatica (Gotu Kola) Extract, Butyrospermum Parkii (Shea) Butter, Glycerin, Tapioca Starch Polymethylsilsesquioxane, Propylene Carbonate, Polysilicone-11, Tromethamine, Polyglyceryl-10 Laurate, Octyldodecanol, Jojoba Esters, Trihydroxystearin, Alumina, Silica, Phenoxyethanol, Ethylhexylglycerin, Titanium Dioxide (CI 77891), Iron Oxide (CI 77491, CI 77492), Lavandula Angustifolia (Lavender) Oil, Pelargonium Graveolens (Rose Geranium) Flower Oil.
Package Labeling:
Label (Label)
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