Active Ingredient(S)
Zinc Oxide 20.00% Sunscreen
Environ Skin Care Rad Shield Mineral Sunscreen Spf 30 Cream
FDA Label NDC 85784-111
Full FDA labeling including Indications, Dosage, Usage, and Precautions
Structured Product Label
The following Structured Product Label (SPL) was submitted to the FDA by Environ Skin Care (pty) Ltd for the product Environ Skin Care Rad Shield Mineral Sunscreen Spf 30 (NDC 85784-111). 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(s), purpose, use, warnings, otc - keep out of reach of children, directions, other safety information, inactive ingredients, and other regulatory disclosures. Use the navigation below to review specific sections of the FDA submission.
Label Section Quick Index
Purpose
Sunscreen
Use
Helps prevent sunburn. • If used as directed with other sun protection measures (see directions), decreases the risk of skin cancer and early skin aging caused by the sun.
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 consult a physician if irritation or rash develops.
• Keep out of reach of children. If swallowed, get medical attention or contact a poison control center immediately.
Otc - Keep Out Of Reach Of Children
Keep out of reach of children. If swallowed, get medical attention or contact a poison control center immediately.
Directions
Apply liberally 15 minutes before sun exposure. • Reapply - at least every 2 hours. - after 80 minutes of swimming or sweating. - immediately after drying with a towel, • Sun Protection Measures: Spending time in the sun increases your risk of skin cancer and early aging. To decrease this risk, regularly use a sunscreen with a broad spectrum SPF rating of 15 or higher, along with other sun protection measures including: - Limit time in the sun, especially between 10 a.m. - 2 p.m. - Wear long-sleeved shirts, pants, hats and sunglasses. - Children under 6 months, consult a physician,
Other Safety Information
Protect this product from excessive heat and direct sunlight.
Inactive Ingredients
Boswella Serrata Resin Extract, Butyloctyl Salicylate, Caprylic/Capric Triglyceride, Caprylyl Glycol, Diatomaceous Earth, Dicaprylyl Carbonate, Dimethicone, Dimethicone Crosspolymer, Dimethicone/Bis-Isobutyl PPG-20 Crosspolymer, Isododecane, Lecithin, Lithothamnion Calcareum Extract, Mannitol, Microcrystalline Cellulose, Neopentyl Glycol Diheptanoate, Polyester-7, Polymethylsilsesquioxane, Silica, Triethoxyoctylsilane, Zinc Sulfate.
Otc - Questions
* Please review the disclaimer below.
