Active Ingredient
Titanium Dioxide 6.00%
Zinc Oxide 6.00%
Mineral Sunscreen Spf-30 Liquid
FDA Label NDC 83387-399
Full FDA labeling including Indications, Dosage, Usage, and Precautions
Structured Product Label
The following Structured Product Label (SPL) was submitted to the FDA by Newco Llc for the product Mineral Sunscreen Spf-30 (NDC 83387-399). 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 consult your doctor, 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.
• Higher SPF gives more sunburn protection.
• Retains SPF after 80 minutes of swimming or sweating.
• 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 Your Doctor
if a rash or irritation occurs.
Keep Out Of Reach Of Children.
If swallowed, get medical help or contact a Poison Control Center right away.
If Pregnant Or Breast-Feeding,
ask a health professional before use.
Directions:
• Apply liberally 15 minutes before sun exposure and as needed.
• Children under 6 months of age: Ask a doctor.
Reapply:
• After 80 minutes of swimming or sweating.
• Immediately after towel drying.
• At least every 2 hours.
Sun Protection Measures: Spending time in the sun increases your risk of skin cancer and early skin aging. To decrease the risk,
regularly use a sunscreen with broad spectrum SPF 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.
Other Information
• Protect the product in this container from excessive heat and direct sun.
Other Ingredients:
*Aloe Barbadensis Leaf (Aloe Vera Gel) Juice, Aqua (Deionized Water), *Camellia Sinensis (Green Tea) Extract, Caprylic/Capric Triglyceride, Caprylyl/Capryl Glucoside, *Carthamus Tinctorius (Safflower) Oil, Ethylhexylglycerin, *Glycerin, Glyceryl Stearate Citrate, *Helianthus Annuus (Sunflower) Oil, Lecithin, Phenoxyethanol, Polyhydroxystearic Acid, *Punica Granatum (Pomegranate) Extract, Stearic Acid, Tetrasodium Glutamate Diacetate, *Theobroma Cacao (Cocoa) Butter, Tocopherol (Vitamin E), Xanthan Gum.
*Denotes organic ingredients
Package Labeling:
Bottle (Bottle)
* Please review the disclaimer below.
