Otc - Active Ingredient
Zinc Oxide 11.5%
Evereden Cooling Mineral Sunstick Spf 30 Stick
FDA Label NDC 72113-115
Full FDA labeling including Indications, Dosage, Usage, and Precautions
Structured Product Label
The following Structured Product Label (SPL) was submitted to the FDA by Eden Brands Inc. for the product Evereden Cooling Mineral Sunstick Spf 30 (NDC 72113-115). 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 statement of identity, otc - active ingredient, otc - purpose, indications & usage, warnings, otc - do not use, otc - when using, otc - stop use, and other regulatory disclosures. Use the navigation below to review specific sections of the FDA submission.
Label Section Quick Index
Otc - Purpose
Sunscreen
Indications & Usage
Uses:
• Helps prevent sunburn
Warnings
• For external use only.
Otc - Do Not Use
Do not useon damaged or broken skin.
Otc - When Using
When using this product keep out of eyes. Rinse with water to remove.
Otc - Stop Use
Stop use and ask a doctor if rash occurs.
Otc - Keep Out Of Reach Of Children
Keep out of reach of children. If swallowed, get medical help or contact a Poison Control Center right away.
Dosage & Administration
Directions:
• Apply liberally 15 minutes before sun exposure.
• Reapply at least every 2 hours.
• Use a water-resistant sunscreen if swimming or sweating.
• Children under 6 months of age: Ask a doctor.
• 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 your time in the sun, especially from 10 a.m. - 2 p.m.
• Wear long-sleeved shirts, pants, hats, and sunglasses.
Inactive Ingredient
Dicaprylyl Carbonate, Octyldodecanol, Water (Aqua), Caprylic/Capric Triglyceride, Silica, Dibutyl Lauroyl Glutamide, Dextrin Palmitate, Dibutyl Ethylhexanoyl Glutamide, 1,2-Hexanediol, Butylene Glycol, Polyglyceryl-10 Behenate/Eicosadioate, Propanediol, Sodium Chloride, Polyhydroxystearic Acid, Jojoba Esters, Bisabolol, Ethyl Ferulate, Pongamia Pinnata Seed Extract, Magnolia Officinalis Bark Extract, Tocopheryl Acetate, Chimyl Alcohol, Sodium Phytate, Glycerin, Tocopherol, Naringin
Other Safety Information
Protect the product in this container from excessive heat and direct sun.
* Please review the disclaimer below.
