Active Ingredients:
Titanium Dioxide 3.7% Zinc Oxide 14%
Evereden Fluid Silk Mineral Sunscreen Pro Spf50
FDA Label NDC 72113-110
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 Fluid Silk Mineral Sunscreen Pro Spf50 (NDC 72113-110). 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, active ingredients:, purpose:, uses:, warnings:, otc - do not use, otc - stop use, otc - when using, 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. • 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.
Otc - Do Not Use
• Do not use on damaged or broken skin.
Otc - Stop Use
• Stop use and ask a doctor if rash occurs.
Otc - When Using
• When using this product keep out of eyes. Rinse with water to remove.
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.
Directions:
• Shake well before use.
• Apply liberally 15 minutes before sun exposure and as needed.
• Reapply: • After 40 minutes of swimming or sweating • Immediately after towel drying • At least every 2 hours
• 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 a 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.
Other Information:
• Protect the product in this container from excessive heat and direct sun.
Inactive Ingredients:
Water (Aqua), Cetyl Ethylhexanoate, Undecane, Caprylic/Capric Triglyceride, C13-15 Alkane, Dicaprylyl Ether, Tridecane, Argania Spinosa Kernel Oil, Propanediol, Tocopheryl Acetate, 1,2-Hexanediol, Polyglyceryl-6 Polyricinoleate, Polyhydroxystearic Acid, Silica, Stearyl Citrate, Trioctyldodecyl Citrate, Aluminum Hydroxide, Stearic Acid, Sodium Chloride, Carthamus Tinctorius (Safflower) Oleosomes, Cucumis Sativus (Cucumber) Fruit Extract, Dextrin Palmitate, Maris Limus Extract, Magnolia Officinalis Bark Extract, Thermus Thermophillus Ferment, Bisabolol, Aloe Barbadensis Leaf Juice, Cocos Nucifera (Coconut) Fruit Juice, Cocos Nucifera (Coconut) Oil, Helianthus Annuus (Sunflower) Seed Oil, Helianthus Annuus (Sunflower) Seed Oil Unsaponifiables, Persea Gratissima (Avocado) Oil, Rosa Rubiginosa Seed Oil, Vitis Vinifera (Grape) Seed Oil, Methyl Diisopropyl Propionamide, Pongamia Pinnata Seed Extract, Xanthan Gum, Cetyl Glyceryl Ether, Sodium Phytate, Glycerin, Pongamia Glabra Seed Oil, Phenylpropanol, Caprylyl Glycol, Potassium Sorbate, Hydroxyacetophenone, Dunaliella Salina Extract, Haematococcus Pluvialis Extract
* Please review the disclaimer below.
