Active Ingredient:
Zinc Oxide 18.8%
Tri-water Sheer Mineral Sunscreen Cushion Spf30 Sponge
FDA Label NDC 72113-111
Full FDA labeling including Indications, Dosage, Usage, and Precautions
Structured Product Label
The following Structured Product Label (SPL) was submitted to the FDA by Eden Brands Inc. for the product Tri-water Sheer Mineral Sunscreen Cushion Spf30 (NDC 72113-111). 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 statement of identity, active ingredient:, 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.
Directions:
• Apply liberally to face and body 15 minutes before sun exposure.
• Use a water resistant sunscreen if swimming or sweating.
• Reapply 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), Glycerin, Isoamyl Laurate, Silica, Caprylic/Capric Triglyceride, Dimethicone, C13-15 Alkane, Squalane, Hydroxyapatite, Dicaprylyl Carbonate, Polyhydroxystearic Acid, Propanediol, Cellulose, Polyglyceryl-4 Oleate, Polyglyceryl-6 Polyricinoleate, Sodium Chloride, 1,2-Hexanediol, Polyglyceryl-6 Oleate, Coco-Caprylate/Caprate, Maris Limus Extract, Pongamia Glabra Seed Oil, Lauroyl Lysine, Aloe Barbadensis Leaf Juice, Cocos Nucifera (Coconut) Fruit Juice, Cucumis Sativus (Cucumber) Fruit Extract, Chimyl Alcohol, Magnolia Officinalis Bark Extract, Pongamia Pinnata Seed Extract, Trisodium Ethylenediamine Disuccinate, Xanthan Gum, Dunaliella Salina Extract, Haematococcus Pluvialis Extract, Hydroxyacetophenone, Tocopherol, Naringin
* Please review the disclaimer below.
