Active Ingredients
Octinoxiate 7% w/w
Titanium Dioxide 2% w/w
Dermesse Sunscreen Spf30
FDA Label NDC 68723-330
Full FDA labeling including Indications, Dosage, Usage, and Precautions
Structured Product Label
The following Structured Product Label (SPL) was submitted to the FDA by Axia Medical Solutions, Llc for the product Dermesse Sunscreen Spf30 (NDC 68723-330). 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 ingredients, purpose, uses:, warnings:, when using this product:, stop use and ask doctor if, keep out of reach of children, warnings, 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
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 Ask Doctor If
• Rash or irritation develops
Keep Out Of Reach Of Children
• If swallowed, get medical help or contact a Poison Control Center right away.
Warnings
Skin Cancer/Skin Aging Alert: Spending time in the sun increases your risk of skin cancer and early skin aging. This product has been shown only to prevent sunburn, not skin cancer or early skin aging.
Directions
• Apply liberally 15 minutes before sun exposure
• Reapply
• After 40 minutes of swimming or sweating
• Immediately after towel drying
• At least every 2 hours
Otc - Ask Doctor
Children under 6 months: Ask a doctor
Inactive Ingredients
Water, Aloe Barbadensis Leaf Extract, Isocetyl Stearate, Sorbitol, Cetearyl Alcohol, Ceteareth-20, Tocopheryl Acetate, Acetyl Hexapdptide-8, Hydrolyzed Rice Protein, Alcohol SDA-40, Dimethicone, Octyl Salicylate, Cety Alcohol, Methicone, Sodium Laureth Sulfate, Carbomer, Green Tea (Carnellia Sinensis) Leaf Extract, Fragrance, Triethanolamine, Stearic Acid, Lecithin, Alumina, Caprylyl Glycol, Methylisothiazolinone
Other Information
Protect this product from excessive heat and direct sun.
Questions Or Comments?
866-494-4466 or visit www.dermesse.com
* Please review the disclaimer below.
