Active Ingredients
Avobenzone 3.00%
Homosalate 10.00%
Octisalate 5.00%
Octocrylene 2.75%
Oxybenzone 6.00%
Dermisa Sunscreen Spf 55
FDA Label NDC 68343-003
Full FDA labeling including Indications, Dosage, Usage, and Precautions
Structured Product Label
The following Structured Product Label (SPL) was submitted to the FDA by Montani Cosmetics Inc for the product Dermisa Sunscreen Spf 55 (NDC 68343-003). 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 a doctor if, keep out of reach of children, directions, and other regulatory disclosures. Use the navigation below to review specific sections of the FDA submission.
Label Section Quick Index
Purpose
Sunscreen
Sunscreen
Sunscreen
Sunscreen
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 A Doctor If
rash occurs
Keep Out Of Reach Of Children
If product is swallowed, get medical help or contact a Poison Control Center right away.
Directions
• apply 15 minutes before sun exposure • 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 this risk, regularly use a sunscreen with a broad spectrum SPF of 15 or higher and other sun protection measures including: • limit time in sun, especially from 10 a.m.- 2 p.m. • wear long-sleeve shirts, pants, hats, and sunglasses
• Children under 6 months: Ask a Doctor
Other Information
• protect this product from excessive heat and direct sun • might stain fabrics • store at room temperature
Inactive Ingredients
Behenyl Alcohol, BHT, Butyloctyl Salicylate, Caprylyl Methicone, Dimethicone, Dimethyl Capramide, Disodium EDTA, Ethylhexyl Stearate, Ethylhexylglycerin, Ethylparaben, Fragrance, Glyceryl Stearate, Iodopropynyl Butylcarbamate, Methylparaben, PEG-100 Stearate, Phenoxyethanol, Polyester-8, Propylparaben, Silica, Sodium Polyacrylate, Styrene/Acrylates Copolymer, Trideceth-6, Trimethylsiloxysilicate, VP/Hexadecene Copolymer, Water, Xanthan Gum
Package Label
Package Label (Drmsaspf55ltn)
* Please review the disclaimer below.
