FDA Label for Dermesse Sunscreen Spf30 Medium Tint

View Indications, Usage & Precautions

Dermesse Sunscreen Spf30 Medium Tint Product Label

The following document was submitted to the FDA by the labeler of this product Axia Medical Solutions, Llc. The document includes published materials associated whith this product with the essential scientific information about this product as well as other prescribing information. Product labels may durg indications and usage, generic names, contraindications, active ingredients, strength dosage, routes of administration, appearance, warnings, inactive ingredients, etc.

​Active Ingredients



Octinoxiate 7.5% w/w

Zinc Oxide 7% w/w


​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 aging caused by the sun.


​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.


​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

• 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 of 15 or higher and other sun protection measures including:

   • Limit time in the sun, especially from 10 a.m. - 2 p.m.

   • Wear long sleeve shirts, pants, hats, and sunglasses


Otc - Ask Doctor



​Children under 6 months: ​Ask a doctor


​Inactive Ingredients



Water, Cyclomethicone, C12-15 Alkyl Benzoate, C18-38 Alkyl Hydroxystearoyl Stearate, Hexylene Glycol, Aloe Barbadensis Leaf Extract, PEG-40 Stearate, Glycerin, Aluminum Starch Octenylsuccinate, Carnauba Wax, Hydroxyethyl Acrylate/Sodium Acryloyldimethyl Taurate Copolymer, PEG100 Stearate, Squalane, Tocopheryl Acetate, Propylene Glycol, Siliconyl Beeswax, Stearoxytrimethylsilane, Green Tea (Camellia Sinensis) Leaf Extract, Glyceryl Dilaurate, Dimethicone, Glyceryl Stearate, Cetearyl Alcohol, Stearyl Alcohol, Steareth-100, Titanium Dioxide, Sorbitan Tristearate, Ceteareth-20, VP/Eicosene Copolymer, Polysorbate-60, Beheneth-5, Triethoxycaprylylsilane, Caprylyl Glycol, Fragrance, Methylisothiazolinone, Iron Oxides: Yellow (C177492), Red (C177491), Black (C177499)


​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.