DERMESSE SUNSCREEN SPF30- octinoxate, titanium dioxide lotion

Dermesse Sunscreen SPF30 by

Drug Labeling and Warnings

Dermesse Sunscreen SPF30 by is a Otc medication manufactured, distributed, or labeled by Axia Medical Solutions, LLC. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

​Active Ingredients

Octinoxiate 7% w/w

Titanium Dioxide 2% w/w

​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

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

PRINCIPAL DISPLAY PANEL

INGREDIENTS AND APPEARANCE

DERMESSE SUNSCREEN SPF30 
octinoxate, titanium dioxide lotion

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 68723-330
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
OCTINOXATE (UNII: 4Y5P7MUD51) (OCTINOXATE - UNII:4Y5P7MUD51)	OCTINOXATE	70 mg  in 1 g
TITANIUM DIOXIDE (UNII: 15FIX9V2JP) (TITANIUM DIOXIDE - UNII:15FIX9V2JP)	TITANIUM DIOXIDE	20 mg  in 1 g

Inactive Ingredients
Ingredient Name	Strength
WATER (UNII: 059QF0KO0R)
ISOCETYL STEARATE (UNII: 3RJ7186O9W)
SORBITOL (UNII: 506T60A25R)
CETOSTEARYL ALCOHOL (UNII: 2DMT128M1S)
POLYOXYL 20 CETOSTEARYL ETHER (UNII: YRC528SWUY)
.ALPHA.-TOCOPHEROL ACETATE (UNII: 9E8X80D2L0)
ACETYL HEXAPEPTIDE-8 (UNII: L4EL31FWIL)
ALCOHOL (UNII: 3K9958V90M)
DIMETHICONE 350 (UNII: 2Y53S6ATLU)
OCTISALATE (UNII: 4X49Y0596W)
CETYL ALCOHOL (UNII: 936JST6JCN)
METHICONE (20 CST) (UNII: 6777U11MKT)
SODIUM LAURETH SULFATE (UNII: BPV390UAP0)
CARBOMER INTERPOLYMER TYPE A (ALLYL SUCROSE CROSSLINKED) (UNII: 59TL3WG5CO)
GREEN TEA LEAF (UNII: W2ZU1RY8B0)
TROLAMINE (UNII: 9O3K93S3TK)
STEARIC ACID (UNII: 4ELV7Z65AP)
LECITHIN, SOYBEAN (UNII: 1DI56QDM62)
ALUMINUM OXIDE (UNII: LMI26O6933)
CAPRYLYL GLYCOL (UNII: 00YIU5438U)
METHYLISOTHIAZOLINONE (UNII: 229D0E1QFA)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 68723-330-02	57 g in 1 BOTTLE; Type 0: Not a Combination Product	04/01/2012

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC monograph final	part352	04/01/2012

Labeler - Axia Medical Solutions, LLC (929224694)

Registrant - Axia Medical Solutions, LLC (929224694)