DERMESSE SUNSCREEN SPF30 MEDIUM TINT- octinoxate, zinc oxide lotion

Dermesse Sunscreen SPF30 Medium Tint by

Drug Labeling and Warnings

Dermesse Sunscreen SPF30 Medium Tint 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 7.5% 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

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

PRINCIPAL DISPLAY PANEL

INGREDIENTS AND APPEARANCE

DERMESSE SUNSCREEN SPF30 MEDIUM TINT 
octinoxate, zinc oxide lotion

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 68723-331
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
OCTINOXATE (UNII: 4Y5P7MUD51) (OCTINOXATE - UNII:4Y5P7MUD51)	OCTINOXATE	75 mg  in 1 g
ZINC OXIDE (UNII: SOI2LOH54Z) (ZINC OXIDE - UNII:SOI2LOH54Z)	ZINC OXIDE	70 mg  in 1 g

Inactive Ingredients
Ingredient Name	Strength
WATER (UNII: 059QF0KO0R)
CYCLOMETHICONE (UNII: NMQ347994Z)
ALKYL (C12-15) BENZOATE (UNII: A9EJ3J61HQ)
HEXYLENE GLYCOL (UNII: KEH0A3F75J)
ALOE VERA LEAF (UNII: ZY81Z83H0X)
PEG-40 STEARATE (UNII: ECU18C66Q7)
GLYCERIN (UNII: PDC6A3C0OX)
ALUMINUM STARCH OCTENYLSUCCINATE (UNII: I9PJ0O6294)
CARNAUBA WAX (UNII: R12CBM0EIZ)
HYDROXYETHYL ACRYLATE/SODIUM ACRYLOYLDIMETHYL TAURATE COPOLYMER (100000 MPA.S AT 1.5%) (UNII: 86FQE96TZ4)
PEG-100 STEARATE (UNII: YD01N1999R)
SQUALANE (UNII: GW89575KF9)
.ALPHA.-TOCOPHEROL ACETATE (UNII: 9E8X80D2L0)
PROPYLENE GLYCOL (UNII: 6DC9Q167V3)
BIS-PEG-12 DIMETHICONE (500 MPA.S) (UNII: 2CNS542YRT)
STEAROXYTRIMETHYLSILANE (UNII: 9862TW94B2)
GREEN TEA LEAF (UNII: W2ZU1RY8B0)
GLYCERYL DILAURATE (UNII: MFL3ZIE8SK)
DIMETHICONE 350 (UNII: 2Y53S6ATLU)
GLYCERYL STEARATE SE (UNII: FCZ5MH785I)
CETEARYL STEARATE (UNII: 9T97Q8P3CK)
STEARYL ALCOHOL (UNII: 2KR89I4H1Y)
STEARETH-100 (UNII: 4OH5W9UM87)
TITANIUM DIOXIDE (UNII: 15FIX9V2JP)
SORBITAN TRISTEARATE (UNII: 6LUM696811)
POLYOXYL 20 CETOSTEARYL ETHER (UNII: YRC528SWUY)
VINYLPYRROLIDONE/EICOSENE COPOLYMER (UNII: 035MV9S1C3)
POLYSORBATE 60 (UNII: CAL22UVI4M)
BEHENETH-5 (UNII: L4A971L76E)
TRIETHOXYCAPRYLYLSILANE (UNII: LDC331P08E)
CAPRYLYL GLYCOL (UNII: 00YIU5438U)
METHYLISOTHIAZOLINONE (UNII: 229D0E1QFA)
FERRIC OXIDE YELLOW (UNII: EX438O2MRT)
FERRIC OXIDE RED (UNII: 1K09F3G675)
FERROSOFERRIC OXIDE (UNII: XM0M87F357)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 68723-331-02	57 g in 1 BOTTLE; Type 0: Not a Combination Product	05/01/2015

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC monograph final	part352	05/01/2015

Labeler - Axia Medical Solutions, LLC (929224694)

Registrant - Axia Medical Solutions, LLC (929224694)