DERMISA SUNSCREEN SPF 55 BROAD SPECTRUM- octinoxate, titanium dioxide, zinc oxide lotion

Dermisa SUNSCREEN SPF 55 by

Drug Labeling and Warnings

Dermisa SUNSCREEN SPF 55 by is a Otc medication manufactured, distributed, or labeled by Montani Cosmetics Inc. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

Active Ingredients

Avobenzone 3.00%

Homosalate 10.00%

Octisalate 5.00%

Octocrylene 2.75%

Oxybenzone 6.00%

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

INGREDIENTS AND APPEARANCE

DERMISA SUNSCREEN SPF 55  BROAD SPECTRUM
octinoxate, titanium dioxide, zinc oxide lotion

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 68343-003
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
OCTOCRYLENE (UNII: 5A68WGF6WM) (OCTOCRYLENE - UNII:5A68WGF6WM)	OCTOCRYLENE	2.75 g  in 100 mL
AVOBENZONE (UNII: G63QQF2NOX) (AVOBENZONE - UNII:G63QQF2NOX)	AVOBENZONE	3 g  in 100 mL
OXYBENZONE (UNII: 95OOS7VE0Y) (OXYBENZONE - UNII:95OOS7VE0Y)	OXYBENZONE	6 g  in 100 mL
OCTISALATE (UNII: 4X49Y0596W) (OCTISALATE - UNII:4X49Y0596W)	OCTISALATE	5 g  in 100 mL
HOMOSALATE (UNII: V06SV4M95S) (HOMOSALATE - UNII:V06SV4M95S)	HOMOSALATE	10 g  in 100 mL

Inactive Ingredients
Ingredient Name	Strength
VINYLPYRROLIDONE/HEXADECENE COPOLYMER (UNII: KFR5QEN0N9)
WATER (UNII: 059QF0KO0R)
TRIDECETH-6 (UNII: 3T5PCR2H0C)
SODIUM POLYACRYLATE (8000 MW) (UNII: 285CYO341L)
SILICON DIOXIDE (UNII: ETJ7Z6XBU4)
DOCOSANOL (UNII: 9G1OE216XY)
BUTYLATED HYDROXYTOLUENE (UNII: 1P9D0Z171K)
BUTYLOCTYL SALICYLATE (UNII: 2EH13UN8D3)
CAPRYLYL TRISILOXANE (UNII: Q95M2P1KJL)
DIMETHICONE (UNII: 92RU3N3Y1O)
DIMETHYL CAPRAMIDE (UNII: O29Y6X2JEZ)
EDETATE DISODIUM ANHYDROUS (UNII: 8NLQ36F6MM)
ETHYLHEXYL STEARATE (UNII: EG3PA2K3K5)
ETHYLHEXYLGLYCERIN (UNII: 147D247K3P)
ETHYLPARABEN (UNII: 14255EXE39)
GLYCERYL STEARATE SE (UNII: FCZ5MH785I)
IODOPROPYNYL BUTYLCARBAMATE (UNII: 603P14DHEB)
METHYLPARABEN (UNII: A2I8C7HI9T)
PEG-100 STEARATE (UNII: YD01N1999R)
PHENOXYETHANOL (UNII: HIE492ZZ3T)
POLYESTER-8 (1400 MW, CYANODIPHENYLPROPENOYL CAPPED) (UNII: T9296U138P)
PROPYLPARABEN (UNII: Z8IX2SC1OH)
TRIMETHYLSILOXYSILICATE (M/Q 0.6-0.8) (UNII: 5041RX63GN)
XANTHAN GUM (UNII: TTV12P4NEE)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 68343-003-04	118 mL in 1 TUBE; Type 0: Not a Combination Product	09/08/2017

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC monograph final	part352	09/08/2017

Labeler - Montani Cosmetics Inc (124852331)