NDC Code(s) : 43419-365-01
Packager : AMOREPACIFIC CORPORATION

Category : HUMAN PRESCRIPTION DRUG LABEL

DEA Schedule : none

Marketing Status : New Drug Application

INGREDIENTS AND APPEARANCE

IOPE MEN UV DEFENSE SUN PROTECTORAVOBENZONE, HOMOSALATE, OCTISALATE, and OCTOCRYLENE LOTION
Product Information
Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:43419-365
Route of Administration TOPICAL DEA Schedule
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
AVOBENZONE(UNII: G63QQF2NOX)
(AVOBENZONE - UNII:G63QQF2NOX) 		AVOBENZONE1.25 g in 50 mL
HOMOSALATE(UNII: V06SV4M95S)
(HOMOSALATE - UNII:V06SV4M95S) 		HOMOSALATE4.5 g in 50 mL
OCTISALATE(UNII: 4X49Y0596W)
(OCTISALATE - UNII:4X49Y0596W) 		OCTISALATE2.25 g in 50 mL
OCTOCRYLENE(UNII: 5A68WGF6WM)
(OCTOCRYLENE - UNII:5A68WGF6WM) 		OCTOCRYLENE4.5 g in 50 mL
Inactive Ingredients
Ingredient Name Strength
WATER(UNII: 059QF0KO0R)
PROPANEDIOL(UNII: 5965N8W85T)
BUTYLOCTYL SALICYLATE(UNII: 2EH13UN8D3)
CYCLOMETHICONE 5(UNII: 0THT5PCI0R)
PHENYL TRIMETHICONE(UNII: DR0K5NOJ4R)
SILICON DIOXIDE(UNII: ETJ7Z6XBU4)
CYCLOMETHICONE 6(UNII: XHK3U310BA)
DOCOSANOL(UNII: 9G1OE216XY)
GLYCERYL MONOSTEARATE(UNII: 230OU9XXE4)
PEG-100 STEARATE(UNII: YD01N1999R)
C14-22 ALCOHOLS(UNII: B1K89384RJ)
POTASSIUM CETYL PHOSPHATE(UNII: 03KCY6P7UT)
CHICORY ROOT(UNII: 090CTY533N)
C12-20 ALKYL GLUCOSIDE(UNII: K67N5Z1RUA)
GLYCERYL MONOCAPRYLATE(UNII: TM2TZD4G4A)
ETHYLHEXYLGLYCERIN(UNII: 147D247K3P)
EDETATE DISODIUM ANHYDROUS(UNII: 8NLQ36F6MM)
POLYSORBATE 20(UNII: 7T1F30V5YH)
MANNITOL(UNII: 3OWL53L36A)
AMMONIUM GLYCYRRHIZATE(UNII: 3VRD35U26C)
CAFFEINE(UNII: 3G6A5W338E)
ZINC GLUCONATE(UNII: U6WSN5SQ1Z)
HORSE CHESTNUT(UNII: 3C18L6RJAZ)
Packaging
# Item Code Package Description Marketing Start Date Marketing End Date
1NDC:43419-365-011 in 1 CARTON 14/11/2016
150 mL in 1 TUBE Type 0: Not a Combination Product
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
OTC MONOGRAPH NOT FINAL part352 11/14/2016

PRINCIPAL DISPLAY PANEL

IOPE
MEN

UV DEFENSE
SUN
PROTECTOR

SUNSCREEN
BROAD SPECTRUM
SPF 50+

Sunscreen care with
high UVA/UVB protection.

BIOSCIENCE FORMULA

50 ml/1.69 FL.OZ.

PRINCIPAL DISPLAY PANEL - 50 ml Tube Carton