NDC Code(s) : 43419-350-18
Packager : AMOREPACIFIC CORPORATION

Category : HUMAN PRESCRIPTION DRUG LABEL

DEA Schedule : none

Marketing Status : New Drug Application

INGREDIENTS AND APPEARANCE

IOPE UV Defense Sun Protector SPF 50plusAVOBENZONE, OCTISALATE, HOMOSALATE, and OCTOCRYLENE CREAM
Product Information
Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:43419-350
Route of Administration TOPICAL DEA Schedule
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
AVOBENZONE(UNII: G63QQF2NOX)
(AVOBENZONE - UNII:G63QQF2NOX) 		AVOBENZONE1.8 g in 60 mL
OCTISALATE(UNII: 4X49Y0596W)
(OCTISALATE - UNII:4X49Y0596W) 		OCTISALATE2.7 g in 60 mL
HOMOSALATE(UNII: V06SV4M95S)
(HOMOSALATE - UNII:V06SV4M95S) 		HOMOSALATE5.4 g in 60 mL
OCTOCRYLENE(UNII: 5A68WGF6WM)
(OCTOCRYLENE - UNII:5A68WGF6WM) 		OCTOCRYLENE5.4 g in 60 mL
Inactive Ingredients
Ingredient Name Strength
WATER(UNII: 059QF0KO0R)
BUTYLENE GLYCOL(UNII: 3XUS85K0RA)
BUTYLOCTYL SALICYLATE(UNII: 2EH13UN8D3)
CYCLOMETHICONE 5(UNII: 0THT5PCI0R)
CYCLOMETHICONE 6(UNII: XHK3U310BA)
DOCOSANOL(UNII: 9G1OE216XY)
SILICON DIOXIDE(UNII: ETJ7Z6XBU4)
C14-22 ALCOHOLS(UNII: B1K89384RJ)
GLYCERYL STEARATE CITRATE(UNII: WH8T92A065)
PEG-100 STEARATE(UNII: YD01N1999R)
CHICORY ROOT(UNII: 090CTY533N)
C12-20 ALKYL GLUCOSIDE(UNII: K67N5Z1RUA)
GLYCERYL MONOCAPRYLATE(UNII: TM2TZD4G4A)
ETHYLHEXYLGLYCERIN(UNII: 147D247K3P)
EDETATE DISODIUM(UNII: 7FLD91C86K)
POLYSORBATE 20(UNII: 7T1F30V5YH)
Packaging
# Item Code Package Description Marketing Start Date Marketing End Date
1NDC:43419-350-181 in 1 CARTON 13/10/2014
160 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 10/13/2014

PRINCIPAL DISPLAY PANEL

IOPE

UV DEFENSE
SUN
PROTECTOR

SUNSCREEN
BROAD SPECTRUM
SPF50+

Advanced sun screen care with
high UVA/UVB protection.

BIOSCIENCE FORMULA

60 ml/2.02 FL.OZ.

PRINCIPAL DISPLAY PANEL - 60 mL Tube Carton