NDC Code(s) : 43419-330-18
Packager : AMOREPACIFIC

Category : HUMAN PRESCRIPTION DRUG LABEL

DEA Schedule : none

Marketing Status : New Drug Application

INGREDIENTS AND APPEARANCE

IOPE BRIGHTGENOXYBENZONE, OCTINOXATE, OCTISALATE, HOMOSALATE, OCTOCRYLENE, and TITANIUM DIOXIDE CREAM
Product Information
Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:43419-330
Route of Administration TOPICAL DEA Schedule
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
OXYBENZONE(UNII: 95OOS7VE0Y)
(OXYBENZONE - UNII:95OOS7VE0Y) 		OXYBENZONE2.7 g in 60 mL
OCTINOXATE(UNII: 4Y5P7MUD51)
(OCTINOXATE - UNII:4Y5P7MUD51) 		OCTINOXATE4.2 g in 60 mL
OCTISALATE(UNII: 4X49Y0596W)
(OCTISALATE - UNII:4X49Y0596W) 		OCTISALATE2.7 g in 60 mL
HOMOSALATE(UNII: V06SV4M95S)
(HOMOSALATE - UNII:V06SV4M95S) 		HOMOSALATE3 g in 60 mL
OCTOCRYLENE(UNII: 5A68WGF6WM)
(OCTOCRYLENE - UNII:5A68WGF6WM) 		OCTOCRYLENE3 g in 60 mL
TITANIUM DIOXIDE(UNII: 15FIX9V2JP)
(TITANIUM DIOXIDE - UNII:15FIX9V2JP) 		TITANIUM DIOXIDE3.12 g in 60 mL
Inactive Ingredients
Ingredient Name Strength
WATER(UNII: 059QF0KO0R)
BUTYLENE GLYCOL(UNII: 3XUS85K0RA)
ALKYL (C12-15) BENZOATE(UNII: A9EJ3J61HQ)
PHENYL TRIMETHICONE(UNII: DR0K5NOJ4R)
GLYCERYL MONOSTEARATE(UNII: 230OU9XXE4)
PEG-100 STEARATE(UNII: YD01N1999R)
PEG-40 STEARATE(UNII: ECU18C66Q7)
CETOSTEARYL ALCOHOL(UNII: 2DMT128M1S)
ALUMINUM STEARATE(UNII: U6XF9NP8HM)
ALUMINUM OXIDE(UNII: LMI26O6933)
POLYHYDROXYSTEARIC ACID (2300 MW)(UNII: YXH47AOU0F)
PHENOXYETHANOL(UNII: HIE492ZZ3T)
STEARIC ACID(UNII: 4ELV7Z65AP)
XANTHAN GUM(UNII: TTV12P4NEE)
PURSLANE(UNII: M6S840WXG5)
MANNITOL(UNII: 3OWL53L36A)
ETHYLHEXYLGLYCERIN(UNII: 147D247K3P)
EDETATE DISODIUM(UNII: 7FLD91C86K)
POLYSORBATE 20(UNII: 7T1F30V5YH)
AMMONIUM GLYCYRRHIZATE(UNII: 3VRD35U26C)
NIACINAMIDE(UNII: 25X51I8RD4)
ZINC GLUCONATE(UNII: U6WSN5SQ1Z)
CAFFEINE(UNII: 3G6A5W338E)
HORSE CHESTNUT(UNII: 3C18L6RJAZ)
FENNEL SEED(UNII: G3QC02NIE6)
Packaging
# Item Code Package Description Marketing Start Date Marketing End Date
1NDC:43419-330-181 in 1 CARTON
160 mL in 1 TUBE
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
OTC MONOGRAPH NOT FINAL part352 08/24/2012

PRINCIPAL DISPLAY PANEL

IOPE

BRIGHTGEN
SUN CREAM

SUNSCREEN
SPF 50 +

CONTAINS SKINCHROMA
COMPLEX™

60 ml / 2.02 fl.oz.

Principal Display Panel - 60 ml Tube Carton