NDC Code(s) : 43419-304-03, 43419-305-03
Packager : AMOREPACIFIC

Category : HUMAN PRESCRIPTION DRUG LABEL

DEA Schedule : none

Marketing Status : New Drug Application

INGREDIENTS AND APPEARANCE

IOPE RETIGEN MOISTURE BASE NATURAL YELLOWOCTINOXATE, TITANIUM DIOXIDE, and ZINC OXIDE LOTION
Product Information
Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:43419-304
Route of Administration TOPICAL DEA Schedule
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
OCTINOXATE(UNII: 4Y5P7MUD51)
(OCTINOXATE - UNII:4Y5P7MUD51) 		OCTINOXATE2.45 g in 35 mL
TITANIUM DIOXIDE(UNII: 15FIX9V2JP)
(TITANIUM DIOXIDE - UNII:15FIX9V2JP) 		TITANIUM DIOXIDE0.581 g in 35 mL
ZINC OXIDE(UNII: SOI2LOH54Z)
(ZINC OXIDE - UNII:SOI2LOH54Z) 		ZINC OXIDE0.686 g in 35 mL
Inactive Ingredients
Ingredient Name Strength
WATER(UNII: 059QF0KO0R)
CYCLOMETHICONE 5(UNII: 0THT5PCI0R)
CYCLOMETHICONE 6(UNII: XHK3U310BA)
PHENYL TRIMETHICONE(UNII: DR0K5NOJ4R)
BUTYLENE GLYCOL(UNII: 3XUS85K0RA)
TRIETHYLHEXANOIN(UNII: 7K3W1BIU6K)
NEOPENTYL GLYCOL DIHEPTANOATE(UNII: 5LKW3C543X)
ARBUTIN(UNII: C5INA23HXF)
DIMETHICONE(UNII: 92RU3N3Y1O)
SQUALANE(UNII: GW89575KF9)
SODIUM CHLORIDE(UNII: 451W47IQ8X)
PHENOXYETHANOL(UNII: HIE492ZZ3T)
ALUMINUM HYDROXIDE(UNII: 5QB0T2IUN0)
CALCIUM STEARATE(UNII: 776XM7047L)
CAPRYLYL GLYCOL(UNII: 00YIU5438U)
STEARIC ACID(UNII: 4ELV7Z65AP)
SORBITAN SESQUIOLEATE(UNII: 0W8RRI5W5A)
GLYCERIN(UNII: PDC6A3C0OX)
TRIETHOXYCAPRYLYLSILANE(UNII: LDC331P08E)
FERRIC OXIDE YELLOW(UNII: EX438O2MRT)
ETHYLHEXYLGLYCERIN(UNII: 147D247K3P)
EDETATE DISODIUM(UNII: 7FLD91C86K)
SILICON DIOXIDE(UNII: ETJ7Z6XBU4)
ADENOSINE(UNII: K72T3FS567)
ALCOHOL(UNII: 3K9958V90M)
GREEN TEA LEAF(UNII: W2ZU1RY8B0)
HYALURONATE SODIUM(UNII: YSE9PPT4TH)
.BETA.-CAROTENE(UNII: 01YAE03M7J)
PROPANEDIOL(UNII: 5965N8W85T)
Packaging
# Item Code Package Description Marketing Start Date Marketing End Date
1NDC:43419-304-0335 mL in 1 BOTTLE, PUMP
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
OTC MONOGRAPH NOT FINAL part352 08/01/2011
IOPE RETIGEN MOISTURE BASE NATURAL GREENOCTINOXATE, TITANIUM DIOXIDE, and ZINC OXIDE LOTION
Product Information
Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:43419-305
Route of Administration TOPICAL DEA Schedule
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
OCTINOXATE(UNII: 4Y5P7MUD51)
(OCTINOXATE - UNII:4Y5P7MUD51) 		OCTINOXATE2.45 g in 35 mL
TITANIUM DIOXIDE(UNII: 15FIX9V2JP)
(TITANIUM DIOXIDE - UNII:15FIX9V2JP) 		TITANIUM DIOXIDE0.581 g in 35 mL
ZINC OXIDE(UNII: SOI2LOH54Z)
(ZINC OXIDE - UNII:SOI2LOH54Z) 		ZINC OXIDE0.686 g in 35 mL
Inactive Ingredients
Ingredient Name Strength
WATER(UNII: 059QF0KO0R)
CYCLOMETHICONE 5(UNII: 0THT5PCI0R)
CYCLOMETHICONE 6(UNII: XHK3U310BA)
PHENYL TRIMETHICONE(UNII: DR0K5NOJ4R)
BUTYLENE GLYCOL(UNII: 3XUS85K0RA)
TRIETHYLHEXANOIN(UNII: 7K3W1BIU6K)
NEOPENTYL GLYCOL DIHEPTANOATE(UNII: 5LKW3C543X)
ARBUTIN(UNII: C5INA23HXF)
DIMETHICONE(UNII: 92RU3N3Y1O)
SQUALANE(UNII: GW89575KF9)
SODIUM CHLORIDE(UNII: 451W47IQ8X)
PHENOXYETHANOL(UNII: HIE492ZZ3T)
ALUMINUM HYDROXIDE(UNII: 5QB0T2IUN0)
CALCIUM STEARATE(UNII: 776XM7047L)
CAPRYLYL GLYCOL(UNII: 00YIU5438U)
STEARIC ACID(UNII: 4ELV7Z65AP)
SORBITAN SESQUIOLEATE(UNII: 0W8RRI5W5A)
GLYCERIN(UNII: PDC6A3C0OX)
TRIETHOXYCAPRYLYLSILANE(UNII: LDC331P08E)
FERRIC OXIDE YELLOW(UNII: EX438O2MRT)
ETHYLHEXYLGLYCERIN(UNII: 147D247K3P)
EDETATE DISODIUM(UNII: 7FLD91C86K)
SILICON DIOXIDE(UNII: ETJ7Z6XBU4)
ADENOSINE(UNII: K72T3FS567)
ALCOHOL(UNII: 3K9958V90M)
GREEN TEA LEAF(UNII: W2ZU1RY8B0)
HYALURONATE SODIUM(UNII: YSE9PPT4TH)
.BETA.-CAROTENE(UNII: 01YAE03M7J)
CHROMIC OXIDE(UNII: X5Z09SU859)
ULTRAMARINE BLUE(UNII: I39WR998BI)
PROPANEDIOL(UNII: 5965N8W85T)
Packaging
# Item Code Package Description Marketing Start Date Marketing End Date
1NDC:43419-305-0335 mL in 1 BOTTLE, PUMP
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
OTC MONOGRAPH NOT FINAL part352 08/01/2011

PRINCIPAL DISPLAY PANEL

IOPE

IOPE
RETIGEN
MOISTURE BASE

SUNSCREEN
BROAD SPECTRUM
[SPF 34]

35 ml/1.1 FL.OZ.

PRINCIPAL DISPLAY PANEL - 35 ml Bottle Carton (natural yellow)

PRINCIPAL DISPLAY PANEL

IOPE

IOPE
RETIGEN
MOISTURE BASE

SUNSCREEN
BROAD SPECTRUM
[SPF 34]

35 ml/1.1 FL.OZ.

PRINCIPAL DISPLAY PANEL - 35 ml Bottle Carton (natural green)