NDC Code(s) : 43419-313-06, 43419-311-06, 43419-312-06
Packager : AMOREPACIFIC

Category : HUMAN PRESCRIPTION DRUG LABEL

DEA Schedule : none

Marketing Status : New Drug Application

INGREDIENTS AND APPEARANCE

IOPE RETIGEN MOISTURE TWIN CAKE NO.17OCTINOXATE, TITANIUM DIOXIDE, and ZINC OXIDE CREAM
Product Information
Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:43419-313
Route of Administration TOPICAL DEA Schedule
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
OCTINOXATE(UNII: 4Y5P7MUD51)
(OCTINOXATE - UNII:4Y5P7MUD51) 		OCTINOXATE0.84 g in 14 g
TITANIUM DIOXIDE(UNII: 15FIX9V2JP)
(TITANIUM DIOXIDE - UNII:15FIX9V2JP) 		TITANIUM DIOXIDE0.868 g in 14 g
ZINC OXIDE(UNII: SOI2LOH54Z)
(ZINC OXIDE - UNII:SOI2LOH54Z) 		ZINC OXIDE0.4116 g in 14 g
Inactive Ingredients
Ingredient Name Strength
MICA(UNII: V8A1AW0880)
TALC(UNII: 7SEV7J4R1U)
SILICON DIOXIDE(UNII: ETJ7Z6XBU4)
BORON NITRIDE(UNII: 2U4T60A6YD)
NYLON-12(UNII: 446U8J075B)
TRIETHOXYCAPRYLYLSILANE(UNII: LDC331P08E)
DIISOSTEARYL MALATE(UNII: QBS8A3XZGQ)
FERRIC OXIDE YELLOW(UNII: EX438O2MRT)
PHENYL TRIMETHICONE(UNII: DR0K5NOJ4R)
FERRIC OXIDE RED(UNII: 1K09F3G675)
ETHYLHEXYLGLYCERIN(UNII: 147D247K3P)
LAUROYL LYSINE(UNII: 113171Q70B)
ALUMINUM HYDROXIDE(UNII: 5QB0T2IUN0)
GLYCERYL CAPRYLATE(UNII: TM2TZD4G4A)
DIMETHICONE(UNII: 92RU3N3Y1O)
WATER(UNII: 059QF0KO0R)
GREEN TEA LEAF(UNII: W2ZU1RY8B0)
FERROSOFERRIC OXIDE(UNII: XM0M87F357)
ULTRAMARINE BLUE(UNII: I39WR998BI)
BUTYLENE GLYCOL(UNII: 3XUS85K0RA)
GLYCERIN(UNII: PDC6A3C0OX)
PROPANEDIOL(UNII: 5965N8W85T)
.BETA.-CAROTENE(UNII: 01YAE03M7J)
CAPRYLYL GLYCOL(UNII: 00YIU5438U)
PHENOXYETHANOL(UNII: HIE492ZZ3T)
SODIUM BENZOATE(UNII: OJ245FE5EU)
POTASSIUM SORBATE(UNII: 1VPU26JZZ4)
Packaging
# Item Code Package Description Marketing Start Date Marketing End Date
1NDC:43419-313-0614 g in 1 CONTAINER
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 TWIN CAKE NO.21OCTINOXATE, TITANIUM DIOXIDE, and ZINC OXIDE CREAM
Product Information
Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:43419-311
Route of Administration TOPICAL DEA Schedule
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
OCTINOXATE(UNII: 4Y5P7MUD51)
(OCTINOXATE - UNII:4Y5P7MUD51) 		OCTINOXATE0.84 g in 14 g
TITANIUM DIOXIDE(UNII: 15FIX9V2JP)
(TITANIUM DIOXIDE - UNII:15FIX9V2JP) 		TITANIUM DIOXIDE0.868 g in 14 g
ZINC OXIDE(UNII: SOI2LOH54Z)
(ZINC OXIDE - UNII:SOI2LOH54Z) 		ZINC OXIDE0.4116 g in 14 g
Inactive Ingredients
Ingredient Name Strength
MICA(UNII: V8A1AW0880)
TALC(UNII: 7SEV7J4R1U)
SILICON DIOXIDE(UNII: ETJ7Z6XBU4)
BORON NITRIDE(UNII: 2U4T60A6YD)
NYLON-12(UNII: 446U8J075B)
TRIETHOXYCAPRYLYLSILANE(UNII: LDC331P08E)
DIISOSTEARYL MALATE(UNII: QBS8A3XZGQ)
FERRIC OXIDE YELLOW(UNII: EX438O2MRT)
PHENYL TRIMETHICONE(UNII: DR0K5NOJ4R)
FERRIC OXIDE RED(UNII: 1K09F3G675)
ETHYLHEXYLGLYCERIN(UNII: 147D247K3P)
LAUROYL LYSINE(UNII: 113171Q70B)
ALUMINUM HYDROXIDE(UNII: 5QB0T2IUN0)
GLYCERYL CAPRYLATE(UNII: TM2TZD4G4A)
DIMETHICONE(UNII: 92RU3N3Y1O)
WATER(UNII: 059QF0KO0R)
GREEN TEA LEAF(UNII: W2ZU1RY8B0)
FERROSOFERRIC OXIDE(UNII: XM0M87F357)
ULTRAMARINE BLUE(UNII: I39WR998BI)
BUTYLENE GLYCOL(UNII: 3XUS85K0RA)
GLYCERIN(UNII: PDC6A3C0OX)
PROPANEDIOL(UNII: 5965N8W85T)
.BETA.-CAROTENE(UNII: 01YAE03M7J)
CAPRYLYL GLYCOL(UNII: 00YIU5438U)
PHENOXYETHANOL(UNII: HIE492ZZ3T)
SODIUM BENZOATE(UNII: OJ245FE5EU)
POTASSIUM SORBATE(UNII: 1VPU26JZZ4)
Packaging
# Item Code Package Description Marketing Start Date Marketing End Date
1NDC:43419-311-0614 g in 1 CONTAINER
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 TWIN CAKE NO.23OCTINOXATE, TITANIUM DIOXIDE, and ZINC OXIDE CREAM
Product Information
Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:43419-312
Route of Administration TOPICAL DEA Schedule
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
OCTINOXATE(UNII: 4Y5P7MUD51)
(OCTINOXATE - UNII:4Y5P7MUD51) 		OCTINOXATE0.84 g in 14 g
TITANIUM DIOXIDE(UNII: 15FIX9V2JP)
(TITANIUM DIOXIDE - UNII:15FIX9V2JP) 		TITANIUM DIOXIDE0.868 g in 14 g
ZINC OXIDE(UNII: SOI2LOH54Z)
(ZINC OXIDE - UNII:SOI2LOH54Z) 		ZINC OXIDE0.4116 g in 14 g
Inactive Ingredients
Ingredient Name Strength
MICA(UNII: V8A1AW0880)
TALC(UNII: 7SEV7J4R1U)
SILICON DIOXIDE(UNII: ETJ7Z6XBU4)
BORON NITRIDE(UNII: 2U4T60A6YD)
NYLON-12(UNII: 446U8J075B)
TRIETHOXYCAPRYLYLSILANE(UNII: LDC331P08E)
DIISOSTEARYL MALATE(UNII: QBS8A3XZGQ)
FERRIC OXIDE YELLOW(UNII: EX438O2MRT)
PHENYL TRIMETHICONE(UNII: DR0K5NOJ4R)
FERRIC OXIDE RED(UNII: 1K09F3G675)
ETHYLHEXYLGLYCERIN(UNII: 147D247K3P)
LAUROYL LYSINE(UNII: 113171Q70B)
ALUMINUM HYDROXIDE(UNII: 5QB0T2IUN0)
GLYCERYL CAPRYLATE(UNII: TM2TZD4G4A)
DIMETHICONE(UNII: 92RU3N3Y1O)
WATER(UNII: 059QF0KO0R)
GREEN TEA LEAF(UNII: W2ZU1RY8B0)
FERROSOFERRIC OXIDE(UNII: XM0M87F357)
ULTRAMARINE BLUE(UNII: I39WR998BI)
BUTYLENE GLYCOL(UNII: 3XUS85K0RA)
GLYCERIN(UNII: PDC6A3C0OX)
PROPANEDIOL(UNII: 5965N8W85T)
.BETA.-CAROTENE(UNII: 01YAE03M7J)
CAPRYLYL GLYCOL(UNII: 00YIU5438U)
PHENOXYETHANOL(UNII: HIE492ZZ3T)
SODIUM BENZOATE(UNII: OJ245FE5EU)
POTASSIUM SORBATE(UNII: 1VPU26JZZ4)
Packaging
# Item Code Package Description Marketing Start Date Marketing End Date
1NDC:43419-312-0614 g in 1 CONTAINER
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 TWIN CAKE

SUNSCREEN
[SPF 25]

Net wt. 12 g/0.4 OZ.

Principal Display Panel - 12 g Container Carton - No.17

PRINCIPAL DISPLAY PANEL

IOPE

IOPE

RETIGEN
MOISTURE TWIN CAKE

SUNSCREEN
[SPF 25]

Net wt. 12 g/0.4 OZ.

Principal Display Panel - 12 g Container Carton - No.21

PRINCIPAL DISPLAY PANEL

IOPE

IOPE

RETIGEN
MOISTURE TWIN CAKE

SUNSCREEN
[SPF 25]

Net wt. 12 g/0.4 OZ.

Principal Display Panel - 12 g Container Carton - No.23