NDC Code(s) : 43419-380-21, 43419-381-21
Packager : AMOREPACIFIC

Category : HUMAN PRESCRIPTION DRUG LABEL

DEA Schedule : none

Marketing Status : New Drug Application

INGREDIENTS AND APPEARANCE

IOPE AIR CUSHION XPOCTINOXATE, TITANIUM DIOXIDE, and ZINC OXIDE LOTION
Product Information
Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:43419-380
Route of Administration TOPICAL DEA Schedule
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
OCTINOXATE(UNII: 4Y5P7MUD51)
(OCTINOXATE - UNII:4Y5P7MUD51) 		OCTINOXATE1.05 g in 15 g
TITANIUM DIOXIDE(UNII: 15FIX9V2JP)
(TITANIUM DIOXIDE - UNII:15FIX9V2JP) 		TITANIUM DIOXIDE0.6225 g in 15 g
ZINC OXIDE(UNII: SOI2LOH54Z)
(ZINC OXIDE - UNII:SOI2LOH54Z) 		ZINC OXIDE1.47 g in 15 g
Inactive Ingredients
Ingredient Name Strength
WATER(UNII: 059QF0KO0R)
CYCLOMETHICONE 5(UNII: 0THT5PCI0R)
CYCLOMETHICONE 6(UNII: XHK3U310BA)
PHENYL TRIMETHICONE(UNII: DR0K5NOJ4R)
BUTYLENE GLYCOL DICAPRYLATE/DICAPRATE(UNII: 75D21FL1PI)
PROPYLENE GLYCOL(UNII: 6DC9Q167V3)
ARBUTIN(UNII: C5INA23HXF)
LAURYL PEG-9 POLYDIMETHYLSILOXYETHYL DIMETHICONE(UNII: 25G622K2RA)
PROPANEDIOL(UNII: 5965N8W85T)
BUTYLENE GLYCOL(UNII: 3XUS85K0RA)
DIMETHICONE(UNII: 92RU3N3Y1O)
SODIUM CHLORIDE(UNII: 451W47IQ8X)
ALUMINUM HYDROXIDE(UNII: 5QB0T2IUN0)
DISTEARDIMONIUM HECTORITE(UNII: X687XDK09L)
PHENOXYETHANOL(UNII: HIE492ZZ3T)
STEARIC ACID(UNII: 4ELV7Z65AP)
TRIETHOXYCAPRYLYLSILANE(UNII: LDC331P08E)
ISOSTEARIC ACID(UNII: X33R8U0062)
ISOPROPYL PALMITATE(UNII: 8CRQ2TH63M)
ETHYLHEXYL PALMITATE(UNII: 2865993309)
GLYCERIN(UNII: PDC6A3C0OX)
ETHYLHEXYLGLYCERIN(UNII: 147D247K3P)
EDETATE DISODIUM(UNII: 7FLD91C86K)
ADENOSINE(UNII: K72T3FS567)
NELUMBO NUCIFERA FLOWER(UNII: 61W322NLDV)
PANTHENOL(UNII: WV9CM0O67Z)
HESPERIDIN(UNII: E750O06Y6O)
.ALPHA.-TOCOPHEROL ACETATE(UNII: 9E8X80D2L0)
PRUNUS MUME FRUIT(UNII: 639190I8CU)
SILICON DIOXIDE(UNII: ETJ7Z6XBU4)
LACTIC ACID(UNII: 33X04XA5AT)
CITRIC ACID MONOHYDRATE(UNII: 2968PHW8QP)
PANCRELIPASE LIPASE(UNII: 8MYC33932O)
FERRIC OXIDE YELLOW(UNII: EX438O2MRT)
FERRIC OXIDE RED(UNII: 1K09F3G675)
FERROSOFERRIC OXIDE(UNII: XM0M87F357)
Packaging
# Item Code Package Description Marketing Start Date Marketing End Date
1NDC:43419-380-212 in 1 CARTON
115 g in 1 CONTAINER
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
OTC MONOGRAPH NOT FINAL part352 08/14/2013
IOPE AIR CUSHION XPOCTINOXATE, TITANIUM DIOXIDE, and ZINC OXIDE LOTION
Product Information
Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:43419-381
Route of Administration TOPICAL DEA Schedule
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
OCTINOXATE(UNII: 4Y5P7MUD51)
(OCTINOXATE - UNII:4Y5P7MUD51) 		OCTINOXATE1.05 g in 15 g
TITANIUM DIOXIDE(UNII: 15FIX9V2JP)
(TITANIUM DIOXIDE - UNII:15FIX9V2JP) 		TITANIUM DIOXIDE0.6225 g in 15 g
ZINC OXIDE(UNII: SOI2LOH54Z)
(ZINC OXIDE - UNII:SOI2LOH54Z) 		ZINC OXIDE1.47 g in 15 g
Inactive Ingredients
Ingredient Name Strength
WATER(UNII: 059QF0KO0R)
CYCLOMETHICONE 5(UNII: 0THT5PCI0R)
CYCLOMETHICONE 6(UNII: XHK3U310BA)
PHENYL TRIMETHICONE(UNII: DR0K5NOJ4R)
BUTYLENE GLYCOL DICAPRYLATE/DICAPRATE(UNII: 75D21FL1PI)
PROPYLENE GLYCOL(UNII: 6DC9Q167V3)
ARBUTIN(UNII: C5INA23HXF)
LAURYL PEG-9 POLYDIMETHYLSILOXYETHYL DIMETHICONE(UNII: 25G622K2RA)
PROPANEDIOL(UNII: 5965N8W85T)
BUTYLENE GLYCOL(UNII: 3XUS85K0RA)
DIMETHICONE(UNII: 92RU3N3Y1O)
SODIUM CHLORIDE(UNII: 451W47IQ8X)
ALUMINUM HYDROXIDE(UNII: 5QB0T2IUN0)
DISTEARDIMONIUM HECTORITE(UNII: X687XDK09L)
STEARIC ACID(UNII: 4ELV7Z65AP)
PHENOXYETHANOL(UNII: HIE492ZZ3T)
TRIETHOXYCAPRYLYLSILANE(UNII: LDC331P08E)
ISOPROPYL PALMITATE(UNII: 8CRQ2TH63M)
ISOSTEARIC ACID(UNII: X33R8U0062)
ETHYLHEXYL PALMITATE(UNII: 2865993309)
GLYCERIN(UNII: PDC6A3C0OX)
ETHYLHEXYLGLYCERIN(UNII: 147D247K3P)
EDETATE DISODIUM(UNII: 7FLD91C86K)
ADENOSINE(UNII: K72T3FS567)
NELUMBO NUCIFERA FLOWER(UNII: 61W322NLDV)
HESPERIDIN(UNII: E750O06Y6O)
.ALPHA.-TOCOPHEROL ACETATE(UNII: 9E8X80D2L0)
PANTHENOL(UNII: WV9CM0O67Z)
PRUNUS MUME FRUIT(UNII: 639190I8CU)
SILICON DIOXIDE(UNII: ETJ7Z6XBU4)
CITRIC ACID MONOHYDRATE(UNII: 2968PHW8QP)
LACTIC ACID(UNII: 33X04XA5AT)
PANCRELIPASE LIPASE(UNII: 8MYC33932O)
FERRIC OXIDE YELLOW(UNII: EX438O2MRT)
FERRIC OXIDE RED(UNII: 1K09F3G675)
FERROSOFERRIC OXIDE(UNII: XM0M87F357)
Packaging
# Item Code Package Description Marketing Start Date Marketing End Date
1NDC:43419-381-212 in 1 CARTON
115 g in 1 CONTAINER
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
OTC MONOGRAPH NOT FINAL part352 08/14/2013

PRINCIPAL DISPLAY PANEL

IOPE

IOPE

AIR CUSHION XP
BROAD SPECTRUM SPF50+ SUNSCREEN
Net wt. 1.05 OZ. / 30 g (15 g X 2)

Principal Display Panel - 30 g Container Carton - Ice Vanilla

PRINCIPAL DISPLAY PANEL

IOPE

IOPE

AIR CUSHION XP
BROAD SPECTRUM SPF50+ SUNSCREEN
Net wt. 1.05 OZ. / 30 g (15 g X 2)

Principal Display Panel - 30 g Container Carton - Ice Beige