NDC Code(s) : 43419-388-06, 43419-387-06
Packager : AMOREPACIFIC

Category : HUMAN PRESCRIPTION DRUG LABEL

DEA Schedule : none

Marketing Status : New Drug Application

INGREDIENTS AND APPEARANCE

IOPE PERFECT SKIN COVER CAKE OCTINOXATE, TITANIUM DIOXIDE, and ZINC OXIDE CREAM
Product Information
Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:43419-388
Route of Administration TOPICAL DEA Schedule
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
OCTINOXATE(UNII: 4Y5P7MUD51)
(OCTINOXATE - UNII:4Y5P7MUD51) 		OCTINOXATE0.7 g in 14 g
TITANIUM DIOXIDE(UNII: 15FIX9V2JP)
(TITANIUM DIOXIDE - UNII:15FIX9V2JP) 		TITANIUM DIOXIDE0.3486 g in 14 g
ZINC OXIDE(UNII: SOI2LOH54Z)
(ZINC OXIDE - UNII:SOI2LOH54Z) 		ZINC OXIDE0.2744 g in 14 g
Inactive Ingredients
Ingredient Name Strength
WATER(UNII: 059QF0KO0R)
CYCLOMETHICONE 5(UNII: 0THT5PCI0R)
BUTYLENE GLYCOL DICAPRYLATE/DICAPRATE(UNII: 75D21FL1PI)
MEDIUM-CHAIN TRIGLYCERIDES(UNII: C9H2L21V7U)
CYCLOMETHICONE 6(UNII: XHK3U310BA)
GLYCERIN(UNII: PDC6A3C0OX)
BUTYLENE GLYCOL(UNII: 3XUS85K0RA)
BARIUM SULFATE(UNII: 25BB7EKE2E)
HIGH DENSITY POLYETHYLENE(UNII: UG00KM4WR7)
FERRIC OXIDE YELLOW(UNII: EX438O2MRT)
SORBITAN ISOSTEARATE(UNII: 01S2G2C1E4)
HEXAMETHYLENE DIISOCYANATE/TRIMETHYLOL HEXYLLACTONE CROSSPOLYMER(UNII: WB5K9Y35Y9)
SORBITAN SESQUIOLEATE(UNII: 0W8RRI5W5A)
VINYLPYRROLIDONE/HEXADECENE COPOLYMER(UNII: KFR5QEN0N9)
ALUMINUM HYDROXIDE(UNII: 5QB0T2IUN0)
CERESIN(UNII: Q1LS2UJO3A)
SODIUM CHLORIDE(UNII: 451W47IQ8X)
LAURYL PEG-9 POLYDIMETHYLSILOXYETHYL DIMETHICONE(UNII: 25G622K2RA)
DISTEARDIMONIUM HECTORITE(UNII: X687XDK09L)
STEARIC ACID(UNII: 4ELV7Z65AP)
BORON NITRIDE(UNII: 2U4T60A6YD)
GLYCERYL CAPRYLATE(UNII: TM2TZD4G4A)
EDETATE DISODIUM(UNII: 7FLD91C86K)
TRIETHOXYCAPRYLYLSILANE(UNII: LDC331P08E)
ADENOSINE(UNII: K72T3FS567)
ISOSTEARIC ACID(UNII: X33R8U0062)
ISOPROPYL PALMITATE(UNII: 8CRQ2TH63M)
ETHYLHEXYL PALMITATE(UNII: 2865993309)
ALCOHOL(UNII: 3K9958V90M)
SILICON DIOXIDE(UNII: ETJ7Z6XBU4)
MAGNESIUM MYRISTATE(UNII: Z1917F0578)
HYALURONATE SODIUM(UNII: YSE9PPT4TH)
HEXANEDIOL(UNII: ZIA319275I)
CAPRYLYL GLYCOL(UNII: 00YIU5438U)
FERRIC OXIDE RED(UNII: 1K09F3G675)
FERROSOFERRIC OXIDE(UNII: XM0M87F357)
Packaging
# Item Code Package Description Marketing Start Date Marketing End Date
1NDC:43419-388-061 in 1 CARTON
114 g in 1 CONTAINER 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 05/12/2015
IOPE PERFECT SKIN COVER CAKE OCTINOXATE, TITANIUM DIOXIDE, and ZINC OXIDE CREAM
Product Information
Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:43419-387
Route of Administration TOPICAL DEA Schedule
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
OCTINOXATE(UNII: 4Y5P7MUD51)
(OCTINOXATE - UNII:4Y5P7MUD51) 		OCTINOXATE0.7 g in 14 g
TITANIUM DIOXIDE(UNII: 15FIX9V2JP)
(TITANIUM DIOXIDE - UNII:15FIX9V2JP) 		TITANIUM DIOXIDE0.3486 g in 14 g
ZINC OXIDE(UNII: SOI2LOH54Z)
(ZINC OXIDE - UNII:SOI2LOH54Z) 		ZINC OXIDE0.2744 g in 14 g
Inactive Ingredients
Ingredient Name Strength
WATER(UNII: 059QF0KO0R)
CYCLOMETHICONE 5(UNII: 0THT5PCI0R)
BUTYLENE GLYCOL DICAPRYLATE/DICAPRATE(UNII: 75D21FL1PI)
MEDIUM-CHAIN TRIGLYCERIDES(UNII: C9H2L21V7U)
CYCLOMETHICONE 6(UNII: XHK3U310BA)
GLYCERIN(UNII: PDC6A3C0OX)
BUTYLENE GLYCOL(UNII: 3XUS85K0RA)
BARIUM SULFATE(UNII: 25BB7EKE2E)
HIGH DENSITY POLYETHYLENE(UNII: UG00KM4WR7)
FERRIC OXIDE YELLOW(UNII: EX438O2MRT)
SORBITAN ISOSTEARATE(UNII: 01S2G2C1E4)
HEXAMETHYLENE DIISOCYANATE/TRIMETHYLOL HEXYLLACTONE CROSSPOLYMER(UNII: WB5K9Y35Y9)
SORBITAN SESQUIOLEATE(UNII: 0W8RRI5W5A)
VINYLPYRROLIDONE/HEXADECENE COPOLYMER(UNII: KFR5QEN0N9)
ALUMINUM HYDROXIDE(UNII: 5QB0T2IUN0)
CERESIN(UNII: Q1LS2UJO3A)
SODIUM CHLORIDE(UNII: 451W47IQ8X)
LAURYL PEG-9 POLYDIMETHYLSILOXYETHYL DIMETHICONE(UNII: 25G622K2RA)
DISTEARDIMONIUM HECTORITE(UNII: X687XDK09L)
STEARIC ACID(UNII: 4ELV7Z65AP)
BORON NITRIDE(UNII: 2U4T60A6YD)
GLYCERYL CAPRYLATE(UNII: TM2TZD4G4A)
EDETATE DISODIUM(UNII: 7FLD91C86K)
TRIETHOXYCAPRYLYLSILANE(UNII: LDC331P08E)
ADENOSINE(UNII: K72T3FS567)
ISOSTEARIC ACID(UNII: X33R8U0062)
ISOPROPYL PALMITATE(UNII: 8CRQ2TH63M)
ETHYLHEXYL PALMITATE(UNII: 2865993309)
ALCOHOL(UNII: 3K9958V90M)
SILICON DIOXIDE(UNII: ETJ7Z6XBU4)
MAGNESIUM MYRISTATE(UNII: Z1917F0578)
HYALURONATE SODIUM(UNII: YSE9PPT4TH)
HEXANEDIOL(UNII: ZIA319275I)
CAPRYLYL GLYCOL(UNII: 00YIU5438U)
FERRIC OXIDE RED(UNII: 1K09F3G675)
FERROSOFERRIC OXIDE(UNII: XM0M87F357)
Packaging
# Item Code Package Description Marketing Start Date Marketing End Date
1NDC:43419-387-061 in 1 CARTON
114 g in 1 CONTAINER 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 05/12/2015

PRINCIPAL DISPLAY PANEL

IOPE

PERFECT SKIN
COVER CAKE

SUNSCREEN
BROAD SPECTRUM
SPF 32
HYALURONIC FORMULA

Net wt. 14 g/0.4 OZ.

PRINCIPAL DISPLAY PANEL - 14 g Container Carton - 21 Light Beige

PRINCIPAL DISPLAY PANEL

IOPE

PERFECT SKIN
COVER CAKE

SUNSCREEN
BROAD SPECTRUM
SPF 32
HYALURONIC FORMULA

Net wt. 14 g/0.4 OZ.

PRINCIPAL DISPLAY PANEL - 14 g Container Carton - 23 Natural Beige