NDC Code(s) : 43419-409-03, 43419-410-03
Packager : AMOREPACIFIC

Category : HUMAN PRESCRIPTION DRUG LABEL

DEA Schedule : none

Marketing Status : New Drug Application

INGREDIENTS AND APPEARANCE

IOPE SUPER VITAL EXTRA MOIST FOUNDATION No.21OCTINOXATE and TITANIUM DIOXIDE LOTION
Product Information
Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:43419-409
Route of Administration TOPICAL DEA Schedule
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
OCTINOXATE(UNII: 4Y5P7MUD51)
(OCTINOXATE - UNII:4Y5P7MUD51) 		OCTINOXATE1.75 g in 35 mL
TITANIUM DIOXIDE(UNII: 15FIX9V2JP)
(TITANIUM DIOXIDE - UNII:15FIX9V2JP) 		TITANIUM DIOXIDE0.35 g in 35 mL
Inactive Ingredients
Ingredient Name Strength
WATER(UNII: 059QF0KO0R)
CYCLOMETHICONE 5(UNII: 0THT5PCI0R)
BUTYLENE GLYCOL DICAPRYLATE/DICAPRATE(UNII: 75D21FL1PI)
BUTYLENE GLYCOL(UNII: 3XUS85K0RA)
PROPYLENE GLYCOL(UNII: 6DC9Q167V3)
CYCLOMETHICONE 6(UNII: XHK3U310BA)
DIMETHICONE(UNII: 92RU3N3Y1O)
POLY(METHYL METHACRYLATE; 450000 MW)(UNII: Z47NNT4J11)
LAURYL PEG-9 POLYDIMETHYLSILOXYETHYL DIMETHICONE(UNII: 25G622K2RA)
SODIUM CHLORIDE(UNII: 451W47IQ8X)
TRIBEHENIN(UNII: 8OC9U7TQZ0)
FERRIC OXIDE YELLOW(UNII: EX438O2MRT)
LAURYL PEG/PPG-18/18 METHICONE(UNII: ZJ5S27D9NX)
TALC(UNII: 7SEV7J4R1U)
DISTEARDIMONIUM HECTORITE(UNII: X687XDK09L)
ASTROCARYUM MURUMURU SEED BUTTER(UNII: 12V64UPU6R)
ALUMINUM HYDROXIDE(UNII: 5QB0T2IUN0)
SILICON DIOXIDE(UNII: ETJ7Z6XBU4)
FERRIC OXIDE RED(UNII: 1K09F3G675)
TRIETHOXYCAPRYLYLSILANE(UNII: LDC331P08E)
ETHYLHEXYL PALMITATE(UNII: 2865993309)
ISOSTEARIC ACID(UNII: X33R8U0062)
ISOPROPYL PALMITATE(UNII: 8CRQ2TH63M)
CAPRYLYL GLYCOL(UNII: 00YIU5438U)
ETHYLHEXYLGLYCERIN(UNII: 147D247K3P)
FERROSOFERRIC OXIDE(UNII: XM0M87F357)
STEARIC ACID(UNII: 4ELV7Z65AP)
EDETATE DISODIUM ANHYDROUS(UNII: 8NLQ36F6MM)
GREEN TEA LEAF(UNII: W2ZU1RY8B0)
RIBES NIGRUM SEED OIL(UNII: GKE1188837)
GLYCERIN(UNII: PDC6A3C0OX)
CARNAUBA WAX(UNII: R12CBM0EIZ)
PROPANEDIOL(UNII: 5965N8W85T)
PENTYLENE GLYCOL(UNII: 50C1307PZG)
UBIDECARENONE(UNII: EJ27X76M46)
DECYL GLUCOSIDE(UNII: Z17H97EA6Y)
AMMONIUM ACRYLOYLDIMETHYLTAURATE/VP COPOLYMER(UNII: W59H9296ZG)
TOCOPHEROL(UNII: R0ZB2556P8)
PEG-60 HYDROGENATED CASTOR OIL(UNII: 02NG325BQG)
PURSLANE(UNII: M6S840WXG5)
XANTHAN GUM(UNII: TTV12P4NEE)
ASCORBIC ACID(UNII: PQ6CK8PD0R)
CAFFEIC ACID(UNII: U2S3A33KVM)
COCOA(UNII: D9108TZ9KG)
.ALPHA.-TOCOPHEROL ACETATE(UNII: 9E8X80D2L0)
ALCOHOL(UNII: 3K9958V90M)
.BETA.-CAROTENE(UNII: 01YAE03M7J)
PREZATIDE COPPER(UNII: 6BJQ43T1I9)
Packaging
# Item Code Package Description Marketing Start Date Marketing End Date
1NDC:43419-409-031 in 1 CONTAINER 01/02/2018
135 mL in 1 BOTTLE, PUMP Type 7: Separate Products Requiring Cross Labeling
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
OTC monograph not final part352 01/02/2018
IOPE SUPER VITAL EXTRA MOIST FOUNDATION No.23OCTINOXATE and TITANIUM DIOXIDE LOTION
Product Information
Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:43419-410
Route of Administration TOPICAL DEA Schedule
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
OCTINOXATE(UNII: 4Y5P7MUD51)
(OCTINOXATE - UNII:4Y5P7MUD51) 		OCTINOXATE1.75 g in 35 mL
TITANIUM DIOXIDE(UNII: 15FIX9V2JP)
(TITANIUM DIOXIDE - UNII:15FIX9V2JP) 		TITANIUM DIOXIDE0.35 g in 35 mL
Inactive Ingredients
Ingredient Name Strength
WATER(UNII: 059QF0KO0R)
CYCLOMETHICONE 5(UNII: 0THT5PCI0R)
BUTYLENE GLYCOL DICAPRYLATE/DICAPRATE(UNII: 75D21FL1PI)
BUTYLENE GLYCOL(UNII: 3XUS85K0RA)
PROPYLENE GLYCOL(UNII: 6DC9Q167V3)
CYCLOMETHICONE 6(UNII: XHK3U310BA)
DIMETHICONE(UNII: 92RU3N3Y1O)
LAURYL PEG-9 POLYDIMETHYLSILOXYETHYL DIMETHICONE(UNII: 25G622K2RA)
POLY(METHYL METHACRYLATE; 450000 MW)(UNII: Z47NNT4J11)
SODIUM CHLORIDE(UNII: 451W47IQ8X)
TRIBEHENIN(UNII: 8OC9U7TQZ0)
FERRIC OXIDE YELLOW(UNII: EX438O2MRT)
LAURYL PEG/PPG-18/18 METHICONE(UNII: ZJ5S27D9NX)
TALC(UNII: 7SEV7J4R1U)
DISTEARDIMONIUM HECTORITE(UNII: X687XDK09L)
ASTROCARYUM MURUMURU SEED BUTTER(UNII: 12V64UPU6R)
ALUMINUM HYDROXIDE(UNII: 5QB0T2IUN0)
SILICON DIOXIDE(UNII: ETJ7Z6XBU4)
FERRIC OXIDE RED(UNII: 1K09F3G675)
TRIETHOXYCAPRYLYLSILANE(UNII: LDC331P08E)
FERROSOFERRIC OXIDE(UNII: XM0M87F357)
ETHYLHEXYL PALMITATE(UNII: 2865993309)
ISOSTEARIC ACID(UNII: X33R8U0062)
ISOPROPYL PALMITATE(UNII: 8CRQ2TH63M)
CAPRYLYL GLYCOL(UNII: 00YIU5438U)
ETHYLHEXYLGLYCERIN(UNII: 147D247K3P)
STEARIC ACID(UNII: 4ELV7Z65AP)
EDETATE DISODIUM ANHYDROUS(UNII: 8NLQ36F6MM)
GREEN TEA LEAF(UNII: W2ZU1RY8B0)
RIBES NIGRUM SEED OIL(UNII: GKE1188837)
GLYCERIN(UNII: PDC6A3C0OX)
CARNAUBA WAX(UNII: R12CBM0EIZ)
PROPANEDIOL(UNII: 5965N8W85T)
PENTYLENE GLYCOL(UNII: 50C1307PZG)
UBIDECARENONE(UNII: EJ27X76M46)
DECYL GLUCOSIDE(UNII: Z17H97EA6Y)
AMMONIUM ACRYLOYLDIMETHYLTAURATE/VP COPOLYMER(UNII: W59H9296ZG)
TOCOPHEROL(UNII: R0ZB2556P8)
PEG-60 HYDROGENATED CASTOR OIL(UNII: 02NG325BQG)
PURSLANE(UNII: M6S840WXG5)
XANTHAN GUM(UNII: TTV12P4NEE)
ASCORBIC ACID(UNII: PQ6CK8PD0R)
CAFFEIC ACID(UNII: U2S3A33KVM)
COCOA(UNII: D9108TZ9KG)
.ALPHA.-TOCOPHEROL ACETATE(UNII: 9E8X80D2L0)
ALCOHOL(UNII: 3K9958V90M)
.BETA.-CAROTENE(UNII: 01YAE03M7J)
PREZATIDE COPPER(UNII: 6BJQ43T1I9)
Packaging
# Item Code Package Description Marketing Start Date Marketing End Date
1NDC:43419-410-031 in 1 CONTAINER 01/02/2018
135 mL in 1 BOTTLE, PUMP Type 7: Separate Products Requiring Cross Labeling
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
OTC monograph not final part352 01/02/2018

PRINCIPAL DISPLAY PANEL

IOPE

IOPE

SUPER VITAL
EXTRA MOIST FOUNDATION

SUNSCREEN
BROAD SPECTRUM
[SPF 12]

35 ml / 1.1 FL.OZ.

PRINCIPAL DISPLAY PANEL - 35 ml Bottle Container - No.21

PRINCIPAL DISPLAY PANEL

IOPE

IOPE

SUPER VITAL
EXTRA MOIST FOUNDATION

SUNSCREEN
BROAD SPECTRUM
[SPF 12]

35 ml / 1.1 FL.OZ.

PRINCIPAL DISPLAY PANEL - 35 ml Bottle Container - No.23