NDC Code(s) : 43419-373-44, 43419-374-45
Packager : AMOREPACIFIC CORPORATION

Category : HUMAN PRESCRIPTION DRUG LABEL

DEA Schedule : none

Marketing Status : New Drug Application

INGREDIENTS AND APPEARANCE

IOPE SUPER VITAL TITANIUM DIOXIDE, OCTINOXATE, AND ZINC OXIDE POWDER
Product Information
Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:43419-373
Route of Administration TOPICAL DEA Schedule
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
OCTINOXATE(UNII: 4Y5P7MUD51)
(OCTINOXATE - UNII:4Y5P7MUD51) 		OCTINOXATE1.08 g in 18 g
TITANIUM DIOXIDE(UNII: 15FIX9V2JP)
(TITANIUM DIOXIDE - UNII:15FIX9V2JP) 		TITANIUM DIOXIDE1.11744 g in 18 g
ZINC OXIDE(UNII: SOI2LOH54Z)
(ZINC OXIDE - UNII:SOI2LOH54Z) 		ZINC OXIDE0.5292 g in 18 g
Inactive Ingredients
Ingredient Name Strength
TALC(UNII: 7SEV7J4R1U)
MICA(UNII: V8A1AW0880)
SILICON DIOXIDE(UNII: ETJ7Z6XBU4)
FERRIC OXIDE YELLOW(UNII: EX438O2MRT)
DIMETHICONE(UNII: 92RU3N3Y1O)
TRIETHOXYCAPRYLYLSILANE(UNII: LDC331P08E)
BUTYLENE GLYCOL DICAPRYLATE/DICAPRATE(UNII: 75D21FL1PI)
FERRIC OXIDE RED(UNII: 1K09F3G675)
ETHYLHEXYLGLYCERIN(UNII: 147D247K3P)
LAUROYL LYSINE(UNII: 113171Q70B)
GLYCERYL MONOCAPRYLATE(UNII: TM2TZD4G4A)
FERROSOFERRIC OXIDE(UNII: XM0M87F357)
ULTRAMARINE BLUE(UNII: I39WR998BI)
WATER(UNII: 059QF0KO0R)
GREEN TEA LEAF(UNII: W2ZU1RY8B0)
RIBES NIGRUM SEED OIL(UNII: GKE1188837)
GLYCERIN(UNII: PDC6A3C0OX)
CARNAUBA WAX(UNII: R12CBM0EIZ)
BUTYLENE GLYCOL(UNII: 3XUS85K0RA)
PROPANEDIOL(UNII: 5965N8W85T)
PENTYLENE GLYCOL(UNII: 50C1307PZG)
UBIDECARENONE(UNII: EJ27X76M46)
DECYL GLUCOSIDE(UNII: Z17H97EA6Y)
AMMONIUM ACRYLOYLDIMETHYLTAURATE/VP COPOLYMER(UNII: W59H9296ZG)
PEG-60 HYDROGENATED CASTOR OIL(UNII: 02NG325BQG)
TOCOPHEROL(UNII: R0ZB2556P8)
XANTHAN GUM(UNII: TTV12P4NEE)
CAFFEIC ACID(UNII: U2S3A33KVM)
ASCORBIC ACID(UNII: PQ6CK8PD0R)
COCOA(UNII: D9108TZ9KG)
ALCOHOL(UNII: 3K9958V90M)
CAPRYLYL GLYCOL(UNII: 00YIU5438U)
PREZATIDE COPPER(UNII: 6BJQ43T1I9)
.BETA.-CAROTENE(UNII: 01YAE03M7J)
.ALPHA.-TOCOPHEROL ACETATE(UNII: 9E8X80D2L0)
ALUMINUM HYDROXIDE(UNII: 5QB0T2IUN0)
PURSLANE(UNII: M6S840WXG5)
Packaging
# Item Code Package Description Marketing Start Date Marketing End Date
1NDC:43419-373-441 in 1 CARTON 02/01/2011
118 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 02/01/2011
IOPE SUPER VITAL TITANIUM DIOXIDE, OCTINOXATE, AND ZINC OXIDE POWDER
Product Information
Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:43419-374
Route of Administration TOPICAL DEA Schedule
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
OCTINOXATE(UNII: 4Y5P7MUD51)
(OCTINOXATE - UNII:4Y5P7MUD51) 		OCTINOXATE1.08 g in 18 g
TITANIUM DIOXIDE(UNII: 15FIX9V2JP)
(TITANIUM DIOXIDE - UNII:15FIX9V2JP) 		TITANIUM DIOXIDE1.11744 g in 18 g
ZINC OXIDE(UNII: SOI2LOH54Z)
(ZINC OXIDE - UNII:SOI2LOH54Z) 		ZINC OXIDE0.5292 g in 18 g
Inactive Ingredients
Ingredient Name Strength
TALC(UNII: 7SEV7J4R1U)
MICA(UNII: V8A1AW0880)
SILICON DIOXIDE(UNII: ETJ7Z6XBU4)
FERRIC OXIDE YELLOW(UNII: EX438O2MRT)
DIMETHICONE(UNII: 92RU3N3Y1O)
TRIETHOXYCAPRYLYLSILANE(UNII: LDC331P08E)
BUTYLENE GLYCOL DICAPRYLATE/DICAPRATE(UNII: 75D21FL1PI)
FERRIC OXIDE RED(UNII: 1K09F3G675)
ETHYLHEXYLGLYCERIN(UNII: 147D247K3P)
LAUROYL LYSINE(UNII: 113171Q70B)
GLYCERYL MONOCAPRYLATE(UNII: TM2TZD4G4A)
FERROSOFERRIC OXIDE(UNII: XM0M87F357)
ULTRAMARINE BLUE(UNII: I39WR998BI)
WATER(UNII: 059QF0KO0R)
GREEN TEA LEAF(UNII: W2ZU1RY8B0)
RIBES NIGRUM SEED OIL(UNII: GKE1188837)
GLYCERIN(UNII: PDC6A3C0OX)
CARNAUBA WAX(UNII: R12CBM0EIZ)
BUTYLENE GLYCOL(UNII: 3XUS85K0RA)
PROPANEDIOL(UNII: 5965N8W85T)
PENTYLENE GLYCOL(UNII: 50C1307PZG)
UBIDECARENONE(UNII: EJ27X76M46)
DECYL GLUCOSIDE(UNII: Z17H97EA6Y)
AMMONIUM ACRYLOYLDIMETHYLTAURATE/VP COPOLYMER(UNII: W59H9296ZG)
PEG-60 HYDROGENATED CASTOR OIL(UNII: 02NG325BQG)
TOCOPHEROL(UNII: R0ZB2556P8)
XANTHAN GUM(UNII: TTV12P4NEE)
CAFFEIC ACID(UNII: U2S3A33KVM)
ASCORBIC ACID(UNII: PQ6CK8PD0R)
COCOA(UNII: D9108TZ9KG)
ALCOHOL(UNII: 3K9958V90M)
CAPRYLYL GLYCOL(UNII: 00YIU5438U)
PREZATIDE COPPER(UNII: 6BJQ43T1I9)
.BETA.-CAROTENE(UNII: 01YAE03M7J)
.ALPHA.-TOCOPHEROL ACETATE(UNII: 9E8X80D2L0)
ALUMINUM HYDROXIDE(UNII: 5QB0T2IUN0)
PURSLANE(UNII: M6S840WXG5)
Packaging
# Item Code Package Description Marketing Start Date Marketing End Date
1NDC:43419-374-451 in 1 CARTON 02/01/2011
118 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 02/01/2011

PRINCIPAL DISPLAY PANEL

IOPE

IOPE

SUPER VITAL
EXTRA MOIST TWIN PACT

SUNSCREEN
[SPF 25]

Net wt. 18 g/0.6 OZ.

Principal Display Panel - 18 g Container Carton - #21

PRINCIPAL DISPLAY PANEL

IOPE

IOPE

SUPER VITAL
EXTRA MOIST TWIN PACT

SUNSCREEN
[SPF 25]

Net wt. 18 g/0.6 OZ.

Principal Display Panel - 18 g Container Carton - #23