NDC Code(s) : 43419-367-03, 43419-367-12
Packager : AMOREPACIFIC

Category : HUMAN PRESCRIPTION DRUG LABEL

DEA Schedule : none

Marketing Status : New Drug Application

INGREDIENTS AND APPEARANCE

IOPE SUPER VITAL EXTRA MOIST B.BOCTINOXATE, TITANIUM DIOXIDE, and ZINC OXIDE LOTION
Product Information
Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:43419-367
Route of Administration TOPICAL DEA Schedule
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
OCTINOXATE(UNII: 4Y5P7MUD51)
(OCTINOXATE - UNII:4Y5P7MUD51) 		OCTINOXATE1.75 mL in 35 mL
TITANIUM DIOXIDE(UNII: 15FIX9V2JP)
(TITANIUM DIOXIDE - UNII:15FIX9V2JP) 		TITANIUM DIOXIDE0.8715 mL in 35 mL
ZINC OXIDE(UNII: SOI2LOH54Z)
(ZINC OXIDE - UNII:SOI2LOH54Z) 		ZINC OXIDE0.686 mL in 35 mL
Inactive Ingredients
Ingredient Name Strength
WATER(UNII: 059QF0KO0R)
BUTYLENE GLYCOL(UNII: 3XUS85K0RA)
CYCLOMETHICONE 5(UNII: 0THT5PCI0R)
CYCLOMETHICONE 6(UNII: XHK3U310BA)
CETYL ETHYLHEXANOATE(UNII: 134647WMX4)
PHENYL TRIMETHICONE(UNII: DR0K5NOJ4R)
DIMETHICONE(UNII: 92RU3N3Y1O)
METHYL TRIMETHICONE(UNII: S73ZQI0GXM)
TRIETHYLHEXANOIN(UNII: 7K3W1BIU6K)
SODIUM CHLORIDE(UNII: 451W47IQ8X)
OCTYLDODECYL MYRISTATE(UNII: S013N99GR8)
FERRIC OXIDE YELLOW(UNII: EX438O2MRT)
ALUMINUM HYDROXIDE(UNII: 5QB0T2IUN0)
PHENOXYETHANOL(UNII: HIE492ZZ3T)
STEARIC ACID(UNII: 4ELV7Z65AP)
FERRIC OXIDE RED(UNII: 1K09F3G675)
TRIETHOXYCAPRYLYLSILANE(UNII: LDC331P08E)
POLYSORBATE 80(UNII: 6OZP39ZG8H)
FERROSOFERRIC OXIDE(UNII: XM0M87F357)
ETHYLHEXYLGLYCERIN(UNII: 147D247K3P)
EDETATE DISODIUM(UNII: 7FLD91C86K)
ADENOSINE(UNII: K72T3FS567)
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)
DECYL GLUCOSIDE(UNII: Z17H97EA6Y)
WHEAT GERM(UNII: YR3G369F5A)
POLYOXYL 60 HYDROGENATED CASTOR OIL(UNII: 02NG325BQG)
XANTHAN GUM(UNII: TTV12P4NEE)
CAFFEIC ACID(UNII: U2S3A33KVM)
ASCORBIC ACID(UNII: PQ6CK8PD0R)
COCOA(UNII: D9108TZ9KG)
ALCOHOL(UNII: 3K9958V90M)
CAPRYLYL GLYCOL(UNII: 00YIU5438U)
BETA CAROTENE(UNII: 01YAE03M7J)
Packaging
# Item Code Package Description Marketing Start Date Marketing End Date
1NDC:43419-367-0335 mL in 1 BOTTLE, PUMP
2NDC:43419-367-125 mL in 1 BOTTLE, PUMP
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
OTC MONOGRAPH NOT FINAL part352 06/01/2011

PRINCIPAL DISPLAY PANEL

IOPE

IOPE

SUPER VITAL
EXTRA MOIST

B ∙ B

PRINCIPAL DISPLAY PANEL - 35 ml Carton