NDC Code(s) : 43419-370-41
Packager : AMOREPACIFIC

Category : HUMAN PRESCRIPTION DRUG LABEL

DEA Schedule : none

Marketing Status : New Drug Application

INGREDIENTS AND APPEARANCE

IOPE SUPER VITAL EXTRA MOIST BASETITANIUM DIOXIDE, OCTINOXATE, and ZINC OXIDE LOTION
Product Information
Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:43419-370
Route of Administration TOPICAL DEA Schedule
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
TITANIUM DIOXIDE(UNII: 15FIX9V2JP)
(TITANIUM DIOXIDE - UNII:15FIX9V2JP) 		TITANIUM DIOXIDE0.8715 g in 35 mL
OCTINOXATE(UNII: 4Y5P7MUD51)
(OCTINOXATE - UNII:4Y5P7MUD51) 		OCTINOXATE1.75 g in 35 mL
ZINC OXIDE(UNII: SOI2LOH54Z)
(ZINC OXIDE - UNII:SOI2LOH54Z) 		ZINC OXIDE0.343 g in 35 mL
Inactive Ingredients
Ingredient Name Strength
WATER(UNII: 059QF0KO0R)
CYCLOMETHICONE 5(UNII: 0THT5PCI0R)
BUTYLENE GLYCOL(UNII: 3XUS85K0RA)
CYCLOMETHICONE 6(UNII: XHK3U310BA)
ASTROCARYUM MURUMURU SEED BUTTER(UNII: 12V64UPU6R)
GLYCERIN(UNII: PDC6A3C0OX)
DICAPRYLYL CARBONATE(UNII: 609A3V1SUA)
TRIETHYLHEXANOIN(UNII: 7K3W1BIU6K)
SQUALANE(UNII: GW89575KF9)
SILICON DIOXIDE(UNII: ETJ7Z6XBU4)
SODIUM CHLORIDE(UNII: 451W47IQ8X)
DISTEARDIMONIUM HECTORITE(UNII: X687XDK09L)
SORBITAN ISOSTEARATE(UNII: 01S2G2C1E4)
CALCIUM STEARATE(UNII: 776XM7047L)
ALUMINUM HYDROXIDE(UNII: 5QB0T2IUN0)
SORBITAN SESQUIOLEATE(UNII: 0W8RRI5W5A)
N-ACETYLGLUCOSAMINE(UNII: V956696549)
DIMETHICONE(UNII: 92RU3N3Y1O)
STEARIC ACID(UNII: 4ELV7Z65AP)
CAPRYLYL GLYCOL(UNII: 00YIU5438U)
CERAMIDE 3(UNII: 4370DF050B)
NIACINAMIDE(UNII: 25X51I8RD4)
CHROMIUM HYDROXIDE GREEN(UNII: RV8FT8XF5R)
PHYTOSPHINGOSINE(UNII: GIN46U9Q2Q)
TRIETHOXYCAPRYLYLSILANE(UNII: LDC331P08E)
EDETATE DISODIUM(UNII: 7FLD91C86K)
ETHYLHEXYLGLYCERIN(UNII: 147D247K3P)
ULTRAMARINE BLUE(UNII: I39WR998BI)
1,2-HEXANEDIOL(UNII: TR046Y3K1G)
CHROMIC OXIDE(UNII: X5Z09SU859)
FERRIC OXIDE YELLOW(UNII: EX438O2MRT)
RIBES NIGRUM SEED OIL(UNII: GKE1188837)
CARNAUBA WAX(UNII: R12CBM0EIZ)
HYALURONIC ACID(UNII: S270N0TRQY)
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)
ASCORBIC ACID(UNII: PQ6CK8PD0R)
COCOA(UNII: D9108TZ9KG)
ALCOHOL(UNII: 3K9958V90M)
.BETA.-CAROTENE(UNII: 01YAE03M7J)
.ALPHA.-TOCOPHEROL ACETATE(UNII: 9E8X80D2L0)
PREZATIDE COPPER(UNII: 6BJQ43T1I9)
PURSLANE(UNII: M6S840WXG5)
PHENOXYETHANOL(UNII: HIE492ZZ3T)
CAFFEIC ACID(UNII: U2S3A33KVM)
Packaging
# Item Code Package Description Marketing Start Date Marketing End Date
1NDC:43419-370-411 in 1 CARTON
135 mL in 1 CONTAINER
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 BASE

SUNSCREEN
BROAD SPECTRUM
[SPF 22]

35 ml/1.1 FL.OZ.

Principal Display Panel - 35 ml Container Carton