NDC Code(s) : 43526-104-01, 43526-104-02
Packager : Inel Cosmetics Co., Ltd.

Category : HUMAN PRESCRIPTION DRUG LABEL

DEA Schedule : none

Marketing Status : New Drug Application

INGREDIENTS AND APPEARANCE

IPKN HYDRO AND PORE BB 01 LIGHT Titanium dioxide, Octinoxate, Octisalate, Zinc Oxide CREAM
Product Information
Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:43526-104
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 DIOXIDE4.0248 mL in 40 mL
OCTINOXATE(UNII: 4Y5P7MUD51)
(OCTINOXATE - UNII:4Y5P7MUD51) 		OCTINOXATE2.8 mL in 40 mL
OCTISALATE(UNII: 4X49Y0596W)
(OCTISALATE - UNII:4X49Y0596W) 		OCTISALATE2.0 mL in 40 mL
ZINC OXIDE(UNII: SOI2LOH54Z)
(ZINC OXIDE - UNII:SOI2LOH54Z) 		ZINC OXIDE1.392 mL in 40 mL
Inactive Ingredients
Ingredient Name Strength
WATER(UNII: 059QF0KO0R)
CYCLOMETHICONE 5(UNII: 0THT5PCI0R)
TALC(UNII: 7SEV7J4R1U)
GLYCERIN(UNII: PDC6A3C0OX)
ISOEICOSANE(UNII: AR294KAG3T)
PEG-10 DIMETHICONE (600 CST)(UNII: 8PR7V1SVM0)
DIPROPYLENE GLYCOL(UNII: E107L85C40)
NIACINAMIDE(UNII: 25X51I8RD4)
CYCLOMETHICONE(UNII: NMQ347994Z)
TRIETHYLHEXANOIN(UNII: 7K3W1BIU6K)
DISTEARYLDIMONIUM(UNII: 251IW5I21C)
HEXYL LAURATE(UNII: 4CG9F9W01Q)
MAGNESIUM SULFATE(UNII: DE08037SAB)
FERRIC OXIDE RED(UNII: 1K09F3G675)
C12-14 PARETH-3(UNII: 93RY22U87E)
PHENOXYETHANOL(UNII: HIE492ZZ3T)
METHICONE (20 CST)(UNII: 6777U11MKT)
DIMETHICONE(UNII: 92RU3N3Y1O)
PALMITIC ACID(UNII: 2V16EO95H1)
BETAINE(UNII: 3SCV180C9W)
ETHYLHEXYLGLYCERIN(UNII: 147D247K3P)
.ALPHA.-TOCOPHEROL ACETATE(UNII: 9E8X80D2L0)
PRUNUS SERRULATA FLOWER(UNII: 60I4615G0K)
ALUMINUM HYDROXIDE(UNII: 5QB0T2IUN0)
ALUMINUM STEARATE(UNII: U6XF9NP8HM)
ADENOSINE(UNII: K72T3FS567)
HEXYLDECYL MYRISTOYL METHYLAMINOPROPIONATE(UNII: 1959TW0O9A)
CENTELLA ASIATICA(UNII: 7M867G6T1U)
HIBISCUS SABDARIFFA FLOWER(UNII: 45TGG6IU6M)
MENTHA X ROTUNDIFOLIA LEAF(UNII: K59TXG2L3U)
BUTYLENE GLYCOL(UNII: 3XUS85K0RA)
MENTHYL PYRROLIDONE CARBOXYLATE, (-),DL-(UNII: 8P18J856U2)
ETHYL MENTHANE CARBOXAMIDE(UNII: 6S7S02945H)
MORINDA CITRIFOLIA LEAF(UNII: 7UOL7P5FF5)
UNDARIA PINNATIFIDA(UNII: ICV1OK7M1S)
HYSSOPUS OFFICINALIS FLOWERING TOP(UNII: X7HKN4FOJI)
CASTANEA SATIVA LEAF(UNII: IV3S2HH53G)
MORUS ALBA LEAF(UNII: M8YIA49Q2P)
PHELLINUS LINTEUS MYCELIUM(UNII: 40K19XJV3C)
CITRUS AURANTIUM FLOWER(UNII: O730ZX2Z83)
CITRUS BERGAMIA LEAF(UNII: ZGS96VDV4T)
FENNEL SEED(UNII: G3QC02NIE6)
HELICHRYSUM ITALICUM FLOWER(UNII: P62Y550X24)
JASMINUM OFFICINALE FLOWER(UNII: 0Q8K841432)
LAMINARIA DIGITATA(UNII: 15E7C67EE8)
LAVANDULA ANGUSTIFOLIA FLOWER(UNII: 19AH1RAF4M)
MELALEUCA ALTERNIFOLIA LEAF(UNII: G43C57162K)
PELARGONIUM GRAVEOLENS FLOWERING TOP(UNII: 1P36QZP48P)
PINUS DENSIFLORA BARK(UNII: U68X322T49)
TRIETHOXYCAPRYLYLSILANE(UNII: LDC331P08E)
CAVIAR, UNSPECIFIED(UNII: 020K6HLU0O)
HYALURONIC ACID(UNII: S270N0TRQY)
ARBUTIN(UNII: C5INA23HXF)
Packaging
# Item Code Package Description Marketing Start Date Marketing End Date
1NDC:43526-104-021 in 1 CARTON
1NDC:43526-104-0140 mL in 1 TUBE
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
OTC monograph not final part352 08/20/2012

PRINCIPAL DISPLAY PANEL