NDC Code(s) : 43526-004-01, 43526-004-02
Packager : Inel Cosmetics Co., Ltd.

Category : HUMAN PRESCRIPTION DRUG LABEL

DEA Schedule : none

Marketing Status : New Drug Application

INGREDIENTS AND APPEARANCE

IPKN Moist and Firm BB 02 MEDIUM TITANIUM DIOXIDE, OCTINOXATE, ZINC OXIDE CREAM
Product Information
Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:43526-004
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 DIOXIDE3.308 mL in 40 mL
OCTINOXATE(UNII: 4Y5P7MUD51)
(OCTINOXATE - UNII:4Y5P7MUD51) 		OCTINOXATE1.2 mL in 40 mL
ZINC OXIDE(UNII: SOI2LOH54Z)
(ZINC OXIDE - UNII:SOI2LOH54Z) 		ZINC OXIDE0.768 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)
CERAMIDE 3(UNII: 4370DF050B)
PORK COLLAGEN(UNII: I8442U2G7J)
GOLD(UNII: 79Y1949PYO)
BUTYLENE GLYCOL(UNII: 3XUS85K0RA)
MENTHYL PYRROLIDONE CARBOXYLATE, (-),DL-(UNII: 8P18J856U2)
ETHYL MENTHANE CARBOXAMIDE(UNII: 6S7S02945H)
MICA(UNII: V8A1AW0880)
Packaging
# Item Code Package Description Marketing Start Date Marketing End Date
1NDC:43526-004-021 in 1 CARTON
1NDC:43526-004-0140 mL in 1 TUBE
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
OTC monograph not final part352 08/30/2012

PRINCIPAL DISPLAY PANEL

Image of Moist Firm 02