NDC Code(s) : 52257-1200-1
Packager : ATOMY CO., LTD.

Category : HUMAN PRESCRIPTION DRUG LABEL

DEA Schedule : none

Marketing Status : New Drug Application

INGREDIENTS AND APPEARANCE

ATOMY MINERAL PACT TITANIUM DIOXIDE, ZINC OXIDE POWDER
Product Information
Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:52257-1200
Route of Administration TOPICAL DEA Schedule
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
TITANIUM DIOXIDE(UNII: 15FIX9V2JP)
(TITANIUM - UNII:D1JT611TNE) 		TITANIUM DIOXIDE2.20 g in 12 g
ZINC OXIDE(UNII: SOI2LOH54Z)
(ZINC CATION - UNII:13S1S8SF37) 		ZINC OXIDE0.23 g in 12 g
Inactive Ingredients
Ingredient Name Strength
MICA(UNII: V8A1AW0880)
TALC(UNII: 7SEV7J4R1U)
SILICON DIOXIDE(UNII: ETJ7Z6XBU4)
DIMETHICONE(UNII: 92RU3N3Y1O)
BORON NITRIDE(UNII: 2U4T60A6YD)
PHENYL TRIMETHICONE(UNII: DR0K5NOJ4R)
TRIETHYLHEXANOIN(UNII: 7K3W1BIU6K)
GLYCERYL CAPRYLATE(UNII: TM2TZD4G4A)
CAPRYLYL GLYCOL(UNII: 00YIU5438U)
ALUMINUM HYDROXIDE(UNII: 5QB0T2IUN0)
DISODIUM STEAROYL GLUTAMATE(UNII: 45ASM2L11M)
ALUMINUM DIMYRISTATE(UNII: J2KA067N9O)
MYRISTIC ACID(UNII: 0I3V7S25AW)
STARCH, CORN(UNII: O8232NY3SJ)
PISTACIA LENTISCUS RESIN(UNII: 7446H202QW)
ALUMINUM OXIDE(UNII: LMI26O6933)
CALCIUM CARBONATE(UNII: H0G9379FGK)
PROPOLIS WAX(UNII: 6Y8XYV2NOF)
ROYAL JELLY(UNII: L497I37F0C)
WATER(UNII: 059QF0KO0R)
Packaging
# Item Code Package Description Marketing Start Date Marketing End Date
1NDC:52257-1200-112 g in 1 CARTON
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
OTC monograph final part352 04/29/2010

PRINCIPAL DISPLAY PANEL

Image of carton