NDC Code(s) : 52257-1206-1
Packager : ATOMY CO., LTD.

Category : HUMAN PRESCRIPTION DRUG LABEL

DEA Schedule : none

Marketing Status : New Drug Application

INGREDIENTS AND APPEARANCE

ATOMY BB TITANIUM DIOXIDE, OCTINOXATE, ZINC OXIDE CREAM
Product Information
Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:52257-1206
Route of Administration TOPICAL DEA Schedule
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
TITANIUM DIOXIDE(UNII: 15FIX9V2JP)
(TITANIUM - UNII:D1JT611TNE) 		TITANIUM DIOXIDE3.168 mL in 40 mL
OCTINOXATE(UNII: 4Y5P7MUD51)
(OCTINOXATE - UNII:4Y5P7MUD51) 		OCTINOXATE1.2 mL in 40 mL
ZINC OXIDE(UNII: SOI2LOH54Z)
(ZINC CATION - UNII:13S1S8SF37) 		ZINC OXIDE0.768 mL in 40 mL
Inactive Ingredients
Ingredient Name Strength
WATER(UNII: 059QF0KO0R)
BUTYLENE GLYCOL(UNII: 3XUS85K0RA)
CYCLOMETHICONE(UNII: NMQ347994Z)
DIMETHICONE(UNII: 92RU3N3Y1O)
ISOPROPYL PALMITATE(UNII: 8CRQ2TH63M)
PRUNUS DULCIS BARK(UNII: 32F32E1WJJ)
TALC(UNII: 7SEV7J4R1U)
ARBUTIN(UNII: C5INA23HXF)
PURSLANE(UNII: M6S840WXG5)
GREEN TEA LEAF(UNII: W2ZU1RY8B0)
MELISSA OFFICINALIS LEAF(UNII: 50D2ZE9219)
ROSEMARY(UNII: IJ67X351P9)
ALTHAEA OFFICINALIS LEAF(UNII: E2QQV92338)
BORAGE(UNII: PB618V0K2W)
GLYCERYL CAPRYLATE(UNII: TM2TZD4G4A)
CAPRYLYL GLYCOL(UNII: 00YIU5438U)
TRIHYDROXYSTEARIN(UNII: 06YD7896S3)
SILICON DIOXIDE(UNII: ETJ7Z6XBU4)
ALUMINUM HYDROXIDE(UNII: 5QB0T2IUN0)
ALUMINUM STEARATE(UNII: U6XF9NP8HM)
SULFUR(UNII: 70FD1KFU70)
Packaging
# Item Code Package Description Marketing Start Date Marketing End Date
1NDC:52257-1206-140 mL 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

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