NDC Code(s) : 52257-1203-1
Packager : ATOMY CO., LTD.

Category : HUMAN PRESCRIPTION DRUG LABEL

DEA Schedule : none

Marketing Status : New Drug Application

INGREDIENTS AND APPEARANCE

ATOMY SUN OCTINOXATE, OCTISALATE, ZINC OXIDE, TITANIUM DIOXIDE CREAM
Product Information
Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:52257-1203
Route of Administration TOPICAL DEA Schedule
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
OCTINOXATE(UNII: 4Y5P7MUD51)
(OCTINOXATE - UNII:4Y5P7MUD51) 		OCTINOXATE4.5 mL in 60 mL
OCTISALATE(UNII: 4X49Y0596W)
(OCTISALATE - UNII:4X49Y0596W) 		OCTISALATE3 mL in 60 mL
ZINC OXIDE(UNII: SOI2LOH54Z)
(ZINC CATION - UNII:13S1S8SF37) 		ZINC OXIDE2.88 mL in 60 mL
TITANIUM DIOXIDE(UNII: 15FIX9V2JP)
(TITANIUM - UNII:D1JT611TNE) 		TITANIUM DIOXIDE1.49 mL in 60 mL
Inactive Ingredients
Ingredient Name Strength
WATER(UNII: 059QF0KO0R)
CYCLOMETHICONE 5(UNII: 0THT5PCI0R)
GLYCERIN(UNII: PDC6A3C0OX)
DIPROPYLENE GLYCOL(UNII: E107L85C40)
CYCLOMETHICONE(UNII: NMQ347994Z)
PHENOXYETHANOL(UNII: HIE492ZZ3T)
ALUMINUM HYDROXIDE(UNII: 5QB0T2IUN0)
ALUMINUM STEARATE(UNII: U6XF9NP8HM)
METHYLPARABEN(UNII: A2I8C7HI9T)
PROPYLPARABEN(UNII: Z8IX2SC1OH)
THYME OIL(UNII: 2UK410MY6B)
ALTHAEA OFFICINALIS LEAF(UNII: E2QQV92338)
MELISSA OFFICINALIS(UNII: YF70189L0N)
CENTELLA ASIATICA(UNII: 7M867G6T1U)
JASMINUM OFFICINALE FLOWER(UNII: 0Q8K841432)
BUTYLPARABEN(UNII: 3QPI1U3FV8)
Packaging
# Item Code Package Description Marketing Start Date Marketing End Date
1NDC:52257-1203-160 mL in 1 CARTON
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
OTC monograph final part352 04/28/2010

PRINCIPAL DISPLAY PANEL

Image of carton