NDC Code(s) : 59535-1001-1
Packager : AMI Cosmetic Co.,Ltd.

Category : HUMAN PRESCRIPTION DRUG LABEL

DEA Schedule : none

Marketing Status : New Drug Application

INGREDIENTS AND APPEARANCE

GOLD CAVIAR BB Zinc oxide CREAM
Product Information
Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:59535-1001
Route of Administration TOPICAL DEA Schedule
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
Zinc oxide(UNII: SOI2LOH54Z)
(Zinc oxide - UNII:SOI2LOH54Z) 		Zinc oxide0.07 g in 1 g
Inactive Ingredients
Ingredient Name Strength
WATER(UNII: 059QF0KO0R)
OCTINOXATE(UNII: 4Y5P7MUD51)
CYCLOMETHICONE 5(UNII: 0THT5PCI0R)
TITANIUM DIOXIDE(UNII: 15FIX9V2JP)
BUTYLENE GLYCOL(UNII: 3XUS85K0RA)
SORBITAN SESQUIOLEATE(UNII: 0W8RRI5W5A)
ARBUTIN(UNII: C5INA23HXF)
CAVIAR, UNSPECIFIED(UNII: 020K6HLU0O)
Packaging
# Item Code Package Description Marketing Start Date Marketing End Date
1NDC:59535-1001-135 g in 1 TUBE
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
OTC monograph final part347 07/26/2013

PRINCIPAL DISPLAY PANEL

package insert