NDC Code(s) : 13733-316-01
Packager : ABLE C&C CO., LTD.

Category : HUMAN PRESCRIPTION DRUG LABEL

DEA Schedule : none

Marketing Status : New Drug Application

INGREDIENTS AND APPEARANCE

All Around Safe Block Essence SunOctinoxate, Octisalate, Ensulizole CREAM
Product Information
Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:13733-316
Route of Administration TOPICAL DEA Schedule
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
OCTINOXATE(UNII: 4Y5P7MUD51)
(OCTINOXATE - UNII:4Y5P7MUD51) 		OCTINOXATE7 mg in 1 g
OCTISALATE(UNII: 4X49Y0596W)
(OCTISALATE - UNII:4X49Y0596W) 		OCTISALATE4.8 mg in 1 g
ENSULIZOLE(UNII: 9YQ9DI1W42)
(ENSULIZOLE - UNII:9YQ9DI1W42) 		ENSULIZOLE4 mg in 1 g
Inactive Ingredients
Ingredient Name Strength
METHYL METHACRYLATE(UNII: 196OC77688)
BEMOTRIZINOL(UNII: PWZ1720CBH)
ALKYL (C12-15) BENZOATE(UNII: A9EJ3J61HQ)
DIETHYLAMINO HYDROXYBENZOYL HEXYL BENZOATE(UNII: ANQ870JD20)
CETOSTEARYL ALCOHOL(UNII: 2DMT128M1S)
GLYCERYL MONOSTEARATE(UNII: 230OU9XXE4)
CETEARYL OLIVATE(UNII: 58B69Q84JO)
WATER(UNII: 059QF0KO0R)
BUTYLENE GLYCOL(UNII: 3XUS85K0RA)
SORBITAN OLIVATE(UNII: MDL271E3GR)
Packaging
# Item Code Package Description Marketing Start Date Marketing End Date
1NDC:13733-316-0150 g in 1 BOTTLE Type 0: Not a Combination Product02/01/2012
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
OTC monograph not final part352 02/01/2012

PRINCIPAL DISPLAY PANEL

Missha All Around Safe Block Essence Sun SPF45