NDC Code(s) : 13733-390-01
Packager : Able C&C Co., Ltd.

Category : HUMAN PRESCRIPTION DRUG LABEL

DEA Schedule : none

Marketing Status : New Drug Application

INGREDIENTS AND APPEARANCE

MISSHA All Around Safe Block Daily Sun For Men SPF50Homosalate, Octisalate, Avobenzone, Octocrylene LOTION
Product Information
Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:13733-390
Route of Administration TOPICAL DEA Schedule
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
AVOBENZONE(UNII: G63QQF2NOX)
(AVOBENZONE - UNII:G63QQF2NOX) 		AVOBENZONE1.5 g in 50 mL
OCTOCRYLENE(UNII: 5A68WGF6WM)
(OCTOCRYLENE - UNII:5A68WGF6WM) 		OCTOCRYLENE0.5 g in 50 mL
HOMOSALATE(UNII: V06SV4M95S)
(HOMOSALATE - UNII:V06SV4M95S) 		HOMOSALATE3.5 g in 50 mL
OCTISALATE(UNII: 4X49Y0596W)
(OCTISALATE - UNII:4X49Y0596W) 		OCTISALATE2.25 g in 50 mL
Inactive Ingredients
Ingredient Name Strength
WATER(UNII: 059QF0KO0R)
ALCOHOL(UNII: 3K9958V90M)
CARBOMER INTERPOLYMER TYPE A (55000 CPS)(UNII: 59TL3WG5CO)
DIMETHICONE(UNII: 92RU3N3Y1O)
PHENOXYETHANOL(UNII: HIE492ZZ3T)
PUERARIA MONTANA VAR. LOBATA ROOT(UNII: PET93F4I3C)
METHYL METHACRYLATE(UNII: 196OC77688)
BEMOTRIZINOL(UNII: PWZ1720CBH)
1,1'-OXYBIS(2-PROPANOL)(UNII: D5SV08985Z)
AMILOXATE(UNII: 376KTP06K8)
AMMONIUM ACRYLOYLDIMETHYLTAURATE/VP COPOLYMER(UNII: W59H9296ZG)
CAPRYLYL GLYCOL(UNII: 00YIU5438U)
POTASSIUM HYDROXIDE(UNII: WZH3C48M4T)
BUTYLENE GLYCOL(UNII: 3XUS85K0RA)
TEA TREE OIL(UNII: VIF565UC2G)
1,2-HEXANEDIOL(UNII: TR046Y3K1G)
BUTYLATED HYDROXYTOLUENE(UNII: 1P9D0Z171K)
EDETATE DISODIUM ANHYDROUS(UNII: 8NLQ36F6MM)
RHUS CHINENSIS GALL(UNII: 4W3Y2V7J3R)
GLYCERIN(UNII: PDC6A3C0OX)
MESEMBRYANTHEMUM CRYSTALLINUM WHOLE(UNII: KFD19SXO43)
DIOSPYROS KAKI LEAF(UNII: Q71GF9OBNO)
ARTEMISIA PRINCEPS LEAF(UNII: SY077EW02G)
CHINESE CINNAMON(UNII: WS4CQ062KM)
ETHYLHEXYLGLYCERIN(UNII: 147D247K3P)
GREEN TEA LEAF(UNII: W2ZU1RY8B0)
CHRYSANTHEMUM INDICUM FLOWER(UNII: I6OER6U04L)
PENTYLENE GLYCOL(UNII: 50C1307PZG)
WHITE MULBERRY(UNII: MN25R0HH5A)
Packaging
# Item Code Package Description Marketing Start Date Marketing End Date
1NDC:13733-390-0150 mL in 1 CARTON Type 0: Not a Combination Product11/08/2017
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
OTC monograph not final part352 11/08/2017

PRINCIPAL DISPLAY PANEL

MISSHA All Around Safe Block Daily Sun For Men SPF50