NDC Code(s) : 13733-234-01
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 Aqua Sun GelOctinoxate, Octocrylene, Octisalate, Avobenzone GEL
Product Information
Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:13733-234
Route of Administration CUTANEOUS DEA Schedule
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
OCTOCRYLENE(UNII: 5A68WGF6WM)
(OCTOCRYLENE - UNII:5A68WGF6WM) 		OCTOCRYLENE5 mg in 1 g
OCTINOXATE(UNII: 4Y5P7MUD51)
(OCTINOXATE - UNII:4Y5P7MUD51) 		OCTINOXATE7 mg in 1 g
OCTISALATE(UNII: 4X49Y0596W)
(OCTISALATE - UNII:4X49Y0596W) 		OCTISALATE4.5 mg in 1 g
AVOBENZONE(UNII: G63QQF2NOX)
(AVOBENZONE - UNII:G63QQF2NOX) 		AVOBENZONE3 mg in 1 g
Inactive Ingredients
Ingredient Name Strength
ALCOHOL(UNII: 3K9958V90M)
1,1'-OXYBIS(2-PROPANOL)(UNII: D5SV08985Z)
BEMOTRIZINOL(UNII: PWZ1720CBH)
METHYL METHACRYLATE(UNII: 196OC77688)
WATER(UNII: 059QF0KO0R)
Packaging
# Item Code Package Description Marketing Start Date Marketing End Date
1NDC:13733-234-0150 g in 1 TUBE Type 0: Not a Combination Product03/01/2017
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
OTC monograph not final part352 03/01/2017

PRINCIPAL DISPLAY PANEL

AllAroundSafeBlockAquaSunGel