NDC Code(s) : 13733-326-01
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:13733-326
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
MEDIUM-CHAIN TRIGLYCERIDES(UNII: C9H2L21V7U)
DIMETHICONE(UNII: 92RU3N3Y1O)
CARBOMER INTERPOLYMER TYPE A (55000 CPS)(UNII: 59TL3WG5CO)
CAPRYLYL GLYCOL(UNII: 00YIU5438U)
BUTYLENE GLYCOL(UNII: 3XUS85K0RA)
ETHYLHEXYLGLYCERIN(UNII: 147D247K3P)
SODIUM HYDROXIDE(UNII: 55X04QC32I)
SODIUM ACRYLATE/SODIUM ACRYLOYLDIMETHYLTAURATE COPOLYMER (4000000 MW)(UNII: 1DXE3F3OZX)
BUTYLATED HYDROXYTOLUENE(UNII: 1P9D0Z171K)
POLYSORBATE 80(UNII: 6OZP39ZG8H)
EDETATE DISODIUM ANHYDROUS(UNII: 8NLQ36F6MM)
MESEMBRYANTHEMUM CRYSTALLINUM WHOLE(UNII: KFD19SXO43)
ROSA DAVURICA FLOWER BUD(UNII: XR42W0H5IU)
CYCLOMETHICONE 5(UNII: 0THT5PCI0R)
PHENOXYETHANOL(UNII: HIE492ZZ3T)
POTASSIUM SORBATE(UNII: 1VPU26JZZ4)
VINYLPYRROLIDONE/HEXADECENE COPOLYMER(UNII: KFR5QEN0N9)
ALCOHOL(UNII: 3K9958V90M)
1,1'-OXYBIS(2-PROPANOL)(UNII: D5SV08985Z)
BEMOTRIZINOL(UNII: PWZ1720CBH)
METHYL METHACRYLATE(UNII: 196OC77688)
WATER(UNII: 059QF0KO0R)
1,2-HEXANEDIOL(UNII: TR046Y3K1G)
LIMONIA ACIDISSIMA BARK(UNII: 68SJ7W9Y65)
ISOHEXADECANE(UNII: 918X1OUF1E)
GLYCERIN(UNII: PDC6A3C0OX)
Packaging
# Item Code Package Description Marketing Start Date Marketing End Date
1NDC:13733-326-0150 g in 1 TUBE Type 0: Not a Combination Product07/01/2017
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
OTC monograph not final part352 07/01/2017

PRINCIPAL DISPLAY PANEL

AllAroundSafeBlockAquaSunGel