NDC Code(s) : 51346-501-01, 51346-501-02
Packager : NATURE REPUBLIC CO., LTD.

Category : HUMAN PRESCRIPTION DRUG LABEL

DEA Schedule : none

Marketing Status : New Drug Application

INGREDIENTS AND APPEARANCE

CALIFORNIA ALOE AQUA SUNOctinoxate, Homosalate, Octisalate, Avobenzone GEL
Product Information
Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:51346-501
Route of Administration TOPICAL DEA Schedule
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
Octinoxate(UNII: 4Y5P7MUD51)
(OCTINOXATE - UNII:4Y5P7MUD51) 		Octinoxate3.60 g in 60 mL
Homosalate(UNII: V06SV4M95S)
(HOMOSALATE - UNII:V06SV4M95S) 		Homosalate3.00 g in 60 mL
Octisalate(UNII: 4X49Y0596W)
(OCTISALATE - UNII:4X49Y0596W) 		Octisalate2.40 g in 60 mL
Avobenzone(UNII: G63QQF2NOX)
(AVOBENZONE - UNII:G63QQF2NOX) 		Avobenzone1.68 g in 60 mL
Inactive Ingredients
Ingredient Name Strength
Water(UNII: 059QF0KO0R)
Dibutyl Adipate(UNII: F4K100DXP3)
Packaging
# Item Code Package Description Marketing Start Date Marketing End Date
1NDC:51346-501-021 in 1 CARTON 01/02/2018
1NDC:51346-501-0160 mL in 1 CONTAINER Type 0: Not a Combination Product
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
OTC monograph not final part352 01/02/2018

PRINCIPAL DISPLAY PANEL

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