NDC Code(s) : 42508-265-09
Packager : Arbonne International, LLC

Category : HUMAN PRESCRIPTION DRUG LABEL

DEA Schedule : none

Marketing Status : New Drug Application

INGREDIENTS AND APPEARANCE

Arbonne RE9 Advanced for Men Octisalate, Octocrylene, and Zinc Oxide LOTION
Product Information
Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:42508-265
Route of Administration TOPICAL DEA Schedule
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
Octisalate(UNII: 4X49Y0596W)
(Octisalate - UNII:4X49Y0596W) 		Octisalate50 mg in 1 mL
Octocrylene(UNII: 5A68WGF6WM)
(Octocrylene - UNII:5A68WGF6WM) 		Octocrylene80 mg in 1 mL
Zinc Oxide(UNII: SOI2LOH54Z)
(Zinc Oxide - UNII:SOI2LOH54Z) 		Zinc Oxide73.5 mg in 1 mL
Inactive Ingredients
Ingredient Name Strength
WATER(UNII: 059QF0KO0R)
C12-15 ALKYL BENZOATE(UNII: A9EJ3J61HQ)
GLYCERIN(UNII: PDC6A3C0OX)
GLYCERYL MONOSTEARATE(UNII: 230OU9XXE4)
CETOSTEARYL ALCOHOL(UNII: 2DMT128M1S)
SILICON DIOXIDE(UNII: ETJ7Z6XBU4)
POLYOXYL 40 STEARATE(UNII: 13A4J4NH9I)
DIMETHICONE(UNII: 92RU3N3Y1O)
POLYOXYL 20 CETOSTEARYL ETHER(UNII: YRC528SWUY)
ORANGE OIL(UNII: AKN3KSD11B)
LEMON OIL(UNII: I9GRO824LL)
CLOVE LEAF OIL(UNII: VCA5491KVF)
MALVA SYLVESTRIS LEAF(UNII: 17H39B00T5)
LAMINARIA DIGITATA(UNII: 15E7C67EE8)
PUERARIA MONTANA VAR. LOBATA ROOT(UNII: PET93F4I3C)
BILBERRY(UNII: 9P2U39H18W)
SUGARCANE(UNII: 81H2R5AOH3)
ORANGE(UNII: 5EVU04N5QU)
LEMON(UNII: 24RS0A988O)
ACER SACCHARUM BARK/SAP(UNII: Z120VL0KAC)
SOY PROTEIN(UNII: R44IWB3RN5)
ALPHA-TOCOPHEROL(UNII: H4N855PNZ1)
TETRAHEXYLDECYL ASCORBATE(UNII: 9LBV3F07AZ)
ALPHA LIPOIC ACID(UNII: 73Y7P0K73Y)
POLYISOBUTYLENE (1200000 MW)(UNII: FLT10CH37X)
POLYSORBATE 20(UNII: 7T1F30V5YH)
BUTYLENE GLYCOL(UNII: 3XUS85K0RA)
LEVOMENOL(UNII: 24WE03BX2T)
CARBOMER HOMOPOLYMER TYPE C(UNII: 4Q93RCW27E)
PALMITOYL TETRAPEPTIDE-7(UNII: Q41S464P1R)
SALICYLIC ACID(UNII: O414PZ4LPZ)
CAPRYLYL GLYCOL(UNII: 00YIU5438U)
ETHYLHEXYLGLYCERIN(UNII: 147D247K3P)
PHENOXYETHANOL(UNII: HIE492ZZ3T)
Packaging
# Item Code Package Description Marketing Start Date Marketing End Date
1NDC:42508-265-091 in 1 CARTON
160 mL in 1 TUBE
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
OTC MONOGRAPH NOT FINAL part352 05/01/2010

PRINCIPAL DISPLAY PANEL

RE9
ADVANCED™
FOR MEN

Facial Moisturizer
SPF 20

ARBONNE ®

2 fl. oz./60 mL

Principal Display Panel - 60 mL Carton