NDC Code(s) : 42508-299-08, 42508-299-15, 42508-299-11
Packager : Arbonne International, LLC

Category : HUMAN PRESCRIPTION DRUG LABEL

DEA Schedule : none

Marketing Status : New Drug Application

INGREDIENTS AND APPEARANCE

Arbonne RE9 Advanced AVOBENZONE, HOMOSALATE, OCTINOXATE, and OCTOCRYLENE LOTION
Product Information
Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:42508-299
Route of Administration TOPICAL DEA Schedule
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
AVOBENZONE(UNII: G63QQF2NOX)
(AVOBENZONE - UNII:G63QQF2NOX) 		AVOBENZONE30 mg in 1 g
HOMOSALATE(UNII: V06SV4M95S)
(HOMOSALATE - UNII:V06SV4M95S) 		HOMOSALATE100 mg in 1 g
OCTINOXATE(UNII: 4Y5P7MUD51)
(OCTINOXATE - UNII:4Y5P7MUD51) 		OCTINOXATE40 mg in 1 g
OCTOCRYLENE(UNII: 5A68WGF6WM)
(OCTOCRYLENE - UNII:5A68WGF6WM) 		OCTOCRYLENE27.5 mg in 1 g
Inactive Ingredients
Ingredient Name Strength
WATER(UNII: 059QF0KO0R)
POLYSORBATE 20(UNII: 7T1F30V5YH)
ALKYL (C12-15) BENZOATE(UNII: A9EJ3J61HQ)
COCO-CAPRYLATE(UNII: 4828G836N6)
GLYCERIN(UNII: PDC6A3C0OX)
STEARYL ALCOHOL(UNII: 2KR89I4H1Y)
METHYL GLUCOSE SESQUISTEARATE(UNII: V1YW10H14D)
GLYCERYL STEARATE SE(UNII: FCZ5MH785I)
STEARIC ACID(UNII: 4ELV7Z65AP)
SACCHARIDE ISOMERATE(UNII: W8K377W98I)
DIMETHICONE 100(UNII: RO266O364U)
ORANGE OIL(UNII: AKN3KSD11B)
BORAGE SEED OIL(UNII: F8XAG1755S)
LAMINARIA DIGITATA(UNII: 15E7C67EE8)
TRIFOLIUM PRATENSE FLOWER(UNII: 4JS0838828)
ROSEMARY(UNII: IJ67X351P9)
NASTURTIUM OFFICINALE(UNII: YH89GMV676)
HYPERICUM PERFORATUM(UNII: XK4IUX8MNB)
CUCUMBER(UNII: YY7C30VXJT)
CHAMOMILE(UNII: FGL3685T2X)
BETULA PUBESCENS LEAF(UNII: 84SOH0O3OO)
PUERARIA MONTANA VAR. LOBATA ROOT(UNII: PET93F4I3C)
VITAMIN A PALMITATE(UNII: 1D1K0N0VVC)
ASCORBYL PALMITATE(UNII: QN83US2B0N)
MAGNESIUM ASCORBYL PHOSPHATE(UNII: 0R822556M5)
.ALPHA.-TOCOPHEROL ACETATE(UNII: 9E8X80D2L0)
.ALPHA.-TOCOPHEROL, DL-(UNII: 7QWA1RIO01)
DEXPANTHENOL(UNII: 1O6C93RI7Z)
LECITHIN, SOYBEAN(UNII: 1DI56QDM62)
MEDIUM-CHAIN TRIGLYCERIDES(UNII: C9H2L21V7U)
POLYISOBUTYLENE (1100000 MW)(UNII: FLT10CH37X)
PALMITOYL HEXAPEPTIDE-12(UNII: HO4ZT5S86C)
PALMITOYL TETRAPEPTIDE-7(UNII: Q41S464P1R)
CARBOMER HOMOPOLYMER TYPE C (ALLYL PENTAERYTHRITOL CROSSLINKED)(UNII: 4Q93RCW27E)
XANTHAN GUM(UNII: TTV12P4NEE)
SODIUM PIDOLATE(UNII: 1V74VH163T)
UREA(UNII: 8W8T17847W)
.ALPHA.-BISABOLOL, (+/-)-(UNII: 36HQN158VC)
SODIUM PHOSPHATE, TRIBASIC, ANHYDROUS(UNII: SX01TZO3QZ)
STEARAMINE(UNII: FFV58UNY7O)
FYTIC ACID(UNII: 7IGF0S7R8I)
THIOCTIC ACID(UNII: 73Y7P0K73Y)
SALICYLIC ACID(UNII: O414PZ4LPZ)
BUTYLENE GLYCOL(UNII: 3XUS85K0RA)
CAPRYLYL GLYCOL(UNII: 00YIU5438U)
CAPRYLHYDROXAMIC ACID(UNII: UPY805K99W)
Packaging
# Item Code Package Description Marketing Start Date Marketing End Date
1NDC:42508-299-081 in 1 CARTON 17/04/2017
150 g in 1 BOTTLE, PUMP Type 0: Not a Combination Product
2NDC:42508-299-1515 g in 1 TUBE Type 0: Not a Combination Product17/04/2017
3NDC:42508-299-113 g in 1 TUBE Type 0: Not a Combination Product17/04/2017
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
OTC MONOGRAPH NOT FINAL part352 04/17/2017

PRINCIPAL DISPLAY PANEL

ARBONNE®

RE9 ADVANCED®

RESTORATIVE
CREAM

BROAD SPECTRUM
SPF 20 SUNSCREEN

Net wt. 1.7 oz./50 g

PRINCIPAL DISPLAY PANEL - 50 g Bottle Carton