ARBONNE RE9 ADVANCED  RESTORATIVE DAY BROAD SPECTRUM SPF 20- avobenzone, homosalate, octinoxate, and octocrylene lotion 
Arbonne International, LLC

Disclaimer: Most OTC drugs are not reviewed and approved by FDA, however they may be marketed if they comply with applicable regulations and policies. FDA has not evaluated whether this product complies.

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Arbonne® RE9 Advanced®
Restorative Day Broad Spectrum SPF 20

Drug Facts

Active ingredients

Avobenzone 3.0%
Homosalate 10.0%
Octinoxate 4.0%
Octocrylene 2.75%

Purpose

Sunscreen

Uses

  • helps prevent sunburn
  • if used as directed with other sun protection measures (see Directions), decreases the risk of skin cancer and early skin aging caused by the sun

Warnings

For external use only

Do not use on damaged or broken skin

When using this product keep out of eyes. Rinse with water to remove.

Stop use and ask a doctor if rash occurs

Keep out of reach of children. If swallowed, get medical help or contact a Poison Control Center right away.

Directions

For sunscreen use:

  • apply liberally and evenly 15 minutes before sun exposure
  • reapply at least every two hours
  • use a water-resistant sunscreen if swimming or sweating
  • children under 6 months of age: ask a doctor
  • Sun Protection Measures
    Spending time in the sun increases your risk of skin cancer and early skin aging. To decrease this risk, regularly use a sunscreen with a broad spectrum SPF value of 15 or higher and other sun protection measures including:
    • limit time in the sun, especially from 10 a.m.–2 p.m.
    • wear long-sleeved shirts, pants, hats, and sunglasses

Other information

  • protect the product in this container from excessive heat and direct sun

Inactive ingredients

water, polysorbate 20, C12-15 alkyl benzoate, coco-caprylate, glycerin, stearyl alcohol, methyl glucose sesquistearate, glyceryl stearate SE, stearic acid, saccharide isomerate, dimethicone, citrus aurantium dulcis (orange) peel oil, borago officinalis seed oil, laminaria digitata extract, trifolium pratense (clover) flower extract, rosmarinus officinalis (rosemary) leaf extract, nasturtium officinale extract, hypericum perforatum extract, cucumis sativus (cucumber) fruit extract, chamomilla recutita (matricaria) flower extract, betula alba leaf extract, pueraria lobate root extract, helianthus annuus (sunflower) seed oil, retinyl palmitate, ascorbyl palmitate, magnesium ascorbyl phosphate, tocopheryl acetate, tocopherol, panthenol, lecithin, caprylic/capric triglyceride, polyacrylate-13, polyisobutene, palmitoyl tripeptide-1, palmitoyl tetrapeptide-7, carbomer, dehydroxanthan gum, sodium PCA, polyamino sugar condensate, urea, bisabolol, trisodium phosphate, stearamine, phytic acid, thioctic acid, salicylic acid, butylene glycol, caprylyl glycol, caprylhydroxamic acid.

Questions or comments?

1.800.272.6663
Monday–Friday
6 a.m.–6 p.m. Pacific time

Distributed by
Arbonne International, LLC
9400 Jeronimo Road
Irvine, CA 92618 USA

PRINCIPAL DISPLAY PANEL - 50 g Bottle Carton

ARBONNE®

RE9 ADVANCED®

RESTORATIVE
CREAM

BROAD SPECTRUM
SPF 20 SUNSCREEN

Net wt. 1.7 oz./50 g

PRINCIPAL DISPLAY PANEL - 50 g Bottle Carton
ARBONNE RE9 ADVANCED   RESTORATIVE DAY BROAD SPECTRUM SPF 20
avobenzone, homosalate, octinoxate, and octocrylene lotion
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:42508-299
Route of AdministrationTOPICAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
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 NameStrength
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 CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:42508-299-081 in 1 CARTON04/17/201709/21/2017
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 Product04/17/201709/21/2017
3NDC:42508-299-113 g in 1 TUBE; Type 0: Not a Combination Product04/17/201709/21/2017
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC MONOGRAPH NOT FINALpart35204/17/201709/21/2017
Labeler - Arbonne International, LLC (021541164)

Revised: 11/2018
Document Id: 9b7faa24-562e-41c2-aa42-a3dbe29a58c3
Set id: 36dbb242-c82f-476d-91a7-fe0d58d6f4ae
Version: 3
Effective Time: 20181115
 
Arbonne International, LLC