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Name:Arbonne Re Advanced For Menfacial Moisturizer Spf 20
Manufacturer:Arbonne International, Llc
Category:Over-the-counter (OTC) Marketed Drugs


RE9 ADVANCED™ FOR MEN Facial Moisturizer SPF 20

ARBONNE RE9 ADVANCED FOR MEN FACIAL MOISTURIZER SPF 20 - octisalate, octocrylene and zinc oxide 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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RE9
ADVANCED
FOR MEN
Facial Moisturizer
SPF 20

Drug Facts

Active Ingredients Purpose
Octisalate 5.0% Sunscreen
Octocrylene 8.0% Sunscreen
Zinc Oxide 7.35% Sunscreen

Uses

  • Helps prevent sunburn.
  • Higher SPF gives more sunburn protection.
  • For skin that sunburns easily.

Warnings

For external use only.

When using this product

  • Keep out of eyes. Rinse with water to remove.

Stop use and ask a doctor if

  • Rash or irritation develops and lasts.

Keep out of reach of children.

If swallowed, get medical help or contact a Poison Control Center right away.

Directions

  • Apply generously and evenly to face. Massage in well before sun exposure and as needed.
  • For adult use only.

Other Information

Store at 20°C–25°C (68°F–77°F)

Sun Alert

Limiting sun exposure, wearing protective clothing and using sunscreens may reduce the risks of skin aging, skin cancer and other harmful effects of the sun.

Inactive Ingredients

Water, C12-15 Alkyl Benzoate, Glycerin, Glyceryl Stearate SE, Cetearyl Alcohol, Silica, PEG-40 Stearate, Dimethicone, Ceteareth-20, Hippophae Rhamnoides Seed Oil, Citrus Aurantium Dulcis (Orange) Peel Oil, Citrus Medica Limonum (Lemon) Peel Oil, Eugenia Caryophyllus (Clove) Leaf Oil, Hydrolyzed Ceratonia Siliqua Seed Extract, Hydrolyzed Cicer Seed Extract, Malva Sylvestris (Mallow) Extract, Laminaria Digitata Extract, Pueraria Lobata Root Extract, Vaccinium Myrtillus Extract, Saccharum Officinarum (Sugar Cane) Extract, Citrus Aurantium Dulcis (Orange) Fruit Extract, Citrus Medica Limonum (Lemon) Fruit Extract, Acer Saccharum (Sugar Maple) Extract, Sodium Phytate, Hexapeptide-10, Glycine Soja (Soybean) Protein, Spent Grain Wax, Tocopherol, Tetrahexyldecyl Ascorbate, Thioctic Acid, Polyisobutene, Polyacrylate-13, Polysorbate 20, Butylene Glycol, Bisabolol, Carbomer, Palmitoyl Oligopeptide, Palmitoyl Tetrapeptide-7, Salicylic Acid, Caprylyl Glycol, Ethylhexylglycerin, Phenoxyethanol.

Questions or Comments?

1.800.ARBONNE

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

Distributed by
Arbonne International, LLC
Irvine, CA 92618 U.S.A.

PRINCIPAL DISPLAY PANEL - 60 mL Carton

RE9
ADVANCED

FOR MEN

Facial Moisturizer
SPF 20

ARBONNE®

2 fl. oz./60 mL

Principal Display Panel - 60 mL Carton

ARBONNE RE9 ADVANCED FOR MEN  FACIAL MOISTURIZER SPF 20
octisalate, octocrylene, and zinc oxide lotion
Product Information
Product Type HUMAN OTC DRUG Item Code (Source) NDC:42508-265
Route of Administration TOPICAL DEA Schedule     
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
Octisalate (Octisalate) Octisalate 50 mg  in 1 mL
Octocrylene (Octocrylene) Octocrylene 80 mg  in 1 mL
Zinc Oxide (Zinc Oxide) Zinc Oxide 73.5 mg  in 1 mL
Inactive Ingredients
Ingredient Name Strength
WATER  
C12-15 ALKYL BENZOATE  
GLYCERIN  
GLYCERYL MONOSTEARATE  
CETOSTEARYL ALCOHOL  
SILICON DIOXIDE  
POLYOXYL 40 STEARATE  
DIMETHICONE  
POLYOXYL 20 CETOSTEARYL ETHER  
ORANGE OIL  
LEMON OIL  
CLOVE LEAF OIL  
MALVA SYLVESTRIS LEAF  
LAMINARIA DIGITATA  
PUERARIA MONTANA VAR. LOBATA ROOT  
BILBERRY  
SUGARCANE  
ORANGE  
LEMON  
ACER SACCHARUM BARK/SAP  
SOY PROTEIN  
ALPHA-TOCOPHEROL  
TETRAHEXYLDECYL ASCORBATE  
ALPHA LIPOIC ACID  
POLYISOBUTYLENE (1200000 MW)  
POLYSORBATE 20  
BUTYLENE GLYCOL  
LEVOMENOL  
CARBOMER HOMOPOLYMER TYPE C  
PALMITOYL TETRAPEPTIDE-7  
SALICYLIC ACID  
CAPRYLYL GLYCOL  
ETHYLHEXYLGLYCERIN  
PHENOXYETHANOL  
Product Characteristics
Color      Score     
Shape Size
Flavor Imprint Code
Contains     
Packaging
# Item Code Package Description Multilevel Packaging
1 NDC:42508-265-09 1 TUBE ( TUBE) in 1 CARTON contains a TUBE
1 60 mL in 1 TUBE This package is contained within the CARTON (42508-265-09)

Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
OTC MONOGRAPH NOT FINAL part352 05/01/2010

Labeler - Arbonne International, LLC (021541164)

Revised: 11/2010 Arbonne International, LLC



Source: http://dailymed.nlm.nih.gov
Reproduced with permission of U.S. National Library of Medicine


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