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Name:Arbonne Revelage Age Spot Brightening Day With Spf 30
Manufacturer:Arbonne International, Llc
Category:Over-the-counter (OTC) Marketed Drugs


Revelâge™ ARBONNE® AGE SPOT BRIGHTENING DAY CREAM WITH SPF 30

ARBONNE REVELAGE  AGE SPOT BRIGHTENING DAY WITH SPF 30 - avobenzone, homosalate, octinoxate, octisalate, octocrylene and oxybenzone 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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Revelâge
ARBONNE®
AGE SPOT BRIGHTENING
DAY CREAM WITH SPF 30

Drug Facts

Active ingredients Purpose
Avobenzone 3.0% Sunscreen
Homosalate 10.0% Sunscreen
Octinoxate 3.5% Sunscreen
Octisalate 5.0% Sunscreen
Octocrylene 2.79% Sunscreen
Oxybenzone 6.0% Sunscreen

Uses

  • helps prevent sunburn
  • higher SPF gives more sunburn protection
  • for skin highly sensitive to sunburn

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, Dimethicone, Butylene Glycol, Glyceryl Stearate, Aluminum Starch Octenylsuccinate, Butyloctyl Salicylate, Silica, PEG-100 Stearate, PEG-12 Glyceryl Dimyristate, Cetyl Alcohol, Polyethylene, Sucrose, Ascorbyl Glucoside, Barium Sulfate, Stearoxymethicone/Dimethicone Copolymer, Ammonium Acryloyldimethyltaurate/VP Copolymer, PEG-75 Stearate, Ceteth-20, Steareth-20, PVP, Ferula Foetida Root Extract, Acetyl Glucosamine, Caffeine, Tocopheryl Acetate, Retinyl Palmitate, Tocopherol, Sodium Hyaluronate, Caprylyl Glycol, Phenylethyl Resorcinol, Ethoxydiglycol, Caprylic/Capric Triglyceride, Linoleic Acid, Lecithin, Phytostearyl Canola Glycerides, Oleic Acid, Palmitic Acid, Stearic Acid, Triolein, Polysorbate 60, BHT, Sodium Hydroxide, Disodium EDTA, Phenoxyethanol, Sorbic Acid, Chlorphenesin, Dodecahydro-3A, 6, 6, 9A-Tetramethylnaphtho (2,1-B) Furan, Hexamethylindanopyran, Isopropyl Myristate, Oxacyclohexadecenone, Methyldihydrojasmonate, Myristica Fragrans (Nutmeg) Kernel Oil.

Questions or comments?

1.800.272.6663

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

PRINCIPAL DISPLAY PANEL - 30 mL Carton

Revelâge
ARBONNE®

AGE SPOT BRIGHTENING
DAY CREAM WITH SPF 30

DERMATOLOGIST TESTED

1 fl. oz./30 mL

Principal Display Panel - 30 mL Carton

ARBONNE REVELAGE   AGE SPOT BRIGHTENING DAY WITH SPF 30
avobenzone, homosalate, octinoxate, octisalate, octocrylene, and oxybenzone lotion
Product Information
Product Type HUMAN OTC DRUG Item Code (Source) NDC:42508-138
Route of Administration TOPICAL DEA Schedule     
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
AVOBENZONE (AVOBENZONE) AVOBENZONE 30 mg  in 1 mL
HOMOSALATE (HOMOSALATE) HOMOSALATE 100 mg  in 1 mL
OCTINOXATE (OCTINOXATE) OCTINOXATE 35 mg  in 1 mL
OCTISALATE (OCTISALATE) OCTISALATE 50 mg  in 1 mL
OCTOCRYLENE (OCTOCRYLENE) OCTOCRYLENE 27.9 mg  in 1 mL
OXYBENZONE (OXYBENZONE) OXYBENZONE 60 mg  in 1 mL
Inactive Ingredients
Ingredient Name Strength
WATER  
DIMETHICONE  
BUTYLENE GLYCOL  
GLYCERYL MONOSTEARATE  
ALUMINUM STARCH OCTENYLSUCCINATE  
BUTYLOCTYL SALICYLATE  
SILICON DIOXIDE  
PEG-100 STEARATE  
CETYL ALCOHOL  
LOW DENSITY POLYETHYLENE  
SUCROSE  
BARIUM SULFATE  
PEG-75 STEARATE  
CETETH-20  
STEARETH-20  
POVIDONE  
FERULA ASSA-FOETIDA ROOT  
N-ACETYLGLUCOSAMINE  
CAFFEINE  
.ALPHA.-TOCOPHEROL ACETATE, D-  
VITAMIN A PALMITATE  
ALPHA-TOCOPHEROL  
HYALURONATE SODIUM  
CAPRYLYL GLYCOL  
PHENYLETHYL RESORCINOL  
DIETHYLENE GLYCOL MONOETHYL ETHER  
MEDIUM-CHAIN TRIGLYCERIDES  
LINOLEIC ACID  
LECITHIN, SOYBEAN  
OLEIC ACID  
PALMITIC ACID  
STEARIC ACID  
TRIOLEIN  
POLYSORBATE 60  
BUTYLATED HYDROXYTOLUENE  
SODIUM HYDROXIDE  
EDETATE DISODIUM  
PHENOXYETHANOL  
SORBIC ACID  
CHLORPHENESIN  
SCLAREOLIDE  
HEXAMETHYLINDANOPYRAN  
ISOPROPYL MYRISTATE  
METHYL DIHYDROJASMONATE  
NUTMEG OIL  
Product Characteristics
Color      Score     
Shape Size
Flavor Imprint Code
Contains     
Packaging
# Item Code Package Description Multilevel Packaging
1 NDC:42508-138-31 1 JAR ( JAR) in 1 CARTON contains a JAR
1 30 mL in 1 JAR This package is contained within the CARTON (42508-138-31)

Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
OTC MONOGRAPH NOT FINAL part352 01/20/2010

Labeler - Arbonne International, LLC (021541164)

Revised: 04/2011 Arbonne International, LLC



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


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