Proactiv® Solution Dark Spot Corrector

Proactiv Solution Dark Spot Corrector by

Drug Labeling and Warnings

Proactiv Solution Dark Spot Corrector by is a Otc medication manufactured, distributed, or labeled by Guthy-Renker LLC. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

PROACTIV SOLUTION DARK SPOT CORRECTOR- hydroquinone lotion 
THE PROACTIV COMPANY 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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Proactiv® Solution Dark Spot Corrector

Drug Facts

Active ingredient

Hydroquinone 2%

Purpose

Skin Lightener

Use

works deep in the ski's surface to fade spots

Warnings

For external use only

  • avoid unnecessary sun exposure and use a sunscreen.
  • some users of this product may experience a mild skin irritation.
  • do not use on children under 12 years of age, unless directed by a doctor.

Stop use and ask a doctor if skin irritation becomes severe or gradual darkening of the skin occurs.

If pregnant or breastfeeding, ask a health professional before use.

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

Directions

  • After cleansing, apply a thin layer on the affected areas, or as directed by a doctor
  • discontinue use if no improvement is seen after three months of treatment

Other information

  • keep away from eyes, lips and mouth
  • avoid product contact with hair and dyed fabrics, including carpets and clothing which may be bleached by this product
  • lightening effect of this product may not be noticeable when used on very dark skin
  • this product may darken over time which is normal and does not affect the product performance

Inactive ingredients

Water, octyldodecanol, cyclopentasiloxane, hexylene glycol, polyquaternium-37, glycolic acid, cyclohexasiloxane, cetearyl alcohol, propylene glycol dicaprylate/dicaprate, ascorbyl palmitate, retinyl palmitate, tocopheryl acetate, propylene glycol, glyceryl dilaurate, PPG-1 trideceth-6, glyceryl stearate, PEG-100 stearate, PEG-40 stearate, sodium sulfite, sodium metabisulfite, sodium hydroxide, disodium EDTA, diazolidinyl urea, methylparaben, propylparaben, fragrance

Questions or comments?

Within US 1-800-490-4134

Dist. by Guthy-Renker®
PO Box 14383
Palm Desert, CA 14383

PRINCIPAL DISPLAY PANEL - 30 mL Tube Box

Rodan & Fields
proactiv®
SOLUTION

DARK
SPOT
CORRECTOR

helps to
fade discolorations

perfect for all skin types

skin lightener

1 FL. OZ. 30 mL

Principal Display Panel - 30 mL Tube Box
PROACTIV SOLUTION DARK SPOT CORRECTOR 
hydroquinone lotion
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC: 11410-053
Route of AdministrationTOPICAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
HYDROQUINONE (UNII: XV74C1N1AE) (HYDROQUINONE - UNII:XV74C1N1AE) HYDROQUINONE2 g  in 100 mL
Inactive Ingredients
Ingredient NameStrength
WATER (UNII: 059QF0KO0R)  
OCTYLDODECANOL (UNII: 461N1O614Y)  
CYCLOMETHICONE 5 (UNII: 0THT5PCI0R)  
HEXYLENE GLYCOL (UNII: KEH0A3F75J)  
POLYQUATERNIUM-37 (10000 MPA.S) (UNII: 41QWS48DFN)  
GLYCOLIC ACID (UNII: 0WT12SX38S)  
CYCLOMETHICONE 6 (UNII: XHK3U310BA)  
CETOSTEARYL ALCOHOL (UNII: 2DMT128M1S)  
PROPYLENE GLYCOL DICAPRYLATE/DICAPRATE (UNII: O4446S9CRA)  
ASCORBYL PALMITATE (UNII: QN83US2B0N)  
VITAMIN A PALMITATE (UNII: 1D1K0N0VVC)  
PROPYLENE GLYCOL (UNII: 6DC9Q167V3)  
GLYCERYL DILAURATE (UNII: MFL3ZIE8SK)  
PPG-1 TRIDECETH-6 (UNII: 1K7417JX6Q)  
GLYCERYL MONOSTEARATE (UNII: 230OU9XXE4)  
PEG-100 STEARATE (UNII: YD01N1999R)  
PEG-40 STEARATE (UNII: ECU18C66Q7)  
SODIUM SULFITE (UNII: VTK01UQK3G)  
SODIUM METABISULFITE (UNII: 4VON5FNS3C)  
SODIUM HYDROXIDE (UNII: 55X04QC32I)  
EDETATE DISODIUM (UNII: 7FLD91C86K)  
DIAZOLIDINYL UREA (UNII: H5RIZ3MPW4)  
METHYLPARABEN (UNII: A2I8C7HI9T)  
PROPYLPARABEN (UNII: Z8IX2SC1OH)  
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC: 11410-053-291 in 1 BOX06/01/201312/02/2019
130 mL in 1 TUBE; Type 0: Not a Combination Product
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC MONOGRAPH NOT FINALpart358A06/01/201312/02/2019
Labeler - THE PROACTIV COMPANY LLC (080216357)
Registrant - THE PROACTIV COMPANY LLC (080216357)

Revised: 1/2020
 
THE PROACTIV COMPANY LLC