PROACTIV SKIN LIGHTENING- 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 Skin Lightening Lotion

SPL UNCLASSIFIED SECTION

Drug Facts

Active Ingredient

Hydroquinone 2%

Purpose

Skin Lightener

Use

works deep in the skin's surface to fade spots

Warnings

For external use only

OTC - WHEN USING SECTION

When using this product

  • 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

OTC - STOP USE SECTION

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

OTC - PREGNANCY OR BREAST FEEDING SECTION

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

OTC - KEEP OUT OF REACH OF CHILDREN SECTION

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

PRINCIPAL DISPLAY PANEL - 30mL Bottle Carton

Rodan & Fields

proactiv®
SOLUTION

SKIN
LIGHTENING
LOTION

helps to
fade discolorations
perfect for all skin types

1 FL. OZ. 30 mL

Principal Display Panel
PROACTIV  SKIN LIGHTENING
hydroquinone lotion
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:11410-408
Route of AdministrationTOPICAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
HYDROQUINONE (UNII: XV74C1N1AE) (HYDROQUINONE - UNII:XV74C1N1AE) HYDROQUINONE2 mg  in 100 mL
Inactive Ingredients
Ingredient NameStrength
Water (UNII: 059QF0KO0R)  
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:11410-408-291 in 1 BOX01/01/199801/01/2019
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 finalpart358A01/01/199801/01/2019
Labeler - THE PROACTIV COMPANY LLC (080216357)
Registrant - THE PROACTIV COMPANY LLC (080216357)

Revised: 1/2020
Document Id: 6c6fda56-9da7-4f41-8b5f-787ebf0c293a
Set id: 863fd03d-5e44-4ea2-9ae4-1e89361aa9fb
Version: 2
Effective Time: 20200128
 
THE PROACTIV COMPANY LLC