PROACTIV PLUS SKIN PURIFYING MASK- sulfur 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+ Skin Purifying Mask

Drug Facts

Active ingredient

Sulfur 6%

Purpose

Acne treatment cream

Use

for the management of acne

Warnings

For external use only

When using this product

  • skin irritation and dryness are more likely to occur if you use another topical acne medication at the same time. If irritation occurs, only use one topical acne medication at a time.
  • apply only to areas with acne.

Do not use on

  • broken skin
  • large areas of the skin

Stop use and ask a doctor if

  • irritation becomes severe.

Keep out of reach of children.

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

Directions

  • cleanse the skin thoroughly before applying this product.
  • cover the entire affected area with a thin layer and rinse thoroughly one to three times daily.
  • because excessive drying of the skin may occur, start with one application daily, then gradually increase to two or three times daily if needed or as directed by a doctor.
  • if bothersome dryness or peeling occurs, reduce application to once a day or every other day.

Inactive ingredients

water (aqua), kaolin, glycereth-26, linoleic acid, cetearyl alcohol, magnesium aluminum silicate, synthetic wax, zinc oxide, sodium lauroyl sarcosinate, ceteareth-20, linolenic acid, cymbopogon schoenanthus extract, geranium maculatum extract, melaleuca alternifolia (tea tree) leaf oil, tocopherol, tocopheryl acetate, butylene glycol, hydrated silica, ethoxydiglycol, phenoxyethanol, methylisothiazolinone, fragrance (parfum), chromium hydroxide green (CI 77289), titanium dioxide (CI 77891)

Questions or comments?

Within US 1-800-950-4695

Dist. by: Guthy-Renker® LLC • PO Box 14383
Palm Desert • CA 92255-4383

PRINCIPAL DISPLAY PANEL - 85 g Tube Box

Rodan & Fields
proactiv+

Skin
Purifying
Mask

Net wt. 3 OZ. 85 g
sulfur acne
treatment

Principal Display Panel - 85 g Tube Box
PROACTIV PLUS SKIN PURIFYING MASK 
sulfur lotion
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:11410-008
Route of AdministrationTOPICAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
SULFUR (UNII: 70FD1KFU70) (SULFUR - UNII:70FD1KFU70) SULFUR6 g  in 100 g
Inactive Ingredients
Ingredient NameStrength
WATER (UNII: 059QF0KO0R)  
KAOLIN (UNII: 24H4NWX5CO)  
GLYCERETH-26 (UNII: NNE56F2N14)  
LINOLEIC ACID (UNII: 9KJL21T0QJ)  
CETOSTEARYL ALCOHOL (UNII: 2DMT128M1S)  
MAGNESIUM ALUMINUM SILICATE (UNII: 6M3P64V0NC)  
SYNTHETIC WAX (1800 MW) (UNII: 248P1AUJ90)  
ZINC OXIDE (UNII: SOI2LOH54Z)  
SODIUM LAUROYL SARCOSINATE (UNII: 632GS99618)  
POLYOXYL 20 CETOSTEARYL ETHER (UNII: YRC528SWUY)  
LINOLENIC ACID (UNII: 0RBV727H71)  
CYMBOPOGON SCHOENANTHUS TOP (UNII: 9SJI1LW39W)  
GERANIUM MACULATUM ROOT (UNII: 93IXI5B6OJ)  
TEA TREE OIL (UNII: VIF565UC2G)  
TOCOPHEROL (UNII: R0ZB2556P8)  
.ALPHA.-TOCOPHEROL ACETATE (UNII: 9E8X80D2L0)  
BUTYLENE GLYCOL (UNII: 3XUS85K0RA)  
HYDRATED SILICA (UNII: Y6O7T4G8P9)  
DIETHYLENE GLYCOL MONOETHYL ETHER (UNII: A1A1I8X02B)  
PHENOXYETHANOL (UNII: HIE492ZZ3T)  
METHYLISOTHIAZOLINONE (UNII: 229D0E1QFA)  
CHROMIUM HYDROXIDE GREEN (UNII: RV8FT8XF5R)  
TITANIUM DIOXIDE (UNII: 15FIX9V2JP)  
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:11410-008-111 in 1 BOX05/23/201906/30/2019
130 g in 1 TUBE; Type 0: Not a Combination Product
2NDC:11410-008-251 in 1 BOX05/23/201906/30/2019
285 g in 1 TUBE; Type 0: Not a Combination Product
3NDC:11410-008-541 in 1 BOX05/23/201906/30/2019
30.28 g in 1 TUBE; Type 0: Not a Combination Product
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC MONOGRAPH FINALpart333D12/31/201206/30/2019
Labeler - THE PROACTIV COMPANY LLC (080216357)
Establishment
NameAddressID/FEIBusiness Operations
VEE PAK, LLC874763303manufacture(11410-008)

Revised: 3/2016
 
THE PROACTIV COMPANY LLC