PROACTIV 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.

----------

Proactiv Skin Purifying Mask

Drug Facts

Active ingredient

Sulfur 6%

Purpose

Acne treatment

Use

for the management of acne

Warnings

For external use only

When using this product

  • skin irritation and dryness is 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
  • avoid contact with eyes.  If contact occurs, rinse eyes thoroughly with water.

Do not use on

  • broken skin
  • large areas of the skin

Keep out of reach of children.

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

Directions

Inactive ingredients

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

Questions or comments?

1-800-950-4695

Distributed by Alchemee LLC
Santa Monica, CA 90401
Made in the USA of Foreign and
Domestic Components
Questions? 1-800-950-4695 • proactiv.com

Proactiv is a registered trademark of
Taro Pharmaceuticals U.S.A., Inc.

PRINCIPAL DISPLAY PANEL - 1 OZ.  28 g

proactiv®              

SKIN
PURIFYING
MASK                  

NET. WT. 1 OZ. (28 g)
sulfur acne medication

unit carton image
PROACTIV SKIN PURIFYING MASK 
sulfur lotion
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:11410-013
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 (1200 Mw) (UNII: Q3Z4BCH099)  
Polyoxyl 20 Cetostearyl Ether (UNII: YRC528SWUY)  
Sodium Lauroyl Sarcosinate (UNII: 632GS99618)  
Linolenic Acid (UNII: 0RBV727H71)  
.alpha.-tocopherol Acetate (UNII: 9E8X80D2L0)  
Tea Tree Oil (UNII: VIF565UC2G)  
Cymbopogon Schoenanthus Top (UNII: 9SJI1LW39W)  
Geranium Maculatum Root (UNII: 93IXI5B6OJ)  
Hydrated Silica (UNII: Y6O7T4G8P9)  
Diethylene Glycol Monoethyl Ether (UNII: A1A1I8X02B)  
Sodium Sulfate (UNII: 0YPR65R21J)  
Butylene Glycol (UNII: 3XUS85K0RA)  
Phenoxyethanol (UNII: HIE492ZZ3T)  
Titanium Dioxide (UNII: 15FIX9V2JP)  
Zinc Oxide (UNII: SOI2LOH54Z)  
Chromium Hydroxide Green (UNII: RV8FT8XF5R)  
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:11410-013-001 in 1 BOX12/31/201205/14/2019
130 g in 1 TUBE; Type 0: Not a Combination Product
2NDC:11410-013-051 in 1 BOX12/31/2013
285 g in 1 TUBE; Type 0: Not a Combination Product
3NDC:11410-013-101 in 1 BOX09/01/2019
39 g in 1 TUBE; Type 0: Not a Combination Product
4NDC:11410-013-021 in 1 BOX12/31/2013
428 g in 1 TUBE; Type 0: Not a Combination Product
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC MONOGRAPH FINALpart333D12/31/2012
Labeler - THE PROACTIV COMPANY LLC (080216357)
Establishment
NameAddressID/FEIBusiness Operations
VEE PAK, LLC874763303manufacture(11410-013)
Establishment
NameAddressID/FEIBusiness Operations
Apex International Mfg LLC079110793manufacture(11410-013)

Revised: 11/2022
Document Id: 7c9cfa80-fda2-4b8f-b410-05fe7a6fd0f5
Set id: 9f0eb12b-4da1-4498-9ffb-de8235264d9b
Version: 5
Effective Time: 20221118
 
THE PROACTIV COMPANY LLC