PROACTIV REFINING MASK- sulfur cream 
Guthy-Renker 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 Refining 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

  • using other topical acne medications at the same time or immediately following use of this product may increase dryness or irritation of the skin. If this occurs, only one medication should be used unless directed by a doctor.
  • do not get into eyes. If excessive skin irritation develops or increases, discontinue use and consult a doctor.
  • do not use on broken skin or large areas of the skin. Apply only to areas with acne.

Stop use and ask a doctor if irritation occurs.

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

Directions

Inactive ingredients

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

Dist. by Guthy-Renker®
PO Box 14383, Palm Desert, CA 92255-4383
proactiv.com

PRINCIPAL DISPLAY PANEL - 70 g Tube Label

Rodan & Fields

proactiv®
SOLUTION

REFINING
MASK

deep cleans

helps to minimize the
appearance of pores

sulfur acne treatment

2.5 OZ. 70 g

Principal Display Panel - 70 g Tube Label
PROACTIV REFINING MASK 
sulfur cream
Product Information
Product Type HUMAN OTC DRUG Item Code (Source) NDC:11410-507
Route of Administration TOPICAL DEA Schedule     
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
Sulfur (UNII: 70FD1KFU70) (Sulfur - UNII:70FD1KFU70) Sulfur 0.06 g  in 1 g
Inactive Ingredients
Ingredient Name Strength
WATER (UNII: 059QF0KO0R)  
KAOLIN (UNII: 24H4NWX5CO)  
LINOLEIC ACID (UNII: 9KJL21T0QJ)  
CETOSTEARYL ALCOHOL (UNII: 2DMT128M1S)  
MAGNESIUM ALUMINUM SILICATE (UNII: 6M3P64V0NC)  
ZINC OXIDE (UNII: SOI2LOH54Z)  
POLYOXYL 20 CETOSTEARYL ETHER (UNII: YRC528SWUY)  
SODIUM LAUROYL SARCOSINATE (UNII: 632GS99618)  
LINOLENIC ACID (UNII: 0RBV727H71)  
TEA TREE OIL (UNII: VIF565UC2G)  
.ALPHA.-TOCOPHEROL (UNII: H4N855PNZ1)  
.ALPHA.-TOCOPHEROL ACETATE, DL- (UNII: WR1WPI7EW8)  
BUTYLENE GLYCOL (UNII: 3XUS85K0RA)  
HYDRATED SILICA (UNII: Y6O7T4G8P9)  
DIETHYLENE GLYCOL MONOETHYL ETHER (UNII: A1A1I8X02B)  
ETHYLPARABEN (UNII: 14255EXE39)  
METHYLPARABEN (UNII: A2I8C7HI9T)  
TITANIUM DIOXIDE (UNII: 15FIX9V2JP)  
Packaging
# Item Code Package Description Marketing Start Date Marketing End Date
1 NDC:11410-507-11 1 in 1 BOX
1 28 g in 1 TUBE
2 NDC:11410-507-17 48 g in 1 TUBE
3 NDC:11410-507-21 1 in 1 BOX
3 70 g in 1 TUBE
4 NDC:11410-507-36 100 g in 1 TUBE
5 NDC:11410-507-66 1 in 1 BOX
5 NDC:11410-507-36 100 g in 1 TUBE
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
OTC MONOGRAPH FINAL part333D 12/01/1998
Labeler - Guthy-Renker LLC (608315453)

Revised: 2/2014
Document Id: 4bd2d761-cfdb-4df8-94f9-7cfffe4c610e
Set id: bda1f6ef-0b5a-4378-9dd9-443a5f341873
Version: 4
Effective Time: 20140207
 
Guthy-Renker LLC