ZO SKIN HEALTH OFFECTS SULFUR MASQUE ACNE TREATMENT- sulfur cream 
ZO Skin Health, Inc.

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.

----------

ZO ® Skin Health Offects® Sulfur Masque

42851-073

Drug Facts

Active Ingredients

Sulfur 10%

Purpose

Acne Treatment

Uses

  • For the treatment of acne.
  • Penetrates pores to clear most acne blemishes, blackheads, and whiteheads.
  • Helps prevent new acne blemishes from forming.

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.

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

  • Clean the skin thoroughly before applying this product.
  • Cover the entire affected area with a thin layer twice a week.
  • Suitable for use on face, chest, back or wherever breakouts occur.
  • Leave on for 10-15 minutes and remove thoroughly with warm water, moist towels or cotton pads.
  • If bothersome dryness or peeling occurs, reduce application frequency as directed by your doctor.

Inactive Ingredients

Water, Talc, Kaolin, Glycerin, Bentonite, Propylene Glycol, Phenoxyethanol, Ethylene Brassylate, Chlorphenesin, Benzyl Alcohol, Caprylyl Glycol, Silica, Tetrasodium EDTA, Ultramarines.

Dist. by ZO Skin Health, Inc. Irvine, CA 92618

Made in USA

PRINCIPAL DISPLAY PANEL - 85 g Tube Carton

ZO ® SKIN HEALTH

BY ZEIN OBAGI MD

NDC 42851-073-85

Offects® Sulfur Masque

Acne Treatment

Net Wt. 85 g / 3 Oz.

US Offects Sulfur Masque Box

ZO SKIN HEALTH OFFECTS SULFUR MASQUE ACNE TREATMENT 
sulfur cream
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:42851-073
Route of AdministrationTOPICAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
SULFUR (UNII: 70FD1KFU70) (SULFUR - UNII:70FD1KFU70) SULFUR100 mg  in 1 g
Inactive Ingredients
Ingredient NameStrength
WATER (UNII: 059QF0KO0R)  
TALC (UNII: 7SEV7J4R1U)  
KAOLIN (UNII: 24H4NWX5CO)  
GLYCERIN (UNII: PDC6A3C0OX)  
BENTONITE (UNII: A3N5ZCN45C)  
PROPYLENE GLYCOL (UNII: 6DC9Q167V3)  
CAPRYLYL GLYCOL (UNII: 00YIU5438U)  
ETHYLENE BRASSYLATE (UNII: 9A87HC7ROD)  
SILICON DIOXIDE (UNII: ETJ7Z6XBU4)  
EDETATE SODIUM (UNII: MP1J8420LU)  
PHENOXYETHANOL (UNII: HIE492ZZ3T)  
CHLORPHENESIN (UNII: I670DAL4SZ)  
BENZYL ALCOHOL (UNII: LKG8494WBH)  
ULTRAMARINE BLUE (UNII: I39WR998BI)  
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:42851-073-851 in 1 CARTON05/01/201507/01/2020
185 g in 1 TUBE; Type 0: Not a Combination Product
2NDC:42851-073-54540 g in 1 CONTAINER; Type 0: Not a Combination Product05/01/201507/01/2020
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph finalpart333D05/01/201507/01/2020
Labeler - ZO Skin Health, Inc. (826468527)
Establishment
NameAddressID/FEIBusiness Operations
G.S. COSMECEUTICAL USA, INC.081239587manufacture(42851-073)

Revised: 4/2023
Document Id: f8b03434-23e7-a3bb-e053-6294a90a467d
Set id: f9c40784-744a-4d92-b54b-084ad5b3c000
Version: 3
Effective Time: 20230406
 
ZO Skin Health, Inc.