Label: SEBUM CLEARING MASQUE- salicylic acid lotion

  • NDC Code(s): 68479-013-00, 68479-013-01, 68479-013-02, 68479-013-04
  • Packager: Dermalogica
  • Category: HUMAN OTC DRUG LABEL
  • DEA Schedule: None
  • Marketing Status: OTC monograph final

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.

Drug Label Information

Updated July 15, 2022

If you are a consumer or patient please visit this version.

View All Sections
  • SPL UNCLASSIFIED SECTION

    Drug Facts
  • Active Ingredient

    Salicylic Acid (0.5%)

  • Purpose

    Acne Treatment

  • Indications

    For the treatment 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.

    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 one to three times per week.
    • Leave on for 10 minutes then rinse thoroughly with warm water.
    • If bothersome dryness or peeling occurs, reduce application to once a week or every other week.
  • Inactive Ingredients

    Water/Aqua/Eau, Kaolin, Bentonite, Glycerin, Polysorbate 20, Pentylene Glycol, Carthamus Tinctorius (Safflower) Seed Oil, Cetearyl Alcohol, Butylene Glycol, Glyceryl Stearate SE, Polysorbate 60, Avena Sativa (Oat) Kernel Extract, Bisabolol, Spiraea Ulmaria Extract, Menthol, 10-Hydroxydecanoic Acid, Sebacic Acid, 1,10-Decanediol, Camphor, Farnesyl Acetate, Panthenyl Triacetate, Tocopheryl Acetate, Dipotassium Glycyrrhizate, Cinnamomum Zeylanicum Bark Extract, Sarcosine, Niacinamide, Yeast Extract, Aesculus Hippocastanum (Horse Chestnut) Seed Extract, Ammonium Glycyrrhizate, Panthenol, Zinc Gluconate, Caffeine, Biotin, Hydroxyethylcellulose, Disodium EDTA, Capryloyl Glycine, 1,2-Hexanediol, Tropolone, Caprylyl Glycol, Caprylhydroxamic Acid, Ethylhexylglycerin, Methylpropanediol, Titanium Dioxide (CI 77891), Zinc Oxide (CI 77947).

  • Questions or comments?

    call toll free 1-800-831-5150 in the USA

  • PRINCIPAL DISPLAY PANEL - 75 mL Tube Carton

    sebum
    clearing
    masque

    purify
    oily skin

    Active Clearing

    2.5 US FL OZ / 75 mL ℮

    dermalogica

    Principal Display Panel - 75 mL Tube Carton
  • INGREDIENTS AND APPEARANCE
    SEBUM CLEARING MASQUE 
    salicylic acid lotion
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:68479-013
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    Salicylic Acid (UNII: O414PZ4LPZ) (Salicylic Acid - UNII:O414PZ4LPZ) Salicylic Acid5 mg  in 1 mL
    Inactive Ingredients
    Ingredient NameStrength
    Water (UNII: 059QF0KO0R)  
    Kaolin (UNII: 24H4NWX5CO)  
    Bentonite (UNII: A3N5ZCN45C)  
    Glycerin (UNII: PDC6A3C0OX)  
    Polysorbate 20 (UNII: 7T1F30V5YH)  
    Pentylene Glycol (UNII: 50C1307PZG)  
    Safflower Oil (UNII: 65UEH262IS)  
    Cetostearyl Alcohol (UNII: 2DMT128M1S)  
    Butylene Glycol (UNII: 3XUS85K0RA)  
    Glyceryl Stearate SE (UNII: FCZ5MH785I)  
    Polysorbate 60 (UNII: CAL22UVI4M)  
    Oat (UNII: Z6J799EAJK)  
    Levomenol (UNII: 24WE03BX2T)  
    Filipendula Ulmaria Root (UNII: 997724QNDS)  
    Menthol, Unspecified Form (UNII: L7T10EIP3A)  
    10-Hydroxydecanoic Acid (UNII: NP03XO416B)  
    Sebacic Acid (UNII: 97AN39ICTC)  
    1,10-Decanediol (UNII: 5I577UDK52)  
    Camphor (Synthetic) (UNII: 5TJD82A1ET)  
    Farnesyl Acetate (UNII: 2ARF3ZNJ1R)  
    Panthenol Triacetate, (+)- (UNII: 1206E8961B)  
    .Alpha.-Tocopherol Acetate (UNII: 9E8X80D2L0)  
    Glycyrrhizinate Dipotassium (UNII: CA2Y0FE3FX)  
    Cinnamon Bark Oil (UNII: XE54U569EC)  
    Sarcosine (UNII: Z711V88R5F)  
    Niacinamide (UNII: 25X51I8RD4)  
    Yeast, Unspecified (UNII: 3NY3SM6B8U)  
    Horse Chestnut (UNII: 3C18L6RJAZ)  
    Ammonium Glycyrrhizate (UNII: 3VRD35U26C)  
    Panthenol (UNII: WV9CM0O67Z)  
    Zinc Gluconate (UNII: U6WSN5SQ1Z)  
    Caffeine (UNII: 3G6A5W338E)  
    Biotin (UNII: 6SO6U10H04)  
    Hydroxyethyl Cellulose (6500 MPA.S at 2%) (UNII: 2Q40985DRM)  
    Edetate Disodium (UNII: 7FLD91C86K)  
    Capryloyl Glycine (UNII: 8TY5YO42NJ)  
    1,2-Hexanediol (UNII: TR046Y3K1G)  
    Tropolone (UNII: 7L6DL16P1T)  
    Caprylyl Glycol (UNII: 00YIU5438U)  
    Caprylhydroxamic Acid (UNII: UPY805K99W)  
    Ethylhexylglycerin (UNII: 147D247K3P)  
    Methylpropanediol (UNII: N8F53B3R4R)  
    Titanium Dioxide (UNII: 15FIX9V2JP)  
    Zinc Oxide (UNII: SOI2LOH54Z)  
    Product Characteristics
    ColorWHITEScore    
    ShapeSize
    FlavorImprint Code
    Contains    
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:68479-013-021 in 1 CARTON05/13/2011
    175 mL in 1 TUBE; Type 0: Not a Combination Product
    2NDC:68479-013-002 mL in 1 POUCH; Type 0: Not a Combination Product05/13/2011
    3NDC:68479-013-0122 mL in 1 TUBE; Type 0: Not a Combination Product05/13/2011
    4NDC:68479-013-04177 mL in 1 TUBE; Type 0: Not a Combination Product05/13/2011
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC MONOGRAPH FINALpart358H05/13/2011
    Labeler - Dermalogica (177698560)
    Establishment
    NameAddressID/FEIBusiness Operations
    Cosway052400223MANUFACTURE(68479-013)
View All Sections

Find additional resources

(also available in the left menu)

Safety

Report Adverse Events, FDA Safety Recalls, Presence in Breast Milk

Related Resources

Medline Plus, Clinical Trials, PubMed, Biochemical Data Summary

More Info on this Drug

View Labeling Archives, RxNorm, Get Label RSS Feed, View NDC Code(s)NEW!