Label: SOFIE PAVITT FACE RESET BENZOYL PEROXIDE ACNE TREATMENT MASK- benzoyl peroxide paste

  • NDC Code(s): 52261-7301-1, 52261-7301-2
  • Packager: Cosco International, Inc.
  • Category: HUMAN OTC DRUG LABEL
  • DEA Schedule: None

Drug Label Information

Updated March 17, 2026

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  • Active Ingredient/Purpose

    Benzoyl Peroxide............Acne Treatment

  • Use

    For the treatment of acne

  • Warnings

    For external use only

    Do not use if you

    • have very sensitive skin
    • are sensitive to benzoyl peroxide

    Ask doctor before use

    if you have redness over the affected area

    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.
    • Avoid unnecessary sun exposure and use a sunscreen
    • Avoid contact with the eyes, lips, and mouth
    • Avoid contact with hair and dyed fabrics, which may be bleached by this product
    • Skin irritation may occur, characterized by redness, burning, itching, peeling, or possibly swelling. Irritation may be reduced by using the product less frequently or in a lower concentration.

    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

    • Clean the skin throughly before applying this product
    • Apply to hands, add and massage gently onto the face. Allow to dry. Rinse thoroughly.
    • Use once a day or as directed by a doctor.
    • If dryness or peeling occurs, reduce application to once every other day.
    • If going outside, apply sunscreen after using this product.
    • If irritation or sensitivity develops, discontinue use and consult a doctor.
  • Other Information

    Store at room temperature 20°-25°C (68°-77°F)

    Protect from heat and direct sunlight.

  • Inactive Ingredients

    Water, Kaolin, Bentonite, Propanediol, Sodium Hyaluronate, Glycolic Acid, Niacinamide, Panthenol, Phenoxyethanol, Ethylhexylglycerin,  Hydroxyethylcellulose, Carbomer, Xanthan Gum, Tocopheryl Acetate, Sodium Hydroxide, Sodium Citrate, Diethylhexyl Sodium Sulfosuccinate, Dimethicone, Silica, Sorbitan Stearate, PEG-40 Stearate

  • PRINCIPAL DISPLAY PANEL

    SP Tube 1 ozSP Tube 1 ozSP Tube 1 ozSP Tube 1 oz

  • PRINCIPAL DISPLAY PANEL

    SP 1oz cartonSP 1oz carton

  • INGREDIENTS AND APPEARANCE
    SOFIE PAVITT FACE RESET BENZOYL PEROXIDE ACNE TREATMENT MASK 
    benzoyl peroxide paste
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:52261-7301
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    Benzoyl Peroxide (UNII: W9WZN9A0GM) (BENZOYL PEROXIDE - UNII:W9WZN9A0GM) Benzoyl Peroxide0.05 kg  in 1 kg
    Inactive Ingredients
    Ingredient NameStrength
    WATER (UNII: 059QF0KO0R)  
    KAOLIN (UNII: 24H4NWX5CO)  
    BENTONITE (UNII: A3N5ZCN45C)  
    PROPANEDIOL (UNII: 5965N8W85T)  
    HYALURONATE SODIUM (UNII: YSE9PPT4TH)  
    PHENOXYETHANOL (UNII: HIE492ZZ3T)  
    ETHYLHEXYLGLYCERIN (UNII: 147D247K3P)  
    GLYCOLIC ACID (UNII: 0WT12SX38S)  
    NIACINAMIDE (UNII: 25X51I8RD4)  
    PANTHENOL (UNII: WV9CM0O67Z)  
    HYDROXYETHYL CELLULOSE, UNSPECIFIED (UNII: T4V6TWG28D)  
    XANTHAN GUM (UNII: TTV12P4NEE)  
    CARBOMER (UNII: 0A5MM307FC)  
    .ALPHA.-TOCOPHEROL ACETATE (UNII: 9E8X80D2L0)  
    SODIUM HYDROXIDE (UNII: 55X04QC32I)  
    DIETHYLHEXYL SODIUM SULFOSUCCINATE (UNII: F05Q2T2JA0)  
    DIMETHICONE (UNII: 92RU3N3Y1O)  
    SILICA (UNII: ETJ7Z6XBU4)  
    SORBITAN STEARATE (UNII: NVZ4I0H58X)  
    PEG-40 STEARATE (UNII: ECU18C66Q7)  
    SODIUM CITRATE (UNII: 1Q73Q2JULR)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:52261-7301-11 in 1 CARTON11/11/2024
    10.0618 kg in 1 TUBE; Type 0: Not a Combination Product
    2NDC:52261-7301-21 in 1 CARTON03/17/2026
    20.0313 kg in 1 TUBE; Type 0: Not a Combination Product
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC Monograph DrugM00611/11/2024
    Labeler - Cosco International, Inc. (016433141)
    Registrant - Cosco International, Inc. (016433141)
    Establishment
    NameAddressID/FEIBusiness Operations
    Cosco International, Inc.016433141manufacture(52261-7301) , label(52261-7301) , pack(52261-7301)
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