Label: SKINCEUTICALS SILYMARIN CF ACNE TREATMENT- salicylic acid solution

  • NDC Code(s): 49967-068-01, 49967-068-02, 49967-068-03, 49967-068-04
  • Packager: L'Oreal USA Products Inc
  • 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 December 23, 2022

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  • Active ingredient


    Salicylic acid 0.5%

  • Purpose

    Acne treatment

  • Uses

    - for the treatment of acne

    - reduces the number and severity of acne blemishes and allows skin to heal

  • Warnings

    For external use only

  • Flammable until dry.

    Keep away from flames and heat.

  • When using this product

    skin irritation and dryness is more liekly 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 daily

    - because excessive drying of the skin may occur, start with one application daily, then gradually increase to two or three times daily if needed or as directed by a doctor

    - if bothersome dryness or peeling occurs, reduce application to once a day or every other day

  • Other information

    store in a cool, dark place

  • Inactive ingredients

    water, alcohol denat., ascorbic acid, propylene glycol, dipropylene glycol, laureth-23, silybum marianum fruit extract, sodium citrate, ferulic acid

  • Questions or comments?

    Call 1-800-811-1660 Monday - Friday (9 a.m. - 5 p.m. CST)

  • PRINCIPAL DISPLAY PANEL

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  • PRINCIPAL DISPLAY PANEL

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  • PRINCIPAL DISPLAY PANEL

    image of a carton

  • PRINCIPAL DISPLAY PANEL

    image of a label

  • PRINCIPAL DISPLAY PANEL

    image of a carton

  • PRINCIPAL DISPLAY PANEL

    image of a label

  • PRINCIPAL DISPLAY PANEL

    image of a carton

  • PRINCIPAL DISPLAY PANEL

    image of a label

  • PRINCIPAL DISPLAY PANEL

    image of a carton

  • INGREDIENTS AND APPEARANCE
    SKINCEUTICALS SILYMARIN CF ACNE TREATMENT 
    salicylic acid solution
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:49967-068
    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)  
    ALCOHOL (UNII: 3K9958V90M)  
    ASCORBIC ACID (UNII: PQ6CK8PD0R)  
    PROPYLENE GLYCOL (UNII: 6DC9Q167V3)  
    DIPROPYLENE GLYCOL (UNII: E107L85C40)  
    LAURETH-23 (UNII: N72LMW566G)  
    MILK THISTLE (UNII: U946SH95EE)  
    SODIUM CITRATE (UNII: 1Q73Q2JULR)  
    FERULIC ACID (UNII: AVM951ZWST)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:49967-068-011 in 1 CARTON01/01/2021
    130 mL in 1 BOTTLE; Type 0: Not a Combination Product
    2NDC:49967-068-021 in 1 CARTON01/01/2021
    255 mL in 1 BOTTLE; Type 0: Not a Combination Product
    3NDC:49967-068-031 in 1 CARTON01/01/2021
    315 mL in 1 BOTTLE; Type 0: Not a Combination Product
    4NDC:49967-068-0410 in 1 CARTON01/01/2021
    44 mL in 1 VIAL; Type 0: Not a Combination Product
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph finalpart333D12/31/2020
    Labeler - L'Oreal USA Products Inc (002136794)
    Establishment
    NameAddressID/FEIBusiness Operations
    Cosmetic Essence, LLC032565959manufacture(49967-068)
    Establishment
    NameAddressID/FEIBusiness Operations
    Cosmetique Active Production282658798manufacture(49967-068)
    Establishment
    NameAddressID/FEIBusiness Operations
    Interspray364829903pack(49967-068)
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