Label: AGE BRIGHT SPOT FADER- salicylic acid gel

  • 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 18, 2019

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  • SPL UNCLASSIFIED SECTION

    Drug Facts

  • Active Ingredient

    Salicylic Acid (2.0%)

  • 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

    • Apply directly upon first sign of breakout. Reapply twice a day until spot fades.
    • If bothersome dryness or peeling occurs, reduce application to once a day or every other day.
  • Inactive Ingredients

    Water/Aqua/Eau, Butylene Glycol, Hamamelis Virginiana (Witch Hazel) Water, Isopropyl Lauroyl Sarcosinate, Niacinamide, Propanediol, Polyacrylate Crosspolymer-6, Caprylyl Methicone, Glycereth-26, Saccharide Isomerate, Hexylresorcinol, Salvia Sclarea (Clary) Oil, Malic Acid, Aloe Barbadensis Extract, Salvia Sclarea (Clary) Extract, Lavandula Angustifolia (Lavender) Oil, Citrus Limon (Lemon) Peel Oil, Rosmarinus Officinalis (Rosemary) Leaf Oil, Lavandula Hybrida Oil, Sclerotium Gum, Sodium Carrageenan, Thymol, Terpineol, Pullulan, Lecithin, Glycerin, Dimethyl Isosorbide, PEG-12 Dimethicone/PPG-20 Crosspolymer, Xanthan Gum, Sodium Citrate, Ethylhexylglycerin, Tetrasodium Glutamate Diacetate, Silica, Tocopherol, Sea Salt, Potassium Sorbate, Sodium Benzoate, Sodium Hydroxide, Citric Acid, Benzoic Acid, Aminomethyl Propanol, Phenoxyethanol.

  • Questions or comments

    Call toll free 1-800-831-5150 in the US.

  • PRINCIPAL DISPLAY PANEL - 15 mL Tube Carton

    NEW

    brightening
    spot
    treatment

    Active Clearing

    0.5 US FL OZ / 15 mL ℮

    PRINCIPAL DISPLAY PANEL - 15 mL Tube Carton
  • INGREDIENTS AND APPEARANCE
    AGE BRIGHT SPOT FADER 
    salicylic acid gel
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:68479-806
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    Salicylic Acid (UNII: O414PZ4LPZ) (Salicylic Acid - UNII:O414PZ4LPZ) Salicylic Acid20 mg  in 1 mL
    Inactive Ingredients
    Ingredient NameStrength
    Water (UNII: 059QF0KO0R)  
    Butylene Glycol (UNII: 3XUS85K0RA)  
    HAMAMELIS VIRGINIANA TOP WATER (UNII: NT00Y05A2V)  
    Isopropyl Lauroyl Sarcosinate (UNII: LYR06W430J)  
    Niacinamide (UNII: 25X51I8RD4)  
    Propanediol (UNII: 5965N8W85T)  
    AMMONIUM ACRYLOYLDIMETHYLTAURATE, DIMETHYLACRYLAMIDE, LAURYL METHACRYLATE AND LAURETH-4 METHACRYLATE COPOLYMER, TRIMETHYLOLPROPANE TRIACRYLATE CROSSLINKED (45000 MPA.S) (UNII: Q7UI015FF9)  
    CAPRYLYL TRISILOXANE (UNII: Q95M2P1KJL)  
    Glycereth-26 (UNII: NNE56F2N14)  
    Saccharide Isomerate (UNII: W8K377W98I)  
    Hexylresorcinol (UNII: R9QTB5E82N)  
    CLARY SAGE OIL (UNII: 87L0D4U3M0)  
    Malic Acid (UNII: 817L1N4CKP)  
    ALOE VERA LEAF (UNII: ZY81Z83H0X)  
    LAVENDER OIL (UNII: ZBP1YXW0H8)  
    LEMON OIL (UNII: I9GRO824LL)  
    ROSEMARY OIL (UNII: 8LGU7VM393)  
    LAVANDIN OIL (UNII: 9RES347CKG)  
    BETASIZOFIRAN (UNII: 2X51AD1X3T)  
    CARRAGEENAN SODIUM (UNII: 7CY8BVL34N)  
    Thymol (UNII: 3J50XA376E)  
    Terpineol (UNII: R53Q4ZWC99)  
    Pullulan (UNII: 8ZQ0AYU1TT)  
    LECITHIN, SOYBEAN (UNII: 1DI56QDM62)  
    Glycerin (UNII: PDC6A3C0OX)  
    Dimethyl Isosorbide (UNII: SA6A6V432S)  
    PEG-12 Dimethicone/PPG-20 Crosspolymer (UNII: 965K72OQXO)  
    Xanthan Gum (UNII: TTV12P4NEE)  
    SODIUM CITRATE, UNSPECIFIED FORM (UNII: 1Q73Q2JULR)  
    Ethylhexylglycerin (UNII: 147D247K3P)  
    Tetrasodium Glutamate Diacetate (UNII: 5EHL50I4MY)  
    SILICON DIOXIDE (UNII: ETJ7Z6XBU4)  
    Tocopherol (UNII: R0ZB2556P8)  
    Sea Salt (UNII: 87GE52P74G)  
    Potassium Sorbate (UNII: 1VPU26JZZ4)  
    Sodium Benzoate (UNII: OJ245FE5EU)  
    Sodium Hydroxide (UNII: 55X04QC32I)  
    CITRIC ACID MONOHYDRATE (UNII: 2968PHW8QP)  
    Benzoic Acid (UNII: 8SKN0B0MIM)  
    AMINOMETHYLPROPANOL (UNII: LU49E6626Q)  
    Phenoxyethanol (UNII: HIE492ZZ3T)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:68479-806-021 in 1 CARTON06/06/2019
    115 mL in 1 TUBE; Type 0: Not a Combination Product
    2NDC:68479-806-002 mL in 1 POUCH; Type 0: Not a Combination Product06/06/2019
    3NDC:68479-806-016 mL in 1 TUBE; Type 0: Not a Combination Product06/06/2019
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC MONOGRAPH FINALpart333D06/06/2019
    Labeler - Dermalogica, Inc (177698560)
    Establishment
    NameAddressID/FEIBusiness Operations
    McKenna Labs, Inc.090631412MANUFACTURE(68479-806)
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