Label: BP ACNE SPOT TREATMENT- acne spot treatment lotion

  • 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 June 22, 2023

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

  • Active Ingredient

    Benzoyl Peroxide 10.0%

  • Purpose

    Acne Treatment

  • Use

    for the management of acne.

  • 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.
    • avoid unnecessary sun exposure and use a sunscreen.
    • avoid contact with 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.
  • Do not use if you

    • have very sensitive skin
    • are sensitive to Benzoyl Peroxide
  • 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 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 daily if needed or as directed by a doctor.
    • If going outside, apply sunscreen after using this product. If irritation or sensitivity develops, stop use of both products and ask a doctor.
    • Sensitivity Test for a New User:
    • ​Apply product sparingly to one or two small affected areas during the first three days. if no discomfort occurs, follow the directions stated above.
  • Inactive Ingredients

    Water, Caprylic/Capric Triglyceride, Propanediol, Glycerin, Dimethicone, Glyceryl Oleate, Glyceryl Stearate, PEG-100 Stearate, Isosorbide Disunflowerseedate, Sodium Hyaluronate, Octyldodecyl PCA, Stearic Acid, Steareth-21, Cucumis Sativus Fruit Extract, Allantoin, Polysorbate 60, Sodium Citrate, Polyhydroxystearic Acid, Panethol, Carbomer, Titanium Dioxide, Hydroxyethyl Acrylate/Sodium Acryloyldimethyl Taurate Copolymer, Acrylates/C10-30 Alkyl Acrylate Crosspolymer, Triethanolamine, Phenoxyethanol, Diethylhexyl Sodium Sulfosuccinate, Ethylhexylglycerin, Tocopheryl Acetate, Aluminum Stearate, Alumina, Sorbitan Isostearate, Citric Acid, Sodium Hydroxide.

  • Questions or comments?

    Questions or comments?

    www.slmdskincare.com

    Distributed by Skin PS Brands

    Culver City, CA 90232

    Made in the USA with globally sourced materials.

  • SLMD Sandra Lee MD

    Skin Care by Dr. Pimple Popper

    BP Acne Spot Treatment

    10% Benzoyl Peroxide

    Maximum Strength

    Creamy lotion to treat and prevent inflammatory acne.

    0.5 fl. oz. - 15 mL

    SANDRA LEE MD

    @SLMDSKINCARE

    Unit Carton:

    BP Acne Spot Treatment

    Real results for everybody.

    AM + PM

    BP Acne Spot Treatment

    Formulated with maximum-strength benzoyl peroxide, one of the mose powerful acne-fighting ingredients to treat inflammatory pimples, cystic acne, and even ingrown hairs.

    Directions: Prep by cleansing skin. Apply a thin layer to the affected area. Reapply throughout the day, as needed.

    Created by Dr. Pimple Popper

    Sandra Lee, MD - pop culture's favorite dermatologist, founded SLMD Skincare to bridge the gap between the cluttered skincare aisle and a doctor's visit. SLMD is committed to offering dermatologist-backed products that address real skin conditions the way a doctor would.

  • INGREDIENTS AND APPEARANCE
    BP ACNE SPOT TREATMENT 
    acne spot treatment lotion
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:73318-7002
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    BENZOYL PEROXIDE (UNII: W9WZN9A0GM) (BENZOYL PEROXIDE - UNII:W9WZN9A0GM) BENZOYL PEROXIDE100 mg  in 1 g
    Inactive Ingredients
    Ingredient NameStrength
    MEDIUM-CHAIN TRIGLYCERIDES (UNII: C9H2L21V7U)  
    PROPANEDIOL (UNII: 5965N8W85T)  
    TROLAMINE (UNII: 9O3K93S3TK)  
    POLYSORBATE 60 (UNII: CAL22UVI4M)  
    GLYCERIN (UNII: PDC6A3C0OX)  
    GLYCERYL OLEATE (UNII: 4PC054V79P)  
    GLYCERYL STEARATE SE (UNII: FCZ5MH785I)  
    PEG-100 STEARATE (UNII: YD01N1999R)  
    WATER (UNII: 059QF0KO0R)  
    HYALURONATE SODIUM (UNII: YSE9PPT4TH)  
    2-OCTYLDODECYL 5-OXO-L-PROLINATE (UNII: E25TY46YTD)  
    STEARIC ACID (UNII: 4ELV7Z65AP)  
    STEARETH-21 (UNII: 53J3F32P58)  
    CUCUMBER (UNII: YY7C30VXJT)  
    CARBOMER HOMOPOLYMER, UNSPECIFIED TYPE (UNII: 0A5MM307FC)  
    TITANIUM DIOXIDE (UNII: 15FIX9V2JP)  
    ETHYLHEXYLGLYCERIN (UNII: 147D247K3P)  
    ALUMINUM OXIDE (UNII: LMI26O6933)  
    CITRIC ACID MONOHYDRATE (UNII: 2968PHW8QP)  
    SODIUM HYDROXIDE (UNII: 55X04QC32I)  
    SORBITAN ISOSTEARATE (UNII: 01S2G2C1E4)  
    POLYHYDROXYSTEARIC ACID (2300 MW) (UNII: YXH47AOU0F)  
    PANTHENOL (UNII: WV9CM0O67Z)  
    HYDROXYETHYL ACRYLATE/SODIUM ACRYLOYLDIMETHYL TAURATE COPOLYMER (45000 MPA.S AT 1%) (UNII: 86FQE96TZ4)  
    PHENOXYETHANOL (UNII: HIE492ZZ3T)  
    .ALPHA.-TOCOPHEROL ACETATE (UNII: 9E8X80D2L0)  
    SODIUM CITRATE (UNII: 1Q73Q2JULR)  
    DOCUSATE SODIUM (UNII: F05Q2T2JA0)  
    ALUMINUM STEARATE (UNII: U6XF9NP8HM)  
    CARBOMER INTERPOLYMER TYPE A (55000 CPS) (UNII: 59TL3WG5CO)  
    DIMETHICONE (UNII: 92RU3N3Y1O)  
    ALLANTOIN (UNII: 344S277G0Z)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:73318-7002-51 in 1 CARTON06/22/2023
    115 g in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph finalM00606/22/2023
    Labeler - Skin PS Brands (081085221)
    Registrant - Skin PS Brands (081085221)
    Establishment
    NameAddressID/FEIBusiness Operations
    Owen Biosciences790003045manufacture(73318-7002)