Label: JOSIE MARAN - ARGAN APOTHECARY DAILY RESPONSE CALMING TREATMENT- sulfur lotion

  • NDC Code(s): 66163-4708-1
  • Packager: Cosmetic Solutions LLC
  • 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 March 13, 2023

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  • SPL UNCLASSIFIED SECTION

    Drug Facts

  • Active Ingredient

    Sulfur 3%

  • Purpose

    Acne treatment lotion

  • Uses

    • For the treatment of acne
    • Helps clear up, dry, and reduce the severity of acne blemishes, acne pimples, blackheads, or whiteheads and allows skin to heal
    • Penetrates pores to help prevent the development of new acne blemishes, acne pimples, blackheads, or whiteheads
  • 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.
    • Apply only to areas with acne.

    Do not use on

    • Broken skin
    • Large areas of the skin

    Keep out of reach of children.

    If swallowed, get medical help or contact a Poison Control Center right away.

  • Other Information

    • Store in a cool, dry place. Keep cap closed when not in use.
  • Directions

    • Clean the skin thoroughly before applying this product.
    • Cover the entire affected area with a thin layer one to three times.
    • Because excessive drying of the skin may occur, start with one application daily, then gradually increase to two 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.
  • Inactive ingredients

    Aqua (Water)1, Caprylic/Capric Triglyceride1, Glycerin1, Argania Spinosa (Argan) Kernel Oil2, Octyldodecyl Stearoyl Stearate, Octyldodecyl Lactate, Linoleic Acid1, lsostearyl lsostearate1, Sorbitan Laurate1, Candelilla/Jojoba/Rice Bran Polyglyceryl-3 Esters1, Capryloyl Glycine1, Oleic Acid1, Acacia Senegal Gum1, Dimethyl lsosorbide, Melaleuca Alternifolia (Tea Tree) Leaf Oil1, Propanediol1, Camelina Sativa (Gold-of-Pleasure) Seed Oil1, Arachidyl Alcohol1, Cetearyl Alcohol1, Glyceryl Stearate1, Pentylene Glycol1, Xanthan Gum1, Behenyl Alcohol1, Sodium Hydroxide, Arachidyl Glucoside1, Palmitic Acid1, Sodium Stearoyl Lactylate1, Argania Spinosa (Argan) Kernel Extract1, Thymus Vulgaris (Thyme) Flower/Leaf/Stem Extract1, Phenethyl Alcohol1, Stearic Acid1, Bisabolol1, Lycium Barbarum (Goji Berry) Fruit Extract1, Phytosphingosine, Pterocarpus Marsupium (Indian Kino Tree) Bark Extract1, Lecithin1, Tetrasodium Glutamate Diacetate, Linolenic Acid1, Calcium Gluconate, Gluconolactone, Sodium Benzoate, Caprylic Acid, Tocopherol1, Sodium Carbonate, Sodium Chloride, Ubiquinone, D-Limonene.

    1
    NATURALLY-DERIVED.
    2
    ORGANIC
  • Questions or Comments?

    Call us at (888) 215-8733 or visit us at www.josiemaran.com Monday to Friday 6am-6pm PST

  • SPL UNCLASSIFIED SECTION

    Dist. by Josie Maran Cosmetics, LLC
    Hollywood, CA 90038

  • PRINCIPAL DISPLAY PANEL - 50 mL Bottle Carton

    JOSIE MARAN
    ARGAN APOTHECARY

    Daily Response
    Calming Treatment
    Lotion

    Medicinal Botanicals
    and Sulfur for Adult Acne,
    Sensitive Skin, and Pores

    50 mL 1.7 fl. oz.

    Principal Display Panel - 50 mL Bottle Carton
  • INGREDIENTS AND APPEARANCE
    JOSIE MARAN - ARGAN APOTHECARY DAILY RESPONSE CALMING TREATMENT 
    sulfur lotion
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:66163-4708
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    SULFUR (UNII: 70FD1KFU70) (SULFUR - UNII:70FD1KFU70) SULFUR30 mg  in 1 mL
    Inactive Ingredients
    Ingredient NameStrength
    Water (UNII: 059QF0KO0R)  
    MEDIUM-CHAIN TRIGLYCERIDES (UNII: C9H2L21V7U)  
    GLYCERIN (UNII: PDC6A3C0OX)  
    ARGAN OIL (UNII: 4V59G5UW9X)  
    OCTYLDODECYL STEAROYL STEARATE (UNII: 3D47Q6D93C)  
    LINOLEIC ACID (UNII: 9KJL21T0QJ)  
    OCTYLDODECYL LACTATE (UNII: 8JKW8M5W35)  
    ISOSTEARYL ISOSTEARATE (UNII: IV0Z586Z4Y)  
    SORBITAN MONOLAURATE (UNII: 6W9PS8B71J)  
    CAPRYLOYL GLYCINE (UNII: 8TY5YO42NJ)  
    OLEIC ACID (UNII: 2UMI9U37CP)  
    ACACIA (UNII: 5C5403N26O)  
    DIMETHYL ISOSORBIDE (UNII: SA6A6V432S)  
    TEA TREE OIL (UNII: VIF565UC2G)  
    PROPANEDIOL (UNII: 5965N8W85T)  
    CAMELINA SATIVA SEED OIL (UNII: 12824X01L0)  
    ARACHIDYL ALCOHOL (UNII: 1QR1QRA9BU)  
    GLYCERYL MONOSTEARATE (UNII: 230OU9XXE4)  
    PENTYLENE GLYCOL (UNII: 50C1307PZG)  
    XANTHAN GUM (UNII: TTV12P4NEE)  
    DOCOSANOL (UNII: 9G1OE216XY)  
    SODIUM HYDROXIDE (UNII: 55X04QC32I)  
    ARACHIDYL GLUCOSIDE (UNII: 6JVW35JOOJ)  
    PALMITIC ACID (UNII: 2V16EO95H1)  
    SODIUM STEAROYL LACTYLATE (UNII: IN99IT31LN)  
    ARGANIA SPINOSA SEED (UNII: 8H7X7XB54H)  
    THYME (UNII: CW657OBU4N)  
    PHENYLETHYL ALCOHOL (UNII: ML9LGA7468)  
    STEARIC ACID (UNII: 4ELV7Z65AP)  
    LEVOMENOL (UNII: 24WE03BX2T)  
    LYCIUM BARBARUM FRUIT (UNII: 930626MWDL)  
    PHYTOSPHINGOSINE (UNII: GIN46U9Q2Q)  
    PTEROCARPUS MARSUPIUM BARK (UNII: B6227M1TS0)  
    LECITHIN, SOYBEAN (UNII: 1DI56QDM62)  
    TETRASODIUM GLUTAMATE DIACETATE (UNII: 5EHL50I4MY)  
    LINOLENIC ACID (UNII: 0RBV727H71)  
    CALCIUM GLUCONATE (UNII: SQE6VB453K)  
    GLUCONOLACTONE (UNII: WQ29KQ9POT)  
    SODIUM BENZOATE (UNII: OJ245FE5EU)  
    CAPRYLIC ACID (UNII: OBL58JN025)  
    TOCOPHEROL (UNII: R0ZB2556P8)  
    SODIUM CARBONATE (UNII: 45P3261C7T)  
    SODIUM CHLORIDE (UNII: 451W47IQ8X)  
    UBIDECARENONE (UNII: EJ27X76M46)  
    LIMONENE, (+)- (UNII: GFD7C86Q1W)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:66163-4708-150 mL in 1 BOTTLE, PUMP; Type 0: Not a Combination Product05/15/2023
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph finalpart333D05/15/2023
    Labeler - Cosmetic Solutions LLC (807907928)
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