Label: CLN BODY MOISTURIZER- colloidal oat moisturizer cream

  • NDC Code(s): 69530-858-01, 69530-858-08
  • Packager: TopMD Skin Care, Inc.
  • Category: HUMAN OTC DRUG LABEL
  • DEA Schedule: None

Drug Label Information

Updated June 18, 2025

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  • Drug Facts

  • Active Ingredients

    2% Collodial Oatmeal

  • Purpose

    Skin Protectant

  • Uses

    Temporarily protects and helps releive minor skin irritation and itching due to: ● rashes ● ezcema

  • Warnings

    For external use only.

    When using this product

    ● avoid contact with eyes

    Stop use and ask doctor if

    ● condition worsens ● symptoms last more than 7 days or clear up and occur again within a few days

    Keep out of reach of children.

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

  • Directions

    ● apply as needed or as directed by doctor ● for children under 2 years of age: Ask a doctor

  • Other Information

    For mild to moderate ezcema

  • Inactive Ingredients

    Water, Glycerin, Propanediol, Dimethicone, Petrolatum, Glyceryl Stearate, Cetyl Alcohol, Phenoxyethanol, Aloe Barbadensis Leaf Juice, Hydrolyzed Jojoba Esters, Tocopheryl Acetate, Bisabolol, Ethylhexylglycerin, Polyacrylate-13, Panthenol, C10-30 Cholesterol/Lanosterol Esters, Lactic Acid, Polyisobutene, Jojoba Esters, Disodium EDTA, Butyrospermum Parkii (Shea) Butter, Zingiber Officinale (Ginger) Root Extract, Avena Sativa (Oat) Kernel Extract, Polysorbate-20, C12-15 Alkyl Benzoate, Sorbitan Isooctadecanoate, Magnesium Ascorbyl Phosphate, Hippophae Ramnoides Oil, Tribenhenin, Ceramide NG, PEG-10 Phytosterol, Palmitoyl Hexapeptide-12

  • PRINCIPAL DISPLAY PANEL

    CLn Body Moisturizer 8 oz TUBE L24.BM08T2_06.17.24

  • INGREDIENTS AND APPEARANCE
    CLN BODY MOISTURIZER 
    colloidal oat moisturizer cream
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:69530-858
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    OATMEAL (UNII: 8PI54V663Y) (OATMEAL - UNII:8PI54V663Y) OATMEAL2 g  in 100 g
    Inactive Ingredients
    Ingredient NameStrength
    LACTIC ACID (UNII: 33X04XA5AT)  
    CERAMIDE NG (UNII: C04977SRJ5)  
    PALMITOYL HEXAPEPTIDE-12 (UNII: HO4ZT5S86C)  
    PHENOXYETHANOL (UNII: HIE492ZZ3T)  
    BISABOLOL (UNII: 24WE03BX2T)  
    POLYACRYLATE-13 (UNII: FS2D4T67EA)  
    PANTHENOL (UNII: WV9CM0O67Z)  
    GINGER (UNII: C5529G5JPQ)  
    C12-15 ALKYL BENZOATE (UNII: A9EJ3J61HQ)  
    GLYCERIN (UNII: PDC6A3C0OX)  
    ALOE VERA LEAF (UNII: ZY81Z83H0X)  
    CETYL ALCOHOL (UNII: 936JST6JCN)  
    BUTYROSPERMUM PARKII (SHEA) BUTTER (UNII: K49155WL9Y)  
    SORBITAN SESQUIISOSTEARATE (UNII: VU97D01BF9)  
    HIPPOPHAE RHAMNOIDES SEED OIL (UNII: T53SBG6741)  
    TRIBEHENIN (UNII: 8OC9U7TQZ0)  
    DIMETHICONE (UNII: 92RU3N3Y1O)  
    WATER (UNII: 059QF0KO0R)  
    GLYCERYL STEARATE (UNII: 230OU9XXE4)  
    ALPHA-TOCOPHEROL ACETATE (UNII: 9E8X80D2L0)  
    ETHYLHEXYLGLYCERIN (UNII: 147D247K3P)  
    C10-30 CHOLESTEROL/LANOSTEROL ESTERS (UNII: 137SL7IL0Y)  
    HYDROLYZED JOJOBA ESTERS (UNII: UDR641JW8W)  
    PETROLATUM (UNII: 4T6H12BN9U)  
    EDETATE DISODIUM (UNII: 7FLD91C86K)  
    MAGNESIUM ASCORBYL PHOSPHATE (UNII: 0R822556M5)  
    POLYSORBATE 20 (UNII: 7T1F30V5YH)  
    OAT (UNII: Z6J799EAJK)  
    POLYISOBUTYLENE (1000 MW) (UNII: 5XB3A63Y52)  
    PROPANEDIOL (UNII: 5965N8W85T)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:69530-858-0130 g in 1 TUBE; Type 0: Not a Combination Product02/15/2025
    2NDC:69530-858-08240 g in 1 TUBE; Type 0: Not a Combination Product02/15/2025
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC Monograph DrugM01702/15/2025
    Labeler - TopMD Skin Care, Inc. (060946293)
    Registrant - Inspec Solutions LLC (081030372)
    Establishment
    NameAddressID/FEIBusiness Operations
    Inspec Solutions LLC081030372manufacture(69530-858)
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