Label: THE INDIGO CALMING- colloidal oatmeal cream

  • NDC Code(s): 69417-140-03, 69417-140-17
  • Packager: TATCHA 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 June 22, 2023

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  • Drug Facts

  • Active Ingredient

    Colloidal Oatmeal 2%

  • Purpose

    Skin Protectant

  • Uses

    Temporarily protects and helps relieve minor skin irritation and itching due to: • rashes • eczema

  • Warnings

    For external use only. When using this product • do not get into eyes

    Stop use and ask a 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.

  • Inactive Ingredients

    Water/Aqua, Squalane, Dimethicone, Propanediol, Glycerin, Diisostearyl malate, Oryza Sativa (Rice) Bran Wax, Behenyl Alcohol, Beheneth-20, Sorbitan Tristearate, Bis-diglyceryl Polyacyladipate-2, Inositol, Saccharomyces/Rice Ferment Filtrate, Camellia Sinensis Leaf Extract, Cladosiphon Okamuranus Extract, Indigofera Tinctoria Leaf Extract, Polygonum Tinctorium Leaf/Stem Extract, Avena Sativa (Oat) Kernel Extract, Sophora Japonica Flower Extract, Oryza Sativa (Rice) Germ Oil, Cocos Nucifera (Coconut) Oil, Sericin, Tetrasodium Tetracarboxymethyl Naringeninchalcone, Caprylyl/Capryl Glucoside, Sorbitan Isostearate, Sodium Hyaluronate, Trihydroxystearin, Dimethicone/Vinyl dimethicone Crosspolymer, Ethylhexylglycerin, Butylene Glycol, Sodium Dilauramidoglutamide Lysine, Ethylhexyl Palmitate, Sodium Acrylate/Acryloyldimethyltaurate/Dimethylacrylamide Crosspolymer, Phenoxyethanol, Titanium Dioxide (CI 77891), Tin Oxide (CI 77861), Mica (CI 77019)

  • Questions?

    Call toll-free (877) 322-8633

  • SPL UNCLASSIFIED SECTION

    soothing skin protectant

    Reveal calm, smooth skin with our rich, fragrance-free moisturizer. This treatment contains Japanese indigo and delivers therapeutic colloidal oatmeal to provide soothing relief of redness and itchiness.

    FORMULATED IN JAPAN
    MADE IN USA

    DIST. TATCHA LLC
    SAN FRANCISCO, CA 94123 USA
    UK: DELPHIC HSE GU14 7NA
    NL: 104 SCHIPHOL, 1118CN
    © 2023 TATCHA LLC

    TATCHA.COM

    BEAUTIFUL FACES, BEAUTIFUL FUTURES
    Your purchase supports education equality

    www.tatcha.com/giving-back

  • Packaging

    Tatcha-140Tatcha-140

  • INGREDIENTS AND APPEARANCE
    THE INDIGO CALMING 
    colloidal oatmeal cream
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:69417-140
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    OATMEAL (UNII: 8PI54V663Y) (OATMEAL - UNII:8PI54V663Y) OATMEAL20 mg  in 1 mL
    Inactive Ingredients
    Ingredient NameStrength
    WATER (UNII: 059QF0KO0R)  
    SQUALANE (UNII: GW89575KF9)  
    DIMETHICONE (UNII: 92RU3N3Y1O)  
    PROPANEDIOL (UNII: 5965N8W85T)  
    GLYCERIN (UNII: PDC6A3C0OX)  
    DIISOSTEARYL MALATE (UNII: QBS8A3XZGQ)  
    RICE BRAN (UNII: R60QEP13IC)  
    BEHENETH-20 (UNII: BJ4GP2IFLN)  
    SORBITAN TRISTEARATE (UNII: 6LUM696811)  
    BIS-DIGLYCERYL POLYACYLADIPATE-2 (UNII: 6L246LAM9T)  
    INOSITOL (UNII: 4L6452S749)  
    GREEN TEA LEAF (UNII: W2ZU1RY8B0)  
    CLADOSIPHON OKAMURANUS (UNII: 2IJE0CH09J)  
    INDIGOFERA TINCTORIA LEAF (UNII: 2K7DF8HZDM)  
    OAT (UNII: Z6J799EAJK)  
    STYPHNOLOBIUM JAPONICUM FLOWER (UNII: 644C3CSB6E)  
    RICE GERM OIL (UNII: D4H5GGS5JF)  
    COCONUT OIL (UNII: Q9L0O73W7L)  
    SILK SERICIN (UNII: 0N1VMU8G9W)  
    CAPRYLYL/CAPRYL OLIGOGLUCOSIDE (UNII: E00JL9G9K0)  
    SORBITAN ISOSTEARATE (UNII: 01S2G2C1E4)  
    HYALURONATE SODIUM (UNII: YSE9PPT4TH)  
    TRIHYDROXYSTEARIN (UNII: 06YD7896S3)  
    DIMETHICONE/VINYL DIMETHICONE CROSSPOLYMER (SOFT PARTICLE) (UNII: 9E4CO0W6C5)  
    ETHYLHEXYLGLYCERIN (UNII: 147D247K3P)  
    BUTYLENE GLYCOL (UNII: 3XUS85K0RA)  
    SODIUM DILAURAMIDOGLUTAMIDE LYSINE (UNII: MNJ7VPT2R5)  
    ETHYLHEXYL PALMITATE (UNII: 2865993309)  
    PHENOXYETHANOL (UNII: HIE492ZZ3T)  
    TITANIUM DIOXIDE (UNII: 15FIX9V2JP)  
    STANNIC OXIDE (UNII: KM7N50LOS6)  
    MICA (UNII: V8A1AW0880)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:69417-140-031 in 1 BOX04/26/2023
    110 mL in 1 JAR; Type 0: Not a Combination Product
    2NDC:69417-140-171 in 1 BOX04/26/2023
    250 mL in 1 JAR; Type 0: Not a Combination Product
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph finalpart34704/26/2023
    Labeler - TATCHA INC. (006811461)
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