THE INDIGO CALMING- colloidal oatmeal cream 
TATCHA INC.

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.

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TATCHA® THE INDIGO CALMING CREAM

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

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

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Packaging

Tatcha-140Tatcha-140

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)

Revised: 6/2023
Document Id: c13fe4eb-4c7f-4786-b14c-725e93a8085d
Set id: f2b9a49d-e91f-416d-a031-15bbde005d2f
Version: 1
Effective Time: 20230622
 
TATCHA INC.