FDA.reportPublic FDA data

TATCHA ® THE INDIGO CALMING CREAM

Manufacturer
TATCHA INC. | Solesence, Inc.
Effective date
2026-09-24
Label type
HUMAN OTC DRUG LABEL
Version
6
Source
daily-update
Hydrated at
2026-10-06 02:02:59

Label at a glance#

ProductTHE INDIGO CALMING
Active ingredientOATMEAL
Label structure9 sections

Indications and uses

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

Dosage and administration

Apply as needed.

Label contents#

Full prescribing information#

Active Ingredient

OTC - ACTIVE INGREDIENT SECTION

Colloidal Oatmeal 2%

Purpose

OTC - PURPOSE SECTION

Skin Protectant

Uses

INDICATIONS & USAGE SECTION

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

Warnings

WARNINGS SECTION

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

OTC - KEEP OUT OF REACH OF CHILDREN SECTION

Keep out of reach of children.If swallowed, get medical help or contact a Poison Control Center right away.

Directions

DOSAGE & ADMINISTRATION SECTION

Apply as needed.

Inactive Ingredients

INACTIVE INGREDIENT SECTION

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?

OTC - QUESTIONS SECTION

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 THE USA OF INTERNATIONAL INGREDIENTS

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

© 2025 TATCHA LLC
QUESTIONS@TATCHA.COM

BEAUTIFUL FACES, BEAUTIFUL FUTURES

Every Tatcha purchase supports education equality worldwide.

www.tatcha.com/giving-back

Packaging

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

Tatcha-140Tatcha-140

Tatcha-140Tatcha-140

Tatcha15-nwTatcha15-nw

Products#

Every source-derived product name is available through these pages.

DailyMed product names page 1 of 1 · 35 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
69417-14069417-140-03, 69417-140-17, 69417-140-04

Ingredients#

Every source-derived ingredient row is available through these pages.

DailyMed ingredient rows page 1 of 1 · 33 matching rows.

Name, UNII, Kind table
NameUNIIKind
OATMEAL8PI54V663YACTIB
WATER059QF0KO0RIACT
SQUALANEGW89575KF9IACT
DIMETHICONE, UNSPECIFIED92RU3N3Y1OIACT
PROPANEDIOL5965N8W85TIACT
GLYCERINPDC6A3C0OXIACT
DIISOSTEARYL MALATEQBS8A3XZGQIACT
RICE BRANR60QEP13ICIACT
BEHENETH-20BJ4GP2IFLNIACT
SORBITAN TRISTEARATE6LUM696811IACT
BIS-DIGLYCERYL POLYACYLADIPATE-26L246LAM9TIACT
INOSITOL4L6452S749IACT
GREEN TEA LEAFW2ZU1RY8B0IACT
CLADOSIPHON OKAMURANUS WHOLE2IJE0CH09JIACT
INDIGOFERA TINCTORIA LEAF2K7DF8HZDMIACT
OATZ6J799EAJKIACT
STYPHNOLOBIUM JAPONICUM FLOWER644C3CSB6EIACT
RICE GERM OILD4H5GGS5JFIACT
COCONUT OILQ9L0O73W7LIACT
SILK SERICIN0N1VMU8G9WIACT
CAPRYLYL/CAPRYL OLIGOGLUCOSIDEE00JL9G9K0IACT
SORBITAN ISOSTEARATE01S2G2C1E4IACT
HYALURONATE SODIUMYSE9PPT4THIACT
TRIHYDROXYSTEARIN06YD7896S3IACT
DIMETHICONE/VINYL DIMETHICONE CROSSPOLYMER (SOFT PARTICLE)9E4CO0W6C5IACT
ETHYLHEXYLGLYCERIN147D247K3PIACT
BUTYLENE GLYCOL3XUS85K0RAIACT
SODIUM DILAURAMIDOGLUTAMIDE LYSINEMNJ7VPT2R5IACT
ETHYLHEXYL PALMITATE2865993309IACT
PHENOXYETHANOLHIE492ZZ3TIACT
TITANIUM DIOXIDE15FIX9V2JPIACT
STANNIC OXIDEKM7N50LOS6IACT
MICAV8A1AW0880IACT

Source Document#

Source XML

Older Hydrated Versions#

Version, Effective date, Source table
VersionEffective dateSourceHydrated
52026-05-27full-release2026-06-01 01:59:04

openFDA label cross-check#

OpenFDA label data provides additional search and identifier links. DailyMed’s Structured Product Label is the canonical label on FDA.report. Matching records are deduplicated before they are shown below.

Matched openFDA labels page 1 of 1 · 1 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
THE INDIGO CALMINGCOLLOIDAL OATMEALTATCHA INC.f2b9a49d-e91f-416d-a031-15bbde005d2f2026-05-27WarningsExact identifier
ndc (package): 69417-140-17
ndc (package): 69417-140-04
ndc (package): 69417-140-03
ndc (product): 69417-140
ndc11 (package): 69417014004
ndc11 (package): 69417014003
ndc11 (package): 69417014017
spl set id: f2b9a49d-e91f-416d-a031-15bbde005d2f

Reported adverse events (FAERS/openFDA)#

Adverse event summaries are temporarily unavailable. Other product information remains available.