FDA.reportPublic FDA data

The Indigo Cream

Manufacturer
TATCHA, Inc. | Thibiant International, Inc.
Effective date
2022-01-31
Label type
HUMAN OTC DRUG LABEL
Version
3
Source
full-release
Hydrated at
2026-05-31 23:47:52

Label at a glance#

ProductThe Indigo Cream
Active ingredientOATMEAL
Label structure10 sections

Label contents#

Full prescribing information#

Drug Facts 

OTC - ACTIVE INGREDIENT SECTION

Active Ingredients

Colloidal Oatmeal 2%

OTC - PURPOSE SECTION

Purpose

Skin Protectant

INDICATIONS & USAGE SECTION

Uses

Temporarily protects and helps relieve minor skin irritation and itching due to

  • rashes
  • eczema 

WARNINGS SECTION

Warnings

For external use only.

When using this product

  • do not get into eyes

OTC - STOP USE SECTION

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.

DOSAGE & ADMINISTRATION SECTION

Directions

  • Apply as needed.

INACTIVE INGREDIENT SECTION

Inactive ingredients

WATER/AQUA, SQUALANE, DIMETHICONE, PROPANEDIOL, GLYCERIN, DIISOSTEARYL MALATE, ORYZA SATIVA (RICE) BRAN WAX, BEHENYL ALCOHOL, SACCHAROMYCES/CAMELLIA SINENSIS LEAF/CLADOSIPHON OKAMURANUS/RICE FERMENT FILTRATE*, 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, INOSITOL, SERICIN, TETRASODIUM TETRACARBOXYMETHYL NARINGENINCHALCONE, AMORPHOPHALLUS KONJAC ROOT POWDER, SODIUM HYALURONATE, SORBITAN TRISTEARATE, TRIHYDROXYSTEARIN, DIMETHICONE/VINYL DIMETHICONE CROSSPOLYMER, BEHENETH-20, BIS-DIGLYCERYL POLYACYLADIPATE-2, ETHYLHEXYLGLYCERIN, BUTYLENE GLYCOL, SODIUM DILAURAMIDOGLUTAMIDE LYSINE, DISODIUM EDTA, ETHYLHEXYL PALMITATE, SODIUM ACRYLATE/ACRYLOYLDIMETHYLTAURATE/ DIMETHYLACRYLAMIDE CROSSPOLYMER, PHENOXYETHANOL, TITANIUM DIOXIDE (CI77891), TIN OXIDE (CI 77861), MICA (CI 77019) * HADASEI-3

OTC - QUESTIONS SECTION

Questions or Comments?

Call toll free (888) 739-2932 ext. 1

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

TATCHA 

THE INDIGO CREAM

soothing skin protectant with colloidal oatmeal 

10 [50] ml/0.34 [1.7] fl. oz. 

Tatcha 10 mL PDPTatcha 10 mL PDP

Tatcha 10 mL PanelTatcha 10 mL Panel

Tatcha 50 mL PDPTatcha 50 mL PDP

Tatcha 50 mL PanelTatcha 50 mL Panel

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYSPL version
1189915colloidal oatmeal 2 % Topical CreamPSN3
1189915colloidal oatmeal 20 MG/ML Topical CreamSCD3
1189915colloidal oatmeal 2 % Topical CreamSY3

DailyMed Pharmacologic Classes#

Class, Version, Type table
ClassVersionTypeEffective
OATMEAL Pharmacologic Class Indexing2Indexing - Pharmacologic Class20181113

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
69417-120-032022-07-29C16284748780-1e4f33bdf-b001-d8a0-e053-dadaa90a6e4eTHE INDIGO CREAM
69417-120-172022-07-29C16284748780-1e4f33bdf-b001-d8a0-e053-dadaa90a6e4eTHE INDIGO CREAM

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
69417-120-03The Indigo Cream1 in 1 BOXCREAM13
69417-120-03The Indigo Cream10 g in 1 TUBECREAM103
69417-120-17The Indigo Cream1 in 1 BOXCREAM13
69417-120-17The Indigo Cream50 g in 1 TUBECREAM503

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
69417-120THE INDIGO CREAM (COLLOIDAL OATMEAL 2%) CREAM [TATCHA, INC.]3Legacy NDC, 4 package rows20220202_44f500eb-3af1-4d8e-9cb7-0f3f0d800d33.zip

Products#

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

DailyMed product names page 1 of 1 · 36 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
69417-12069417-120-17, 69417-120-03

Ingredients#

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

DailyMed ingredient rows page 1 of 1 · 34 matching rows.

Name, UNII, Kind table
NameUNIIKind
WATER059QF0KO0RIACT
SQUALANEGW89575KF9IACT
DIMETHICONE CROSSPOLYMER (450000 MPA.S AT 12% IN CYCLOPENTASILOXANE)UF7620L1W6IACT
PROPANEDIOL5965N8W85TIACT
GLYCERINPDC6A3C0OXIACT
DIISOSTEARYL MALATEQBS8A3XZGQIACT
RICE BRANR60QEP13ICIACT
DOCOSANOL9G1OE216XYIACT
CAMELLIA SINENSIS WHOLEC5M4585ZBZIACT
INDIGOFERA TINCTORIA LEAF2K7DF8HZDMIACT
PERSICARIA TINCTORIA LEAFFU6582QMPVIACT
OAT KERNEL OIL3UVP41R77RIACT
STYPHNOLOBIUM JAPONICUM FLOWER644C3CSB6EIACT
RICE GERM OILD4H5GGS5JFIACT
COCONUT OILQ9L0O73W7LIACT
INOSITOL4L6452S749IACT
SERICIN 1N6466G03F7IACT
AMORPHOPHALLUS KONJAC ROOTF7KU2UY3HEIACT
HYALURONATE SODIUMYSE9PPT4THIACT
SORBITAN TRISTEARATE6LUM696811IACT
TRIHYDROXYSTEARIN06YD7896S3IACT
DIMETHICONE/VINYL DIMETHICONE CROSSPOLYMER (SOFT PARTICLE)9E4CO0W6C5IACT
BEHENETH-20BJ4GP2IFLNIACT
BIS-DIGLYCERYL POLYACYLADIPATE-26L246LAM9TIACT
ETHYLHEXYLGLYCERIN147D247K3PIACT
BUTYLENE GLYCOL3XUS85K0RAIACT
DISODIUM EDTA-COPPER6V475AX06UIACT
ETHYLHEXYL PALMITATE2865993309IACT
SODIUM ACRYLATE7C98FKB43HIACT
PHENOXYETHANOLHIE492ZZ3TIACT
TITANIUM DIOXIDE15FIX9V2JPIACT
STANNIC OXIDEKM7N50LOS6IACT
MICAV8A1AW0880IACT
OATMEAL8PI54V663YACTIB

Source Document#

Source XML

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
b1fdfc36-f245-430b-bf7a-9edae013b4e744f500eb-3af1-4d8e-9cb7-0f3f0d800d332022-01-31WarningsExact identifier
spl id: b1fdfc36-f245-430b-bf7a-9edae013b4e7
spl set id: 44f500eb-3af1-4d8e-9cb7-0f3f0d800d33

Reported adverse events (FAERS/openFDA)#

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