Drug Facts

Active Ingredients

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, 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

Questions or Comments?

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

TATCHA

THE INDIGO CREAM

soothing skin protectant with colloidal oatmeal

10 [50] ml/0.34 [1.7] fl. oz.

Tatcha 10 mL PDP

Tatcha 10 mL Panel

Tatcha 50 mL PDP

Tatcha 50 mL Panel

THE INDIGO CREAM
colloidal oatmeal 2% cream

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC:69417-120
Route of Administration	TOPICAL

Ingredient Name	Basis of Strength	Strength
Active Ingredient/Active Moiety
OATMEAL (UNII: 8PI54V663Y) (OATMEAL - UNII:8PI54V663Y)	OATMEAL	2 mg in 1 g

Ingredient Name	Strength
Inactive Ingredients
WATER (UNII: 059QF0KO0R)
SQUALANE (UNII: GW89575KF9)
DIMETHICONE CROSSPOLYMER (450000 MPA.S AT 12% IN CYCLOPENTASILOXANE) (UNII: UF7620L1W6)
PROPANEDIOL (UNII: 5965N8W85T)
GLYCERIN (UNII: PDC6A3C0OX)
DIISOSTEARYL MALATE (UNII: QBS8A3XZGQ)
RICE BRAN (UNII: R60QEP13IC)
DOCOSANOL (UNII: 9G1OE216XY)
CAMELLIA SINENSIS WHOLE (UNII: C5M4585ZBZ)
INDIGOFERA TINCTORIA LEAF (UNII: 2K7DF8HZDM)
PERSICARIA TINCTORIA LEAF (UNII: FU6582QMPV)
OAT KERNEL OIL (UNII: 3UVP41R77R)
STYPHNOLOBIUM JAPONICUM FLOWER (UNII: 644C3CSB6E)
RICE GERM OIL (UNII: D4H5GGS5JF)
COCONUT OIL (UNII: Q9L0O73W7L)
INOSITOL (UNII: 4L6452S749)
SERICIN 1 (UNII: N6466G03F7)
AMORPHOPHALLUS KONJAC ROOT (UNII: F7KU2UY3HE)
HYALURONATE SODIUM (UNII: YSE9PPT4TH)
SORBITAN TRISTEARATE (UNII: 6LUM696811)
TRIHYDROXYSTEARIN (UNII: 06YD7896S3)
DIMETHICONE/VINYL DIMETHICONE CROSSPOLYMER (SOFT PARTICLE) (UNII: 9E4CO0W6C5)
BEHENETH-20 (UNII: BJ4GP2IFLN)
BIS-DIGLYCERYL POLYACYLADIPATE-2 (UNII: 6L246LAM9T)
ETHYLHEXYLGLYCERIN (UNII: 147D247K3P)
BUTYLENE GLYCOL (UNII: 3XUS85K0RA)
DISODIUM EDTA-COPPER (UNII: 6V475AX06U)
ETHYLHEXYL PALMITATE (UNII: 2865993309)
SODIUM ACRYLATE (UNII: 7C98FKB43H)
PHENOXYETHANOL (UNII: HIE492ZZ3T)
TITANIUM DIOXIDE (UNII: 15FIX9V2JP)
STANNIC OXIDE (UNII: KM7N50LOS6)
MICA (UNII: V8A1AW0880)

#	Item Code	Package Description	Marketing Start Date
Packaging
1	NDC:69417-120-17	1 in 1 BOX	08/02/2018
1		50 g in 1 TUBE; Type 0: Not a Combination Product
2	NDC:69417-120-03	1 in 1 BOX	08/02/2018
2		10 g in 1 TUBE; Type 0: Not a Combination Product

Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
Marketing Information
OTC monograph final	part347	08/02/2018

Labeler - TATCHA, Inc. (006811461)

Name	Address	ID/FEI	Business Operations
Establishment
Thibiant International, Inc.		083913913	manufacture(69417-120)