THE INDIGO CALMING- colloidal oatmeal cream

THE INDIGO CALMING by

Drug Labeling and Warnings

THE INDIGO CALMING by is a Otc medication manufactured, distributed, or labeled by TATCHA INC.. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

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

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Packaging

INGREDIENTS AND APPEARANCE

THE INDIGO CALMING 
colloidal oatmeal cream

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 69417-140
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
OATMEAL (UNII: 8PI54V663Y) (OATMEAL - UNII:8PI54V663Y)	OATMEAL	20 mg  in 1 mL

Inactive Ingredients
Ingredient Name	Strength
WATER (UNII: 059QF0KO0R)
SQUALANE (UNII: GW89575KF9)
DIMETHICONE, UNSPECIFIED (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 WHOLE (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 Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 69417-140-03	1 in 1 BOX	04/26/2023
1		10 mL in 1 JAR; Type 0: Not a Combination Product
2	NDC: 69417-140-17	1 in 1 BOX	04/26/2023
2		50 mL in 1 JAR; Type 0: Not a Combination Product

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC Monograph Drug	M016	04/26/2023

Labeler - TATCHA INC. (006811461)