INDIGO SOOTHING TRIPLE RECOVERY CREAM- colloidal oatmeal lotion 
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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DRUG FACTS

Purpose

Skin Protectant

Active Ingredients

Colloidal Oatmeal 3.00%

Uses

Temporarily protects and helps releive minor skin irritation and itching due to eczema rashes

Warnings

When using this product do not get into eyes

Stop use and ask a doctor if

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

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

Directions

Inactive Ingredients

WATER, SQUALANE, GLYCERIN, PROPANEDIOL, CYCLOPENTASILOXANE,
DIISOSTEARYL MALATE, ORYZA SATIVA (RICE) BRAN WAX, XYLITOL,
BEHENYL ALCOHOL, POLYGONUM TINCTORIUM (JAPANESE INDIGO)
LEAF/STEM EXTRACT, INDIGOFERA TINCTORIA LEAF EXTRACT, AVENA
SATIVA (OAT) KERNEL EXTRACT, CAMELLIA SINENSIS (GREEN TEA) LEAF
EXTRACT, COCOS NUCIFERA (COCONUT) OIL, SOPHORA JAPONICA FLOWER
EXTRACT, PRUNUS LANNESIANA FLOWER EXTRACT, ORYZA SATIVA (RICE)
GERM OIL, INOSITOL (RICE EXTRACT), SERICIN (SILK EXTRACT),
TETRASODIUM TETRACARBOXYMETHYL NARINGENINCHALCONE,
CHONDRUS CRISPUS (RED ALGAE) EXTRACT, AMORPHOPHALLUS KONJAC
ROOT POWDER, SODIUM HYALURONATE, DEXTRIN, SORBITAN
TRISTEARATE, TRIHYDROXYSTEARIN, DIMETHICONE, DIMETHICONE/VINYL
DIMETHICONE CROSSPOLYMER, BEHENETH-20, BIS-DIGLYCERYL
POLYACYLADIPATE-2, ETHYLHEXYLGLYCERIN, SODIUM
DILAURAMIDOGLUTAMIDE LYSINE, DISODIUM EDTA, ETHYLHEXYL
PALMITATE, SODIUM ACRYLATE/ACRYLOYLDIMETHYLTAURATE/
DIMETHYLACRYLAMIDE CROSSPOLYMER, TITANIUM DIOXIDE, CALCIUM
CARBONATE, TIN OXIDE, PHENOXYETHANOL, MICA

Other Information

Store at 20-25C (68-77)F

Principal Display Panel

69417-100-03

INDIGO SOOTHING TRIPLE RECOVERY CREAM 
colloidal oatmeal lotion
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:69417-100
Route of AdministrationTOPICAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
OATMEAL (UNII: 8PI54V663Y) (OATMEAL - UNII:8PI54V663Y) OATMEAL3 g  in 50 g
Inactive Ingredients
Ingredient NameStrength
WATER (UNII: 059QF0KO0R)  
SQUALANE (UNII: GW89575KF9)  
GLYCERIN (UNII: PDC6A3C0OX)  
PROPANEDIOL (UNII: 5965N8W85T)  
DIMETHICONE CROSSPOLYMER (450000 MPA.S AT 12% IN CYCLOPENTASILOXANE) (UNII: UF7620L1W6)  
DIISOSTEARYL MALATE (UNII: QBS8A3XZGQ)  
ORYZA SATIVA WHOLE (UNII: 84IVV0906Z)  
XYLITOL (UNII: VCQ006KQ1E)  
BEHENETH-20 (UNII: BJ4GP2IFLN)  
SODIUM ACRYLATE (UNII: 7C98FKB43H)  
SORBITAN TRISTEARATE (UNII: 6LUM696811)  
DIMETHICONE/DIENE DIMETHICONE CROSSPOLYMER (UNII: RSA9I561OK)  
ETHYLHEXYLGLYCERIN (UNII: 147D247K3P)  
PHENOXYETHANOL (UNII: HIE492ZZ3T)  
DIMETHICONE (UNII: 92RU3N3Y1O)  
TITANIUM DIOXIDE (UNII: 15FIX9V2JP)  
MICA (UNII: V8A1AW0880)  
COCOS NUCIFERA WHOLE (UNII: 245J88W96L)  
INOSITOL (UNII: 4L6452S749)  
AMORPHOPHALLUS KONJAC ROOT (UNII: F7KU2UY3HE)  
DISODIUM EDTA-COPPER (UNII: 6V475AX06U)  
INDIGOFERA TINCTORIA LEAF (UNII: 2K7DF8HZDM)  
SERICIN 1 (UNII: N6466G03F7)  
ETHYLHEXYL PALMITATE (UNII: 2865993309)  
CAMELLIA SINENSIS WHOLE (UNII: C5M4585ZBZ)  
CHONDRUS CRISPUS (UNII: OQS23HUA1X)  
AVENA SATIVA WHOLE (UNII: 5P8D0Z74RG)  
PRUNUS APETALA WHOLE (UNII: 70PO4VL8CO)  
SOPHORA FLAVESCENS WHOLE (UNII: X8KX602M5L)  
DEXTRAN 1 (UNII: I8LHQ0D645)  
CALCIUM CARBONATE (UNII: H0G9379FGK)  
POLYGONUM ARENASTRUM WHOLE (UNII: M7IQ4O4186)  
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:69417-100-0310 g in 1 TUBE; Type 0: Not a Combination Product
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph finalpart34706/16/2015
Labeler - TATCHA INC. (006811461)

Revised: 6/2015
Document Id: 18a20dca-9587-0070-e054-00144ff8d46c
Set id: 30a4d55a-c21f-4756-a77b-f2f7e3f18fc8
Version: 2
Effective Time: 20150616
 
TATCHA INC.