FDA.reportPublic FDA data

The Zoeun Skin Total Cleanser

Product NDC
83636-112
11-digit product format
836360112
Labeler code
83636
Product ID
83636-112_4275eecd-67bc-fb1c-e063-6294a90aa09a
Type
HUMAN OTC DRUG
Nonproprietary name
Colloidal Oatmeal
Dosage form
SOLUTION
Route
TOPICAL
Labeler
Sturgeonbio Co.,Ltd.
Application
M016
Marketing category
OTC MONOGRAPH DRUG
Marketing start
2025-10-01
Substance
OATMEAL
Active strength
.007 g/100mL
Pharmacologic classes
Allergens [CS], Cell-mediated Immunity [PE], Dietary Proteins [CS], Grain Proteins [EXT], Increased Histamine Release [PE], Non-Standardized Food Allergenic Extract [EPC], Non-Standardized Plant Allergenic Extract [EPC], Plant Proteins [CS]
NDC exclude flag
No
Listing certified through
2026-12-31
Current FDA listing
Yes

Reported adverse events (FAERS/openFDA)#

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

Additional Listing Data#

Finished product
Yes
Brand name base
The Zoeun Skin Total Cleanser
Listing expiration
2026-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
OATMEAL.007 g/100mL

Harmonized UNII identifiers#

UNII identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
8PI54V663YInternal UNII lookup

Harmonized SPL set identifiers#

SPL set identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
4275eecd-67bb-fb1c-e063-6294a90aa09aAvailable on FDA.report

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
83636-112-01The Zoeun Skin Total Cleanser150 mL in 1 BOTTLE, PUMPSOLUTION1501

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 21 of 68 · 1,357 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Daily MoisturizingDIMETHICONETopco Associates LLC47e54eee-70e0-4bfa-ae77-d61a6560a9e12026-02-13Warnings, Adverse reactionsExact identifier
application number: M016
Witch HazelWITCH HAZELTopco Associates LLC471a9f8d-ba12-41d3-a510-20c1a13ff8502026-02-13Warnings, Adverse reactionsExact identifier
application number: M016
Skin ProtectantPETROLATUMWakefern Food Corp.b799229b-f7ca-494c-afde-1fd096aef66e2026-02-13Warnings, Adverse reactionsExact identifier
application number: M016
Diaper RashZINC OXIDEWinCo Foods, LLC659cc8c7-6300-41c0-a684-c5fde7f2b1002026-02-12Warnings, Adverse reactionsExact identifier
application number: M016
Zinc OxideZINC OXIDEWalgreen Co.220f70e1-0802-4fe2-92d0-78dec557c9932026-02-12Warnings, Adverse reactionsExact identifier
application number: M016
Witch HazelWITCH HAZELWalgreen Co.417ae199-54bb-420f-a3cf-1c096062d78c2026-02-12Warnings, Adverse reactionsExact identifier
application number: M016
First Aid Beauty Dry Skin Rescue KitCOLLOIDAL OATMEALThe Procter & Gamble Manufacturing Company4a93d029-d721-0bb5-e063-6294a90a17c42026-02-11WarningsExact identifier
application number: M016
Natouch Eczema WipesECZEMA WIPESNatouch LLC0a9756a4-2fa9-cd19-e063-6294a90a93ad2026-02-10WarningsExact identifier
application number: M016
EARTHS CARE Eczema CreamECZEMADLC Laboratories, Inc.17436fa0-d6c7-1052-e063-6294a90adae42026-02-09WarningsExact identifier
application number: M016
PetrolatumWHITE PETROLATUMRetail Business Services, LLCbf0c9494-0138-4346-9348-e235ca4d9e582026-02-06Warnings, Adverse reactionsExact identifier
application number: M016
Clear Anti-ItchPRAMOXINE HCL, ZINC ACETATERetail Business Services, LLCa80b8fee-2dd9-4640-a4f8-4cf940df85632026-02-06Warnings, Adverse reactionsExact identifier
application number: M016
Advanced HealingPETROLATUMRetail Business Services, LLC6e9121c8-5eb9-4d0b-86c5-b892e14bdab82026-02-06WarningsExact identifier
application number: M016
PetrolatumWHITE PETROLATUMRetail Business Services, LLCbf73c618-ed2f-4468-a51f-ff61c7b1f5062026-02-06Warnings, Adverse reactionsExact identifier
application number: M016
Daily MoisturizingDIMETHICONERetail Business Services, LLCc8a876e2-0a34-4c3d-a0bc-549dd3048e8a2026-02-06Warnings, Adverse reactionsExact identifier
application number: M016
PetroleumWHITE PETROLATUMSalado Sales Inc.f973e3a5-3b45-4842-99ce-dff676ae1f962026-02-06Warnings, Adverse reactionsExact identifier
application number: M016
Petroleum Skin ProtectantWHITE PETROLATUMPharmacy Value Alliance, LLC0ce03cd1-c48d-45cf-b11f-08bade55dcb62026-02-05Warnings, Adverse reactionsExact identifier
application number: M016
Daily MoisturizingDIMETHICONEPublix Super Markets, Inc.28ac9de4-2a63-4839-bed5-9bcc59ebeb2a2026-02-05Warnings, Adverse reactionsExact identifier
application number: M016
Witch HazelWITCH HAZELPublix Super Markets, Inc.0098c983-c518-4a14-8635-c7bdde7bff4f2026-02-05Warnings, Adverse reactionsExact identifier
application number: M016
TN Dickinsons Pain and Itch ReliefPRAMOXINE HYDROCHLORIDE AND ZINC ACETATEDickinson Brands Inc.537c9c27-ee81-4920-8e3f-21edb844c9cf2026-02-05WarningsExact identifier
application number: M016
Aveeno Eczema Therapy Nighttime Itch Relief BalmCOLLOIDAL OATMEALKenvue Brands LLCe3350a8f-b983-7c4d-e053-2a95a90a53f52026-02-04WarningsExact identifier
application number: M016

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startSampleExclude flagStatus
83636-112-0183636011201150 mL in 1 BOTTLE, PUMP (83636-112-01) 150 ml2025-10-01NoNoCurrent