FDA.reportPublic FDA data

Anubis Barcelona Total Hydrating

Product NDC
83021-692
11-digit product format
830210692
Labeler code
83021
Product ID
83021-692_0452aac5-a077-8ea7-e063-6394a90a7c02
Type
HUMAN OTC DRUG
Nonproprietary name
Betaine, Glycerin, Polysorbate 20
Dosage form
LOTION
Route
TOPICAL
Labeler
ANUBIS COSMETICS SL
Application
M016
Marketing category
OTC MONOGRAPH FINAL
Marketing start
2022-10-13
Marketing end
2027-09-12
Substance
BETAINE; FRAGRANCE 13576; FD&C BLUE NO. 1; BENZOIC ACID; GLYCERIN; PHENOXYETHANOL; ETHYLHEXYLGLYCERIN; POLYSORBATE 20; WATER; IMIDUREA
Active strength
5; .125; .00025; 1.75; 5; 2.25; .125; 2.75; 232.139; .75 g/250mL; g/250mL; g/250mL; g/250mL; g/250mL; g/250mL; g/250mL; g/250mL; mL/250mL; g/250mL
Pharmacologic classes
Allergens [CS], Allergens [CS], Ammonium Ion Binding Activity [MoA], Cell-mediated Immunity [PE], Cell-mediated Immunity [PE], Glycerol [CS], Increased Histamine Release [PE], Increased Histamine Release [PE], Increased IgG Production [PE], Methylating Activity [MoA], Methylating Agent [EPC], Nitrogen Binding Agent [EPC], Non-Standardized Chemical Allergen [EPC], Standardized Chemical Allergen [EPC]
NDC exclude flag
No
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
Anubis Barcelona Total Hydrating

Active Ingredients#

Ingredient, Strength table
IngredientStrength
BETAINE5 g/250mL
FRAGRANCE 13576.125 g/250mL
FD&C BLUE NO. 1.00025 g/250mL
BENZOIC ACID1.75 g/250mL
GLYCERIN5 g/250mL
PHENOXYETHANOL2.25 g/250mL
ETHYLHEXYLGLYCERIN.125 g/250mL
POLYSORBATE 202.75 g/250mL
WATER232.139 mL/250mL
IMIDUREA.75 g/250mL

Harmonized UNII identifiers#

UNII identifiers page 1 of 1 · 10 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
3SCV180C9WInternal UNII lookup
5EM498GW35Internal UNII lookup
H3R47K3TBDInternal UNII lookup
8SKN0B0MIMInternal UNII lookup
PDC6A3C0OXInternal UNII lookup
HIE492ZZ3TInternal UNII lookup
147D247K3PInternal UNII lookup
7T1F30V5YHInternal UNII lookup
059QF0KO0RInternal UNII lookup
M629807ATLInternal UNII lookup

Harmonized SPL set identifiers#

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

Identifier, FDA.report destination table
IdentifierFDA.report destination
eaefe3b9-9064-18b1-e053-2a95a90a5765Available on FDA.report

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
d1c9d1af-bddd-448d-86f7-69052b7d5b47Product name120220627
c6f86816-7da6-43ea-8c25-ac9758311cc5Product name120220118
252e11b6-1a9a-4283-a242-df2c129c496dProduct name320170717

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
83021-692-01Anubis Barcelona Total Hydrating250 mL in 1 BOTTLE, SPRAYLOTION2502

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
83021-692ANUBIS BARCELONA TOTAL HYDRATING (BETAINE, GLYCERIN, POLYSORBATE 20) LOTION [ANUBIS COSMETICS SL]2Current NDC, Legacy NDC, 1 package rows20230902_eaefe3b9-9064-18b1-e053-2a95a90a5765.zip

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 37 of 68 · 1,357 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
THE ZOEUN SKIN TOTAL CARECOLLOIDAL OATMEAL, STURGEON EXTRACTSturgeonbio Co.,Ltd.42712685-64d4-0170-e063-6394a90a75d72025-10-01WarningsExact identifier
application number: M016
The Zoeun Skin Total CleanserCOLLOIDAL OATMEALSturgeonbio Co.,Ltd.4275eecd-67bb-fb1c-e063-6294a90aa09a2025-10-01WarningsExact identifier
application number: M016
The Zoeun Skin Mist TonerCOLLOIDAL OATMEALSturgeonbio Co.,Ltd.42766f41-74bc-d19d-e063-6294a90aba532025-10-01WarningsExact identifier
application number: M016
The Zoeun Skin Y-Zone Feminine MoisturizerCOLLOIDAL OATMEALSturgeonbio Co.,Ltd.42773426-f39f-bebe-e063-6394a90a73d92025-10-01WarningsExact identifier
application number: M016
The Zoeun Skin Eye CreamCOLLOIDAL OATMEALSturgeonbio Co.,Ltd.42792a80-555b-e86c-e063-6294a90a2f302025-10-01WarningsExact identifier
application number: M016
The Zoeun Skin Night MaskCOLLOIDAL OATMEALSturgeonbio Co.,Ltd.42843691-8761-3f32-e063-6394a90a59bc2025-10-01WarningsExact identifier
application number: M016
The Zoeun Skin Nourishing CreamCOLLOIDAL OATMEALSturgeonbio Co.,Ltd.42849f5c-a983-c3ce-e063-6394a90a2fb52025-10-01WarningsExact identifier
application number: M016
The Zoeun Skin Sturgeon Body WashCOLLOIDAL OATMEALSturgeonbio Co.,Ltd.4285320a-bf0b-915d-e063-6394a90a9cfd2025-10-01WarningsExact identifier
application number: M016
The Zoeun Skin Sturgeon GelCOLLOIDAL OATMEALSturgeonbio Co.,Ltd.42859de3-15dd-c7b9-e063-6394a90af5012025-10-01WarningsExact identifier
application number: M016
The Zoeun Skin Sturgeon Hair EssenceCOLLOIDAL OATMAELSturgeonbio Co.,Ltd.4285eb13-d1a2-0663-e063-6294a90ac40f2025-10-01WarningsExact identifier
application number: M016
The Zoeun Skin Total Care CreamCOLLOIDAL OATMEALSturgeonbio Co.,Ltd.428643c3-e932-4db5-e063-6294a90ac36c2025-10-01WarningsExact identifier
application number: M016
Zinc OxideZINC OXIDEGeri-Gentle Corporationf5cfab62-8aab-4109-b15b-4fe380f7cb9e2025-09-29WarningsExact identifier
application number: M016
GoodSense Petroleum JellyWHITE PETROLATUMGOOD SENSE3492f044-250e-45f7-8638-e3c55713e0f52025-09-29WarningsExact identifier
application number: M016
Aveeno Baby Eczema Therapy MoisturizingOATMEALKenvue Brands LLC2a028465-1dff-4ae7-abf6-7521c2784dd12025-09-26WarningsExact identifier
application number: M016
Johnsons Baby First Touch Gift SetZINC OXIDEKenvue Brands LLC3f838eb7-42a3-c96b-e063-6294a90a74912025-09-26WarningsExact identifier
application number: M016
HealthWise Petroleum Jelly OriginalWHITE PETROLATUMVeridian Healthcare1fb96a6c-7d13-4ccf-8fa6-55ec79e6877c2025-09-25WarningsExact identifier
application number: M016
HealthWise Petroleum Jelly Baby FreshWHITE PETROLATUMVeridian Healthcare0d3e6c1a-3ba9-4442-bae0-27312d658d072025-09-25WarningsExact identifier
application number: M016
HealthWise Petroleum Jelly Cocoa ButterWHITE PETROLATUMVeridian Healthcare5c7d9eb6-c129-4fd9-9671-2e0f0453fd282025-09-25WarningsExact identifier
application number: M016
SKIN TAG REMOVERSALICYLIC ACIDShengnan (Guangzhou) Cosmetics Co., LTD3ee79d66-e728-48dd-e063-6394a90a64632025-09-16WarningsExact identifier
application number: M016
ProCure LanaCareLANOLIN 50%Twin Med LLC3aabd4ea-107c-a02c-e063-6294a90aee072025-09-15WarningsExact identifier
application number: M016

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
83021-692-0183021069201250 mL in 1 BOTTLE, SPRAY (83021-692-01) 250 ml2022-10-132027-09-12NoNoCurrent