FDA.reportPublic FDA data

Anubis Barcelona Vital Line

Product NDC
83021-064
11-digit product format
830210064
Labeler code
83021
Product ID
83021-064_0414db8c-fb90-8076-e063-6394a90a2d3d
Type
HUMAN OTC DRUG
Nonproprietary name
Hydrolyzed Collagen
Dosage form
CREAM
Route
TOPICAL
Labeler
ANUBIS COSMETICS SL
Application
M016
Marketing category
OTC MONOGRAPH FINAL
Marketing start
2023-02-23
Marketing end
2026-10-20
Substance
PHENOXYETHANOL; FRAGRANCE 13576; ETHYLHEXYLGLYCERIN; AVOBENZONE; .BETA.-SITOSTEROL; HYDROLYSED MARINE COLLAGEN (ENZYMATIC; 2000 MW); LINOLEIC ACID; TOCOPHEROL; MALVA SYLVESTRIS FLOWERING TOP; PAPAVER RHOEAS FLOWER; MEDIUM-CHAIN TRIGLYCERIDES; SHEA BUTTER; LINOLENIC ACID; POLYGLYCERYL-4 ISOSTEARATE; HEXYL LAURATE; WHITE WAX; HYDROGENATED CASTOR OIL; AMILOXATE; CETYL PEG/PPG-10/1 DIMETHICONE (HLB 4); SQUALANE; WATER; GLYCERIN; CETEARYL ETHYLHEXANOATE
Active strength
1.8; .8; .2; 2; .01; .2; .16; .08; .06; .04; 34; 4; .04; 3; 2.7; 1; 4; 4; 3; .01; 125.88; 7; 4 g/200mL; g/200mL; g/200mL; g/200mL; g/200mL; g/200mL; g/200mL; g/200mL; g/200mL; g/200mL; g/200mL; g/200mL; g/200mL; g/200mL; g/200mL; g/200mL; g/200mL; g/200mL; g/200mL; g/200mL; g/200mL; g/200mL; g/200mL
Pharmacologic classes
Allergens [CS], Cell-mediated Immunity [PE], Glycerol [CS], Increased Histamine Release [PE], Increased IgG Production [PE], Non-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 Vital Line

Active Ingredients#

Ingredient, Strength table
IngredientStrength
PHENOXYETHANOL1.8 g/200mL
FRAGRANCE 13576.8 g/200mL
ETHYLHEXYLGLYCERIN.2 g/200mL
AVOBENZONE2 g/200mL
.BETA.-SITOSTEROL.01 g/200mL
HYDROLYSED MARINE COLLAGEN (ENZYMATIC.2 g/200mL
2000 MW).16 g/200mL
LINOLEIC ACID.08 g/200mL
TOCOPHEROL.06 g/200mL
MALVA SYLVESTRIS FLOWERING TOP.04 g/200mL
PAPAVER RHOEAS FLOWER34 g/200mL
MEDIUM-CHAIN TRIGLYCERIDES4 g/200mL
SHEA BUTTER.04 g/200mL
LINOLENIC ACID3 g/200mL
POLYGLYCERYL-4 ISOSTEARATE2.7 g/200mL
HEXYL LAURATE1 g/200mL
WHITE WAX4 g/200mL
HYDROGENATED CASTOR OIL4 g/200mL
AMILOXATE3 g/200mL
CETYL PEG/PPG-10/1 DIMETHICONE (HLB 4).01 g/200mL
SQUALANE125.88 g/200mL
WATER7 g/200mL
GLYCERIN4 g/200mL
CETEARYL ETHYLHEXANOATE

Harmonized UNII identifiers#

UNII identifiers page 1 of 2 · 22 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
HIE492ZZ3TInternal UNII lookup
5EM498GW35Internal UNII lookup
147D247K3PInternal UNII lookup
G63QQF2NOXInternal UNII lookup
S347WMO6M4Internal UNII lookup
9KJL21T0QJInternal UNII lookup
R0ZB2556P8Internal UNII lookup
X1U1U0N90JInternal UNII lookup
Y1MLS7E68XInternal UNII lookup
C9H2L21V7UInternal UNII lookup
K49155WL9YInternal UNII lookup
0RBV727H71Internal UNII lookup
820DPX33S7Internal UNII lookup
4CG9F9W01QInternal UNII lookup
7G1J5DA97FInternal UNII lookup
ZF94AP8MEYInternal UNII lookup
376KTP06K8Internal UNII lookup
8INO2K35FAInternal UNII lookup
GW89575KF9Internal UNII lookup
059QF0KO0RInternal UNII lookup

Harmonized SPL set identifiers#

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

Identifier, FDA.report destination table
IdentifierFDA.report destination
f564bbf0-3b5c-4a81-e053-2a95a90a7ea6Available on FDA.report

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
83021-064-01Anubis Barcelona Vital Line200 mL in 1 TUBECREAM2002

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
83021-064ANUBIS BARCELONA VITAL LINE (HYDROLYZED COLLAGEN) CREAM [ANUBIS COSMETICS SL]2Current NDC, 1 package rows20230830_f564bbf0-3b5c-4a81-e053-2a95a90a7ea6.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 60 of 68 · 1,357 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
THERA Calazinc Body ShieldZINC OXIDEMcKesson Medical-Surgical Inc.974b1046-83ee-4207-91d3-40982beb9c632024-06-17WarningsExact identifier
application number: M016
DimethiconeBODY CLEANSERMcKesson8ffe6ec3-8f5f-0c9b-e053-2995a90ac3a82024-06-14WarningsExact identifier
application number: M016
Dr. Mom Butt BalmDIMETHICONE PETROLATUMFerndale Laboratories, Inc.ec06f1fd-c3e1-5dfc-e053-2a95a90a7cdd2024-06-13WarningsExact identifier
application number: M016
Secura ProtectivePETROLATUMSmith & Nephew Medical Ltd20906566-fbf2-46d9-a5d8-c7f7356d10802024-06-12WarningsExact identifier
application number: M016
CalamineFERRIC OXIDE REDNuCare Pharmaceuticals,Inc.66e98554-e158-a519-e053-2a91aa0a67832024-06-06Warnings, Adverse reactionsExact identifier
application number: M016
CVS Health Vitamin A and D Skin ProtectantLANOLIN AND PETROLATUMCVS Healthfe3ccabb-9644-4091-9dca-ffd96a43ecaf2024-05-28WarningsExact identifier
application number: M016
Babo Botanicals Sensitive Baby Fragrance Free Diaper RashZINC OXIDEBabo Botanicals, Inc.186a9642-cd73-adfb-e063-6394a90a75c72024-05-14WarningsExact identifier
application number: M016
Honest Eczema BalmCOLLOIDAL OATMEALThe Honest Company, Inc.35b8bc5c-420e-4d31-9659-f36cabbd897a2024-05-14WarningsExact identifier
application number: M016
Extra Strength Itch StoppingITCH STOPPING CREAMUniversal Distribution Centre LLCb9a42aa3-1903-76f0-e053-2a95a90a51d12024-05-13WarningsExact identifier
application number: M016
Calamine ClearPRAMOXINE HYDROCHLORIDE AND ZINC ACETATE LOTIONCardinal Health, 110 dba Leader7f733c0a-82b2-d3b0-e053-2991aa0a6b0f2024-05-13WarningsExact identifier
application number: M016
Walgreens Maximum Diaper RashZINC OXIDEWalgreens Company5eb2152f-6fa2-4191-878a-207416e698182024-05-07WarningsExact identifier
application number: M016
Cetaphil Eczema Rapid Relief CreamCOLLOIDAL OATMEALGalderma Laboratories, L.P.02a405fa-8ae9-41e9-b86f-ef5fb6e3844a2024-05-02WarningsExact identifier
application number: M016
ChapstickAVOBENZONE, OCTINOXATE, AND WHITE PETROLATUMHaleon US Holdings LLC0e34fc74-772e-48fd-a353-58807ef412c12024-05-01WarningsExact identifier
application number: M016
Diaper Rash Cream 40% ZINCZINC OXIDEASTONEA LABS PRIVATE LIMITED16da985a-6210-ec82-e063-6294a90a132d2024-04-24WarningsExact identifier
application number: M016
Petrolatum JellyPETROLATUMASTONEA LABS PRIVATE LIMITED16dac8e5-aeb8-592d-e063-6394a90ae2b62024-04-24WarningsExact identifier
application number: M016
Monistat Complete Care Chafing ReliefDIMETHICONEInsight Pharmaceuticals LLC07d7c883-1fa3-4786-905c-a1fab649765e2024-04-19WarningsExact identifier
application number: M016
zinc oxide 20%ZINC OXIDE 20%Bionpharma Inc1549500a-0941-0fba-e063-6394a90a564e2024-04-18WarningsExact identifier
application number: M016
ARC Skin ProtectantALLANTOINAnjon Biologics, Incf4ff79dd-cb38-4cca-9631-a2758a1718732024-04-18WarningsExact identifier
application number: M016
ZinctralZINC OXIDEPureTek Corporationde990834-00da-0c7a-e053-2995a90a7c372024-04-15WarningsExact identifier
application number: M016
Chapstick Moisturizer Variety PackAVOBENZONE, HOMOSALATE, OCTISALATE, OCTOCRYLENE, WHITE PETROLATUMHaleon US Holdings LLCbfb9a2d5-1ad2-45b8-a215-9d1370af53372024-04-12WarningsExact identifier
application number: M016

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
83021-064-0183021006401200 mL in 1 TUBE (83021-064-01) 200 ml2023-02-232026-10-20NoNoHistorical