FDA.reportPublic FDA data

Anubis Barcelona Vital Line

Product NDC
83021-187
11-digit product format
830210187
Labeler code
83021
Product ID
83021-187_045289e2-7a72-8d91-e063-6394a90ab123
Type
HUMAN OTC DRUG
Nonproprietary name
Hydrolyzed Elastin, Hydrolysed Collagen, Cocoglycerides
Dosage form
CREAM
Route
TOPICAL
Labeler
ANUBIS COSMETICS SL
Application
M016
Marketing category
OTC MONOGRAPH FINAL
Marketing start
2022-10-25
Marketing end
2026-10-20
Substance
AVOBENZONE; PHENOXYETHANOL; FRAGRANCE 13576; DEHYDROACETIC ACID; HYDROLYZED BOVINE ELASTIN (BASE; 1000 MW); OCTINOXATE; COCO-GLYCERIDES; GLYCERIN; HYDROLYSED MARINE COLLAGEN (ENZYMATIC; 2000 MW); CETOSTEARYL ALCOHOL; MEDIUM-CHAIN TRIGLYCERIDES; CETYL ALCOHOL; .ALPHA.-HEXYLCINNAMALDEHYDE; WATER; BENZOIC ACID; CENTAUREA CYANUS FLOWER; VIOLA ODORATA; LIMONENE, (+)-; POTASSIUM PHOSPHATE, UNSPECIFIED FORM; .BETA.-CITRONELLOL, (R)-; ISOMETHYL-.ALPHA.-IONONE; BUTYLATED HYDROXYTOLUENE
Active strength
2; 1.62; .98; .14; .03; 5; 8; 6.94; .6; 12.58; 12; 4; .16; 140; .24; .05; .05; .038; .006; .0056; .0054; .005 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; mL/200mL; g/200mL; g/200mL; g/200mL; g/200mL; g/200mL; g/200mL; g/200mL; g/200mL
Pharmacologic classes
Allergens [CS], Ammonium Ion Binding Activity [MoA], Cell-mediated Immunity [PE], Glycerol [CS], Increased Histamine Release [PE], Increased IgG Production [PE], Nitrogen Binding Agent [EPC], 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
AVOBENZONE2 g/200mL
PHENOXYETHANOL1.62 g/200mL
FRAGRANCE 13576.98 g/200mL
DEHYDROACETIC ACID.14 g/200mL
HYDROLYZED BOVINE ELASTIN (BASE.03 g/200mL
1000 MW)5 g/200mL
OCTINOXATE8 g/200mL
COCO-GLYCERIDES6.94 g/200mL
GLYCERIN.6 g/200mL
HYDROLYSED MARINE COLLAGEN (ENZYMATIC12.58 g/200mL
2000 MW)12 g/200mL
CETOSTEARYL ALCOHOL4 g/200mL
MEDIUM-CHAIN TRIGLYCERIDES.16 g/200mL
CETYL ALCOHOL140 mL/200mL
.ALPHA.-HEXYLCINNAMALDEHYDE.24 g/200mL
WATER.05 g/200mL
BENZOIC ACID.05 g/200mL
CENTAUREA CYANUS FLOWER.038 g/200mL
VIOLA ODORATA.006 g/200mL
LIMONENE, (+)-.0056 g/200mL
POTASSIUM PHOSPHATE, UNSPECIFIED FORM.0054 g/200mL
.BETA.-CITRONELLOL, (R)-.005 g/200mL
ISOMETHYL-.ALPHA.-IONONE
BUTYLATED HYDROXYTOLUENE

Harmonized UNII identifiers#

UNII identifiers page 1 of 1 · 20 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
G63QQF2NOXInternal UNII lookup
HIE492ZZ3TInternal UNII lookup
5EM498GW35Internal UNII lookup
2KAG279R6RInternal UNII lookup
4Y5P7MUD51Internal UNII lookup
ISE9I7DNUGInternal UNII lookup
PDC6A3C0OXInternal UNII lookup
2DMT128M1SInternal UNII lookup
C9H2L21V7UInternal UNII lookup
936JST6JCNInternal UNII lookup
7X6O37OK2IInternal UNII lookup
059QF0KO0RInternal UNII lookup
8SKN0B0MIMInternal UNII lookup
QZ239038YCInternal UNII lookup
AET12U8B74Internal UNII lookup
GFD7C86Q1WInternal UNII lookup
B7862WZ632Internal UNII lookup
P01OUT964KInternal UNII lookup
9XP4LC555BInternal UNII lookup
1P9D0Z171KInternal UNII lookup

Harmonized SPL set identifiers#

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

Identifier, FDA.report destination table
IdentifierFDA.report destination
ebe024f7-7c45-ad60-e053-2995a90a45d6Available on FDA.report

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
726062af-1135-4707-a1d7-57256991bbf9Product name220250226
c6f86816-7da6-43ea-8c25-ac9758311cc5Product name120220118
252e11b6-1a9a-4283-a242-df2c129c496dProduct name320170717
19c71a3d-ed9c-166b-a7e5-38c250c35631Product name120140508

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
83021-187-01Anubis Barcelona Vital Line200 mL in 1 TUBECREAM2002

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
83021-187ANUBIS BARCELONA VITAL LINE (HYDROLYZED ELASTIN, HYDROLYSED COLLAGEN, COCOGLYCERIDES) CREAM [ANUBIS COSMETICS SL]2Current NDC, Legacy NDC, 1 package rows20230902_ebe024f7-7c45-ad60-e053-2995a90a45d6.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 · 1,350 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
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
ChapStick Classic SpearmintPETROLATUMHaleon US Holdings LLCd39786e8-bcd8-479d-8990-142a21788a472024-04-12WarningsExact identifier
application number: M016
Chapstick 12 Days of ChristmasWHITE PETROLATUMHaleon US Holdings LLCd6eb2ea6-27c7-40a6-a1f0-789ea2131de32024-04-11WarningsExact identifier
application number: M016
Chapstick Active 2in1 Variety PackZINC OXIDEHaleon US Holdings LLCd1998a9e-d61f-4b4c-91b0-5e66754bcc4a2024-04-11WarningsExact identifier
application number: M016
Chapstick 12 Days of ChristmasWHITE PETROLATUMHaleon US Holdings LLC040694f0-b5ba-4203-bde9-699fa9b1afef2024-04-11WarningsExact identifier
application number: M016
Chapstick Holiday Classics KitWHITE PETROLATUMHaleon US Holdings LLC6df216dc-c03d-463a-8029-5e54c1dc3d272024-04-11WarningsExact identifier
application number: M016
Carmex Classic Lip Balm Medicated SPF15 Triple Force FormulaOCTINOXATE, OXYBENZONE, WHITE PETROLATUMCarma Laboratories, Inc.3eb0f8ff-89e7-4410-8573-3349e49465482024-04-02WarningsExact identifier
application number: M016
Pure Cornstarch BabyCORN STARCHWalgreen Companyd0e9bd13-b568-4f7e-b036-8d23e71ad8bf2024-03-25WarningsExact identifier
application number: M016

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
83021-187-0183021018701200 mL in 1 TUBE (83021-187-01) 200 ml2022-10-252026-10-20NoNoCurrent