FDA.reportPublic FDA data

Anubis Barcelona Vital Line

Product NDC
83021-064
Requested package NDC
83021-064-01
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 g/200mL; .8 g/200mL; .2 g/200mL; 2 g/200mL; .01 g/200mL; .16 g/200mL; .08 g/200mL; .06 g/200mL; .04 g/200mL; 34 g/200mL; 4 g/200mL; 3 g/200mL; 2.7 g/200mL; 1 g/200mL; 125.88 g/200mL; 7 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]
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]21 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 14 of 68 · 1,350 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
ChapStick Sweet Valetine Berry Much Besties, Mint To Be, Cherish Me CherryLIP BALM SKIN PROTECTANTSuave Brands Company47a2487d-b2e5-7195-e063-6394a90ae4812026-03-30WarningsExact identifier
application number: M016
ChapStick Classic CherrySKIN PROTECTANT LIP BALMSuave Brands Co., LLC4512b5a0-ce1f-c53e-e063-6294a90a56b62026-03-30WarningsExact identifier
application number: M016
ChapStick Classic StrawberrySKIN PROTECTANT LIP BALMSuave Brands Co., LLC42770fff-d70a-d9d1-e063-6294a90aa98d2026-03-30WarningsExact identifier
application number: M016
Aveeno Skin Relief HealingGLYCERINKenvue Brands LLC345fdde5-700b-7103-e063-6394a90a0e3e2026-03-27WarningsExact identifier
application number: M016
Critic Aid ClearPETROLATUMColoplast Corp0b6da97e-519b-4579-9895-f4ede5c48b472026-03-27WarningsExact identifier
application number: M016
Baza ProtectZINC OXIDE AND DIMETHICONEColoplast Corp256dfcfc-a91c-49b0-9439-452586a0880e2026-03-27WarningsExact identifier
application number: M016
Sween 24DIMETHICONEColoplast Corpa623c8d7-8db0-410a-9980-02ac02f7b6ea2026-03-27WarningsExact identifier
application number: M016
Baza Cleanse and Protect Odor ControlDIMETHICONEColoplast Corpca5fa4ae-c18d-4457-b520-4a9318ea821f2026-03-27WarningsExact identifier
application number: M016
Baza Cleanse and ProtectDIMETHICONEColoplast Corp82eff041-0c9d-4261-a6b6-5a041a6600742026-03-27WarningsExact identifier
application number: M016
Baza ClearPETROLATUMColoplast Corp69d9f456-1a35-4146-8366-c0285648a1722026-03-27WarningsExact identifier
application number: M016
Vitamin A DLANOLIN, PETROLATUMTopco Associates LLC5126fdf6-5df5-474b-bc0d-3a82dea61abb2026-03-26Warnings, Adverse reactionsExact identifier
application number: M016
Advanced HealingPETROLATUMAmazon.com Services LLCcdf1bd12-ac59-4f06-be0f-ef6eb3caeeff2026-03-26Warnings, Adverse reactionsExact identifier
application number: M016
Dynashield with DimethiconeZINC OXIDEDynarex Corporationb5dcf9e8-4689-4a08-ae73-3a859b4cbffe2026-03-26WarningsExact identifier
application number: M016
Eczema Relief CreamCOLLOIDAL OATMEALLavior Pharma Incbdd2fc9f-2718-1d88-e053-2995a90a86822026-03-26WarningsExact identifier
application number: M016
FB HYDRATING HAND SANITIZERFB HYDRATING HAND SANITIZERFAMILY DOLLAR SERVICES, LLC36f2dec8-7ffc-fc3e-e063-6294a90a76ff2026-03-26WarningsExact identifier
application number: M016
FB HYDRATING HAND SANITIZERFB HYDRATING HAND SANITIZERFAMILY DOLLAR SERVICES, LLC36f33001-7fec-682e-e063-6394a90a94282026-03-26WarningsExact identifier
application number: M016
FB HYDRATING HAND SANITIZERFB HYDRATING HAND SANITIZERFAMILY DOLLAR SERVICES, LLC36f3b300-f32f-8881-e063-6394a90a1a2a2026-03-26WarningsExact identifier
application number: M016
White PetrolatumPETROLATUMDynarex Corporation81f5092d-0632-bf47-e053-2991aa0ac5632026-03-25WarningsExact identifier
application number: M016
MYEVERESTRIOL CREAMHubei Redrui Building Materials Co., Ltd.3ed85485-a441-4c05-e063-6394a90afef52026-03-25WarningsExact identifier
application number: M016
Softlips Peppermint SwirlDIMETHICONEThe Mentholatum Company4dbea50e-d82d-c702-e063-6394a90ac6e42026-03-24WarningsExact identifier
application number: M016

Packages#

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