FDA.reportPublic FDA data

Anubis Barcelona Regul OIl

Manufacturer
ANUBIS COSMETICS SL | GDC OF FLORIDA IMPORTS, INC.
Effective date
2023-09-01
Label type
HUMAN OTC DRUG LABEL
Version
2
Source
full-release
Hydrated at
2026-05-31 23:56:03

Label at a glance#

ProductAnubis Barcelona Regul OIl
Active ingredientALCOHOL, POLYOXYL 40 HYDROGENATED CASTOR OIL, YEAST, UNSPECIFIED, PROPYLENE GLYCOL, ARCTIUM LAPPA ROOT, ALLANTOIN, POWDERED CELLULOSE, PROPYLPARABEN, TOCOPHEROL, FRAGRANCE 13576, ETHYLPARABEN, ASCORBYL PALMITATE, WATER, TIOXOLONE, LEVOMENOL, HYDROXYETHYL CELLULOSE, UNSPECIFIED, ISOPROPYL ALCOHOL, FARNESOL, METHYLPARABEN, PANTHENOL, PHENOXYETHANOL, BUTYLPARABEN, NIACINAMIDE, RIBOFLAVIN, CITRAL, LIMONENE, (+)-, FD&C YELLOW NO. 5
Label structure9 sections

Label contents#

Full prescribing information#

OTC - ACTIVE INGREDIENT SECTION

RO Roll on ingredientRO Roll on ingredient

INDICATIONS & USAGE SECTION

RO Roll on indicationsRO Roll on indications

OTC - DO NOT USE SECTION

RO Roll on do not useRO Roll on do not use

OTC - KEEP OUT OF REACH OF CHILDREN SECTION

RO Roll on keep out of reachRO Roll on keep out of reach

DOSAGE & ADMINISTRATION SECTION

RO Roll on dosageRO Roll on dosage

WARNINGS SECTION

RO Roll on warningsRO Roll on warnings

INACTIVE INGREDIENT SECTION

RO Roll on ingredient listRO Roll on ingredient list

OTC - PURPOSE SECTION

RO Roll on purposeRO Roll on purpose

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

RO Roll on displayRO Roll on display

DailyMed Pharmacologic Classes#

Class, Version, Type table
ClassVersionTypeEffective
BUTYLPARABEN Pharmacologic Class Indexing2Indexing - Pharmacologic Class20180813
ETHYLPARABEN Pharmacologic Class Indexing2Indexing - Pharmacologic Class20180813
METHYLPARABEN Pharmacologic Class Indexing2Indexing - Pharmacologic Class20180813
PROPYLPARABEN Pharmacologic Class Indexing2Indexing - Pharmacologic Class20180813
YEAST Pharmacologic Class Indexing2Indexing - Pharmacologic Class20180813

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
cf050ccd-1144-f76a-e00d-e5698d8597d4Product name620250625
59361619-24d9-b610-eca6-5a7f25ed5e03Product name520240909
6bd95106-a412-1dad-b9cc-4cb74bfb27ceProduct name220230315
5e18e798-5614-cf5c-0185-38b1cb77a093Product name220160822
d5e51f11-ad28-caa4-4b49-4143974782adProduct name120150831
290f523a-f9db-9774-b5a9-e1f908ac1782Product name120150828
0ca1d589-929b-4b33-bc5b-1d84abdafa6aProduct name120150324
fc363c46-397b-4476-ac0f-70e43e8e4592Product name120150324
c6b65c52-69c7-df49-550a-a50c137f6218Product name120140508

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
83021-624-10Anubis Barcelona Regul OIl10 mL in 1 BOTTLE, WITH APPLICATORCONCENTRATE102

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
83021-624ANUBIS BARCELONA REGUL OIL (PEG-40 HYDROGENATED CASTOR OIL, PROPYLENE GLYCOL, ARCTIUM MAJUS ROOT EXTRACT) CONCENTRATE [ANUBIS COSMETICS SL]2Current NDC, Legacy NDC, 1 package rows20230902_eb905bd0-c600-b8b2-e053-2995a90ad259.zip

Products#

Every source-derived product name is available through these pages.

DailyMed product names page 1 of 1 · 35 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
83021-62483021-624-10

Ingredients#

Every source-derived ingredient row is available through these pages.

DailyMed ingredient rows page 1 of 1 · 33 matching rows.

Name, UNII, Kind table
NameUNIIKind
ALCOHOL3K9958V90MACTIB
POLYOXYL 40 HYDROGENATED CASTOR OIL7YC686GQ8FACTIB
YEAST, UNSPECIFIED3NY3SM6B8UACTIB
PROPYLENE GLYCOL6DC9Q167V3ACTIB
ARCTIUM LAPPA ROOT597E9BI3Z3ACTIB
ALLANTOIN344S277G0ZACTIB
POWDERED CELLULOSESMD1X3XO9MACTIB
PROPYLPARABENZ8IX2SC1OHACTIB
THIAMINE HYDROCHLORIDEM572600E5PIACT
TOCOPHEROLR0ZB2556P8ACTIB
.ALPHA.-TOCOPHEROL ACETATE9E8X80D2L0IACT
FRAGRANCE 135765EM498GW35ACTIB
PYRIDOXINE HYDROCHLORIDE68Y4CF58BVIACT
VITAMIN A PALMITATE1D1K0N0VVCIACT
ETHYLPARABEN14255EXE39ACTIB
ASCORBYL PALMITATEQN83US2B0NACTIB
WATER059QF0KO0RACTIB
SODIUM ACETATE4550K0SC9BIACT
TIOXOLONES0FAJ1R9CDACTIB
LEVOMENOL24WE03BX2TACTIB
HYDROXYETHYL CELLULOSE, UNSPECIFIEDT4V6TWG28DACTIB
ISOPROPYL ALCOHOLND2M416302ACTIB
FARNESOLEB41QIU6JLACTIB
EDETATE DISODIUM ANHYDROUS8NLQ36F6MMIACT
METHYLPARABENA2I8C7HI9TACTIB
PANTHENOLWV9CM0O67ZACTIB
PHENOXYETHANOLHIE492ZZ3TACTIB
BUTYLPARABEN3QPI1U3FV8ACTIB
NIACINAMIDE25X51I8RD4ACTIB
RIBOFLAVINTLM2976OFRACTIB
CITRALT7EU0O9VPPACTIB
LIMONENE, (+)-GFD7C86Q1WACTIB
FD&C YELLOW NO. 5I753WB2F1MACTIB

Source Document#

Source XML

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 1 of 1 · 1 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Anubis Barcelona Regul OIlPEG-40 HYDROGENATED CASTOR OIL, PROPYLENE GLYCOL, ARCTIUM MAJUS ROOT EXTRACTANUBIS COSMETICS SLeb905bd0-c600-b8b2-e053-2995a90ad2592023-09-01WarningsExact identifier
ndc (package): 83021-624-10
ndc (product): 83021-624
ndc11 (package): 83021062410
spl id: 0452a0dd-b516-29ea-e063-6294a90aecca
spl set id: eb905bd0-c600-b8b2-e053-2995a90ad259

Reported adverse events (FAERS/openFDA)#

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