FDA.reportPublic FDA data

Anubis Barcelona Regul Oil

Product NDC
83021-742
11-digit product format
830210742
Labeler code
83021
Product ID
83021-742_04529ef6-e358-95c2-e063-6394a90ae70d
Type
HUMAN OTC DRUG
Nonproprietary name
Cetearyl Ethylhexanoate, Propylene Glycol, Glyceryl Stearate Se
Dosage form
CREAM
Route
TOPICAL
Labeler
ANUBIS COSMETICS SL
Application
M006
Marketing category
OTC MONOGRAPH FINAL
Marketing start
2022-10-19
Marketing end
2027-02-20
Substance
GLYCERIN; GERANIOL; ISOPROPYL ALCOHOL; ALCOHOL; OXYBENZONE; PHENOXYETHANOL; TEA TREE OIL; IMIDUREA; WATER; GLYCERYL STEARATE SE; CARBOMER HOMOPOLYMER, UNSPECIFIED TYPE; TIOXOLONE; LINALOOL, (+/-)-; FD&C YELLOW NO. 5; BENZYL BENZOATE; PANTHENOL; COUMARIN; C12-20 ACID PEG-8 ESTER; ARCTIUM LAPPA ROOT; PROPYLPARABEN; CETYL ALCOHOL; YEAST, UNSPECIFIED; RIBOFLAVIN; PROPYLENE GLYCOL; CETEARYL ETHYLHEXANOATE; HYDROXYETHYL CELLULOSE, UNSPECIFIED; BUTYLATED HYDROXYTOLUENE; CITRAL; GREEN TEA LEAF; ALLANTOIN; LIMONENE, (+)-; NIACINAMIDE; POWDERED CELLULOSE; POLYOXYL 40 HYDROGENATED CASTOR OIL; .ALPHA.-HEXYLCINNAMALDEHYDE; OCTINOXATE; METHYLPARABEN; FRAGRANCE 13576
Active strength
.08784; .003398; .002132; 3.5436; 1.6; 1.3; .1; .4; 155.839258; 6; .8; .3; .026404; .01044; .004; .04; .003924; 4; .003512; .28; .015; .1; .00012; 6.469044; 10; .12863; .104; .01032; .00679; .2; .061818; .02; .001066; 1.8; .00574; 3.996; .6; .5 g/200mL; g/200mL; g/200mL; mL/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; 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], Allergens [CS], Allergens [CS], Allergens [CS], Allergens [CS], Allergens [CS], Cell-mediated Immunity [PE], Cell-mediated Immunity [PE], Cell-mediated Immunity [PE], Cell-mediated Immunity [PE], Cell-mediated Immunity [PE], Cell-mediated Immunity [PE], Dietary Proteins [CS], Fungal Proteins [CS], Glycerol [CS], Increased Histamine Release [PE], Increased Histamine Release [PE], Increased Histamine Release [PE], Increased Histamine Release [PE], Increased Histamine Release [PE], Increased Histamine Release [PE], Increased IgG Production [PE], Non-Standardized Chemical Allergen [EPC], Non-Standardized Food Allergenic Extract [EPC], Non-Standardized Fungal Allergenic Extract [EPC], Standardized Chemical Allergen [EPC], Standardized Chemical Allergen [EPC], 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 Regul Oil

Active Ingredients#

Ingredient, Strength table
IngredientStrength
GLYCERIN.08784 g/200mL
GERANIOL.003398 g/200mL
ISOPROPYL ALCOHOL.002132 g/200mL
ALCOHOL3.5436 mL/200mL
OXYBENZONE1.6 g/200mL
PHENOXYETHANOL1.3 g/200mL
TEA TREE OIL.1 g/200mL
IMIDUREA.4 g/200mL
WATER155.839258 mL/200mL
GLYCERYL STEARATE SE6 g/200mL
CARBOMER HOMOPOLYMER, UNSPECIFIED TYPE.8 g/200mL
TIOXOLONE.3 g/200mL
LINALOOL, (+/-)-.026404 g/200mL
FD&C YELLOW NO. 5.01044 g/200mL
BENZYL BENZOATE.004 g/200mL
PANTHENOL.04 g/200mL
COUMARIN.003924 g/200mL
C12-20 ACID PEG-8 ESTER4 g/200mL
ARCTIUM LAPPA ROOT.003512 g/200mL
PROPYLPARABEN.28 g/200mL
CETYL ALCOHOL.015 g/200mL
YEAST, UNSPECIFIED.1 g/200mL
RIBOFLAVIN.00012 g/200mL
PROPYLENE GLYCOL6.469044 g/200mL
CETEARYL ETHYLHEXANOATE10 g/200mL
HYDROXYETHYL CELLULOSE, UNSPECIFIED.12863 g/200mL
BUTYLATED HYDROXYTOLUENE.104 g/200mL
CITRAL.01032 g/200mL
GREEN TEA LEAF.00679 g/200mL
ALLANTOIN.2 g/200mL
LIMONENE, (+)-.061818 g/200mL
NIACINAMIDE.02 g/200mL
POWDERED CELLULOSE.001066 g/200mL
POLYOXYL 40 HYDROGENATED CASTOR OIL1.8 g/200mL
.ALPHA.-HEXYLCINNAMALDEHYDE.00574 g/200mL
OCTINOXATE3.996 g/200mL
METHYLPARABEN.6 g/200mL
FRAGRANCE 13576.5 g/200mL

Harmonized UNII identifiers#

UNII identifiers page 1 of 2 · 38 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
PDC6A3C0OXInternal UNII lookup
L837108USYInternal UNII lookup
ND2M416302Internal UNII lookup
3K9958V90MInternal UNII lookup
95OOS7VE0YInternal UNII lookup
HIE492ZZ3TInternal UNII lookup
VIF565UC2GInternal UNII lookup
M629807ATLInternal UNII lookup
059QF0KO0RInternal UNII lookup
FCZ5MH785IInternal UNII lookup
0A5MM307FCInternal UNII lookup
S0FAJ1R9CDInternal UNII lookup
D81QY6I88EInternal UNII lookup
I753WB2F1MInternal UNII lookup
N863NB338GInternal UNII lookup
WV9CM0O67ZInternal UNII lookup
A4VZ22K1WTInternal UNII lookup
9M7A3K4339Internal UNII lookup
597E9BI3Z3Internal UNII lookup
Z8IX2SC1OHInternal UNII lookup

Harmonized SPL set identifiers#

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

Identifier, FDA.report destination table
IdentifierFDA.report destination
eb68c3ab-7835-1a1c-e053-2995a90a0d66Available on FDA.report

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
83021-742-01Anubis Barcelona Regul Oil200 mL in 1 TUBECREAM2002

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
83021-742ANUBIS BARCELONA REGUL OIL (CETEARYL ETHYLHEXANOATE, PROPYLENE GLYCOL, GLYCERYL STEARATE SE) CREAM [ANUBIS COSMETICS SL]2Current NDC, Legacy NDC, 1 package rows20230902_eb68c3ab-7835-1a1c-e053-2995a90a0d66.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 54 of 55 · 1,088 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Artistry Studio Done With Zit Acne Treatment Clearing GelSALICYLIC ACIDAccess Business Group LLC7a9bb4a0-c463-44e8-90a3-12bd58829f9d2023-10-21WarningsExact identifier
application number: M006
PERSISTENT BODY ACNE WASH 8.5OZSALICYLIC ACIDChina Ningbo Shangge Cosmetics Technology Corp.074079cd-866d-0af0-e063-6394a90a72142023-10-09WarningsExact identifier
application number: M006
Skin Laundry. Clean Slate Exfoliating 2 Salicylic Acid Treatment Gel Cleanser Cleanse ExfoliateSALICYLIC ACIDSkin Laundry Holdings, Inc.07100fe5-3884-0948-e063-6294a90a6ec72023-10-06WarningsExact identifier
application number: M006
NAS PORE REFINING SCRUBSALICYLIC ACIDBURT'S BEES, INC.bc2c6b1e-999c-91a7-e053-2a95a90a9d1a2023-10-05WarningsExact identifier
application number: M006
NAS Targeted Spot TreatmentSALICYLIC ACIDBurt's Beesbc193e1f-c2bd-6415-e053-2995a90ae6eb2023-10-05WarningsExact identifier
application number: M006
ACNE AND LINE CORRECTING SERUMSALICYLIC ACIDCLINIQUE LABORATORIES LLCb03bdef4-a099-4543-8673-85466bd649612023-10-05WarningsExact identifier
application number: M006
SPOT ACNE TREATMENT 0.75OZBENZOYL PEROXIDERejoice International Corp.06de40a2-45bf-bf4b-e063-6294a90a586c2023-10-04WarningsExact identifier
application number: M006
PERSISTENT BODY ACNE WASH 8.5OZSALICYLIC ACIDRejoice International Corp.06df07f7-e4c5-ccef-e063-6394a90a9f3c2023-10-04WarningsExact identifier
application number: M006
SPOT ACNE TREATMENT 0.75OZBENZOYL PEROXIDEChina Ningbo Shangge Cosmetics Technology Corp.06e07266-6483-e7ef-e063-6294a90a93952023-10-04WarningsExact identifier
application number: M006
Acne ControlCREAMWalgreenfc60cccb-405b-e49e-e053-6394a90a5a122023-09-11WarningsExact identifier
application number: M006
AnubisMedAZELAIC ACID, SALICYLIC ACIDANUBIS COSMETICS SLebf3153d-30f5-54e4-e053-2995a90a74b12023-09-05WarningsExact identifier
application number: M006
AnubisMedGLYCOLIC ACID, CITRIC ACID, LACTIC ACID, KOJIC ACIDANUBIS COSMETICS SLeca95dde-cb57-2ab6-e053-2995a90af84f2023-09-05WarningsExact identifier
application number: M006
Anubis BarcelonaPEG-40 HYDROGENATED CASTOR OIL, PROPYLENE GLYCOL, ALLANTOINANUBIS COSMETICS SLeb9244ea-6102-3cbe-e053-2a95a90ab8f62023-09-01WarningsExact identifier
application number: M006
Anubis Barcelona Regul OilPROPYLENE GLYCOL, PANTHENOL, THIAMINE HCLANUBIS COSMETICS SLeb8e5beb-4452-58c2-e053-2a95a90a66e02023-09-01WarningsExact identifier
application number: M006
Anubis Barcelona Regul OilCETEARYL ETHYLHEXANOATE, PROPYLENE GLYCOL, GLYCERYL STEARATE SEANUBIS COSMETICS SLeb68c3ab-7835-1a1c-e053-2995a90a0d662023-09-01WarningsExact identifier
application number: M006
ndc (product): 83021-742
Anubis Barcelona Regul OIlPEG-40 HYDROGENATED CASTOR OIL, PROPYLENE GLYCOL, ARCTIUM MAJUS ROOT EXTRACTANUBIS COSMETICS SLeb905bd0-c600-b8b2-e053-2995a90ad2592023-09-01WarningsExact identifier
application number: M006
Anubis Barcelona Regul OilPROPYLENE GLYCOL, GLYCERYL STEARATE SE, HUMULUS LUPULUS (HOPS) CONE EXTRACTANUBIS COSMETICS SLeb7c418b-8bee-26a3-e053-2a95a90a4e962023-09-01WarningsExact identifier
application number: M006
ACNE CLEANSINGSALICYLIC ACIDCLINIQUE LABORATORIES LLC7bae5802-cf51-4b41-9d7c-d72f1eb4c4af2023-08-30WarningsExact identifier
application number: M006
Gly-Sal 2-2 PadsSALICYLIC ACIDTopiderm, Inc.a92a9ffb-5c5b-43a4-b669-04667324920b2023-02-16WarningsExact identifier
application number: M006
Derma E Acne Clarifying MaskSULFURderma e55df8fb4-abc3-43fe-b89b-6e7d638b27a62023-02-14WarningsExact identifier
application number: M006

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
83021-742-0183021074201200 mL in 1 TUBE (83021-742-01) 200 ml2022-10-192027-02-20NoNoCurrent