anubis barcelona regul oil

Generic: propylene glycol, glyceryl stearate se, humulus lupulus (hops) cone extract

Labeler: anubis cosmetics sl
NDC Directory HUMAN OTC DRUG OTC MONOGRAPH FINAL Inactive Finished

Drug Facts

Product Profile

Brand Name anubis barcelona regul oil
Generic Name propylene glycol, glyceryl stearate se, humulus lupulus (hops) cone extract
Labeler anubis cosmetics sl
Dosage Form CREAM
Routes
TOPICAL
Active Ingredients

alcohol .08 mL/200mL, arctium lappa root .012 g/200mL, c13-14 isoparaffin .48 g/200mL, cetearyl ethylhexanoate 4 g/200mL, cetostearyl alcohol 26 g/200mL, ethylhexylglycerin .0028 g/200mL, fd&c yellow no. 5 .00004 g/200mL, fragrance 13576 .6 g/200mL, glycerin .048 g/200mL, glyceryl stearate se 7 g/200mL, hops .0012 g/200mL, imidurea .6 g/200mL, laureth-7 .12 g/200mL, limonene, (+)- .08398 g/200mL, methylchloroisothiazolinone .045 g/200mL, methylisothiazolinone .15 g/200mL, methylparaben .48 g/200mL, mineral oil 6 g/200mL, niacinamide .023 g/200mL, panthenol .1 g/200mL, peg/ppg-20/6 dimethicone 1.372 g/200mL, pentaerythritol tetrakis(3-(3,5-di-tert-butyl-4-hydroxyphenyl)propionate) .0012 g/200mL, phenoxyethanol .0252 g/200mL, polyacrylamide (crosslinked .8 g/200mL, 0.01-0.2 mole percent bisacrylamide) 10.148 g/200mL, propylene glycol .24 g/200mL, propylparaben .00012 g/200mL, riboflavin .3 g/200mL, tioxolone .004 g/200mL, triisopropanolamine 123.55598 mL/200mL, water .023 g/200mL, yeast, unspecified

Manufacturer
ANUBIS COSMETICS SL

Identifiers & Regulatory

Product NDC 83021-300
Product ID 83021-300_0452aac5-a076-8ea7-e063-6394a90a7c02
Product Type HUMAN OTC DRUG
Marketing Category OTC MONOGRAPH FINAL
Application Number M006
Marketing Start 2022-10-20
Marketing End 2028-02-03

Pharmacologic Class

Established (EPC)
non-standardized chemical allergen [epc] non-standardized food allergenic extract [epc] non-standardized plant allergenic extract [epc] standardized chemical allergen [epc]
Chemical Structure
allergens [cs] glycerol [cs] dietary proteins [cs] plant proteins [cs] food additives [cs]
Physiologic Effect
increased histamine release [pe] cell-mediated immunity [pe] increased igg production [pe]

Normalized Code Variants

Searchable formats for this product NDC code

Digits Only 83021300
Hyphenated Format 83021-300

Supplemental Identifiers

UPC
8436019941300
UNII
3K9958V90M 597E9BI3Z3 E4F12ROE70 9M64UO4C25 2DMT128M1S 147D247K3P I753WB2F1M 5EM498GW35 PDC6A3C0OX FCZ5MH785I 01G73H6H83 M629807ATL Z95S6G8201 GFD7C86Q1W DEL7T5QRPN 229D0E1QFA A2I8C7HI9T T5L8T28FGP 25X51I8RD4 WV9CM0O67Z PWZ7N4UIKE 255PIF62MS HIE492ZZ3T 6DC9Q167V3 Z8IX2SC1OH TLM2976OFR S0FAJ1R9CD W9EN9DLM98 059QF0KO0R 3NY3SM6B8U
NUI
N0000185370 N0000175629 N0000184306 N0000185001 M0000728 M0009417 N0000185371 N0000185375 M0006342 M0016962 M0008672 N0000185508

Packaging Origin

Original Packager
true

Resolved Product View

Precedence rule: structured NDC data is preferred, falling back to linked label metadata when unavailable. Source tags show the origin of each value.

Resolved Identity

Brand Name anubis barcelona regul oil (source: ndc)
Generic Name propylene glycol, glyceryl stearate se, humulus lupulus (hops) cone extract (source: ndc)
Application Number M006 (source: ndc)
Routes
TOPICAL
source: ndc

Resolved Composition

Strengths
  • 10.148 g/200mL
  • .08 mL/200mL
  • .012 g/200mL
  • .48 g/200mL
  • 4 g/200mL
  • 26 g/200mL
  • .0028 g/200mL
  • .00004 g/200mL
  • .6 g/200mL
  • .048 g/200mL
  • 7 g/200mL
  • .0012 g/200mL
  • .12 g/200mL
  • .08398 g/200mL
  • .045 g/200mL
  • .15 g/200mL
  • 6 g/200mL
  • .023 g/200mL
  • .1 g/200mL
  • 1.372 g/200mL
  • .0252 g/200mL
  • .8 g/200mL
  • .24 g/200mL
  • .00012 g/200mL
  • .3 g/200mL
  • .004 g/200mL
  • 123.55598 mL/200mL
source: ndc
Packaging
  • 200 mL in 1 TUBE (83021-300-01)
source: ndc

Packages (1)

83021-300-01 200 mL in 1 TUBE (83021-300-01)

Ingredients (32)

0.01-0.2 mole percent bisacrylamide) (10.148 g/200mL) alcohol (.08 mL/200mL) arctium lappa root (.012 g/200mL) c13-14 isoparaffin (.48 g/200mL) cetearyl ethylhexanoate (4 g/200mL) cetostearyl alcohol (26 g/200mL) ethylhexylglycerin (.0028 g/200mL) fd&c yellow no. 5 (.00004 g/200mL) fragrance 13576 (.6 g/200mL) glycerin (.048 g/200mL) glyceryl stearate se (7 g/200mL) hops (.0012 g/200mL) imidurea (.6 g/200mL) laureth-7 (.12 g/200mL) limonene, (+)- (.08398 g/200mL) methylchloroisothiazolinone (.045 g/200mL) methylisothiazolinone (.15 g/200mL) methylparaben (.48 g/200mL) mineral oil (6 g/200mL) niacinamide (.023 g/200mL) panthenol (.1 g/200mL) peg/ppg-20/6 dimethicone (1.372 g/200mL) pentaerythritol tetrakis(3-(3,5-di-tert-butyl-4-hydroxyphenyl)propionate) (.0012 g/200mL) phenoxyethanol (.0252 g/200mL) polyacrylamide (crosslinked (.8 g/200mL) propylene glycol (.24 g/200mL) propylparaben (.00012 g/200mL) riboflavin (.3 g/200mL) tioxolone (.004 g/200mL) triisopropanolamine (123.55598 mL/200mL) water (.023 g/200mL) yeast, unspecified

Linked Drug Pages (1)

Anubis Barcelona Regul Oil ndc-match (0.9)

Raw FDA Data

View complete raw FDA NDC JSON payload 
{"route": ["TOPICAL"], "spl_id": "0452aac5-a076-8ea7-e063-6394a90a7c02", "openfda": {"nui": ["N0000185370", "N0000175629", "N0000184306", "N0000185001", "M0000728", "M0009417", "N0000185371", "N0000185375", "M0006342", "M0016962", "M0008672", "N0000185508"], "upc": ["8436019941300"], "unii": ["3K9958V90M", "597E9BI3Z3", "E4F12ROE70", "9M64UO4C25", "2DMT128M1S", "147D247K3P", "I753WB2F1M", "5EM498GW35", "PDC6A3C0OX", "FCZ5MH785I", "01G73H6H83", "M629807ATL", "Z95S6G8201", "GFD7C86Q1W", "DEL7T5QRPN", "229D0E1QFA", "A2I8C7HI9T", "T5L8T28FGP", "25X51I8RD4", "WV9CM0O67Z", "PWZ7N4UIKE", "255PIF62MS", "HIE492ZZ3T", "6DC9Q167V3", "Z8IX2SC1OH", "TLM2976OFR", "S0FAJ1R9CD", "W9EN9DLM98", "059QF0KO0R", "3NY3SM6B8U"], "spl_set_id": ["eb7c418b-8bee-26a3-e053-2a95a90a4e96"], "pharm_class_cs": ["Allergens [CS]", "Glycerol [CS]", "Dietary Proteins [CS]", "Plant Proteins [CS]", "Food Additives [CS]"], "pharm_class_pe": ["Increased Histamine Release [PE]", "Cell-mediated Immunity [PE]", "Increased IgG Production [PE]"], "pharm_class_epc": ["Non-Standardized Chemical Allergen [EPC]", "Non-Standardized Food Allergenic Extract [EPC]", "Non-Standardized Plant Allergenic Extract [EPC]", "Standardized Chemical Allergen [EPC]"], "manufacturer_name": ["ANUBIS COSMETICS SL"], "is_original_packager": [true]}, "finished": true, "packaging": [{"sample": false, "description": "200 mL in 1 TUBE (83021-300-01)", "package_ndc": "83021-300-01", "marketing_end_date": "20280203", "marketing_start_date": "20221020"}], "brand_name": "Anubis Barcelona Regul Oil", "product_id": "83021-300_0452aac5-a076-8ea7-e063-6394a90a7c02", "dosage_form": "CREAM", "pharm_class": ["Allergens [CS]", "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]", "Cell-mediated Immunity [PE]", "Dietary Proteins [CS]", "Dietary Proteins [CS]", "Food Additives [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 Histamine Release [PE]", "Increased IgG Production [PE]", "Non-Standardized Chemical Allergen [EPC]", "Non-Standardized Food Allergenic Extract [EPC]", "Non-Standardized Food Allergenic Extract [EPC]", "Non-Standardized Fungal Allergenic Extract [EPC]", "Non-Standardized Plant Allergenic Extract [EPC]", "Plant Proteins [CS]", "Standardized Chemical Allergen [EPC]", "Standardized Chemical Allergen [EPC]", "Standardized Chemical Allergen [EPC]", "Standardized Chemical Allergen [EPC]"], "product_ndc": "83021-300", "generic_name": "Propylene Glycol, Glyceryl Stearate Se, Humulus Lupulus (Hops) Cone Extract", "labeler_name": "ANUBIS COSMETICS SL", "product_type": "HUMAN OTC DRUG", "brand_name_base": "Anubis Barcelona Regul Oil", "active_ingredients": [{"name": "ALCOHOL", "strength": ".08 mL/200mL"}, {"name": "ARCTIUM LAPPA ROOT", "strength": ".012 g/200mL"}, {"name": "C13-14 ISOPARAFFIN", "strength": ".48 g/200mL"}, {"name": "CETEARYL ETHYLHEXANOATE", "strength": "4 g/200mL"}, {"name": "CETOSTEARYL ALCOHOL", "strength": "26 g/200mL"}, {"name": "ETHYLHEXYLGLYCERIN", "strength": ".0028 g/200mL"}, {"name": "FD&C YELLOW NO. 5", "strength": ".00004 g/200mL"}, {"name": "FRAGRANCE 13576", "strength": ".6 g/200mL"}, {"name": "GLYCERIN", "strength": ".048 g/200mL"}, {"name": "GLYCERYL STEARATE SE", "strength": "7 g/200mL"}, {"name": "HOPS", "strength": ".0012 g/200mL"}, {"name": "IMIDUREA", "strength": ".6 g/200mL"}, {"name": "LAURETH-7", "strength": ".12 g/200mL"}, {"name": "LIMONENE, (+)-", "strength": ".08398 g/200mL"}, {"name": "METHYLCHLOROISOTHIAZOLINONE", "strength": ".045 g/200mL"}, {"name": "METHYLISOTHIAZOLINONE", "strength": ".15 g/200mL"}, {"name": "METHYLPARABEN", "strength": ".48 g/200mL"}, {"name": "MINERAL OIL", "strength": "6 g/200mL"}, {"name": "NIACINAMIDE", "strength": ".023 g/200mL"}, {"name": "PANTHENOL", "strength": ".1 g/200mL"}, {"name": "PEG/PPG-20/6 DIMETHICONE", "strength": "1.372 g/200mL"}, {"name": "PENTAERYTHRITOL TETRAKIS(3-(3,5-DI-TERT-BUTYL-4-HYDROXYPHENYL)PROPIONATE)", "strength": ".0012 g/200mL"}, {"name": "PHENOXYETHANOL", "strength": ".0252 g/200mL"}, {"name": "POLYACRYLAMIDE (CROSSLINKED", "strength": ".8 g/200mL"}, {"name": "0.01-0.2 MOLE PERCENT BISACRYLAMIDE)", "strength": "10.148 g/200mL"}, {"name": "PROPYLENE GLYCOL", "strength": ".24 g/200mL"}, {"name": "PROPYLPARABEN", "strength": ".00012 g/200mL"}, {"name": "RIBOFLAVIN", "strength": ".3 g/200mL"}, {"name": "TIOXOLONE", "strength": ".004 g/200mL"}, {"name": "TRIISOPROPANOLAMINE", "strength": "123.55598 mL/200mL"}, {"name": "WATER", "strength": ".023 g/200mL"}, {"name": "YEAST, UNSPECIFIED"}], "application_number": "M006", "marketing_category": "OTC MONOGRAPH FINAL", "marketing_end_date": "20280203", "marketing_start_date": "20221020"}