Label: ANUBIS BARCELONA REGUL OIL- cetearyl ethylhexanoate, propylene glycol, glyceryl stearate se cream

  • Category: HUMAN OTC DRUG LABEL
  • DEA Schedule: None
  • Marketing Status: OTC monograph final

DISCLAIMER: Most OTC drugs are not reviewed and approved by FDA, however they may be marketed if they comply with applicable regulations and policies. FDA has not evaluated whether this product complies.

Drug Label Information

Updated September 1, 2023

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  • ACTIVE INGREDIENT

    Regul Oil Serum ingredients

  • INDICATIONS & USAGE

    Regul Oil Serum indications

  • DO NOT USE

    Regul Oil Serum do not use

  • KEEP OUT OF REACH OF CHILDREN

    Regul Oil Serum keep

  • DOSAGE & ADMINISTRATION

    Regul Oil Serum dosage

  • WARNINGS

    Regul Oil Serum warnings

  • INACTIVE INGREDIENT

    Regul Oil Serum ingredients list

  • PURPOSE

    Regul Oil Serum purpose

  • PRINCIPAL DISPLAY PANEL

    Regul Oil Serum display

  • INGREDIENTS AND APPEARANCE
    ANUBIS BARCELONA REGUL OIL 
    cetearyl ethylhexanoate, propylene glycol, glyceryl stearate se cream
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:83021-742
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    GLYCERIN (UNII: PDC6A3C0OX) (GLYCERIN - UNII:PDC6A3C0OX) GLYCERIN0.08784 g  in 200 mL
    GERANIOL (UNII: L837108USY) (GERANIOL - UNII:L837108USY) GERANIOL0.003398 g  in 200 mL
    ISOPROPYL ALCOHOL (UNII: ND2M416302) (ISOPROPYL ALCOHOL - UNII:ND2M416302) ISOPROPYL ALCOHOL0.002132 g  in 200 mL
    ALCOHOL (UNII: 3K9958V90M) (ALCOHOL - UNII:3K9958V90M) ALCOHOL3.5436 mL  in 200 mL
    OXYBENZONE (UNII: 95OOS7VE0Y) (OXYBENZONE - UNII:95OOS7VE0Y) OXYBENZONE1.6 g  in 200 mL
    PHENOXYETHANOL (UNII: HIE492ZZ3T) (PHENOXYETHANOL - UNII:HIE492ZZ3T) PHENOXYETHANOL1.3 g  in 200 mL
    TEA TREE OIL (UNII: VIF565UC2G) (TEA TREE OIL - UNII:VIF565UC2G) TEA TREE OIL0.1 g  in 200 mL
    IMIDUREA (UNII: M629807ATL) (IMIDUREA - UNII:M629807ATL) IMIDUREA0.4 g  in 200 mL
    WATER (UNII: 059QF0KO0R) (WATER - UNII:059QF0KO0R) WATER155.839258 mL  in 200 mL
    GLYCERYL STEARATE SE (UNII: FCZ5MH785I) (GLYCERYL STEARATE SE - UNII:FCZ5MH785I) GLYCERYL STEARATE SE6 g  in 200 mL
    CARBOMER HOMOPOLYMER, UNSPECIFIED TYPE (UNII: 0A5MM307FC) (CARBOMER HOMOPOLYMER, UNSPECIFIED TYPE - UNII:0A5MM307FC) CARBOMER HOMOPOLYMER, UNSPECIFIED TYPE0.8 g  in 200 mL
    TIOXOLONE (UNII: S0FAJ1R9CD) (TIOXOLONE - UNII:S0FAJ1R9CD) TIOXOLONE0.3 g  in 200 mL
    LINALOOL, (+/-)- (UNII: D81QY6I88E) (LINALOOL, (+/-)- - UNII:D81QY6I88E) LINALOOL, (+/-)-0.026404 g  in 200 mL
    FD&C YELLOW NO. 5 (UNII: I753WB2F1M) (FD&C YELLOW NO. 5 - UNII:I753WB2F1M) FD&C YELLOW NO. 50.01044 g  in 200 mL
    BENZYL BENZOATE (UNII: N863NB338G) (BENZYL BENZOATE - UNII:N863NB338G) BENZYL BENZOATE0.004 g  in 200 mL
    PANTHENOL (UNII: WV9CM0O67Z) (PANTHENOL - UNII:WV9CM0O67Z) PANTHENOL0.04 g  in 200 mL
    COUMARIN (UNII: A4VZ22K1WT) (COUMARIN - UNII:A4VZ22K1WT) COUMARIN0.003924 g  in 200 mL
    C12-20 ACID PEG-8 ESTER (UNII: 9M7A3K4339) (C12-20 ACID PEG-8 ESTER - UNII:9M7A3K4339) C12-20 ACID PEG-8 ESTER4 g  in 200 mL
    ARCTIUM LAPPA ROOT (UNII: 597E9BI3Z3) (ARCTIUM LAPPA ROOT - UNII:597E9BI3Z3) ARCTIUM LAPPA ROOT0.003512 g  in 200 mL
    PROPYLPARABEN (UNII: Z8IX2SC1OH) (PROPYLPARABEN - UNII:Z8IX2SC1OH) PROPYLPARABEN0.28 g  in 200 mL
    CETYL ALCOHOL (UNII: 936JST6JCN) (CETYL ALCOHOL - UNII:936JST6JCN) CETYL ALCOHOL0.015 g  in 200 mL
    YEAST, UNSPECIFIED (UNII: 3NY3SM6B8U) (YEAST, UNSPECIFIED - UNII:3NY3SM6B8U) YEAST, UNSPECIFIED0.1 g  in 200 mL
    RIBOFLAVIN (UNII: TLM2976OFR) (RIBOFLAVIN - UNII:TLM2976OFR) RIBOFLAVIN0.00012 g  in 200 mL
    PROPYLENE GLYCOL (UNII: 6DC9Q167V3) (PROPYLENE GLYCOL - UNII:6DC9Q167V3) PROPYLENE GLYCOL6.469044 g  in 200 mL
    CETEARYL ETHYLHEXANOATE (UNII: 9M64UO4C25) (CETEARYL ETHYLHEXANOATE - UNII:9M64UO4C25) CETEARYL ETHYLHEXANOATE10 g  in 200 mL
    HYDROXYETHYL CELLULOSE, UNSPECIFIED (UNII: T4V6TWG28D) (HYDROXYETHYL CELLULOSE, UNSPECIFIED - UNII:T4V6TWG28D) HYDROXYETHYL CELLULOSE, UNSPECIFIED0.12863 g  in 200 mL
    BUTYLATED HYDROXYTOLUENE (UNII: 1P9D0Z171K) (BUTYLATED HYDROXYTOLUENE - UNII:1P9D0Z171K) BUTYLATED HYDROXYTOLUENE0.104 g  in 200 mL
    CITRAL (UNII: T7EU0O9VPP) (CITRAL - UNII:T7EU0O9VPP) CITRAL0.01032 g  in 200 mL
    GREEN TEA LEAF (UNII: W2ZU1RY8B0) (GREEN TEA LEAF - UNII:W2ZU1RY8B0) GREEN TEA LEAF0.00679 g  in 200 mL
    ALLANTOIN (UNII: 344S277G0Z) (ALLANTOIN - UNII:344S277G0Z) ALLANTOIN0.2 g  in 200 mL
    LIMONENE, (+)- (UNII: GFD7C86Q1W) (LIMONENE, (+)- - UNII:GFD7C86Q1W) LIMONENE, (+)-0.061818 g  in 200 mL
    NIACINAMIDE (UNII: 25X51I8RD4) (NIACINAMIDE - UNII:25X51I8RD4) NIACINAMIDE0.02 g  in 200 mL
    POWDERED CELLULOSE (UNII: SMD1X3XO9M) (POWDERED CELLULOSE - UNII:SMD1X3XO9M) POWDERED CELLULOSE0.001066 g  in 200 mL
    POLYOXYL 40 HYDROGENATED CASTOR OIL (UNII: 7YC686GQ8F) (POLYOXYL 40 HYDROGENATED CASTOR OIL - UNII:7YC686GQ8F) POLYOXYL 40 HYDROGENATED CASTOR OIL1.8 g  in 200 mL
    .ALPHA.-HEXYLCINNAMALDEHYDE (UNII: 7X6O37OK2I) (.ALPHA.-HEXYLCINNAMALDEHYDE - UNII:7X6O37OK2I) .ALPHA.-HEXYLCINNAMALDEHYDE0.00574 g  in 200 mL
    OCTINOXATE (UNII: 4Y5P7MUD51) (OCTINOXATE - UNII:4Y5P7MUD51) OCTINOXATE3.996 g  in 200 mL
    METHYLPARABEN (UNII: A2I8C7HI9T) (METHYLPARABEN - UNII:A2I8C7HI9T) METHYLPARABEN0.6 g  in 200 mL
    FRAGRANCE 13576 (UNII: 5EM498GW35) (FRAGRANCE 13576 - UNII:5EM498GW35) FRAGRANCE 135760.5 g  in 200 mL
    Inactive Ingredients
    Ingredient NameStrength
    PYRIDOXINE HYDROCHLORIDE (UNII: 68Y4CF58BV) 0.002 g  in 200 mL
    CETYL PHOSPHATE (UNII: VT07D6X67O) 0.585 g  in 200 mL
    SODIUM BENZOATE (UNII: OJ245FE5EU) 0.000892 g  in 200 mL
    SODIUM CHLORIDE (UNII: 451W47IQ8X) 0.00156 g  in 200 mL
    CITRIC ACID MONOHYDRATE (UNII: 2968PHW8QP) 0.03 g  in 200 mL
    THIAMINE HYDROCHLORIDE (UNII: M572600E5P) 0.012 g  in 200 mL
    EDETATE DISODIUM ANHYDROUS (UNII: 8NLQ36F6MM) 0.2 g  in 200 mL
    TROLAMINE (UNII: 9O3K93S3TK) 0.8 mL  in 200 mL
    POTASSIUM SORBATE (UNII: 1VPU26JZZ4) 0.000892 g  in 200 mL
    SODIUM ACETATE (UNII: 4550K0SC9B) 0.00462 g  in 200 mL
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:83021-742-01200 mL in 1 TUBE; Type 0: Not a Combination Product10/19/2022
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph finalM00610/19/202202/20/2027
    Labeler - ANUBIS COSMETICS SL (468680293)
    Registrant - GDC OF FLORIDA IMPORTS, INC. (807003988)
    Establishment
    NameAddressID/FEIBusiness Operations
    ANUBIS COSMETICS SL468680293manufacture(83021-742)
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