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

  • Category: HUMAN OTC DRUG LABEL

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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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