Label: ANUBIS BARCELONA VITAL LINE- hydrolyzed collagen cream

  • Category: HUMAN OTC DRUG LABEL

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 August 29, 2023

If you are a healthcare professional or from the pharmaceutical industry please visit this version.

  • ACTIVE INGREDIENT

    OTC active ingredients section

  • INDICATIONS & USAGE

    indications usage section

  • DO NOT USE

    otc do no use

  • KEEP OUT OF REACH OF CHILDREN

    otc keep out children

  • DOSAGE & ADMINISTRATION

    dosage

  • WARNINGS

    warning

  • INACTIVE INGREDIENT

    inactive

  • PURPOSE

    otc purpose

  • PRINCIPAL DISPLAY PANEL

    frente

  • INGREDIENTS AND APPEARANCE
    ANUBIS BARCELONA VITAL LINE 
    hydrolyzed collagen cream
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:83021-064
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    PHENOXYETHANOL (UNII: HIE492ZZ3T) (PHENOXYETHANOL - UNII:HIE492ZZ3T) PHENOXYETHANOL1.8 g  in 200 mL
    FRAGRANCE 13576 (UNII: 5EM498GW35) (FRAGRANCE 13576 - UNII:5EM498GW35) FRAGRANCE 135760.8 g  in 200 mL
    ETHYLHEXYLGLYCERIN (UNII: 147D247K3P) (ETHYLHEXYLGLYCERIN - UNII:147D247K3P) ETHYLHEXYLGLYCERIN0.2 g  in 200 mL
    AVOBENZONE (UNII: G63QQF2NOX) (AVOBENZONE - UNII:G63QQF2NOX) AVOBENZONE2 g  in 200 mL
    .BETA.-SITOSTEROL (UNII: S347WMO6M4) (.BETA.-SITOSTEROL - UNII:S347WMO6M4) .BETA.-SITOSTEROL0.01 g  in 200 mL
    HYDROLYSED MARINE COLLAGEN (ENZYMATIC; 2000 MW) (UNII: 2WID9OCG7P) (HYDROLYSED MARINE COLLAGEN (ENZYMATIC; 2000 MW) - UNII:2WID9OCG7P) HYDROLYSED MARINE COLLAGEN (ENZYMATIC; 2000 MW)0.2 g  in 200 mL
    LINOLEIC ACID (UNII: 9KJL21T0QJ) (LINOLEIC ACID - UNII:9KJL21T0QJ) LINOLEIC ACID0.16 g  in 200 mL
    TOCOPHEROL (UNII: R0ZB2556P8) (TOCOPHEROL - UNII:R0ZB2556P8) TOCOPHEROL0.08 g  in 200 mL
    MALVA SYLVESTRIS FLOWERING TOP (UNII: X1U1U0N90J) (MALVA SYLVESTRIS FLOWERING TOP - UNII:X1U1U0N90J) MALVA SYLVESTRIS FLOWERING TOP0.06 g  in 200 mL
    PAPAVER RHOEAS FLOWER (UNII: Y1MLS7E68X) (PAPAVER RHOEAS FLOWER - UNII:Y1MLS7E68X) PAPAVER RHOEAS FLOWER0.04 g  in 200 mL
    MEDIUM-CHAIN TRIGLYCERIDES (UNII: C9H2L21V7U) (MEDIUM-CHAIN TRIGLYCERIDES - UNII:C9H2L21V7U) MEDIUM-CHAIN TRIGLYCERIDES34 g  in 200 mL
    SHEA BUTTER (UNII: K49155WL9Y) (SHEA BUTTER - UNII:K49155WL9Y) SHEA BUTTER4 g  in 200 mL
    LINOLENIC ACID (UNII: 0RBV727H71) (LINOLENIC ACID - UNII:0RBV727H71) LINOLENIC ACID0.04 g  in 200 mL
    POLYGLYCERYL-4 ISOSTEARATE (UNII: 820DPX33S7) (POLYGLYCERYL-4 ISOSTEARATE - UNII:820DPX33S7) POLYGLYCERYL-4 ISOSTEARATE3 g  in 200 mL
    HEXYL LAURATE (UNII: 4CG9F9W01Q) (HEXYL LAURATE - UNII:4CG9F9W01Q) HEXYL LAURATE2.7 g  in 200 mL
    WHITE WAX (UNII: 7G1J5DA97F) (WHITE WAX - UNII:7G1J5DA97F) WHITE WAX1 g  in 200 mL
    HYDROGENATED CASTOR OIL (UNII: ZF94AP8MEY) (HYDROGENATED CASTOR OIL - UNII:ZF94AP8MEY) HYDROGENATED CASTOR OIL4 g  in 200 mL
    AMILOXATE (UNII: 376KTP06K8) (AMILOXATE - UNII:376KTP06K8) AMILOXATE4 g  in 200 mL
    CETYL PEG/PPG-10/1 DIMETHICONE (HLB 4) (UNII: 8INO2K35FA) (CETYL PEG/PPG-10/1 DIMETHICONE (HLB 4) - UNII:8INO2K35FA) CETYL PEG/PPG-10/1 DIMETHICONE (HLB 4)3 g  in 200 mL
    SQUALANE (UNII: GW89575KF9) (SQUALANE - UNII:GW89575KF9) SQUALANE0.01 g  in 200 mL
    WATER (UNII: 059QF0KO0R) (WATER - UNII:059QF0KO0R) WATER125.88 g  in 200 mL
    GLYCERIN (UNII: PDC6A3C0OX) (GLYCERIN - UNII:PDC6A3C0OX) GLYCERIN7 g  in 200 mL
    CETEARYL ETHYLHEXANOATE (UNII: 9M64UO4C25) (CETEARYL ETHYLHEXANOATE - UNII:9M64UO4C25) CETEARYL ETHYLHEXANOATE4 g  in 200 mL
    Inactive Ingredients
    Ingredient NameStrength
    EDETATE DISODIUM ANHYDROUS (UNII: 8NLQ36F6MM) 0.4 g  in 200 mL
    MAGNESIUM SULFATE, UNSPECIFIED (UNII: DE08037SAB) 1.6 g  in 200 mL
    POTASSIUM SORBATE (UNII: 1VPU26JZZ4) 0.01 g  in 200 mL
    SODIUM BENZOATE (UNII: OJ245FE5EU) 0.01 g  in 200 mL
    CITRIC ACID MONOHYDRATE (UNII: 2968PHW8QP) 0.00004 g  in 200 mL
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:83021-064-01200 mL in 1 TUBE; Type 0: Not a Combination Product02/23/2023
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph finalM01602/23/202310/20/2026
    Labeler - ANUBIS COSMETICS SL (468680293)
    Registrant - GDC OF FLORIDA IMPORTS, INC. (807003988)
    Establishment
    NameAddressID/FEIBusiness Operations
    ANUBIS COSMETICS SL468680293manufacture(83021-064)