Label: ANUBIS BARCELONA VITAL LINE- hydrolyzed elastin, hydrolysed collagen, cocoglycerides 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

    Hidroelastin Cream ingrdients

  • INDICATIONS & USAGE

    Hidroelastin Cream indications

  • DO NOT USE

    Hidroelastin Cream do not use

  • KEEP OUT OF REACH OF CHILDREN

    Hidroelastin Cream keep

  • DOSAGE & ADMINISTRATION

    Hidroelastin Cream dosage

  • WARNINGS

    Hidroelastin Cream warnings

  • INACTIVE INGREDIENT

    Hidroelastin Cream ingredient list

  • PURPOSE

    Hidroelastin Cream purpose

  • PRINCIPAL DISPLAY PANEL

    Hidroelastin Cream display panel

  • INGREDIENTS AND APPEARANCE
    ANUBIS BARCELONA VITAL LINE 
    hydrolyzed elastin, hydrolysed collagen, cocoglycerides cream
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:83021-187
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    AVOBENZONE (UNII: G63QQF2NOX) (AVOBENZONE - UNII:G63QQF2NOX) AVOBENZONE2 g  in 200 mL
    PHENOXYETHANOL (UNII: HIE492ZZ3T) (PHENOXYETHANOL - UNII:HIE492ZZ3T) PHENOXYETHANOL1.62 g  in 200 mL
    FRAGRANCE 13576 (UNII: 5EM498GW35) (FRAGRANCE 13576 - UNII:5EM498GW35) FRAGRANCE 135760.98 g  in 200 mL
    DEHYDROACETIC ACID (UNII: 2KAG279R6R) (DEHYDROACETIC ACID - UNII:2KAG279R6R) DEHYDROACETIC ACID0.14 g  in 200 mL
    HYDROLYZED BOVINE ELASTIN (BASE; 1000 MW) (UNII: ZR28QKN0WT) (HYDROLYZED BOVINE ELASTIN (BASE; 1000 MW) - UNII:ZR28QKN0WT) HYDROLYZED BOVINE ELASTIN (BASE; 1000 MW)0.03 g  in 200 mL
    OCTINOXATE (UNII: 4Y5P7MUD51) (OCTINOXATE - UNII:4Y5P7MUD51) OCTINOXATE5 g  in 200 mL
    COCO-GLYCERIDES (UNII: ISE9I7DNUG) (COCO-GLYCERIDES - UNII:ISE9I7DNUG) COCO-GLYCERIDES8 g  in 200 mL
    GLYCERIN (UNII: PDC6A3C0OX) (GLYCERIN - UNII:PDC6A3C0OX) GLYCERIN6.94 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)0.6 g  in 200 mL
    CETOSTEARYL ALCOHOL (UNII: 2DMT128M1S) (CETOSTEARYL ALCOHOL - UNII:2DMT128M1S) CETOSTEARYL ALCOHOL12.58 g  in 200 mL
    MEDIUM-CHAIN TRIGLYCERIDES (UNII: C9H2L21V7U) (MEDIUM-CHAIN TRIGLYCERIDES - UNII:C9H2L21V7U) MEDIUM-CHAIN TRIGLYCERIDES12 g  in 200 mL
    CETYL ALCOHOL (UNII: 936JST6JCN) (CETYL ALCOHOL - UNII:936JST6JCN) CETYL ALCOHOL4 g  in 200 mL
    .ALPHA.-HEXYLCINNAMALDEHYDE (UNII: 7X6O37OK2I) (.ALPHA.-HEXYLCINNAMALDEHYDE - UNII:7X6O37OK2I) .ALPHA.-HEXYLCINNAMALDEHYDE0.16 g  in 200 mL
    WATER (UNII: 059QF0KO0R) (WATER - UNII:059QF0KO0R) WATER140 mL  in 200 mL
    BENZOIC ACID (UNII: 8SKN0B0MIM) (BENZOIC ACID - UNII:8SKN0B0MIM) BENZOIC ACID0.24 g  in 200 mL
    CENTAUREA CYANUS FLOWER (UNII: QZ239038YC) (CENTAUREA CYANUS FLOWER - UNII:QZ239038YC) CENTAUREA CYANUS FLOWER0.05 g  in 200 mL
    VIOLA ODORATA (UNII: AET12U8B74) (VIOLA ODORATA - UNII:AET12U8B74) VIOLA ODORATA0.05 g  in 200 mL
    LIMONENE, (+)- (UNII: GFD7C86Q1W) (LIMONENE, (+)- - UNII:GFD7C86Q1W) LIMONENE, (+)-0.038 g  in 200 mL
    POTASSIUM PHOSPHATE, UNSPECIFIED FORM (UNII: B7862WZ632) (POTASSIUM PHOSPHATE, UNSPECIFIED FORM - UNII:B7862WZ632) POTASSIUM PHOSPHATE, UNSPECIFIED FORM0.006 g  in 200 mL
    .BETA.-CITRONELLOL, (R)- (UNII: P01OUT964K) (.BETA.-CITRONELLOL, (R)- - UNII:P01OUT964K) .BETA.-CITRONELLOL, (R)-0.0056 g  in 200 mL
    ISOMETHYL-.ALPHA.-IONONE (UNII: 9XP4LC555B) (ISOMETHYL-.ALPHA.-IONONE - UNII:9XP4LC555B) ISOMETHYL-.ALPHA.-IONONE0.0054 g  in 200 mL
    BUTYLATED HYDROXYTOLUENE (UNII: 1P9D0Z171K) (BUTYLATED HYDROXYTOLUENE - UNII:1P9D0Z171K) BUTYLATED HYDROXYTOLUENE0.005 g  in 200 mL
    Inactive Ingredients
    Ingredient NameStrength
    CITRIC ACID MONOHYDRATE (UNII: 2968PHW8QP) 0.008 g  in 200 mL
    SODIUM BENZOATE (UNII: OJ245FE5EU) 0.006 g  in 200 mL
    POTASSIUM SORBATE (UNII: 1VPU26JZZ4) 0.024 g  in 200 mL
    SODIUM CETOSTEARYL SULFATE (UNII: 7ZBS06BH4B) 1.4 g  in 200 mL
    EDETATE DISODIUM ANHYDROUS (UNII: 8NLQ36F6MM) 4 g  in 200 mL
    SODIUM HYDROXIDE (UNII: 55X04QC32I) 0.1 g  in 200 mL
    SODIUM PHOSPHATE, DIBASIC, ANHYDROUS (UNII: 22ADO53M6F) 0.012 g  in 200 mL
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:83021-187-01200 mL in 1 TUBE; Type 0: Not a Combination Product10/25/2022
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph finalM01610/25/202210/20/2026
    Labeler - ANUBIS COSMETICS SL (468680293)
    Registrant - GDC OF FLORIDA IMPORTS, INC. (807003988)
    Establishment
    NameAddressID/FEIBusiness Operations
    ANUBIS COSMETICS SL468680293manufacture(83021-187)
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