Label: ANUBIS BARCELONA SPA LINE (oryza sativa- rice starch, perlite, palmitic acid 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 October 14, 2022

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  • ACTIVE INGREDIENT

    Rice Peeling ingredients

  • INDICATIONS & USAGE

    Rice Peeling indications

  • DO NOT USE

    Rice Peeling do not use

  • DOSAGE & ADMINISTRATION

    Rice Peeling dosage

  • WARNINGS

    Rice Peeling warnings

  • INACTIVE INGREDIENT

    Rice Peeling ingredients list

  • PURPOSE

    Rice Peeling purpose

  • KEEP OUT OF REACH OF CHILDREN

    Rice Peeling keep

  • PRINCIPAL DISPLAY PANEL

    Rice peeling display

  • INGREDIENTS AND APPEARANCE
    ANUBIS BARCELONA SPA LINE 
    oryza sativa (rice) starch, perlite, palmitic acid cream
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:83021-305
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    FRAGRANCE 13576 (UNII: 5EM498GW35) (FRAGRANCE 13576 - UNII:5EM498GW35) FRAGRANCE 135760.15 g  in 50 mL
    GRAPE SEED OIL (UNII: 930MLC8XGG) (GRAPE SEED OIL - UNII:930MLC8XGG) GRAPE SEED OIL0.25 g  in 50 mL
    LINALOOL, (+/-)- (UNII: D81QY6I88E) (LINALOOL, (+/-)- - UNII:D81QY6I88E) LINALOOL, (+/-)-0.0114 g  in 50 mL
    PHENOXYETHANOL (UNII: HIE492ZZ3T) (PHENOXYETHANOL - UNII:HIE492ZZ3T) PHENOXYETHANOL0.45 g  in 50 mL
    PROPYLENE GLYCOL (UNII: 6DC9Q167V3) (PROPYLENE GLYCOL - UNII:6DC9Q167V3) PROPYLENE GLYCOL1.5 g  in 50 mL
    TITANIUM DIOXIDE (UNII: 15FIX9V2JP) (TITANIUM DIOXIDE - UNII:15FIX9V2JP) TITANIUM DIOXIDE0.25 g  in 50 mL
    PALMITIC ACID (UNII: 2V16EO95H1) (PALMITIC ACID - UNII:2V16EO95H1) PALMITIC ACID1 g  in 50 mL
    BUTYLATED HYDROXYTOLUENE (UNII: 1P9D0Z171K) (BUTYLATED HYDROXYTOLUENE - UNII:1P9D0Z171K) BUTYLATED HYDROXYTOLUENE0.25 g  in 50 mL
    STARCH, RICE (UNII: 4DGK8B7I3S) (STARCH, RICE - UNII:4DGK8B7I3S) STARCH, RICE5.5 g  in 50 mL
    ALCOHOL (UNII: 3K9958V90M) (ALCOHOL - UNII:3K9958V90M) ALCOHOL4.752 mL  in 50 mL
    C12-20 ACID PEG-8 ESTER (UNII: 9M7A3K4339) (C12-20 ACID PEG-8 ESTER - UNII:9M7A3K4339) C12-20 ACID PEG-8 ESTER1 g  in 50 mL
    TROLAMINE (UNII: 9O3K93S3TK) (TROLAMINE - UNII:9O3K93S3TK) TROLAMINE0.25 g  in 50 mL
    ISOMETHYL-.ALPHA.-IONONE (UNII: 9XP4LC555B) (ISOMETHYL-.ALPHA.-IONONE - UNII:9XP4LC555B) ISOMETHYL-.ALPHA.-IONONE0.00639 g  in 50 mL
    HYDROXYACETOPHENONE (UNII: G1L3HT4CMH) (HYDROXYACETOPHENONE - UNII:G1L3HT4CMH) HYDROXYACETOPHENONE0.25 g  in 50 mL
    PERLITE (UNII: 0SG101ZGK9) (PERLITE - UNII:0SG101ZGK9) PERLITE4 g  in 50 mL
    GLYCERIN (UNII: PDC6A3C0OX) (GLYCERIN - UNII:PDC6A3C0OX) GLYCERIN0.0115 g  in 50 mL
    ETHYLHEXYLGLYCERIN (UNII: 147D247K3P) (ETHYLHEXYLGLYCERIN - UNII:147D247K3P) ETHYLHEXYLGLYCERIN0.05 g  in 50 mL
    .BETA.-CITRONELLOL, (R)- (UNII: P01OUT964K) (.BETA.-CITRONELLOL, (R)- - UNII:P01OUT964K) .BETA.-CITRONELLOL, (R)-0.012 g  in 50 mL
    WATER (UNII: 059QF0KO0R) (WATER - UNII:059QF0KO0R) WATER25.04945 g  in 50 mL
    STEARIC ACID (UNII: 4ELV7Z65AP) (STEARIC ACID - UNII:4ELV7Z65AP) STEARIC ACID1 g  in 50 mL
    CETEARYL ETHYLHEXANOATE (UNII: 9M64UO4C25) (CETEARYL ETHYLHEXANOATE - UNII:9M64UO4C25) CETEARYL ETHYLHEXANOATE0.75 g  in 50 mL
    GLYCERYL MONOSTEARATE (UNII: 230OU9XXE4) (GLYCERYL MONOSTEARATE - UNII:230OU9XXE4) GLYCERYL MONOSTEARATE3.5 g  in 50 mL
    Inactive Ingredients
    Ingredient NameStrength
    LIMONENE, (+)- (UNII: GFD7C86Q1W) 0.00726 g  in 50 mL
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:83021-305-5050 mL in 1 TUBE; Type 0: Not a Combination Product10/14/2022
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph finalM01610/14/2022
    Labeler - ANUBIS COSMETICS SL (468680293)
    Registrant - GDC OF FLORIDA IMPORTS, INC. (807003988)
    Establishment
    NameAddressID/FEIBusiness Operations
    ANUBIS COSMETICS SL468680293manufacture(83021-305)