ANUBIS BARCELONA REGUL OIL- cetearyl ethylhexanoate, propylene glycol, glyceryl stearate se cream 
ANUBIS COSMETICS SL

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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)

Revised: 9/2023
Document Id: 04529ef6-e358-95c2-e063-6394a90ae70d
Set id: eb68c3ab-7835-1a1c-e053-2995a90a0d66
Version: 2
Effective Time: 20230901
 
ANUBIS COSMETICS SL