ANUBIS BARCELONA REGUL OIL- propylene glycol, glyceryl stearate se, humulus lupulus (hops) cone extract cream 
ANUBIS COSMETICS SL

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ANUBIS BARCELONA REGUL OIL 
propylene glycol, glyceryl stearate se, humulus lupulus (hops) cone extract cream
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:83021-300
Route of AdministrationTOPICAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
ARCTIUM LAPPA ROOT (UNII: 597E9BI3Z3) (ARCTIUM LAPPA ROOT - UNII:597E9BI3Z3) ARCTIUM LAPPA ROOT0.012 g  in 200 mL
POLYACRYLAMIDE (CROSSLINKED; 0.01-0.2 MOLE PERCENT BISACRYLAMIDE) (UNII: RHA9LWJ494) (POLYACRYLAMIDE (CROSSLINKED; 0.01-0.2 MOLE PERCENT BISACRYLAMIDE) - UNII:RHA9LWJ494) POLYACRYLAMIDE (CROSSLINKED; 0.01-0.2 MOLE PERCENT BISACRYLAMIDE)0.8 g  in 200 mL
LAURETH-7 (UNII: Z95S6G8201) (LAURETH-7 - UNII:Z95S6G8201) LAURETH-70.12 g  in 200 mL
PEG/PPG-20/6 DIMETHICONE (UNII: PWZ7N4UIKE) (PEG/PPG-20/6 DIMETHICONE - UNII:PWZ7N4UIKE) PEG/PPG-20/6 DIMETHICONE1.372 g  in 200 mL
ALCOHOL (UNII: 3K9958V90M) (ALCOHOL - UNII:3K9958V90M) ALCOHOL0.08 mL  in 200 mL
GLYCERIN (UNII: PDC6A3C0OX) (GLYCERIN - UNII:PDC6A3C0OX) GLYCERIN0.048 g  in 200 mL
CETEARYL ETHYLHEXANOATE (UNII: 9M64UO4C25) (CETEARYL ETHYLHEXANOATE - UNII:9M64UO4C25) CETEARYL ETHYLHEXANOATE4 g  in 200 mL
LIMONENE, (+)- (UNII: GFD7C86Q1W) (LIMONENE, (+)- - UNII:GFD7C86Q1W) LIMONENE, (+)-0.08398 g  in 200 mL
PANTHENOL (UNII: WV9CM0O67Z) (PANTHENOL - UNII:WV9CM0O67Z) PANTHENOL0.1 g  in 200 mL
IMIDUREA (UNII: M629807ATL) (IMIDUREA - UNII:M629807ATL) IMIDUREA0.6 g  in 200 mL
FD&C YELLOW NO. 5 (UNII: I753WB2F1M) (FD&C YELLOW NO. 5 - UNII:I753WB2F1M) FD&C YELLOW NO. 50.00004 g  in 200 mL
RIBOFLAVIN (UNII: TLM2976OFR) (RIBOFLAVIN - UNII:TLM2976OFR) RIBOFLAVIN0.00012 g  in 200 mL
PHENOXYETHANOL (UNII: HIE492ZZ3T) (PHENOXYETHANOL - UNII:HIE492ZZ3T) PHENOXYETHANOL0.0252 g  in 200 mL
FRAGRANCE 13576 (UNII: 5EM498GW35) (FRAGRANCE 13576 - UNII:5EM498GW35) FRAGRANCE 135760.6 g  in 200 mL
WATER (UNII: 059QF0KO0R) (WATER - UNII:059QF0KO0R) WATER123.55598 mL  in 200 mL
CETOSTEARYL ALCOHOL (UNII: 2DMT128M1S) (CETOSTEARYL ALCOHOL - UNII:2DMT128M1S) CETOSTEARYL ALCOHOL26 g  in 200 mL
PROPYLENE GLYCOL (UNII: 6DC9Q167V3) (PROPYLENE GLYCOL - UNII:6DC9Q167V3) PROPYLENE GLYCOL10.148 g  in 200 mL
MINERAL OIL (UNII: T5L8T28FGP) (MINERAL OIL - UNII:T5L8T28FGP) MINERAL OIL6 g  in 200 mL
ETHYLHEXYLGLYCERIN (UNII: 147D247K3P) (ETHYLHEXYLGLYCERIN - UNII:147D247K3P) ETHYLHEXYLGLYCERIN0.0028 g  in 200 mL
METHYLCHLOROISOTHIAZOLINONE (UNII: DEL7T5QRPN) (METHYLCHLOROISOTHIAZOLINONE - UNII:DEL7T5QRPN) METHYLCHLOROISOTHIAZOLINONE0.045 g  in 200 mL
METHYLISOTHIAZOLINONE (UNII: 229D0E1QFA) (METHYLISOTHIAZOLINONE - UNII:229D0E1QFA) METHYLISOTHIAZOLINONE0.15 g  in 200 mL
HOPS (UNII: 01G73H6H83) (HOPS - UNII:01G73H6H83) HOPS0.0012 g  in 200 mL
TIOXOLONE (UNII: S0FAJ1R9CD) (TIOXOLONE - UNII:S0FAJ1R9CD) TIOXOLONE0.3 g  in 200 mL
PROPYLPARABEN (UNII: Z8IX2SC1OH) (PROPYLPARABEN - UNII:Z8IX2SC1OH) PROPYLPARABEN0.24 g  in 200 mL
YEAST, UNSPECIFIED (UNII: 3NY3SM6B8U) (YEAST, UNSPECIFIED - UNII:3NY3SM6B8U) YEAST, UNSPECIFIED0.023 g  in 200 mL
NIACINAMIDE (UNII: 25X51I8RD4) (NIACINAMIDE - UNII:25X51I8RD4) NIACINAMIDE0.023 g  in 200 mL
C13-14 ISOPARAFFIN (UNII: E4F12ROE70) (C13-14 ISOPARAFFIN - UNII:E4F12ROE70) C13-14 ISOPARAFFIN0.48 g  in 200 mL
METHYLPARABEN (UNII: A2I8C7HI9T) (METHYLPARABEN - UNII:A2I8C7HI9T) METHYLPARABEN0.48 g  in 200 mL
GLYCERYL STEARATE SE (UNII: FCZ5MH785I) (GLYCERYL STEARATE SE - UNII:FCZ5MH785I) GLYCERYL STEARATE SE7 g  in 200 mL
TRIISOPROPANOLAMINE (UNII: W9EN9DLM98) (TRIISOPROPANOLAMINE - UNII:W9EN9DLM98) TRIISOPROPANOLAMINE0.004 g  in 200 mL
PENTAERYTHRITOL TETRAKIS(3-(3,5-DI-TERT-BUTYL-4-HYDROXYPHENYL)PROPIONATE) (UNII: 255PIF62MS) (PENTAERYTHRITOL TETRAKIS(3-(3,5-DI-TERT-BUTYL-4-HYDROXYPHENYL)PROPIONATE) - UNII:255PIF62MS) PENTAERYTHRITOL TETRAKIS(3-(3,5-DI-TERT-BUTYL-4-HYDROXYPHENYL)PROPIONATE)0.0012 g  in 200 mL
Inactive Ingredients
Ingredient NameStrength
EDETATE DISODIUM ANHYDROUS (UNII: 8NLQ36F6MM) 0.1 g  in 200 mL
SODIUM SULFATE (UNII: 0YPR65R21J) 0.9 g  in 200 mL
SODIUM BENZOATE (UNII: OJ245FE5EU) 0.00024 g  in 200 mL
MAGNESIUM ALUMINUM SILICATE (UNII: 6M3P64V0NC) 4 g  in 200 mL
POTASSIUM SORBATE (UNII: 1VPU26JZZ4) 0.00024 g  in 200 mL
PYRIDOXINE HYDROCHLORIDE (UNII: 68Y4CF58BV) 0.002 g  in 200 mL
SODIUM LAURETH SULFATE (UNII: BPV390UAP0) 12.6 g  in 200 mL
MAGNESIUM CHLORIDE (UNII: 02F3473H9O) 0.045 g  in 200 mL
MAGNESIUM NITRATE (UNII: 77CBG3UN78) 0.045 g  in 200 mL
THIAMINE HYDROCHLORIDE (UNII: M572600E5P) 0.012 g  in 200 mL
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:83021-300-01200 mL in 1 TUBE; Type 0: Not a Combination Product10/20/2022
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph finalM00610/20/202202/03/2028
Labeler - ANUBIS COSMETICS SL (468680293)
Registrant - GDC OF FLORIDA IMPORTS, INC. (807003988)
Establishment
NameAddressID/FEIBusiness Operations
ANUBIS COSMETICS SL468680293manufacture(83021-300)

Revised: 9/2023
Document Id: 0452aac5-a076-8ea7-e063-6394a90a7c02
Set id: eb7c418b-8bee-26a3-e053-2a95a90a4e96
Version: 2
Effective Time: 20230901
 
ANUBIS COSMETICS SL