ANUBISMED- ha hyaluronic cream 
ANUBIS COSMETICS SL

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.

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ANUBISMED 
ha hyaluronic cream
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:83021-750
Route of AdministrationTOPICAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
ALLANTOIN (UNII: 344S277G0Z) (ALLANTOIN - UNII:344S277G0Z) ALLANTOIN0.05 g  in 50 mL
ALOE VERA LEAF (UNII: ZY81Z83H0X) (ALOE VERA LEAF - UNII:ZY81Z83H0X) ALOE VERA LEAF2.5 g  in 50 mL
FRAGRANCE 13576 (UNII: 5EM498GW35) (FRAGRANCE 13576 - UNII:5EM498GW35) FRAGRANCE 135760.225 g  in 50 mL
GLYCERYL MONOSTEARATE (UNII: 230OU9XXE4) (GLYCERYL MONOSTEARATE - UNII:230OU9XXE4) GLYCERYL MONOSTEARATE0.875 g  in 50 mL
TROLAMINE (UNII: 9O3K93S3TK) (TROLAMINE - UNII:9O3K93S3TK) TROLAMINE0.3 g  in 50 mL
BUTYLATED HYDROXYTOLUENE (UNII: 1P9D0Z171K) (BUTYLATED HYDROXYTOLUENE - UNII:1P9D0Z171K) BUTYLATED HYDROXYTOLUENE0.0535 g  in 50 mL
PROPYLENE GLYCOL (UNII: 6DC9Q167V3) (PROPYLENE GLYCOL - UNII:6DC9Q167V3) PROPYLENE GLYCOL1.996 g  in 50 mL
CETYL ALCOHOL (UNII: 936JST6JCN) (CETYL ALCOHOL - UNII:936JST6JCN) CETYL ALCOHOL0.0038 g  in 50 mL
TROPOLONE (UNII: 7L6DL16P1T) (TROPOLONE - UNII:7L6DL16P1T) TROPOLONE0.004 g  in 50 mL
TOCOPHEROL (UNII: R0ZB2556P8) (TOCOPHEROL - UNII:R0ZB2556P8) TOCOPHEROL0.0004 g  in 50 mL
DIMETHICONE (UNII: 92RU3N3Y1O) (DIMETHICONE - UNII:92RU3N3Y1O) DIMETHICONE0.25 g  in 50 mL
1,2-HEXANEDIOL (UNII: TR046Y3K1G) (1,2-HEXANEDIOL - UNII:TR046Y3K1G) 1,2-HEXANEDIOL0.198 g  in 50 mL
IMIDUREA (UNII: M629807ATL) (IMIDUREA - UNII:M629807ATL) IMIDUREA0.15 g  in 50 mL
CARBOMER HOMOPOLYMER, UNSPECIFIED TYPE (UNII: 0A5MM307FC) (CARBOMER HOMOPOLYMER, UNSPECIFIED TYPE - UNII:0A5MM307FC) CARBOMER HOMOPOLYMER, UNSPECIFIED TYPE0.25 g  in 50 mL
CETEARYL ETHYLHEXANOATE (UNII: 9M64UO4C25) (CETEARYL ETHYLHEXANOATE - UNII:9M64UO4C25) CETEARYL ETHYLHEXANOATE1.75 g  in 50 mL
MEDIUM-CHAIN TRIGLYCERIDES (UNII: C9H2L21V7U) (MEDIUM-CHAIN TRIGLYCERIDES - UNII:C9H2L21V7U) MEDIUM-CHAIN TRIGLYCERIDES1.5 g  in 50 mL
CAPRYLYL GLYCOL (UNII: 00YIU5438U) (CAPRYLYL GLYCOL - UNII:00YIU5438U) CAPRYLYL GLYCOL0.198 g  in 50 mL
OCTINOXATE (UNII: 4Y5P7MUD51) (OCTINOXATE - UNII:4Y5P7MUD51) OCTINOXATE3.4965 g  in 50 mL
GLYCERIN (UNII: PDC6A3C0OX) (GLYCERIN - UNII:PDC6A3C0OX) GLYCERIN0.4975 g  in 50 mL
GLYCERYL STEARATE SE (UNII: FCZ5MH785I) (GLYCERYL STEARATE SE - UNII:FCZ5MH785I) GLYCERYL STEARATE SE1.5 g  in 50 mL
WATER (UNII: 059QF0KO0R) (WATER - UNII:059QF0KO0R) WATER27.4065 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 ESTER2.25 g  in 50 mL
OXYBENZONE (UNII: 95OOS7VE0Y) (OXYBENZONE - UNII:95OOS7VE0Y) OXYBENZONE2 g  in 50 mL
DECYL OLEATE (UNII: ZGR06DO97T) (DECYL OLEATE - UNII:ZGR06DO97T) DECYL OLEATE1.9996 g  in 50 mL
Inactive Ingredients
Ingredient NameStrength
CETYL PHOSPHATE (UNII: VT07D6X67O) 0.1463 g  in 50 mL
SODIUM CHONDROITIN SULFATE (PORCINE; 5500 MW) (UNII: H5BJH23Z9A) 0.05 g  in 50 mL
HYALURONATE SODIUM (UNII: YSE9PPT4TH) 0.25 g  in 50 mL
.ALPHA.-TOCOPHEROL ACETATE (UNII: 9E8X80D2L0) 0.1 g  in 50 mL
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:83021-750-5050 mL in 1 JAR; Type 0: Not a Combination Product10/17/2022
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph finalM01610/17/202201/16/2028
Labeler - ANUBIS COSMETICS SL (468680293)
Registrant - GDC OF FLORIDA IMPORTS, INC. (807003988)
Establishment
NameAddressID/FEIBusiness Operations
ANUBIS COSMETICS SL468680293manufacture(83021-750)

Revised: 9/2023
Document Id: 049f9ce0-73cc-2865-e063-6394a90a505a
Set id: eac771e2-4c1b-3808-e053-2995a90ac5fc
Version: 2
Effective Time: 20230905
 
ANUBIS COSMETICS SL