ANUBISMED- aloe barbadensis leaf extract, propylene glycol, cetearyl ethylhexanoate 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 
aloe barbadensis leaf extract, propylene glycol, cetearyl ethylhexanoate cream
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:83021-774
Route of AdministrationTOPICAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
GLYCERIN (UNII: PDC6A3C0OX) (GLYCERIN - UNII:PDC6A3C0OX) GLYCERIN0.15 g  in 15 mL
WATER (UNII: 059QF0KO0R) (WATER - UNII:059QF0KO0R) WATER11.358 mL  in 15 mL
IMIDUREA (UNII: M629807ATL) (IMIDUREA - UNII:M629807ATL) IMIDUREA0.045 g  in 15 mL
FRAGRANCE 13576 (UNII: 5EM498GW35) (FRAGRANCE 13576 - UNII:5EM498GW35) FRAGRANCE 135760.0375 g  in 15 mL
TROPOLONE (UNII: 7L6DL16P1T) (TROPOLONE - UNII:7L6DL16P1T) TROPOLONE0.0012 g  in 15 mL
SILICON DIOXIDE (UNII: ETJ7Z6XBU4) (SILICON DIOXIDE - UNII:ETJ7Z6XBU4) SILICON DIOXIDE0.0024 g  in 15 mL
CARBOMER HOMOPOLYMER, UNSPECIFIED TYPE (UNII: 0A5MM307FC) (CARBOMER HOMOPOLYMER, UNSPECIFIED TYPE - UNII:0A5MM307FC) CARBOMER HOMOPOLYMER, UNSPECIFIED TYPE0.12 g  in 15 mL
TROLAMINE (UNII: 9O3K93S3TK) (TROLAMINE - UNII:9O3K93S3TK) TROLAMINE0.12 g  in 15 mL
BUTYLATED HYDROXYTOLUENE (UNII: 1P9D0Z171K) (BUTYLATED HYDROXYTOLUENE - UNII:1P9D0Z171K) BUTYLATED HYDROXYTOLUENE0.015 g  in 15 mL
HEXAMETHYLENE DIISOCYANATE/TRIMETHYLOL HEXYLLACTONE CROSSPOLYMER (UNII: WB5K9Y35Y9) (HEXAMETHYLENE DIISOCYANATE/TRIMETHYLOL HEXYLLACTONE CROSSPOLYMER - UNII:WB5K9Y35Y9) HEXAMETHYLENE DIISOCYANATE/TRIMETHYLOL HEXYLLACTONE CROSSPOLYMER0.1176 g  in 15 mL
ARGAN OIL (UNII: 4V59G5UW9X) (ARGAN OIL - UNII:4V59G5UW9X) ARGAN OIL0.075 g  in 15 mL
DECYL OLEATE (UNII: ZGR06DO97T) (DECYL OLEATE - UNII:ZGR06DO97T) DECYL OLEATE0.2999994 g  in 15 mL
ALLANTOIN (UNII: 344S277G0Z) (ALLANTOIN - UNII:344S277G0Z) ALLANTOIN0.015 g  in 15 mL
C12-20 ACID PEG-8 ESTER (UNII: 9M7A3K4339) (C12-20 ACID PEG-8 ESTER - UNII:9M7A3K4339) C12-20 ACID PEG-8 ESTER0.15 g  in 15 mL
ALOE VERA LEAF (UNII: ZY81Z83H0X) (ALOE VERA LEAF - UNII:ZY81Z83H0X) ALOE VERA LEAF0.6 g  in 15 mL
PROPYLENE GLYCOL (UNII: 6DC9Q167V3) (PROPYLENE GLYCOL - UNII:6DC9Q167V3) PROPYLENE GLYCOL0.6 g  in 15 mL
BUTYROSPERMUM PARKII (SHEA) BUTTER UNSAPONIFIABLES (UNII: 0C9AC7D6XU) (BUTYROSPERMUM PARKII (SHEA) BUTTER UNSAPONIFIABLES - UNII:0C9AC7D6XU) BUTYROSPERMUM PARKII (SHEA) BUTTER UNSAPONIFIABLES0.15 g  in 15 mL
CAPRYLYL GLYCOL (UNII: 00YIU5438U) (CAPRYLYL GLYCOL - UNII:00YIU5438U) CAPRYLYL GLYCOL0.0588 g  in 15 mL
MEDIUM-CHAIN TRIGLYCERIDES (UNII: C9H2L21V7U) (MEDIUM-CHAIN TRIGLYCERIDES - UNII:C9H2L21V7U) MEDIUM-CHAIN TRIGLYCERIDES0.375 g  in 15 mL
TOCOPHEROL (UNII: R0ZB2556P8) (TOCOPHEROL - UNII:R0ZB2556P8) TOCOPHEROL0.0000006 g  in 15 mL
1,2-HEXANEDIOL (UNII: TR046Y3K1G) (1,2-HEXANEDIOL - UNII:TR046Y3K1G) 1,2-HEXANEDIOL0.06 g  in 15 mL
GRAPE SEED OIL (UNII: 930MLC8XGG) (GRAPE SEED OIL - UNII:930MLC8XGG) GRAPE SEED OIL0.15 g  in 15 mL
Inactive Ingredients
Ingredient NameStrength
CETYL PHOSPHATE (UNII: VT07D6X67O) 0.0045 g  in 15 mL
CETEARYL ETHYLHEXANOATE (UNII: 9M64UO4C25) 0.375 g  in 15 mL
.ALPHA.-TOCOPHEROL ACETATE (UNII: 9E8X80D2L0) 0.03 g  in 15 mL
HYALURONATE SODIUM (UNII: YSE9PPT4TH) 0.075 g  in 15 mL
EDETATE DISODIUM ANHYDROUS (UNII: 8NLQ36F6MM) 0.015 g  in 15 mL
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:83021-774-1515 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 finalM01610/14/202202/03/2026
Labeler - ANUBIS COSMETICS SL (468680293)
Registrant - GDC OF FLORIDA IMPORTS, INC. (807003988)
Establishment
NameAddressID/FEIBusiness Operations
ANUBIS COSMETICS SL468680293manufacture(83021-774)

Revised: 9/2023
Document Id: 049fc41b-5140-1a0c-e063-6394a90ac8d7
Set id: eb04d402-e74f-6281-e053-2995a90a5ef3
Version: 2
Effective Time: 20230905
 
ANUBIS COSMETICS SL