ANUBIS BARCELONA TOTAL HYDRATING- betaine, glycerin, polysorbate 20 lotion 
ANUBIS COSMETICS SL

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ANUBIS BARCELONA TOTAL HYDRATING 
betaine, glycerin, polysorbate 20 lotion
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:83021-692
Route of AdministrationTOPICAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
BETAINE (UNII: 3SCV180C9W) (BETAINE - UNII:3SCV180C9W) BETAINE5 g  in 250 mL
FRAGRANCE 13576 (UNII: 5EM498GW35) (FRAGRANCE 13576 - UNII:5EM498GW35) FRAGRANCE 135760.125 g  in 250 mL
FD&C BLUE NO. 1 (UNII: H3R47K3TBD) (FD&C BLUE NO. 1 - UNII:H3R47K3TBD) FD&C BLUE NO. 10.00025 g  in 250 mL
BENZOIC ACID (UNII: 8SKN0B0MIM) (BENZOIC ACID - UNII:8SKN0B0MIM) BENZOIC ACID1.75 g  in 250 mL
GLYCERIN (UNII: PDC6A3C0OX) (GLYCERIN - UNII:PDC6A3C0OX) GLYCERIN5 g  in 250 mL
PHENOXYETHANOL (UNII: HIE492ZZ3T) (PHENOXYETHANOL - UNII:HIE492ZZ3T) PHENOXYETHANOL2.25 g  in 250 mL
ETHYLHEXYLGLYCERIN (UNII: 147D247K3P) (ETHYLHEXYLGLYCERIN - UNII:147D247K3P) ETHYLHEXYLGLYCERIN0.125 g  in 250 mL
POLYSORBATE 20 (UNII: 7T1F30V5YH) (POLYSORBATE 20 - UNII:7T1F30V5YH) POLYSORBATE 202.75 g  in 250 mL
WATER (UNII: 059QF0KO0R) (WATER - UNII:059QF0KO0R) WATER232.139 mL  in 250 mL
IMIDUREA (UNII: M629807ATL) (IMIDUREA - UNII:M629807ATL) IMIDUREA0.75 g  in 250 mL
Inactive Ingredients
Ingredient NameStrength
DEHYDROACETIC ACID (UNII: 2KAG279R6R) 0.1 g  in 250 mL
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:83021-692-01250 mL in 1 BOTTLE, SPRAY; Type 0: Not a Combination Product10/13/2022
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph finalM01610/13/202209/12/2027
Labeler - ANUBIS COSMETICS SL (468680293)
Registrant - GDC OF FLORIDA IMPORTS, INC. (807003988)
Establishment
NameAddressID/FEIBusiness Operations
ANUBIS COSMETICS SL468680293manufacture(83021-692)

Revised: 9/2023
Document Id: 0452aac5-a077-8ea7-e063-6394a90a7c02
Set id: eaefe3b9-9064-18b1-e053-2a95a90a5765
Version: 2
Effective Time: 20230901
 
ANUBIS COSMETICS SL