ANUBIS BARCELONA- dmae, zirhafirm cream 
ANUBIS COSMETICS SL

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ANUBIS BARCELONA 
dmae, zirhafirm cream
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:83021-553
Route of AdministrationTOPICAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
ALOE VERA LEAF (UNII: ZY81Z83H0X) (ALOE VERA LEAF - UNII:ZY81Z83H0X) ALOE VERA LEAF5.988 g  in 60 mL
LINALOOL, (+/-)- (UNII: D81QY6I88E) (LINALOOL, (+/-)- - UNII:D81QY6I88E) LINALOOL, (+/-)-0.0006 g  in 60 mL
EUGENOL (UNII: 3T8H1794QW) (EUGENOL - UNII:3T8H1794QW) EUGENOL0.0006 g  in 60 mL
PROPANEDIOL (UNII: 5965N8W85T) (PROPANEDIOL - UNII:5965N8W85T) PROPANEDIOL2.496 g  in 60 mL
BENZYL ALCOHOL (UNII: LKG8494WBH) (BENZYL ALCOHOL - UNII:LKG8494WBH) BENZYL ALCOHOL0.456 g  in 60 mL
CETOSTEARYL ALCOHOL (UNII: 2DMT128M1S) (CETOSTEARYL ALCOHOL - UNII:2DMT128M1S) CETOSTEARYL ALCOHOL1.2 g  in 60 mL
DICAPRYLYL ETHER (UNII: 77JZM5516Z) (DICAPRYLYL ETHER - UNII:77JZM5516Z) DICAPRYLYL ETHER1.5 g  in 60 mL
SORBIC ACID (UNII: X045WJ989B) (SORBIC ACID - UNII:X045WJ989B) SORBIC ACID0.024 g  in 60 mL
XANTHAN GUM (UNII: TTV12P4NEE) (XANTHAN GUM - UNII:TTV12P4NEE) XANTHAN GUM0.18 g  in 60 mL
.BETA.-CITRONELLOL, (R)- (UNII: P01OUT964K) (.BETA.-CITRONELLOL, (R)- - UNII:P01OUT964K) .BETA.-CITRONELLOL, (R)-0.0006 g  in 60 mL
GLYCERYL MONOSTEARATE (UNII: 230OU9XXE4) (GLYCERYL MONOSTEARATE - UNII:230OU9XXE4) GLYCERYL MONOSTEARATE2.4 g  in 60 mL
FRAGRANCE 13576 (UNII: 5EM498GW35) (FRAGRANCE 13576 - UNII:5EM498GW35) FRAGRANCE 135760.114 g  in 60 mL
SALICYLIC ACID (UNII: O414PZ4LPZ) (SALICYLIC ACID - UNII:O414PZ4LPZ) SALICYLIC ACID0.09 g  in 60 mL
JUJUBE SEED (UNII: I51YGQ1Q2L) (JUJUBE SEED - UNII:I51YGQ1Q2L) JUJUBE SEED0.048 g  in 60 mL
LECITHIN, SOYBEAN (UNII: 1DI56QDM62) (LECITHIN, SOYBEAN - UNII:1DI56QDM62) LECITHIN, SOYBEAN0.036 g  in 60 mL
BAICALIN (UNII: 347Q89U4M5) (BAICALIN - UNII:347Q89U4M5) BAICALIN0.012 g  in 60 mL
LEUZEA CARTHAMOIDES ROOT (UNII: P8CUH2KYHL) (LEUZEA CARTHAMOIDES ROOT - UNII:P8CUH2KYHL) LEUZEA CARTHAMOIDES ROOT0.012 g  in 60 mL
WATER (UNII: 059QF0KO0R) (WATER - UNII:059QF0KO0R) WATER33.2616 mL  in 60 mL
LIMONENE, (+)- (UNII: GFD7C86Q1W) (LIMONENE, (+)- - UNII:GFD7C86Q1W) LIMONENE, (+)-0.006 g  in 60 mL
HYDROXYCITRONELLAL (UNII: 8SQ0VA4YUR) (HYDROXYCITRONELLAL - UNII:8SQ0VA4YUR) HYDROXYCITRONELLAL0.0024 g  in 60 mL
TOCOPHEROL (UNII: R0ZB2556P8) (TOCOPHEROL - UNII:R0ZB2556P8) TOCOPHEROL0.0018 g  in 60 mL
GLYCERIN (UNII: PDC6A3C0OX) (GLYCERIN - UNII:PDC6A3C0OX) GLYCERIN3.036 g  in 60 mL
DECYL OLEATE (UNII: ZGR06DO97T) (DECYL OLEATE - UNII:ZGR06DO97T) DECYL OLEATE3.9 g  in 60 mL
SHEA BUTTER (UNII: K49155WL9Y) (SHEA BUTTER - UNII:K49155WL9Y) SHEA BUTTER2.1 g  in 60 mL
Inactive Ingredients
Ingredient NameStrength
SODIUM HYDROXIDE (UNII: 55X04QC32I) 0.042 g  in 60 mL
POTASSIUM SORBATE (UNII: 1VPU26JZZ4) 0.012 g  in 60 mL
CITRIC ACID MONOHYDRATE (UNII: 2968PHW8QP) 0.0018 g  in 60 mL
PHYTATE SODIUM (UNII: 88496G1ERL) 0.054 g  in 60 mL
HYDROGENATED PALM GLYCERIDES CITRATE (UNII: 23AS6RA25L) 0.0006 g  in 60 mL
DEANOL BITARTRATE (UNII: D240J05W14) 0.012 g  in 60 mL
SODIUM BENZOATE (UNII: OJ245FE5EU) 0.006 g  in 60 mL
HYALURONATE SODIUM (UNII: YSE9PPT4TH) 0.006 g  in 60 mL
GLYCERYL STEARATE CITRATE (UNII: WH8T92A065) 3 g  in 60 mL
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:83021-553-6060 mL in 1 JAR; Type 0: Not a Combination Product01/13/2023
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph finalM01601/13/202303/06/2028
Labeler - ANUBIS COSMETICS SL (468680293)
Registrant - GDC OF FLORIDA IMPORTS, INC. (807003988)
Establishment
NameAddressID/FEIBusiness Operations
ANUBIS COSMETICS SL468680293manufacture(83021-553)

Revised: 9/2023
Document Id: 045252bb-c4ae-54e9-e063-6394a90aba06
Set id: f2274f8c-08aa-eb02-e053-2a95a90a3998
Version: 2
Effective Time: 20230901
 
ANUBIS COSMETICS SL