ANUBIS BARCELONA VITAL LINE- hydrolyzed collagen 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.

----------

OTC active ingredients section

indications usage section

otc do no use

otc keep out children

dosage

warning

inactive

otc purpose

frente

ANUBIS BARCELONA VITAL LINE 
hydrolyzed collagen cream
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:83021-064
Route of AdministrationTOPICAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
PHENOXYETHANOL (UNII: HIE492ZZ3T) (PHENOXYETHANOL - UNII:HIE492ZZ3T) PHENOXYETHANOL1.8 g  in 200 mL
FRAGRANCE 13576 (UNII: 5EM498GW35) (FRAGRANCE 13576 - UNII:5EM498GW35) FRAGRANCE 135760.8 g  in 200 mL
ETHYLHEXYLGLYCERIN (UNII: 147D247K3P) (ETHYLHEXYLGLYCERIN - UNII:147D247K3P) ETHYLHEXYLGLYCERIN0.2 g  in 200 mL
AVOBENZONE (UNII: G63QQF2NOX) (AVOBENZONE - UNII:G63QQF2NOX) AVOBENZONE2 g  in 200 mL
.BETA.-SITOSTEROL (UNII: S347WMO6M4) (.BETA.-SITOSTEROL - UNII:S347WMO6M4) .BETA.-SITOSTEROL0.01 g  in 200 mL
HYDROLYSED MARINE COLLAGEN (ENZYMATIC; 2000 MW) (UNII: 2WID9OCG7P) (HYDROLYSED MARINE COLLAGEN (ENZYMATIC; 2000 MW) - UNII:2WID9OCG7P) HYDROLYSED MARINE COLLAGEN (ENZYMATIC; 2000 MW)0.2 g  in 200 mL
LINOLEIC ACID (UNII: 9KJL21T0QJ) (LINOLEIC ACID - UNII:9KJL21T0QJ) LINOLEIC ACID0.16 g  in 200 mL
TOCOPHEROL (UNII: R0ZB2556P8) (TOCOPHEROL - UNII:R0ZB2556P8) TOCOPHEROL0.08 g  in 200 mL
MALVA SYLVESTRIS FLOWERING TOP (UNII: X1U1U0N90J) (MALVA SYLVESTRIS FLOWERING TOP - UNII:X1U1U0N90J) MALVA SYLVESTRIS FLOWERING TOP0.06 g  in 200 mL
PAPAVER RHOEAS FLOWER (UNII: Y1MLS7E68X) (PAPAVER RHOEAS FLOWER - UNII:Y1MLS7E68X) PAPAVER RHOEAS FLOWER0.04 g  in 200 mL
MEDIUM-CHAIN TRIGLYCERIDES (UNII: C9H2L21V7U) (MEDIUM-CHAIN TRIGLYCERIDES - UNII:C9H2L21V7U) MEDIUM-CHAIN TRIGLYCERIDES34 g  in 200 mL
SHEA BUTTER (UNII: K49155WL9Y) (SHEA BUTTER - UNII:K49155WL9Y) SHEA BUTTER4 g  in 200 mL
LINOLENIC ACID (UNII: 0RBV727H71) (LINOLENIC ACID - UNII:0RBV727H71) LINOLENIC ACID0.04 g  in 200 mL
POLYGLYCERYL-4 ISOSTEARATE (UNII: 820DPX33S7) (POLYGLYCERYL-4 ISOSTEARATE - UNII:820DPX33S7) POLYGLYCERYL-4 ISOSTEARATE3 g  in 200 mL
HEXYL LAURATE (UNII: 4CG9F9W01Q) (HEXYL LAURATE - UNII:4CG9F9W01Q) HEXYL LAURATE2.7 g  in 200 mL
WHITE WAX (UNII: 7G1J5DA97F) (WHITE WAX - UNII:7G1J5DA97F) WHITE WAX1 g  in 200 mL
HYDROGENATED CASTOR OIL (UNII: ZF94AP8MEY) (HYDROGENATED CASTOR OIL - UNII:ZF94AP8MEY) HYDROGENATED CASTOR OIL4 g  in 200 mL
AMILOXATE (UNII: 376KTP06K8) (AMILOXATE - UNII:376KTP06K8) AMILOXATE4 g  in 200 mL
CETYL PEG/PPG-10/1 DIMETHICONE (HLB 4) (UNII: 8INO2K35FA) (CETYL PEG/PPG-10/1 DIMETHICONE (HLB 4) - UNII:8INO2K35FA) CETYL PEG/PPG-10/1 DIMETHICONE (HLB 4)3 g  in 200 mL
SQUALANE (UNII: GW89575KF9) (SQUALANE - UNII:GW89575KF9) SQUALANE0.01 g  in 200 mL
WATER (UNII: 059QF0KO0R) (WATER - UNII:059QF0KO0R) WATER125.88 g  in 200 mL
GLYCERIN (UNII: PDC6A3C0OX) (GLYCERIN - UNII:PDC6A3C0OX) GLYCERIN7 g  in 200 mL
CETEARYL ETHYLHEXANOATE (UNII: 9M64UO4C25) (CETEARYL ETHYLHEXANOATE - UNII:9M64UO4C25) CETEARYL ETHYLHEXANOATE4 g  in 200 mL
Inactive Ingredients
Ingredient NameStrength
EDETATE DISODIUM ANHYDROUS (UNII: 8NLQ36F6MM) 0.4 g  in 200 mL
MAGNESIUM SULFATE, UNSPECIFIED (UNII: DE08037SAB) 1.6 g  in 200 mL
POTASSIUM SORBATE (UNII: 1VPU26JZZ4) 0.01 g  in 200 mL
SODIUM BENZOATE (UNII: OJ245FE5EU) 0.01 g  in 200 mL
CITRIC ACID MONOHYDRATE (UNII: 2968PHW8QP) 0.00004 g  in 200 mL
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:83021-064-01200 mL in 1 TUBE; Type 0: Not a Combination Product02/23/2023
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph finalM01602/23/202310/20/2026
Labeler - ANUBIS COSMETICS SL (468680293)
Registrant - GDC OF FLORIDA IMPORTS, INC. (807003988)
Establishment
NameAddressID/FEIBusiness Operations
ANUBIS COSMETICS SL468680293manufacture(83021-064)

Revised: 8/2023
Document Id: 0414db8c-fb90-8076-e063-6394a90a2d3d
Set id: f564bbf0-3b5c-4a81-e053-2a95a90a7ea6
Version: 2
Effective Time: 20230829
 
ANUBIS COSMETICS SL