Label: ANUBIS BARCELONA VITAL LINE- hydrolyzed collagen cream
- NDC Code(s): 83021-064-01
- Packager: ANUBIS COSMETICS SL
- Category: HUMAN OTC DRUG LABEL
- DEA Schedule: None
- Marketing Status: OTC monograph final
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.
Drug Label Information
Updated August 29, 2023
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- ACTIVE INGREDIENT
- INDICATIONS & USAGE
- DO NOT USE
- KEEP OUT OF REACH OF CHILDREN
- DOSAGE & ADMINISTRATION
- WARNINGS
- INACTIVE INGREDIENT
- PURPOSE
- PRINCIPAL DISPLAY PANEL
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INGREDIENTS AND APPEARANCE
ANUBIS BARCELONA VITAL LINE
hydrolyzed collagen creamProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:83021-064 Route of Administration TOPICAL Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength PHENOXYETHANOL (UNII: HIE492ZZ3T) (PHENOXYETHANOL - UNII:HIE492ZZ3T) PHENOXYETHANOL 1.8 g in 200 mL FRAGRANCE 13576 (UNII: 5EM498GW35) (FRAGRANCE 13576 - UNII:5EM498GW35) FRAGRANCE 13576 0.8 g in 200 mL ETHYLHEXYLGLYCERIN (UNII: 147D247K3P) (ETHYLHEXYLGLYCERIN - UNII:147D247K3P) ETHYLHEXYLGLYCERIN 0.2 g in 200 mL AVOBENZONE (UNII: G63QQF2NOX) (AVOBENZONE - UNII:G63QQF2NOX) AVOBENZONE 2 g in 200 mL .BETA.-SITOSTEROL (UNII: S347WMO6M4) (.BETA.-SITOSTEROL - UNII:S347WMO6M4) .BETA.-SITOSTEROL 0.01 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 ACID 0.16 g in 200 mL TOCOPHEROL (UNII: R0ZB2556P8) (TOCOPHEROL - UNII:R0ZB2556P8) TOCOPHEROL 0.08 g in 200 mL MALVA SYLVESTRIS FLOWERING TOP (UNII: X1U1U0N90J) (MALVA SYLVESTRIS FLOWERING TOP - UNII:X1U1U0N90J) MALVA SYLVESTRIS FLOWERING TOP 0.06 g in 200 mL PAPAVER RHOEAS FLOWER (UNII: Y1MLS7E68X) (PAPAVER RHOEAS FLOWER - UNII:Y1MLS7E68X) PAPAVER RHOEAS FLOWER 0.04 g in 200 mL MEDIUM-CHAIN TRIGLYCERIDES (UNII: C9H2L21V7U) (MEDIUM-CHAIN TRIGLYCERIDES - UNII:C9H2L21V7U) MEDIUM-CHAIN TRIGLYCERIDES 34 g in 200 mL SHEA BUTTER (UNII: K49155WL9Y) (SHEA BUTTER - UNII:K49155WL9Y) SHEA BUTTER 4 g in 200 mL LINOLENIC ACID (UNII: 0RBV727H71) (LINOLENIC ACID - UNII:0RBV727H71) LINOLENIC ACID 0.04 g in 200 mL POLYGLYCERYL-4 ISOSTEARATE (UNII: 820DPX33S7) (POLYGLYCERYL-4 ISOSTEARATE - UNII:820DPX33S7) POLYGLYCERYL-4 ISOSTEARATE 3 g in 200 mL HEXYL LAURATE (UNII: 4CG9F9W01Q) (HEXYL LAURATE - UNII:4CG9F9W01Q) HEXYL LAURATE 2.7 g in 200 mL WHITE WAX (UNII: 7G1J5DA97F) (WHITE WAX - UNII:7G1J5DA97F) WHITE WAX 1 g in 200 mL HYDROGENATED CASTOR OIL (UNII: ZF94AP8MEY) (HYDROGENATED CASTOR OIL - UNII:ZF94AP8MEY) HYDROGENATED CASTOR OIL 4 g in 200 mL AMILOXATE (UNII: 376KTP06K8) (AMILOXATE - UNII:376KTP06K8) AMILOXATE 4 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) SQUALANE 0.01 g in 200 mL WATER (UNII: 059QF0KO0R) (WATER - UNII:059QF0KO0R) WATER 125.88 g in 200 mL GLYCERIN (UNII: PDC6A3C0OX) (GLYCERIN - UNII:PDC6A3C0OX) GLYCERIN 7 g in 200 mL CETEARYL ETHYLHEXANOATE (UNII: 9M64UO4C25) (CETEARYL ETHYLHEXANOATE - UNII:9M64UO4C25) CETEARYL ETHYLHEXANOATE 4 g in 200 mL Inactive Ingredients Ingredient Name Strength 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 Code Package Description Marketing Start Date Marketing End Date 1 NDC:83021-064-01 200 mL in 1 TUBE; Type 0: Not a Combination Product 02/23/2023 Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date OTC monograph final M016 02/23/2023 10/20/2026 Labeler - ANUBIS COSMETICS SL (468680293) Registrant - GDC OF FLORIDA IMPORTS, INC. (807003988) Establishment Name Address ID/FEI Business Operations ANUBIS COSMETICS SL 468680293 manufacture(83021-064)
