ANUBIS BARCELONA PROTECTIVE LINE- ethylhexyl methoxycinnamate, butyl methoxydibenzoylmethane, ethylhexyl salicylate, octocrylene cream 
ANUBIS COSMETICS SL

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ANUBIS BARCELONA PROTECTIVE LINE 
ethylhexyl methoxycinnamate, butyl methoxydibenzoylmethane, ethylhexyl salicylate, octocrylene cream
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:83021-686
Route of AdministrationTOPICAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
OCTINOXATE (UNII: 4Y5P7MUD51) (OCTINOXATE - UNII:4Y5P7MUD51) OCTINOXATE3.5982 g  in 50 mL
TITANIUM DIOXIDE (UNII: 15FIX9V2JP) (TITANIUM DIOXIDE - UNII:15FIX9V2JP) TITANIUM DIOXIDE0.425 g  in 50 mL
CHLORPHENESIN (UNII: I670DAL4SZ) (CHLORPHENESIN - UNII:I670DAL4SZ) CHLORPHENESIN0.1 g  in 50 mL
OCTISALATE (UNII: 4X49Y0596W) (OCTISALATE - UNII:4X49Y0596W) OCTISALATE1.8 g  in 50 mL
BUTYLENE GLYCOL (UNII: 3XUS85K0RA) (BUTYLENE GLYCOL - UNII:3XUS85K0RA) BUTYLENE GLYCOL2.5 g  in 50 mL
PROPYLENE GLYCOL (UNII: 6DC9Q167V3) (PROPYLENE GLYCOL - UNII:6DC9Q167V3) PROPYLENE GLYCOL2.5 g  in 50 mL
POLY(METHYL METHACRYLATE; 450000 MW) (UNII: Z47NNT4J11) (POLY(METHYL METHACRYLATE; 450000 MW) - UNII:Z47NNT4J11) POLY(METHYL METHACRYLATE; 450000 MW)2.1 g  in 50 mL
WATER (UNII: 059QF0KO0R) (WATER - UNII:059QF0KO0R) WATER27.55 mL  in 50 mL
SILICON DIOXIDE (UNII: ETJ7Z6XBU4) (SILICON DIOXIDE - UNII:ETJ7Z6XBU4) SILICON DIOXIDE0.575 g  in 50 mL
BUTYLATED HYDROXYTOLUENE (UNII: 1P9D0Z171K) (BUTYLATED HYDROXYTOLUENE - UNII:1P9D0Z171K) BUTYLATED HYDROXYTOLUENE0.0018 g  in 50 mL
DIMETHICONE (UNII: 92RU3N3Y1O) (DIMETHICONE - UNII:92RU3N3Y1O) DIMETHICONE1.25 g  in 50 mL
CARBOMER HOMOPOLYMER, UNSPECIFIED TYPE (UNII: 0A5MM307FC) (CARBOMER HOMOPOLYMER, UNSPECIFIED TYPE - UNII:0A5MM307FC) CARBOMER HOMOPOLYMER, UNSPECIFIED TYPE0.025 g  in 50 mL
C20-22 ALCOHOLS (UNII: O4M0347C6A) (C20-22 ALCOHOLS - UNII:O4M0347C6A) C20-22 ALCOHOLS0.3375 g  in 50 mL
FRAGRANCE 13576 (UNII: 5EM498GW35) (FRAGRANCE 13576 - UNII:5EM498GW35) FRAGRANCE 135760.3 g  in 50 mL
CARBOMER COPOLYMER TYPE A (ALLYL PENTAERYTHRITOL CROSSLINKED) (UNII: 71DD5V995L) (CARBOMER COPOLYMER TYPE A (ALLYL PENTAERYTHRITOL CROSSLINKED) - UNII:71DD5V995L) CARBOMER COPOLYMER TYPE A (ALLYL PENTAERYTHRITOL CROSSLINKED)0.075 g  in 50 mL
TROMETHAMINE (UNII: 023C2WHX2V) (TROMETHAMINE - UNII:023C2WHX2V) TROMETHAMINE0.22 g  in 50 mL
BEMOTRIZINOL (UNII: PWZ1720CBH) (BEMOTRIZINOL - UNII:PWZ1720CBH) BEMOTRIZINOL1.45 g  in 50 mL
POLYETHYLENE GLYCOL 400 (UNII: B697894SGQ) (POLYETHYLENE GLYCOL 400 - UNII:B697894SGQ) POLYETHYLENE GLYCOL 4000.14225 g  in 50 mL
ASCORBYL PALMITATE (UNII: QN83US2B0N) (ASCORBYL PALMITATE - UNII:QN83US2B0N) ASCORBYL PALMITATE0.00125 g  in 50 mL
PHENOXYETHANOL (UNII: HIE492ZZ3T) (PHENOXYETHANOL - UNII:HIE492ZZ3T) PHENOXYETHANOL0.35 g  in 50 mL
OCTOCRYLENE (UNII: 5A68WGF6WM) (OCTOCRYLENE - UNII:5A68WGF6WM) OCTOCRYLENE1.8 g  in 50 mL
AVOBENZONE (UNII: G63QQF2NOX) (AVOBENZONE - UNII:G63QQF2NOX) AVOBENZONE1.8 g  in 50 mL
LINOLENIC ACID (UNII: 0RBV727H71) (LINOLENIC ACID - UNII:0RBV727H71) LINOLENIC ACID0.00275 g  in 50 mL
ASCORBIC ACID (UNII: PQ6CK8PD0R) (ASCORBIC ACID - UNII:PQ6CK8PD0R) ASCORBIC ACID0.00025 g  in 50 mL
TOCOPHEROL (UNII: R0ZB2556P8) (TOCOPHEROL - UNII:R0ZB2556P8) TOCOPHEROL0.006 g  in 50 mL
LINOLEIC ACID (UNII: 9KJL21T0QJ) (LINOLEIC ACID - UNII:9KJL21T0QJ) LINOLEIC ACID0.49725 g  in 50 mL
GLYCERIN (UNII: PDC6A3C0OX) (GLYCERIN - UNII:PDC6A3C0OX) GLYCERIN0.005 g  in 50 mL
Inactive Ingredients
Ingredient NameStrength
CITRIC ACID MONOHYDRATE (UNII: 2968PHW8QP) 0.00025 g  in 50 mL
C20-22 ALKYL PHOSPHATE (UNII: L4VKP0Y7RP) 0.4125 g  in 50 mL
EDETATE DISODIUM ANHYDROUS (UNII: 8NLQ36F6MM) 0.025 g  in 50 mL
POTASSIUM CETYL PHOSPHATE (UNII: 03KCY6P7UT) 0.15 g  in 50 mL
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:83021-686-5050 mL in 1 BOTTLE; Type 0: Not a Combination Product11/02/2022
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph finalM02011/02/202203/09/2028
Labeler - ANUBIS COSMETICS SL (468680293)
Registrant - GDC OF FLORIDA IMPORTS, INC. (807003988)
Establishment
NameAddressID/FEIBusiness Operations
ANUBIS COSMETICS SL468680293manufacture(83021-686)

Revised: 9/2023
Document Id: 0452914b-b325-8a71-e063-6394a90a92de
Set id: ec83846f-11c0-8f59-e053-2995a90ab9d2
Version: 2
Effective Time: 20230901
 
ANUBIS COSMETICS SL