Home NDC 83021-686 Anubis Barcelona Protective Line
Product NDC 83021-686
11-digit product format 830210686
Labeler code 83021
Product ID 83021-686_0452914b-b325-8a71-e063-6394a90a92de
Type HUMAN OTC DRUG
Nonproprietary name Ethylhexyl Methoxycinnamate, Butyl Methoxydibenzoylmethane, Ethylhexyl Salicylate, Octocrylene
Dosage form CREAM
Route TOPICAL
Labeler ANUBIS COSMETICS SL
Application M020
Marketing category OTC MONOGRAPH FINAL
Marketing start 2022-11-02
Marketing end 2028-03-09
Substance OCTINOXATE; TITANIUM DIOXIDE; CHLORPHENESIN; OCTISALATE; BUTYLENE GLYCOL; PROPYLENE GLYCOL; POLY(METHYL METHACRYLATE; 450000 MW); WATER; SILICON DIOXIDE; BUTYLATED HYDROXYTOLUENE; DIMETHICONE; CARBOMER HOMOPOLYMER, UNSPECIFIED TYPE; C20-22 ALCOHOLS; FRAGRANCE 13576; CARBOMER COPOLYMER TYPE A (ALLYL PENTAERYTHRITOL CROSSLINKED); TROMETHAMINE; BEMOTRIZINOL; POLYETHYLENE GLYCOL 400; ASCORBYL PALMITATE; PHENOXYETHANOL; OCTOCRYLENE; AVOBENZONE; LINOLENIC ACID; ASCORBIC ACID; TOCOPHEROL; LINOLEIC ACID; GLYCERIN
Active strength 3.5982; .425; .1; 1.8; 2.5; 2.5; 2.1; 27.55; .575; .0018; 1.25; .025; .3375; .3; .075; .22; 1.45; .14225; .00125; .35; 1.8; 1.8; .00275; .00025; .006; .49725; .005 g/50mL; g/50mL; g/50mL; g/50mL; g/50mL; g/50mL; g/50mL; mL/50mL; g/50mL; g/50mL; g/50mL; g/50mL; g/50mL; g/50mL; g/50mL; g/50mL; g/50mL; g/50mL; g/50mL; g/50mL; g/50mL; g/50mL; g/50mL; g/50mL; g/50mL; g/50mL; g/50mL
Pharmacologic classes Allergens [CS], Ascorbic Acid [CS], Cell-mediated Immunity [PE], Glycerol [CS], Increased Histamine Release [PE], Increased IgG Production [PE], Non-Standardized Chemical Allergen [EPC], Skin Barrier Activity [PE], Vitamin C [EPC]
NDC exclude flag No
Current FDA listing Yes Reported adverse events (FAERS/openFDA)# Adverse event summaries are temporarily unavailable. Other product information remains available.
Additional Listing Data#
Finished product Yes
Brand name base Anubis Barcelona Protective Line Active Ingredients# Ingredient, Strength table Ingredient Strength OCTINOXATE 3.5982 g/50mL TITANIUM DIOXIDE .425 g/50mL CHLORPHENESIN .1 g/50mL OCTISALATE 1.8 g/50mL BUTYLENE GLYCOL 2.5 g/50mL PROPYLENE GLYCOL 2.5 g/50mL POLY(METHYL METHACRYLATE 2.1 g/50mL 450000 MW) 27.55 mL/50mL WATER .575 g/50mL SILICON DIOXIDE .0018 g/50mL BUTYLATED HYDROXYTOLUENE 1.25 g/50mL DIMETHICONE .025 g/50mL CARBOMER HOMOPOLYMER, UNSPECIFIED TYPE .3375 g/50mL C20-22 ALCOHOLS .3 g/50mL FRAGRANCE 13576 .075 g/50mL CARBOMER COPOLYMER TYPE A (ALLYL PENTAERYTHRITOL CROSSLINKED) .22 g/50mL TROMETHAMINE 1.45 g/50mL BEMOTRIZINOL .14225 g/50mL POLYETHYLENE GLYCOL 400 .00125 g/50mL ASCORBYL PALMITATE .35 g/50mL PHENOXYETHANOL 1.8 g/50mL OCTOCRYLENE 1.8 g/50mL AVOBENZONE .00275 g/50mL LINOLENIC ACID .00025 g/50mL ASCORBIC ACID .006 g/50mL TOCOPHEROL .49725 g/50mL LINOLEIC ACID .005 g/50mL GLYCERIN
Harmonized UNII identifiers# UNII identifiers page 1 of 2 · 26 matching rows.
Harmonized SPL set identifiers# SPL set identifiers page 1 of 1 · 1 matching rows.
DailyMed Product Concepts# DailyMed Package Descriptions# Package NDC, Product, Description table Package NDC Product Description Form Quantity Strength SPL version 83021-686-50 Anubis Barcelona Protective Line 50 mL in 1 BOTTLE CREAM 50 2
DailyMed Dashboard NDC Coverage# NDC, Dashboard title, SPL version table NDC Dashboard title SPL version Validation Dashboard ZIP 83021-686 ANUBIS BARCELONA PROTECTIVE LINE (ETHYLHEXYL METHOXYCINNAMATE, BUTYL METHOXYDIBENZOYLMETHANE, ETHYLHEXYL SALICYLATE, OCTOCRYLENE) CREAM [ANUBIS COSMETICS SL] 2 Current NDC, Legacy NDC, 1 package rows 20230902_ec83846f-11c0-8f59-e053-2995a90ab9d2.zip
openFDA label cross-check# OpenFDA label data provides additional search and identifier links. DailyMed’s Structured Product Label is the canonical label on FDA.report. Matching records are deduplicated before they are shown below.
Matched openFDA labels page 26 of 357 · 7,139 matching rows.
Packages# Package NDC, 11-digit format, Description table Package NDC 11-digit format Description Units Marketing start Marketing end Sample Exclude flag Status 83021-686-50 83021068650 50 mL in 1 BOTTLE (83021-686-50) 50 ml 2022-11-02 2028-03-09 No No Current