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 279 of 346 · 6,912 matching rows.
Brand, Generic, Manufacturer table Brand Generic Manufacturer SPL set ID Effective date Available safety fields Join Kroger Dry Oil Tanning Sunscreen Broad Spectrum SPF 15 Reef Friendly AVOBENZONE, HOMOSALATE, OCTISALATE, OXYBENZONE THE KROGER COMPANY c706aaf0-a978-7848-e053-2995a90a0aca 2024-10-15 Warnings Exact identifier application number: M020 TopCare Everyday Ultimate Sheer Sun Broad Spectrum SPF 70 AVOBENZONE, HOMOSALATE, OCTISALATE, OCTOCRYLENE, OXYBENZONE TOPCO ASSOCIATES LLC c51029f4-ede0-08ef-e053-2995a90aecaf 2024-10-15 Warnings Exact identifier application number: M020 TOPCARE EVERYDAY SPORT CONTINUOUS BROAD SPECTRUM SPF 30 AVOBENZONE, HOMOSALATE, OCTOCRYLENE, TOPCO ASSOCIATES LLC c8af028e-9d68-4023-e053-2995a90ad18a 2024-10-15 Warnings Exact identifier application number: M020 TOPCARE EVERYDAY ULTRA PROTECTION SPF 50 AVOBENZONE, HOMOSALATE, OCTISALATE, OCTOCRYLENE TOPCO ASSOCIATES LLC c5601d22-2353-7319-e053-2a95a90a16c0 2024-10-15 Warnings Exact identifier application number: M020 TOPCARE EVERYDAY CONTINUOUS BROAD SPECTRUM SPF 50 AVOBENZONE, HOMOSALATE, OCTISALATE, OCTOCRYLENE TOPCO ASSOCIATES LLC c8c12a5a-59f5-6515-e053-2995a90a58f7 2024-10-15 Warnings Exact identifier application number: M020 Topcare Everyday Ultimate Sheer Sun Broad Spectrum SPF 55 AVOBENZONE, HOMOSALATE, OCTISALATE, OCTOCRYLENE TOPCO ASSOCIATES LLC c6268778-8dcc-24b6-e053-2995a90acf03 2024-10-15 Warnings Exact identifier application number: M020 TopCare Everyday Sport Sun SPF 50 AVOBENZONE, HOMOSALATE, OCTOCRYLENE TOPCO ASSOCIATES LLC f0de2999-f12b-89b1-e053-2a95a90ac610 2024-10-15 Warnings Exact identifier application number: M020 TOPCO TOPCARE EVERYDAY MINERAL SUNSCREEN ZINC OXIDE SPF 50 ZINC OXIDE TOPCO ASSOCIATES LLC d501a94e-3bcd-d8e4-e053-2a95a90a33b0 2024-10-15 Warnings Exact identifier application number: M020 TopCare Everyday Kids Mineral Sunscreen ZINC OXIDE TOPCO ASSOCIATES LLC dbee42c8-9cae-7a81-e053-2a95a90a2329 2024-10-15 Warnings Exact identifier application number: M020 TopCare Everyday Sport Sun Broad Spectrum SPF 30 AVOBENZONE, HOMOSALATE, OCTISALATE, OCTOCRYLENE TOPCO ASSOCIATES LLC f12c09b1-8ffe-4933-e053-2995a90a434f 2024-10-15 Warnings Exact identifier application number: M020 TopCare Everyday Mineral Sunscreen Zinc Oxide SPF 30 ZINC OXIDE TOPCO ASSOCIATES LLC dbf03882-ab1a-9805-e053-2995a90a7109 2024-10-15 Warnings Exact identifier application number: M020 TopCare Everyday Mineral Sunscreen Continuous Broad Spectrum SPF 50 Reef-Conscious Formula TITANIUM DIOXIDE, ZINC OXIDE TOPCO ASSOCIATES LLC f14f43e6-ee57-5495-e053-2a95a90a4011 2024-10-15 Warnings Exact identifier application number: M020 TopCare Everyday Sport Continuous Broad Spectrum SPF 70 AVOBENZONE, HOMOSALATE, OCTISALATE, OCTOCRYLENE, OXYBENZONE TOPCO ASSOCIATES LLC f31ea60e-1f52-c55f-e053-2a95a90afe64 2024-10-15 Warnings Exact identifier application number: M020 Topco Topcare Everyday Mineral Sunscreen Continuous SPF 30 ZINC OXIDE TOPCO ASSOCIATES LLC f71e019b-392a-f8eb-e053-6394a90a871e 2024-10-15 Warnings Exact identifier application number: M020 TOPCARE EVERYDAY SPORT SPF 70 SUNSCREEN AVOBENZONE, HOMOSALATE, OCTISALATE, OCTOCRYLENE, OXYBENZONE TOPCO ASSOCIATES LLC a5b06600-f2b0-6d9b-e053-2995a90a59f0 2024-10-15 Warnings Exact identifier application number: M020 TopCare Everyday Ultra Protection Sun SPF 30 AVOBENZONE, HOMOSALATE, OCTISALATE, OCTOCRYLENE TOPCO ASSOCIATES LLC f41d4c46-7998-afe6-e053-2995a90ab361 2024-10-15 Warnings Exact identifier application number: M020 TOPCO TOPCARE EVERYDAY BABY PROTECTION SUN SPF 50 OCTISALATE, ZINC OXIDE TOPCO ASSOCIATES LLC f71c9060-3daf-e1be-e053-6294a90a4f91 2024-10-15 Warnings Exact identifier application number: M020 MINERAL SUNSCREEN SPF 50 ZINC OXIDE, TITANIUM DIOXIDE TOPCO ASSOCIATES LLC bfe076fa-f21f-2c46-e053-2a95a90acee4 2024-10-15 Warnings Exact identifier application number: M020 HEB SPF 50 Mineral Sunscreen Stick ZINC OXIDE H.E.B. f58f0199-bf22-2197-e053-2995a90ae64f 2024-10-15 Warnings Exact identifier application number: M020 HEB SPF 50 Kids Blue Mineral Sunscreen Stick Berry Scented ZINC OXIDE H.E.B. f58d328c-8b30-b4d4-e053-2a95a90adb59 2024-10-15 Warnings Exact identifier application number: M020
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