Home NDC 84440-003 Biocorneum
Product NDC 84440-003
11-digit product format 844400003
Labeler code 84440
Product ID 84440-003_2996022f-311c-4161-b6cc-1c746e9151d9
Type HUMAN OTC DRUG
Nonproprietary name Avobenzone, Homosalate, Meradimate, Octisalate, and Octocrylene
Dosage form GEL
Route TOPICAL
Labeler Biodermis LLC
Application M020
Marketing category OTC MONOGRAPH DRUG
Marketing start 2024-09-01
Substance AVOBENZONE; HOMOSALATE; MERADIMATE; OCTISALATE; OCTOCRYLENE
Active strength 30; 150; 50; 50; 100 mg/g; mg/g; mg/g; mg/g; mg/g
NDC exclude flag No
Listing certified through 2027-12-31
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 Biocorneum
Listing expiration 2027-12-31 Active Ingredients# Ingredient, Strength table Ingredient Strength AVOBENZONE 30 mg/g HOMOSALATE 150 mg/g MERADIMATE 50 mg/g OCTISALATE 50 mg/g OCTOCRYLENE 100 mg/g
Harmonized UNII identifiers# UNII identifiers page 1 of 1 · 5 matching rows.
Harmonized SPL set identifiers# SPL set identifiers page 1 of 1 · 1 matching rows.
DailyMed Package Descriptions# DailyMed Dashboard NDC Coverage# NDC, Dashboard title, SPL version table NDC Dashboard title SPL version Validation Dashboard ZIP 84440-003 BIOCORNEUM (AVOBENZONE, HOMOSALATE, MERADIMATE, OCTISALATE, AND OCTOCRYLENE) GEL [BIODERMIS LLC] 1 Current NDC, 6 package rows 20240901_ef95f2b7-e438-4990-880d-81621edb2002.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 148 of 354 · 7,077 matching rows.
Brand, Generic, Manufacturer table Brand Generic Manufacturer SPL set ID Effective date Available safety fields Join Mineral SPF 40, Tinted TITANIUM DIOXIDE, ZINC OXIDE Acne Specialists LLC 2fb19ed7-8cee-ce80-e063-6394a90ad3dc 2025-12-08 Warnings Exact identifier application number: M020 Mineral SPF 40, Tinted TITANIUM DIOXIDE, ZINC OXIDE Acne Specialists LLC 2fb14c4f-a435-aa6e-e063-6394a90a7d8d 2025-12-08 Warnings Exact identifier application number: M020 Mineral Sunscreen SPF 40 Non-Tinted TITANIUM DIOXIDE, ZINC OXIDE Skin Restoration Aesthetics 2fc4f701-eea2-7913-e063-6294a90a8693 2025-12-08 Warnings Exact identifier application number: M020 Mineral Sunscreen SPF 40 Tinted TITANIUM DIOXIDE, ZINC OXIDE Skin Restoration Aesthetics 2fc55e8c-41d6-15cc-e063-6394a90ac543 2025-12-08 Warnings Exact identifier application number: M020 Zinc Oxide SPF 40 Tinted ZINC OXIDE Skin Restoration Aesthetics 2fc60a39-789b-3d11-e063-6294a90a9abf 2025-12-08 Warnings Exact identifier application number: M020 Zinc Oxide SPF 40 Non-Tinted ZINC OXIDE Skin Restoration Aesthetics 2fc68041-acfe-8db6-e063-6294a90ad8ba 2025-12-08 Warnings Exact identifier application number: M020 Daily Tinted Mineral SPF TITANIUM DIOXIDE, ZINC OXIDE Skin Restoration Aesthetics 2fc6e168-b2c1-bf9d-e063-6394a90aade7 2025-12-08 Warnings Exact identifier application number: M020 Ultra Solar Shield non-tinted moisturizing mineral SPF 40 ZINC OXIDE Joyce Kelly Enterprises 365bdf7a-c034-beef-e063-6394a90a4dd7 2025-12-08 Exact identifier application number: M020 UV Shade tinted matte mineral SPF 40 TITANIUM DIOXIDE, ZINC OXIDE Joyce Kelly Enterprises 365b3a1e-8410-da06-e063-6294a90a462f 2025-12-08 Exact identifier application number: M020 Solar Shield non-tinted matte mineral SPF 40 TITANIUM DIOXIDE, ZINC OXIDE Joyce Kelly Enterprises 365b68a0-0f89-0f43-e063-6294a90a5eee 2025-12-08 Exact identifier application number: M020 Ultra UV Shade tinted moisturizing mineral SPF 40 ZINC OXIDE Joyce Kelly Enterprises 365ba78a-b7df-a31f-e063-6394a90a1673 2025-12-08 Exact identifier application number: M020 Mineral Sunscreen tinted TITANIUM DIOXIDE, ZINC OXIDE Face 5, LLC 3000a0a7-2b51-b832-e063-6294a90a4a08 2025-12-08 Warnings Exact identifier application number: M020 Non-Tinted Mineral Sunscreen TITANIUM DIOXIDE, ZINC OXIDE Face 5, LLC 3001028b-bb36-04ec-e063-6294a90a1e49 2025-12-08 Warnings Exact identifier application number: M020 Tinted Mineral Sunscreen TITANIUM DIOXIDE, ZINC OXIDE Face 5, LLC 3001aa3a-cc8b-6ad4-e063-6394a90a223f 2025-12-08 Warnings Exact identifier application number: M020 Tinted Mineral Sunscreen TITANIUM DIOXIDE, ZINC OXIDE Face 5, LLC 300268ff-f9ef-1006-e063-6294a90a5fdf 2025-12-08 Warnings Exact identifier application number: M020 Illuminating Daily SPF 40 Lightly Tinted ZINC OXIDE Face 5, LLC 3001ef4f-4cbb-8931-e063-6394a90a5cef 2025-12-08 Warnings Exact identifier application number: M020 Illuminating Daily SPF40 Non-Tinted ZINC OXIDE Face 5, LLC 300218c9-65cf-d984-e063-6294a90a1517 2025-12-08 Warnings Exact identifier application number: M020 Illuminating Daily SPF 40 Lightly Tinted ZINC OXIDE Face 5, LLC 300303e7-ef89-7449-e063-6294a90ac811 2025-12-08 Warnings Exact identifier application number: M020 Clear Path Tinted Facial Sunscreen TITANIUM DIOXIDE, ZINC OXIDE LULUS SPA BOUTIQUE 37657755-fa82-88a0-e063-6394a90ade47 2025-12-08 Exact identifier application number: M020 Tinted Lip Sunscreen TITANIUM DIOXIDE, ZINC OXIDE Dermacare 376468ce-8d9b-b672-e063-6294a90a0bd1 2025-12-08 Exact identifier application number: M020
Packages# Package NDC, 11-digit format, Description table Package NDC 11-digit format Description Units Marketing start Sample Exclude flag Status 84440-003-10 84440000310 1 TUBE in 1 CARTON (84440-003-10) / 10 g in 1 TUBE 1 tube 2024-09-01 No No Current 84440-003-20 84440000320 1 TUBE in 1 CARTON (84440-003-20) / 20 g in 1 TUBE 1 tube 2024-09-01 No No Current 84440-003-50 84440000350 1 TUBE in 1 CARTON (84440-003-50) / 50 g in 1 TUBE 1 tube 2024-09-01 No No Current