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 101 of 357 · 7,139 matching rows.
Brand, Generic, Manufacturer table Brand Generic Manufacturer SPL set ID Effective date Available safety fields Join COCO AND EVE SUNNY HONEY PROTECT TAN BOOSTING ANTI-AGING SPF 45 SUNSCREEN OIL Soleil Collective LLC 471c0eed-f7ca-3c3b-e063-6294a90ad2c6 2025-12-29 Warnings Exact identifier application number: M020 EIGHT HOUR NOURISHING LIP SPF 20 OCTINOXATE, AVOBENZONE REVLON b3c16e60-752d-6eba-e053-2995a90a2b20 2025-12-29 Warnings Exact identifier application number: M020 CERAMIDE PREMIERE BROAD SPECTRUM SPF 30 OCTINOXATE, OCTISALATE, OXYBENZONE, OCTOCRYLENE, AVOBENZONE REVLON b3358bfd-7fe5-33e2-e053-2a95a90ac2ea 2025-12-29 Warnings Exact identifier application number: M020 Prevage anti aging SPF 30 OCTISALATE, OCTINOXATE, OXYBENZONE, AVOBENZONE, OCTOCRYLENE, Revlon b2bff796-1579-2686-e053-2995a90ad6c7 2025-12-29 Warnings Exact identifier application number: M020 FLAWLESS FUTURE SPF 30 OCTINOXATE, OCTISALATE, OXYBENZONE, AVAOBENZONE REVLON b553aec1-5002-3a3f-e053-2995a90a22e5 2025-12-29 Warnings Exact identifier application number: M020 Prevage Anti-aging eye cream SPF 15 OCTINOXATE, OXYBENZONE Revlon b2a92d72-e634-7379-e053-2995a90a2bca 2025-12-29 Warnings Exact identifier application number: M020 Prevage Anti-aging Moisture Cream OCTINOXATE, OCTISALATE, OXYBENZONE, OCTOCRYLENE, AVOBENZONE Revlon Consumer Products Corp b247adbe-dfe8-df0a-e053-2995a90a34d9 2025-12-29 Warnings Exact identifier application number: M020 Sheer Protection SPF 30 ZINC OXIDE Skin Script, LLC 0450dcc9-3f8f-e2c2-e063-6294a90af60b 2025-12-29 Warnings Exact identifier application number: M020 RE-NUTRIV ULTRA RADIANCE MAKEUP BROAD SPECTRUM SPF 20 OCTINOXATE AND TITANIUM DIOXIDE ESTEE LAUDER INC 897b8edb-f089-4a49-baca-e05806b0a068 2025-12-29 Warnings Exact identifier application number: M020 Mine Line Coconut Sunscreen SPF 50 ZINC OXIDE Spa de Soleil 4642b1cc-43b1-6997-e063-6394a90ac764 2025-12-29 Warnings Exact identifier application number: M020 SnugZ SPF 30 Broad Spectrum Sunscreen SPF 30 BROAD SPECTRUM SUNSCREEN SnugZ/USA, LLC 69ac1218-76e6-04ff-e053-2a91aa0a4080 2025-12-29 Warnings Exact identifier application number: M020 SnugZ SPF 50 Sunscreen Spry SPF 50 SUNSCREEN SPRAY SnugZ USA 9390ea21-9f9f-14e2-e053-2a95a90ac577 2025-12-29 Warnings Exact identifier application number: M020 SnugZ SPF 15 Flavored Beeswax Lip Balm SPF 15 FLAVORED BEESWAX LIP BALM SnugZ/USA, LLC 69bdfaaf-d49e-bf31-e053-2a91aa0affd3 2025-12-29 Warnings Exact identifier application number: M020 SnugZ SPF 50 Broad Spectrum Sunscreen SPF 50 BROAD SPECTRUM SUNSCREEN SnugZ/USA, LLC b7a3eed5-c8ca-ffda-e053-2a95a90a73bb 2025-12-29 Warnings Exact identifier application number: M020 SnugZ SPF 15 Beeswax Lip Balm SPF 15 BEESWAX LIP BALM SnugZ/USA, LLC 68816d3a-dbe9-7ce3-e053-2a91aa0a395e 2025-12-29 Warnings Exact identifier application number: M020 SnugZ SPF 30 Soy Lip Balm SPF 30 SOY LIP BALM SnugZ/USA, LLC 687ff49d-2d0e-2534-e053-2991aa0a2864 2025-12-29 Warnings Exact identifier application number: M020 SnugZ SPF 50 Sunscreen Stick SPF 50 SUNSTICK SnugZ/USA, LLC 6e1179cf-5bfb-1156-e053-2991aa0a5b46 2025-12-29 Warnings Exact identifier application number: M020 OUHOE Face Body Sunscreen TITANIUM DIOXIDE Shantou Ouhoe Technology Co., Ltd. 46d36f60-2a5d-816e-e063-6294a90a2ddc 2025-12-26 Warnings Exact identifier application number: M020 OUHOE Bean Sunscreen TITANIUM DIOXIDE Shantou Ouhoe Technology Co., Ltd. 46d3b11f-93d9-0e38-e063-6294a90a41c3 2025-12-26 Warnings Exact identifier application number: M020 Cream ZINC OXIDE MONAT GLOBAL CORP e922d89c-4232-77d8-e053-2995a90a85e5 2025-12-26 Warnings 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