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 333 of 346 · 6,912 matching rows.
Brand, Generic, Manufacturer table Brand Generic Manufacturer SPL set ID Effective date Available safety fields Join Carmex 10 Count Variety Pack SPF 15 Sunscreen OCTINOXATE, OXYBENZONE, PETROLATUM Carma Laboratories, Inc. bacc60ec-0b6a-4ba2-b246-a59694f06b77 2023-10-25 Warnings Exact identifier application number: M020 Carmex Daily Care Moisturizing Lip Balm Tropical Colada SPF 15 OCTINOXATE, OXYBENZONE Carma Laboratories, Inc. d5538bd0-4bab-4401-a0b8-632809a1e04c 2023-10-25 Warnings Exact identifier application number: M020 Carmex Classic Lip Balm Medicated Free Cupcake Batter Stick Sunscreen SPF 15 OCTINOXATE, OXYBENZONE, WHITE PETROLATUM Carma Laboratories, Inc. 5720bd35-de4a-4db4-a4df-0fbc59719bfd 2023-10-25 Warnings Exact identifier application number: M020 Carmex Classic Lip Balm Medicated SPF 15 OCTINOXATE, OXYBENZONE, PETROLATUM Carma Laboratories, Inc. ca20b2dc-97e5-461a-94c8-5c109cd15285 2023-10-25 Warnings Exact identifier application number: M020 Carmex Daily Care Moisturizing Lip Balm Orange Dream SPF 15 OCTINOXATE, OXYBENZONE Carma Laboratories, Inc. aeea02a0-233e-43b6-b1b8-95ae64b7fa00 2023-10-25 Warnings Exact identifier application number: M020 Carmex Daily Care moisturizing Lip Balm Winter Mint SPF 15 OCTINOXATE, OXYBENZONE Carma Laboratories, Inc. 41e4fca8-22c0-4a8a-95d3-e4aad559548a 2023-10-25 Warnings Exact identifier application number: M020 Carmex Daily Care Moisturizing Lip Balm Honey Dew Melon SPF 15 OCTINOXATE, OXYBENZONE Carma Laboratories, Inc. 2f721ae7-1922-4463-bb5f-64699907a669 2023-10-25 Warnings Exact identifier application number: M020 Carmex Daily Care Moisturizing Lip Balm Free Cupcake Batter Stick Sunscreen SPF 15 OCTINOXATE, OXYBENZONE Carma Laboratories, Inc. 6ef888a3-77c0-498f-92c4-d482cf96ef46 2023-10-25 Warnings Exact identifier application number: M020 Carmex Daily Care Moisturizing Lip Balm SPF 15 Sunscreen Minis OCTINOXATE, OXYBENZONE Carma Laboratories, Inc. 4e868b1a-7c47-45de-83cd-0bd5fbb05a27 2023-10-25 Warnings Exact identifier application number: M020 Carmex Daily Care Moisturizing Lip Balm SPF 15 OCTINOXATE, OXYBENZONE Carma Laboratories, Inc. a298815d-9f1f-419d-9dad-6bbfcddc7a48 2023-10-25 Warnings Exact identifier application number: M020 Carmex Daily Care Moisturizing Lip Balm SPF 15 Assorted OCTINOXATE, OXYBENZONE Carma Laboratories, Inc. bb6086c1-f775-70ed-e053-2995a90a531e 2023-10-25 Warnings Exact identifier application number: M020 Carmex Daily Care Moisturizing Lip Balm Sweets SPF 15 OCTINOXATE, OXYBENZONE Carma Laboratories, Inc. bb62d499-1d78-1324-e053-2a95a90abe3c 2023-10-25 Warnings Exact identifier application number: M020 Carmex Daily Care Moisturizing Lip Balm Sunscreen SPF 15 OCTINOXATE, OXYBENZONE Carma Laboratories, Inc. f3eb98dc-9ab3-4123-9490-a1bbf9b3259a 2023-10-25 Warnings Exact identifier application number: M020 Carmex Daily Care Moisturizing Lip Balm SPF 15 Assorted OCTINOXATE, OXYBENZONE Carma Laboratories, Inc. bb132025-658f-d6f8-e053-2995a90a089b 2023-10-25 Warnings Exact identifier application number: M020 Carmex Daily Care Moisturizing Lip Balm with Free Cupcake Batter Stick Sunscreen SPF 15 OCTINOXATE, OXYBENZONE Carma Laboratories, Inc. 2caa7b23-2adb-4953-b044-1b1ad9a5798b 2023-10-25 Warnings Exact identifier application number: M020 Carmex Daily Care Moisturizing Lip Balm Fresh Cherry SPF 15 OCTINOXATE, OXYBENZONE Carma Laboratories, Inc. bae876db-e410-64f6-e053-2995a90a9ebe 2023-10-25 Warnings Exact identifier application number: M020 Carmex Daily Care Moisturizing Lip Balm SPF 15 Minis OCTINOXATE, OXYBENZONE Carma Laboratories, Inc. bb029c71-4f07-2754-e053-2995a90a7c78 2023-10-25 Warnings Exact identifier application number: M020 Carmex Daily Care Moisturizing Lip Balm Free Wintergreen and Fresh Cherry SPF 15 OCTINOXATE, OXYBENZONE Carma Laboratories, Inc. bb28c2e7-4189-fc11-e053-2995a90a92ad 2023-10-25 Warnings Exact identifier application number: M020 Carmex Daily Care Moisturizing Lip Balm Favorites SPF 15 OCTINOXATE, OXYBENZONE Carma Laboratories, Inc. bb611c57-a8ac-0c23-e053-2995a90a5b40 2023-10-25 Warnings Exact identifier application number: M020 Carmex Daily Care Moisturizing Lip Balm Holiday SPF 15 OCTINOXATE, OXYBENZONE Carma Laboratories, Inc. bbf118c0-7cd5-5a82-e053-2a95a90ac8c8 2023-10-25 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