FDA.reportPublic FDA data

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
IngredientStrength
AVOBENZONE30 mg/g
HOMOSALATE150 mg/g
MERADIMATE50 mg/g
OCTISALATE50 mg/g
OCTOCRYLENE100 mg/g

Harmonized UNII identifiers#

UNII identifiers page 1 of 1 · 5 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
G63QQF2NOXInternal UNII lookup
V06SV4M95SInternal UNII lookup
J9QGD60OUZInternal UNII lookup
4X49Y0596WInternal UNII lookup
5A68WGF6WMInternal UNII lookup

Harmonized SPL set identifiers#

SPL set identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
ef95f2b7-e438-4990-880d-81621edb2002Available on FDA.report

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
84440-003-10Biocorneum1 in 1 CARTONGEL11
84440-003-10Biocorneum10 g in 1 TUBEGEL101
84440-003-20Biocorneum20 g in 1 TUBEGEL201
84440-003-20Biocorneum1 in 1 CARTONGEL11
84440-003-50Biocorneum1 in 1 CARTONGEL11
84440-003-50Biocorneum50 g in 1 TUBEGEL501

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
84440-003BIOCORNEUM (AVOBENZONE, HOMOSALATE, MERADIMATE, OCTISALATE, AND OCTOCRYLENE) GEL [BIODERMIS LLC]1Current NDC, 6 package rows20240901_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 208 of 353 · 7,041 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Ultra Balm Moisturizing Protective Balm for lips SPF 20 Nude CaramelOCTINOXATE, ZINC OXIDEBEL STAR S Ac4f95c1b-acbe-4bb7-e053-2995a90a91202025-06-19WarningsExact identifier
application number: M020
LBEL NUDE SKIN ULTRA LIGHT MATTE FOUNDATION WITH VITAMINS SPF 20 ALMENDRA 230-NOCTINOXATE, ZINC OXIDEBel Star S.A.d22fde8a-ba14-2cc7-e053-2a95a90a0e532025-06-19WarningsExact identifier
application number: M020
Correct and Protect Serum Broad Spectrum SPF 45ZINC OXIDEMurad, LLCdba6e01b-a8ec-4812-bbe0-e418bb0670322025-06-19WarningsExact identifier
application number: M020
Truffoire Truffle BrighteningOCTINOXATE, HOMOSALATE, OCTISALATE, OXYBENZONE AND AVOBENZONEInnovation Brands Inc.e3068ecf-0bee-4e8a-a439-4bb707a2845d2025-06-18WarningsExact identifier
application number: M020
Aveeno Kids Continuous Protection Sensitive Skin Mineral Sunscreen Broad Spectrum SPF 50ZINC OXIDEKenvue Brands LLC383de98b-65b5-4398-a876-87367dc01d0b2025-06-18WarningsExact identifier
application number: M020
CB Multi-Active Moisturizer with SPF 30OCTINOXATE, HOMOSALATE, OCTISALATE, OXYBENZONE AND AVOBENZONEInnovation Brands Inc.d9557a6c-78e9-4b01-8a4b-e0eceb511c4e2025-06-18WarningsExact identifier
application number: M020
1000 Roses CC Color plus Correct Sheer Beige SPF 30ZINC OXIDEAndalou naturals2e7f3570-f710-41dd-95a0-7c0613b317a22025-06-17WarningsExact identifier
application number: M020
Skin by Scottie Beach Mode Mineral Sunscreen Roll-On SPF 30TITANIUM DIOXIDE, ZINC OXIDESKIN CARE BY SCOTTIE LLCa9afa58c-f438-48c6-bd30-eda41334df742025-06-16WarningsExact identifier
application number: M020
Wellage Real Hyaluronic Watery Glow Sun ScreenAVOBENZONE, HOMOSALATE, OCTISALATE, OCTOCRYLENEHugel, Inc.37aa2f7b-afa4-5cc9-e063-6294a90ae7412025-06-16WarningsExact identifier
application number: M020
Dermaka Sunscreen SPF 42, TintedTITANIUM DIOXIDE, ZINC OXIDEDERMAKA SKIN PRODUCTS9a967cd1-9eec-4255-b14b-ac2e33e4dbf02025-06-16WarningsExact identifier
application number: M020
Elizabeth Arden Eight Hour Hydraplay SPF 40OCTISALATE, HOMOSALATE, AVOBENZONE, OCTOCRYLENERevlon Consumer Products Corp2cc74177-0f62-106e-e063-6394a90a6e282025-06-16WarningsExact identifier
application number: M020
BALI BODY SPF15 BRONZE SHIMMERING TANNINGAVOBENZONE, OCTISALATE, OCTOCRYLENEBali Body Pty Ltd240d4d80-641c-ac57-e063-6394a90abe752025-06-16WarningsExact identifier
application number: M020
Environ Skin Care RAD Shield Mineral Sunscreen SPF 30SUNSCREENENVIRON SKIN CARE (PTY) LTD3778547e-11a8-3b30-e063-6394a90ab5b12025-06-13WarningsExact identifier
application number: M020
Voupre Age DefenseOCTINOXATE, HOMOSALATE, OCTISALATE, OXYBENZONE AND AVOBENZONEInnovation Brands Inc.8dfaa076-c62a-47ee-bc5d-75360416fa1a2025-06-13WarningsExact identifier
application number: M020
Instantly DryTITANIUM DIOXIDE, ZINC OXIDECLEAN BEAUTY BY ANAK LLC37624bf6-4949-1b10-e063-6294a90ac4882025-06-12Exact identifier
application number: M020
silk SPF facial sunscreen fluid hybrid broad spectrum SPF 30 UVA/UVBZINC OXIDE AND HOMOSALATEOneKind.25d739bc43-d76e-9258-e053-2a95a90a3d2c2025-06-12WarningsExact identifier
application number: M020
ULTRA SHEER DAILY DEFENSE FACIAL SPF 18HOMOSALATE, OCTISALATE, AND AVOBENZONEAndalou naturals0f7c6d3a-73ea-44d8-a8b9-6a6f1bb02c6f2025-06-11WarningsExact identifier
application number: M020
Hydrating Sheer Lip Balm Trio The Vivids Broad Spectrum SPF 30AVOBENZONE, OCTISALATE, AND HOMOSALATEMDSolarSciences374e770f-75b5-08d0-e063-6394a90adf922025-06-11WarningsExact identifier
application number: M020
Reflecting Mineral SunscreenZINC OXIDE, TITANIUM DIOXIDEHelande, LLC3750f04b-7f9f-8793-e063-6294a90a91432025-06-11WarningsExact identifier
application number: M020
Vitamin C BB Beauty Balm Sheer Tint SFP 30ZINC OXIDEAndalou naturalsf423b484-2119-4c95-a0da-77bcd07303eb2025-06-11WarningsExact identifier
application number: M020

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startSampleExclude flagStatus
84440-003-10844400003101 TUBE in 1 CARTON (84440-003-10) / 10 g in 1 TUBE1 tube2024-09-01NoNoCurrent
84440-003-20844400003201 TUBE in 1 CARTON (84440-003-20) / 20 g in 1 TUBE1 tube2024-09-01NoNoCurrent
84440-003-50844400003501 TUBE in 1 CARTON (84440-003-50) / 50 g in 1 TUBE1 tube2024-09-01NoNoCurrent