FDA.reportPublic FDA data

Biocorneum

Manufacturer
Biodermis LLC | Formulated Solutions, LLC
Effective date
2024-08-13
Label type
HUMAN OTC DRUG LABEL
Version
1
Source
full-release
Hydrated at
2026-06-01 00:18:27

Label at a glance#

ProductBiocorneum
Active ingredientAvobenzone, Homosalate, Meradimate, Octisalate, Octocrylene
Label structure9 sections

Indications and uses

BIOCORNEUM ® can reduce the appearance of scars and is ideal for use on any intact skin surface, including skin that flexes (such as joints) and areas exposed to sun (such as the face and hands).

Dosage and administration

Ensure that the affected area is clean and dry. Apply a thin, even layer twice daily. Allow to dry. Wait 15 minutes before sun exposure. Children under 6 months of age: Ask a doctor.

Storage and handling

Protect product in this container from excessive heat and direct sun.

Label contents#

Full prescribing information#

SPL UNCLASSIFIED SECTION

Drug Facts

OTC - ACTIVE INGREDIENT SECTION

OTC - PURPOSE SECTION

Active IngredientsPurpose
Avobenzone 3%Sunscreen
Homosalate 15%Sunscreen
Meradimate 5%Sunscreen
Octisalate 5%Sunscreen
Octocrylene 10%Sunscreen

Dosage Form: Gel

Uses

INDICATIONS & USAGE SECTION

BIOCORNEUM® can reduce the appearance of scars and is ideal for use on any intact skin surface, including skin that flexes (such as joints) and areas exposed to sun (such as the face and hands).

Warnings

WARNINGS SECTION

Skin Cancer/Skin Aging Alert

SPL UNCLASSIFIED SECTION

Spending time in the sun increases your risk of skin cancer and early skin aging. This product has been shown only to help prevent sunburn, not skin cancer or early skin aging.

For external use only.

OTC - KEEP OUT OF REACH OF CHILDREN SECTION

Keep out of reach of children.

OTC - DO NOT USE SECTION

Do not use on damaged or broken skin.

OTC - WHEN USING SECTION

When using this product keep out of eyes. Rinse with water to remove.

OTC - STOP USE SECTION

Stop use and ask a doctor if rash occurs.

Directions

DOSAGE & ADMINISTRATION SECTION

  • Ensure that the affected area is clean and dry.
  • Apply a thin, even layer twice daily.
  • Allow to dry. Wait 15 minutes before sun exposure.
  • Children under 6 months of age: Ask a doctor.

Other Information

STORAGE AND HANDLING SECTION

Protect product in this container from excessive heat and direct sun.

Inactive Ingredients

INACTIVE INGREDIENT SECTION

Cyclopentasiloxane, Dimethicone, Dimethicone Crosspolymer, Silicon Dioxide

Questions?

OTC - QUESTIONS SECTION

Call 800.322.3729

PRINCIPAL DISPLAY PANEL - 50 g Tube Carton

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

BIOCORNEUM®

ADVANCED
SCAR TREATMENT

SILISHIELD®
CROSSLINKED SILICONE
+ BROAD SPECTRUM SPF 30

NET WT 1.73 fl oz (50g)

PRINCIPAL DISPLAY PANEL - 50 g Tube Carton
PRINCIPAL DISPLAY PANEL - 50 g Tube Carton

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

Products#

Every source-derived product name is available through these pages.

DailyMed product names page 1 of 1 · 11 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
84440-00384440-003-10, 84440-003-20, 84440-003-50

Ingredients#

Every source-derived ingredient row is available through these pages.

DailyMed ingredient rows page 1 of 1 · 9 matching rows.

Name, UNII, Kind table
NameUNIIKind
AvobenzoneG63QQF2NOXACTIB
HomosalateV06SV4M95SACTIB
MeradimateJ9QGD60OUZACTIB
Octisalate4X49Y0596WACTIB
Octocrylene5A68WGF6WMACTIB
CYCLOMETHICONE 50THT5PCI0RIACT
DIMETHICONE92RU3N3Y1OIACT
DIMETHICONE CROSSPOLYMER (450000 MPA.S AT 12% IN CYCLOPENTASILOXANE)UF7620L1W6IACT
SILICON DIOXIDEETJ7Z6XBU4IACT

Source Document#

Source XML

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 1 of 1 · 1 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
BiocorneumAVOBENZONE, HOMOSALATE, MERADIMATE, OCTISALATE, AND OCTOCRYLENEBiodermis LLCef95f2b7-e438-4990-880d-81621edb20022024-08-13WarningsExact identifier
ndc (package): 84440-003-20
ndc (package): 84440-003-50
ndc (package): 84440-003-10
ndc (product): 84440-003
ndc11 (package): 84440000350
ndc11 (package): 84440000320
ndc11 (package): 84440000310
spl id: 2996022f-311c-4161-b6cc-1c746e9151d9
spl set id: ef95f2b7-e438-4990-880d-81621edb2002

Reported adverse events (FAERS/openFDA)#

Adverse event summaries are temporarily unavailable. Other product information remains available.