FDA.reportPublic FDA data

BIOCORNEUM PLUS SPF 30 ADVANCED SCAR TREATMENT

Manufacturer
SIENTRA, INC.
Effective date
2017-11-30
Label type
HUMAN OTC DRUG LABEL
Version
1
Source
legacy-cache
Hydrated at
2026-08-02 01:09:33

Label at a glance#

ProductBIOCORNEUM PLUS SPF 30 ADVANCED SCAR TREATMENT
Active ingredientOCTINOXATE, OCTISALATE, OCTOCRYLENE, OXYBENZONE
Label structure8 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.

Label contents#

Full prescribing information#

Active Ingredients

OTC - ACTIVE INGREDIENT SECTION

Active Ingredients                        Purpose
Octinoxate 7.5% ..........................Sunscreen
Octisalate 5.0%.............................Sunscreen
Octocrylene 10%..........................Sunscreen
Oxybenzone 6.0%......................Sunscreen

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: 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.

Keep out of reach of children.

Do not use on damaged or broken skin.

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

Stop use and ask a doctor if rash occurs.

Directions

INFORMATION FOR PATIENTS 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

OTHER SAFETY INFORMATION


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

Inactive Ingredients

INACTIVE INGREDIENT SECTION


Isopropyl Myristrate, Polysiloxanes, Silicone Dioxide

Questions?

OTC - QUESTIONS SECTION

Call 888.708.0808

Product Package Label

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

1 gm package1 gm package

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
71241-001-012024-01-30C16284748780-11030e365-3134-111a-e063-dadaa90a10e2DRUG FACTS

Products#

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

DailyMed product names page 1 of 1 · 8 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
71241-00171241-001-96, 71241-001-01

Ingredients#

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

DailyMed ingredient rows page 1 of 1 · 6 matching rows.

Name, UNII, Kind table
NameUNIIKind
ISOPROPYL MYRISTATE0RE8K4LNJSIACT
SILICON DIOXIDEETJ7Z6XBU4IACT
OCTINOXATE4Y5P7MUD51ACTIB
OCTISALATE4X49Y0596WACTIB
OCTOCRYLENE5A68WGF6WMACTIB
OXYBENZONE95OOS7VE0YACTIB

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
5f3b5e21-38fb-59d5-e053-2991aa0adc615f3b5e21-38fa-59d5-e053-2991aa0adc612017-11-30WarningsExact identifier
spl id: 5f3b5e21-38fb-59d5-e053-2991aa0adc61
spl set id: 5f3b5e21-38fa-59d5-e053-2991aa0adc61

Reported adverse events (FAERS/openFDA)#

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