BIOCORNEUM PLUS BROAD SPECTRUM SPF 30 ADVANCED SCAR TREATMENT gel

Manufacturer
Sientra, Inc. | FORMULATED SOLUTIONS, LLC
Effective date
2021-09-02
Label type
HUMAN OTC DRUG LABEL
Version
1
Source
legacy-cache
Hydrated at
2026-08-01 22:30:01

Label at a glance#

ProductBIOCORNEUM PLUS BROAD SPECTRUM SPF 30 ADVANCED SCAR TREATMENT gel
Active ingredientOCTOCRYLENE, OCTISALATE, MERADIMATE, AVOBENZONE, HOMOSALATE
Label structure10 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#

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.

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.

Dosage Form

DOSAGE FORMS & STRENGTHS SECTION

Gel

DIRECTIONS

INSTRUCTIONS FOR USE 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.

USES

INTENDED USE OF THE DEVICE

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).

INACTIVE INGREDIENTS

INACTIVE INGREDIENT SECTION

Cyclopentasiloxane, Dimethicone,
Dimethicone Crosspolymer, Silicon
Dioxide

PURPOSE

OTC - PURPOSE 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).

KEEP OUT OF REACH OF CHILDREN.

OTC - KEEP OUT OF REACH OF CHILDREN SECTION

Keep out of reach of children.

DOSAGE AND ADMINISTRATION SECTION

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.

PRINCIPLE DISPLAY SECTION

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

Biocorneum Advanced Scar Treatment Broad Spectrum SPF 30

For Professional Use Only

NET WT 3.35 fl oz (95g)

BIOCORNEUM by Sientra is
the only advanced scar
treatment with Silishield
patented crosslinked silicone
plus SPF 30 protection.
What is Silishield?
Silishield advances the
benefits of traditional silicone
sheeting through the comfort
and ease of a gel. Patented
crosslinked silicone creates
an invisible shield that feels
like a second skin and helps
reduce the appearance of
scars. It can reduce redness
and discoloration, soften
and flatten new and older
hypertrophic and keloid scars
resulting from surgical
procedures, injuries and burns.
The SPF is designed to be
effective while also maintaining
Silishield’s silky-smooth feel
and clear appearance.
Manufactured in the USA for
Sientra, Inc., Santa Barbara, CA 93117
2021 Sientra, Inc.
sientra.com
BIOCORNEUM and Silishield are
registered trademarks of Sientra, Inc.
May be covered by one or more of
the following U.S. patents:
5,741,509; 8,021,683; 8,802,133;
9,339,546; 9,795,706

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

Carton ImageCarton Image

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
71241-004-942024-01-30C16284748780-11030e365-469c-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
71241-00471241-004-95, 71241-004-94

Ingredients#

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

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

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
cb06b127-5797-0933-e053-2995a90acda9cb06b127-5796-0933-e053-2995a90acda92021-09-02WarningsExact identifier
spl id: cb06b127-5797-0933-e053-2995a90acda9
spl set id: cb06b127-5796-0933-e053-2995a90acda9

Reported adverse events (FAERS/openFDA)#

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