BIOCORNEUM PLUS BROAD SPECTRUM SPF 30 ADVANCED SCAR TREATMENT

Manufacturer
Sientra, Inc
Effective date
2022-10-07
Label type
HUMAN OTC DRUG LABEL
Version
3
Source
legacy-cache
Hydrated at
2026-08-01 21:52:07

Label at a glance#

ProductBIOCORNEUM PLUS BROAD SPECTRUM SPF 30 ADVANCED SCAR TREATMENT
Active ingredientHOMOSALATE, MERADIMATE, OCTISALATE, OCTOCRYLENE, AVOBENZONE
Label structure11 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

Avobenzone 3%............Sunscreen
Homosalate 15%............Sunscreen
Meradimate 5%.............Sunscreen
Octisalate 5%................Sunscreen
Octocrylene 10%...........Sunscreen

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

INDICATIONS & USAGE 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

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).

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

BioCorneumBioCorneumBiocorneum Advanced Scar Treatment Broad Spectrum SPF 30

For Professional Use Only

NET WT 0.35 fl oz (10g)

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

2019 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

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
71241-003-992024-01-30C16284748780-11030e365-51c2-111a-e063-dadaa90a10e2Drug Facts

Products#

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

DailyMed product names page 1 of 1 · 7 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
71241-00371241-003-50, 71241-003-99

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
ea797ee5-0401-1961-e053-2995a90a7f3e994b027a-d7ed-7fb1-e053-2a95a90a3f962022-10-07WarningsExact identifier
spl id: ea797ee5-0401-1961-e053-2995a90a7f3e
spl set id: 994b027a-d7ed-7fb1-e053-2a95a90a3f96

Reported adverse events (FAERS/openFDA)#

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