BIOCORNEUM PLUS BROAD SPECTRUM SPF 30 ADVANCED SCAR TREATMENT GEL- avobenzone,homosalate,meradimate,octisalate,octocrylene gel

BIOCORNEUM PLUS BROAD SPECTRUM SPF 30 ADVANCED SCAR TREATMENT gel by

Drug Labeling and Warnings

BIOCORNEUM PLUS BROAD SPECTRUM SPF 30 ADVANCED SCAR TREATMENT gel by is a Otc medication manufactured, distributed, or labeled by Sientra, Inc., FORMULATED SOLUTIONS, LLC. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

Warnings

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

Gel

DIRECTIONS

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

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

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).

INACTIVE INGREDIENTS

Cyclopentasiloxane, Dimethicone,
Dimethicone Crosspolymer, Silicon
Dioxide

PURPOSE

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.

Keep out of reach of children.

DOSAGE AND 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

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

INGREDIENTS AND APPEARANCE

BIOCORNEUM PLUS BROAD SPECTRUM SPF 30 ADVANCED SCAR TREATMENT GEL 
avobenzone,homosalate,meradimate,octisalate,octocrylene gel

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 71241-004
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
OCTOCRYLENE (UNII: 5A68WGF6WM) (OCTOCRYLENE - UNII:5A68WGF6WM)	OCTOCRYLENE	10 g  in 100 g
OCTISALATE (UNII: 4X49Y0596W) (OCTISALATE - UNII:4X49Y0596W)	OCTISALATE	5 g  in 100 g
MERADIMATE (UNII: J9QGD60OUZ) (MERADIMATE - UNII:J9QGD60OUZ)	MERADIMATE	5 g  in 100 g
AVOBENZONE (UNII: G63QQF2NOX) (AVOBENZONE - UNII:G63QQF2NOX)	AVOBENZONE	3 g  in 100 g
HOMOSALATE (UNII: V06SV4M95S) (HOMOSALATE - UNII:V06SV4M95S)	HOMOSALATE	15 g  in 100 g

Inactive Ingredients
Ingredient Name	Strength
DIMETHICONE CROSSPOLYMER (450000 MPA.S AT 12% IN CYCLOPENTASILOXANE) (UNII: UF7620L1W6)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 71241-004-94	1 in 1 CARTON	11/01/2021
1	NDC: 71241-004-95	95 g in 1 BOTTLE, PUMP; Type 0: Not a Combination Product

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC monograph not final	part352	11/01/2021

Labeler - Sientra, Inc. (010209877)

Establishment
Name	Address	ID/FEI	Business Operations
FORMULATED SOLUTIONS, LLC		143266687	manufacture(71241-004)