BIOCORNEUM PLUS BROAD SPECTRUM SPF 30 ADVANCED SCAR TREATMENT gel

BIOCORNEUM PLUS BROAD SPECTRUM SPF 30 ADVANCED SCAR TREATMENT by

Drug Labeling and Warnings

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

Drug Details [pdf]

Active Ingredients

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

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 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

INGREDIENTS AND APPEARANCE

BIOCORNEUM PLUS BROAD SPECTRUM SPF 30 ADVANCED SCAR TREATMENT 
biocorneum plus broad spectrum spf 30 advanced scar treatment gel

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 71241-003
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
HOMOSALATE (UNII: V06SV4M95S) (HOMOSALATE - UNII:V06SV4M95S)	HOMOSALATE	15 g  in 100 g
MERADIMATE (UNII: J9QGD60OUZ) (MERADIMATE - UNII:J9QGD60OUZ)	MERADIMATE	5 g  in 100 g
OCTISALATE (UNII: 4X49Y0596W) (OCTISALATE - UNII:4X49Y0596W)	OCTISALATE	5 g  in 100 g
OCTOCRYLENE (UNII: 5A68WGF6WM) (OCTOCRYLENE - UNII:5A68WGF6WM)	OCTOCRYLENE	10 g  in 100 g
AVOBENZONE (UNII: G63QQF2NOX) (AVOBENZONE - UNII:G63QQF2NOX)	AVOBENZONE	3 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: 71241-003-96	1 in 1 CARTON	03/31/2020
1	NDC: 71241-003-01	1 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	03/31/2020

Labeler - Sientra, Inc (010209877)