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NDC 71241-0003-99 BIOCORNEUM PLUS BROAD SPECTRUM SPF 30 ADVANCED SCAR TREATMENT 3; 15; 5; 5; 10 g/100g; g/100g; g/100g; g/100g; g/100g Details

BIOCORNEUM PLUS BROAD SPECTRUM SPF 30 ADVANCED SCAR TREATMENT 3; 15; 5; 5; 10 g/100g; g/100g; g/100g; g/100g; g/100g

BIOCORNEUM PLUS BROAD SPECTRUM SPF 30 ADVANCED SCAR TREATMENT is a TOPICAL GEL in the HUMAN OTC DRUG category. It is labeled and distributed by Sientra, Inc. The primary component is AVOBENZONE; HOMOSALATE; MERADIMATE; OCTISALATE; OCTOCRYLENE.

Product Information

NDC	71241-0003
Product ID	71241-003_ea798eb6-187d-9d98-e053-2995a90a7af0
Associated GPIs
GCN Sequence Number	n/a
GCN Sequence Number Description	n/a
HIC3	n/a
HIC3 Description	n/a
GCN	n/a
HICL Sequence Number	n/a
HICL Sequence Number Description	n/a
Brand/Generic	n/a
Proprietary Name	BIOCORNEUM PLUS BROAD SPECTRUM SPF 30 ADVANCED SCAR TREATMENT
Proprietary Name Suffix	n/a
Non-Proprietary Name	BIOCORNEUM PLUS BROAD SPECTRUM SPF 30 ADVANCED SCAR TREATMENT
Product Type	HUMAN OTC DRUG
Dosage Form	GEL
Route	TOPICAL
Active Ingredient Strength	3; 15; 5; 5; 10
Active Ingredient Units	g/100g; g/100g; g/100g; g/100g; g/100g
Substance Name	AVOBENZONE; HOMOSALATE; MERADIMATE; OCTISALATE; OCTOCRYLENE
Labeler Name	Sientra, Inc
Pharmaceutical Class	n/a
DEA Schedule	n/a
Marketing Category	OTC MONOGRAPH NOT FINAL
Application Number	part352
Listing Certified Through	2023-12-31

Package

Package Images

NDC 71241-0003-99 (71241000399)

Pricing Information	N/A
NDC Package Code	71241-003-99
Billing NDC	71241000399
Package	1 BOTTLE, PUMP in 1 CARTON (71241-003-99) / 50 g in 1 BOTTLE, PUMP (71241-003-50)
Marketing Start Date	2020-03-31
NDC Exclude Flag	N

Standard Product Labeling (SPL)/Prescribing Information SPL 98fa343f-85c9-3289-e053-2a95a90ae114 Details

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.

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

Ingredient Name	Basis of Strength	Strength
Active Ingredient/Active Moiety
AVOBENZONE (UNII: G63QQF2NOX) (AVOBENZONE - UNII:G63QQF2NOX)	AVOBENZONE	3 g in 100 g
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

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

#	Item Code	Package Description	Marketing Start Date
Packaging
1	NDC:71241-003-97	1 in 1 CARTON	03/31/2020
1	NDC:71241-003-10	10 g in 1 BOTTLE, PUMP; Type 0: Not a Combination Product

Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
Marketing Information
OTC monograph not final	part352	03/31/2020

Labeler - Sientra, Inc (010209877)

Revised: 10/2022

Document Id: ea798eb6-187d-9d98-e053-2995a90a7af0

Set id: 98fa343f-85c9-3289-e053-2a95a90ae114

Version: 3

Effective Time: 20221007