NDC 71241-004 Biocorneum Plus Broad Spectrum Spf 30 Advanced Scar Treatment Gel

Avobenzone, Homosalate, Meradimate, Octisalate, Octocrylene

NDC Product Code 71241-004

NDC CODE: 71241-004

Proprietary Name: Biocorneum Plus Broad Spectrum Spf 30 Advanced Scar Treatment Gel What is the Proprietary Name?
The proprietary name also known as the trade name is the name of the product chosen by the medication labeler for marketing purposes.

Non-Proprietary Name: Avobenzone, Homosalate, Meradimate, Octisalate, Octocrylene What is the Non-Proprietary Name?
The non-proprietary name is sometimes called the generic name. The generic name usually includes the active ingredient(s) of the product.

NDC Code Structure

  • 71241 - Sientra, Inc.
    • 71241-004 - Biocorneum Plus Broad Spectrum Spf 30 Advanced Scar Treatment Gel

NDC 71241-004-94

Package Description: 1 BOTTLE, PUMP in 1 CARTON > 95 g in 1 BOTTLE, PUMP (71241-004-95)

NDC Product Information

Biocorneum Plus Broad Spectrum Spf 30 Advanced Scar Treatment Gel with NDC 71241-004 is a a human over the counter drug product labeled by Sientra, Inc.. The generic name of Biocorneum Plus Broad Spectrum Spf 30 Advanced Scar Treatment Gel is avobenzone, homosalate, meradimate, octisalate, octocrylene. The product's dosage form is gel and is administered via topical form.

Dosage Form: Gel - A semisolid3 dosage form that contains a gelling agent to provide stiffness to a solution or a colloidal dispersion.4 A gel may contain suspended particles.

Product Type: Human Otc Drug What kind of product is this?
Indicates the type of product, such as Human Prescription Drug or Human Over the Counter Drug. This data element matches the “Document Type” field of the Structured Product Listing.

Biocorneum Plus Broad Spectrum Spf 30 Advanced Scar Treatment Gel Active Ingredient(s)

What is the Active Ingredient(s) List?
This is the active ingredient list. Each ingredient name is the preferred term of the UNII code submitted.


Inactive Ingredient(s)

About the Inactive Ingredient(s)
The inactive ingredients are all the component of a medicinal product OTHER than the active ingredient(s). The acronym "UNII" stands for “Unique Ingredient Identifier” and is used to identify each inactive ingredient present in a product.

  • DIMETHICONE CROSSPOLYMER (450000 MPA.S AT 12% IN CYCLOPENTASILOXANE) (UNII: UF7620L1W6)

Administration Route(s)

What are the Administration Route(s)?
The translation of the route code submitted by the firm, indicating route of administration.

  • Topical - Administration to a particular spot on the outer surface of the body. The E2B term TRANSMAMMARY is a subset of the term TOPICAL.

Product Labeler Information

What is the Labeler Name?
Name of Company corresponding to the labeler code segment of the Product NDC.

Labeler Name: Sientra, Inc.
Labeler Code: 71241
FDA Application Number: part352 What is the FDA Application Number?
This corresponds to the NDA, ANDA, or BLA number reported by the labeler for products which have the corresponding Marketing Category designated. If the designated Marketing Category is OTC Monograph Final or OTC Monograph Not Final, then the Application number will be the CFR citation corresponding to the appropriate Monograph (e.g. “part 341”). For unapproved drugs, this field will be null.

Marketing Category: OTC MONOGRAPH NOT FINAL - A product marketed pursuant to an Over-the-Counter (OTC) Drug Monograph that is not final. What is the Marketing Category?
Product types are broken down into several potential Marketing Categories, such as NDA/ANDA/BLA, OTC Monograph, or Unapproved Drug. One and only one Marketing Category may be chosen for a product, not all marketing categories are available to all product types. Currently, only final marketed product categories are included. The complete list of codes and translations can be found at www.fda.gov/edrls under Structured Product Labeling Resources.

Start Marketing Date: 11-01-2021 What is the Start Marketing Date?
This is the date that the labeler indicates was the start of its marketing of the drug product.

Listing Expiration Date: 12-31-2022 What is the Listing Expiration Date?
This is the date when the listing record will expire if not updated or certified by the product labeler.

Exclude Flag: N - NO What is the NDC Exclude Flag?
This field indicates whether the product has been removed/excluded from the NDC Directory for failure to respond to FDA"s requests for correction to deficient or non-compliant submissions ("Y"), or because the listing certification is expired ("E"), or because the listing data was inactivated by FDA ("I"). Values = "Y", "N", "E", or "I".

* Please review the disclaimer below.

Biocorneum Plus Broad Spectrum Spf 30 Advanced Scar Treatment Gel Product Label Images

Biocorneum Plus Broad Spectrum Spf 30 Advanced Scar Treatment Gel Product Labeling Information

The product labeling information includes all published material associated to a drug. Product labeling documents include information like generic names, active ingredients, ingredient strength dosage, routes of administration, appearance, usage, warnings, inactive ingredients, etc.

Product Labeling Index

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 30For Professional Use OnlyNET 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

* Please review the disclaimer below.