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NDC 71241-0001-50 BIOCORNEUM PLUS SPF 30 ADVANCED SCAR TREATMENT 7.5; 5; 10; 6 g/100g; g/100g; g/100g; g/100g Details

BIOCORNEUM PLUS SPF 30 ADVANCED SCAR TREATMENT 7.5; 5; 10; 6 g/100g; g/100g; g/100g; g/100g

BIOCORNEUM PLUS 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 OCTINOXATE; OCTISALATE; OCTOCRYLENE; OXYBENZONE.

Product Information

NDC	71241-0001
Product ID	71241-001_6595cc1e-556a-da98-e053-2a91aa0a01b0
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 SPF 30 ADVANCED SCAR TREATMENT
Proprietary Name Suffix	n/a
Non-Proprietary Name	Octinoxate Octisalate Octocrylene Oxybenzone
Product Type	HUMAN OTC DRUG
Dosage Form	GEL
Route	TOPICAL
Active Ingredient Strength	7.5; 5; 10; 6
Active Ingredient Units	g/100g; g/100g; g/100g; g/100g
Substance Name	OCTINOXATE; OCTISALATE; OCTOCRYLENE; OXYBENZONE
Labeler Name	SIENTRA, INC.
Pharmaceutical Class	n/a
DEA Schedule	n/a
Marketing Category	OTC MONOGRAPH FINAL
Application Number	part352
Listing Certified Through	2023-12-31

Package

Package Images

NDC 71241-0001-50 (71241000150)

Pricing Information	N/A
NDC Package Code	71241-001-50
Billing NDC	71241000150
Package	1 BOTTLE, PUMP in 1 CARTON (71241-001-50) / 50 g in 1 BOTTLE, PUMP (71241-001-99)
Marketing Start Date	2016-03-09
NDC Exclude Flag	N

Standard Product Labeling (SPL)/Prescribing Information SPL a5a0a96b-996c-4760-8064-d9c9ad0f2434 Details

Active Ingredients

Active Ingredients Purpose

Octinoxate 7.5% ..........................Sunscreen

Octisalate 5.0%.............................Sunscreen

Octocrylene 10%..........................Sunscreen

Oxybenzone 6.0%......................Sunscreen

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).

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.

Keep out of reach of children.

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.

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.

Inactive Ingredients

Isopropyl Myristrate, Polysiloxanes, Silicone Dioxide

Questions?

Call 888.708.0808

Product Package Label

INGREDIENTS AND APPEARANCE

BIOCORNEUM PLUS SPF 30 ADVANCED SCAR TREATMENT

octinoxate octisalate octocrylene oxybenzone gel

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC:71241-001
Route of Administration	TOPICAL

Ingredient Name	Basis of Strength	Strength
Active Ingredient/Active Moiety
OCTINOXATE (UNII: 4Y5P7MUD51) (OCTINOXATE - UNII:4Y5P7MUD51)	OCTINOXATE	7.5 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
OXYBENZONE (UNII: 95OOS7VE0Y) (OXYBENZONE - UNII:95OOS7VE0Y)	OXYBENZONE	6 g in 100 g

Ingredient Name	Strength
Inactive Ingredients
ISOPROPYL MYRISTATE (UNII: 0RE8K4LNJS)
SILICON DIOXIDE (UNII: ETJ7Z6XBU4)

#	Item Code	Package Description	Marketing Start Date
Packaging
1	NDC:71241-001-98	1 in 1 CARTON	03/01/2017
1	NDC:71241-001-20	20 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 final	part352	03/01/2017

Labeler - SIENTRA, INC. (010209877)

Revised: 2/2018

Document Id: 6595cc1e-556a-da98-e053-2a91aa0a01b0

Set id: a5a0a96b-996c-4760-8064-d9c9ad0f2434

Version: 12

Effective Time: 20180219