BIOCORNEUM PLUS SPF 30 ADVANCED SCAR TREATMENT- octinoxate octisalate octocrylene oxybenzone gel
SIENTRA, INC.

Disclaimer: Most OTC drugs are not reviewed and approved by FDA, however they may be marketed if they comply with applicable regulations and policies. FDA has not evaluated whether this product complies.

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DRUG FACTS

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

50g monograph

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
SILICON DIOXIDE (UNII: ETJ7Z6XBU4)
ISOPROPYL MYRISTATE (UNII: 0RE8K4LNJS)

#	Item Code	Package Description	Marketing Start Date
Packaging
1	NDC:71241-001-50	1 in 1 CARTON	03/09/2016
1	NDC:71241-001-99	50 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	03/09/2016

Labeler - SIENTRA, INC. (010209877)