BIOCORNEUM PLUS BROAD SPECTRUM SPF 30 ADVANCED SCAR TREATMENT gel

Country: United States

Language: English

Source: NLM (National Library of Medicine)

Active ingredient:

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

Available from:

Sientra, Inc

Administration route:

TOPICAL

Prescription type:

OTC DRUG

Therapeutic indications:

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). 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).

Authorization status:

OTC monograph not final

Summary of Product characteristics

BIOCORNEUM PLUS BROAD SPECTRUM SPF 30 ADVANCED SCAR TREATMENT-
BIOCORNEUM PLUS BROAD SPECTRUM SPF 30 ADVANCED SCAR TREATMENT 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._
----------
DRUG FACTS
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