BIOCORNEUM- avobenzone, homosalate, meradimate, octisalate, and octocrylene gel

Biocorneum by

Drug Labeling and Warnings

Biocorneum by is a Otc medication manufactured, distributed, or labeled by Biodermis LLC, Formulated Solutions, LLC. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

SPL UNCLASSIFIED SECTION

Drug Facts

ACTIVE INGREDIENT

Active Ingredients	Purpose
Avobenzone 3%	Sunscreen
Homosalate 15%	Sunscreen
Meradimate 5%	Sunscreen
Octisalate 5%	Sunscreen
Octocrylene 10%	Sunscreen

Dosage Form: Gel

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

Cyclopentasiloxane, Dimethicone, Dimethicone Crosspolymer, Silicon Dioxide

Questions?

Call 800.322.3729

PRINCIPAL DISPLAY PANEL - 50 g Tube Carton

BIOCORNEUM®

ADVANCED
SCAR TREATMENT

SILISHIELD®
CROSSLINKED SILICONE
+ BROAD SPECTRUM SPF 30

NET WT 1.73 fl oz (50g)

INGREDIENTS AND APPEARANCE

BIOCORNEUM 
avobenzone, homosalate, meradimate, octisalate, and octocrylene gel

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 84440-003
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
Avobenzone (UNII: G63QQF2NOX) (Avobenzone - UNII:G63QQF2NOX)	Avobenzone	30 mg  in 1 g
Homosalate (UNII: V06SV4M95S) (Homosalate - UNII:V06SV4M95S)	Homosalate	150 mg  in 1 g
Meradimate (UNII: J9QGD60OUZ) (Meradimate - UNII:J9QGD60OUZ)	Meradimate	50 mg  in 1 g
Octisalate (UNII: 4X49Y0596W) (Octisalate - UNII:4X49Y0596W)	Octisalate	50 mg  in 1 g
Octocrylene (UNII: 5A68WGF6WM) (Octocrylene - UNII:5A68WGF6WM)	Octocrylene	100 mg  in 1 g

Inactive Ingredients
Ingredient Name	Strength
CYCLOMETHICONE 5 (UNII: 0THT5PCI0R)
DIMETHICONE (UNII: 92RU3N3Y1O)
DIMETHICONE CROSSPOLYMER (450000 MPA.S AT 12% IN CYCLOPENTASILOXANE) (UNII: UF7620L1W6)
SILICON DIOXIDE (UNII: ETJ7Z6XBU4)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 84440-003-10	1 in 1 CARTON	09/01/2024
1		10 g in 1 TUBE; Type 0: Not a Combination Product
2	NDC: 84440-003-20	1 in 1 CARTON	09/01/2024
2		20 g in 1 TUBE; Type 0: Not a Combination Product
3	NDC: 84440-003-50	1 in 1 CARTON	09/01/2024
3		50 g in 1 TUBE; Type 0: Not a Combination Product

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC monograph drug	M020	09/01/2024

Labeler - Biodermis LLC (809650005)

Establishment
Name	Address	ID/FEI	Business Operations
Formulated Solutions, LLC		143266687	MANUFACTURE(84440-003)