Biocorneum®

Biocorneum®
SPL v1
SPL
SPL Set ID ef95f2b7-e438-4990-880d-81621edb2002
Route
TOPICAL
Published
Effective Date 2024-08-13
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients
Avobenzone (30 mg) Homosalate (150 mg) Meradimate (50 mg) Octisalate (100 mg) Octocrylene
Inactive Ingredients
Cyclomethicone 5 Dimethicone Dimethicone Crosspolymer (450000 Mpa.s At 12% In Cyclopentasiloxane) Silicon Dioxide

Identifiers & Packaging

Marketing Status
OTC MONOGRAPH DRUG Active Since 2024-09-01
Description

Drug Facts

Medication Information

Description

Drug Facts

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).

Section 42229-5

Drug Facts

Section 50565-1

Keep out of reach of children.

Section 50566-9

Stop use and ask a doctor if rash occurs.

Section 50567-7

When using this product keep out of eyes. Rinse with water to remove.

Section 50570-1

Do not use on damaged or broken skin.

Section 55105-1
Active Ingredients Purpose
Avobenzone 3% Sunscreen
Homosalate 15% Sunscreen
Meradimate 5% Sunscreen
Octisalate 5% Sunscreen
Octocrylene 10% Sunscreen

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.
Questions?

Call 800.322.3729

Other Information

Protect product in this container from excessive heat and direct sun.

Inactive Ingredients

Cyclopentasiloxane, Dimethicone, Dimethicone Crosspolymer, Silicon Dioxide

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.

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)

Structured Label Content

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).

Section 42229-5 (42229-5)

Drug Facts

Section 50565-1 (50565-1)

Keep out of reach of children.

Section 50566-9 (50566-9)

Stop use and ask a doctor if rash occurs.

Section 50567-7 (50567-7)

When using this product keep out of eyes. Rinse with water to remove.

Section 50570-1 (50570-1)

Do not use on damaged or broken skin.

Section 55105-1 (55105-1)
Active Ingredients Purpose
Avobenzone 3% Sunscreen
Homosalate 15% Sunscreen
Meradimate 5% Sunscreen
Octisalate 5% Sunscreen
Octocrylene 10% Sunscreen

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.
Questions?

Call 800.322.3729

Other Information

Protect product in this container from excessive heat and direct sun.

Inactive Ingredients

Cyclopentasiloxane, Dimethicone, Dimethicone Crosspolymer, Silicon Dioxide

Skin Cancer/skin Aging Alert (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.

Principal Display Panel 50 G Tube Carton (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)

Advanced Ingredient Data

Raw Label Data

All Sections (JSON)

Additional Information

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Source: dailymed · Ingested: 2026-02-15T12:03:30.995087 · Updated: 2026-03-14T23:03:38.391930