Biocorneum Plus Spf 30 Advanced Scar Supervision
FDA Label NDC 43474-001

Full FDA labeling including Indications, Dosage, Usage, and Precautions

Structured Product Label

The following Structured Product Label (SPL) was submitted to the FDA by Enaltus Inc for the product Biocorneum Plus Spf 30 Advanced Scar Supervision (NDC 43474-001). This document serves as the official prescribing information, containing essential scientific data and clinical materials required for healthcare providers and patients.

This specific version of the label includes detailed information regarding biocorneum + plus spf 30 advanced scar supervision, active ingredients, purpose, uses, warnings, keep out of reach of children., otc - when using, otc - do not use, and other regulatory disclosures. Use the navigation below to review specific sections of the FDA submission.

Label Section Quick Index

Biocorneum + Plus Spf 30 Advanced Scar Supervision


Active Ingredients

Octinoxate 7.5%
Octisalate 5.0%
Octocrylene 10%
Oxybenzone 6.0%

Purpose

Sunscreen

Uses

bioCorneumis a unique scar therapy providing a patented silicone gel to help prevent abnormal scar formation with high protection sunscreen agents.

Warnings

For external use only

Keep Out Of Reach Of Children.


Otc - When Using

Avoid direct contact with eyes, mucous membranes, third degree burns, and open wounds.

Otc - Do Not Use

Should not be used on dermatological conditions that disrupt the integrity of the skin.

Otc - Stop Use

If irritation occurs, discontinue use and consult your physician.

Directions

Sun Protection Measures. Spending time in the sun increases your risk of skin cancer and early skin aging. To decrease this risk, regularly use a sunscreen with a Broad Spectrum SPF value of 15 or higher and other sun protection measures including:

  • limit time in the sun, especially from 10 a.m. - 2 p.m.
  • wear long-sleeved shirts, pants, hats and sunglasses
  • ensure that the affected area is clean and dry
  • apply evenly in a thin layer twice daily, 15 minutes before sun exposure
  • allow to dry
  • children under 6 months: ask a doctor

Other Information

  • store below 25oC (77oF)

Inactive Ingredients

Polysiloxanes, Silicon Dioxide, Isopropyl Myristate

Questions?

1-800-240-8227

Representative Labeling

bioCorneum + plus SPF 30 advanced SCAR SUPERVISION 50g (43474-001-50)
bioCorneum + plus SPF 30 advanced SCAR SUPERVISION 20g (43474-001-20)
bioCorneum + plus SPF 30 advanced SCAR SUPERVISION 10g (43474-001-10)



Outer Label (Outerlabel)

Outer Label (Outerlabel)


Inner Label (Innerlabel)

Inner Label (Innerlabel)


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