Label: BIOCORNEUM PLUS SPF 30 ADVANCED SCAR TREATMENT- octinoxate octisalate octocrylene oxybenzone gel

  • Category: HUMAN OTC DRUG LABEL
  • DEA Schedule: None
  • Marketing Status: OTC monograph final

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 Label Information

Updated November 30, 2017

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  • 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

  • INGREDIENTS AND APPEARANCE
    BIOCORNEUM PLUS SPF 30 ADVANCED SCAR TREATMENT 
    octinoxate octisalate octocrylene oxybenzone gel
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:71241-001
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    OCTINOXATE (UNII: 4Y5P7MUD51) (OCTINOXATE - UNII:4Y5P7MUD51) OCTINOXATE7.5 g  in 100 g
    OCTISALATE (UNII: 4X49Y0596W) (OCTISALATE - UNII:4X49Y0596W) OCTISALATE5 g  in 100 g
    OCTOCRYLENE (UNII: 5A68WGF6WM) (OCTOCRYLENE - UNII:5A68WGF6WM) OCTOCRYLENE10 g  in 100 g
    OXYBENZONE (UNII: 95OOS7VE0Y) (OXYBENZONE - UNII:95OOS7VE0Y) OXYBENZONE6 g  in 100 g
    Inactive Ingredients
    Ingredient NameStrength
    SILICON DIOXIDE (UNII: ETJ7Z6XBU4)  
    ISOPROPYL MYRISTATE (UNII: 0RE8K4LNJS)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:71241-001-501 in 1 CARTON03/09/2016
    1NDC:71241-001-9950 g in 1 BOTTLE, PUMP; Type 0: Not a Combination Product
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph finalpart35203/09/2016
    Labeler - SIENTRA, INC. (010209877)
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