Label: BIOSOLIS SUN SPF50- titanium dioxide cream

  • Category: HUMAN OTC DRUG LABEL
  • DEA Schedule: None
  • Marketing Status: OTC monograph not 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 December 2, 2022

If you are a consumer or patient please visit this version.

View All Sections
  • Drug Facts

  • Active ingredients

    Titanium Dioxide 15.9%

    Purpose

    Sunscreen

  • Uses

    • helps prevent sunburn.
    • If used as directed with other sun protection measures (see Directions), decreases the risk of skin cancer and early skin aging caused by the sun.
  • Warnings

    For external use only

    • shake  well before each use

    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

    Keep out of reach of children.

    If swallowed, get medical help or contact Poison Control Center right away

  • Directions

    • Apply liberally 15 minutes before  sun exposure
    • Reapply at least every 2 hours
    • Use a water resistant sunscreen if swimming or sweating
    • 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 aBroad 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
    • Children under 6 months of age: Ask a doctor
  • Other information

    • Protect the product in this container from excessive heat and direct sun.
  • Inactive ingredients

    DICAPRYLYL CARBONATE, BRASSICA CAMPESTRIS (RAPESEED) OIL *, POLYHYDROXYSTEARIC ACID, CAPRYLIC/CAPRIC TRIGLYCERIDE,
    PONGAMIA GLABRA SEED OIL, DIETHYL SEBACATE, STEARIC ACID, ALUMINUM HYDROXYDE, HYDROGENATED COCONUT OIL, POLYGLYCERYL-2 DIPOLYHYDROXYSTEARATE, SESAMUM INDICUM SEED OIL*, COCOS NUCIFERA OIL, BISABOLOL, TOCOPHEROL, PARFUM.

  • Questions or comments?

    info@biosolis.info or Call  Adverse Event Reporting: 1-866-8539427

  • Package Labeling:

    Label

  • INGREDIENTS AND APPEARANCE
    BIOSOLIS SUN SPF50 
    titanium dioxide cream
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:61296-005
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    TITANIUM DIOXIDE (UNII: 15FIX9V2JP) (TITANIUM DIOXIDE - UNII:15FIX9V2JP) TITANIUM DIOXIDE159 mg  in 1 mL
    Inactive Ingredients
    Ingredient NameStrength
    DICAPRYLYL CARBONATE (UNII: 609A3V1SUA)  
    BRASSICA RAPA SUBSP. OLEIFERA OIL (UNII: N4G8379626)  
    MEDIUM-CHAIN TRIGLYCERIDES (UNII: C9H2L21V7U)  
    KARUM SEED OIL (UNII: 62160PU6FJ)  
    DIETHYL SEBACATE (UNII: I41B9FJK6V)  
    ALUMINUM HYDROXIDE (UNII: 5QB0T2IUN0)  
    HYDROGENATED COCONUT OIL (UNII: JY81OXM1OM)  
    POLYGLYCERYL-2 DIPOLYHYDROXYSTEARATE (UNII: 9229XJ4V12)  
    SESAME OIL (UNII: QX10HYY4QV)  
    LEVOMENOL (UNII: 24WE03BX2T)  
    TOCOPHEROL (UNII: R0ZB2556P8)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:61296-005-001 in 1 BOX02/01/201904/30/2024
    1100 mL in 1 BOTTLE, SPRAY; Type 0: Not a Combination Product
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph not finalpart35202/01/201904/30/2024
    Labeler - Pro Vera SA (375713286)
View All Sections

Find additional resources

(also available in the left menu)

Safety

Report Adverse Events, FDA Safety Recalls, Presence in Breast Milk

Related Resources

Medline Plus, Clinical Trials, PubMed, Biochemical Data Summary

More Info on this Drug

View Labeling Archives, RxNorm, Get Label RSS Feed, View NDC Code(s)NEW!