Label: BIOSOLIS SUNSCREEN BROADSPECTRUM SPF50- titanium dioxide, zinc oxide cream

  • Category: HUMAN OTC DRUG LABEL
  • DEA Schedule: None

Drug Label Information

Updated January 10, 2024

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  • Drug Facts

  • Active ingredients

    Titanium dioxide 10.8%

    Zinc oxide 14.2%

  • 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

    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
    • 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. – 3 p.m.
    • wear long-sleeved shirts, pants, hats and sunglasses
    • reapply
    • after swimming or sweating
    • immediately after towel drying
    • at least every 2 hours
    • 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

    ALUMINUM HYDROXIDE, BISABOLOL*,CAPRYLIC/CAPRIC TRIGLYCERIDE, COCONUT OIL*, DICAPRYLYL CARBONATE, FRAGANCE,HYDROGENATED COCONUT OIL**, KARANJATREE SEED EXTRACT, LIMONENE, LINALOOL,POLYGLYCERYL-2 DIPOLYHYDROXYSTEARATE,POLYGLYCERYL-3 DIISOSTEARATE ,POLYHYDROXYSTEARIC ACID, PROPANEDIOL,SESAME OIL*, STEARIC ACID, TOCOPHEROL,WATER.

  • Questions or comments?

    1-866-853-9427

  • Package Labeling:61296-016-00

    SPF50 spray outer levelSPF50 spray bottle

  • INGREDIENTS AND APPEARANCE
    BIOSOLIS SUNSCREEN BROADSPECTRUM SPF50 
    titanium dioxide, zinc oxide cream
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:61296-016
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    TITANIUM DIOXIDE (UNII: 15FIX9V2JP) (TITANIUM DIOXIDE - UNII:15FIX9V2JP) TITANIUM DIOXIDE108 mg  in 1 mL
    ZINC OXIDE (UNII: SOI2LOH54Z) (ZINC CATION - UNII:13S1S8SF37) ZINC CATION142 mg  in 1 mL
    Inactive Ingredients
    Ingredient NameStrength
    ALUMINUM HYDROXIDE (UNII: 5QB0T2IUN0)  
    LEVOMENOL (UNII: 24WE03BX2T)  
    MEDIUM-CHAIN TRIGLYCERIDES (UNII: C9H2L21V7U)  
    COCONUT OIL (UNII: Q9L0O73W7L)  
    DICAPRYLYL CARBONATE (UNII: 609A3V1SUA)  
    HYDROGENATED COCONUT OIL (UNII: JY81OXM1OM)  
    PONGAMIA PINNATA SEED (UNII: C2BRV53B1V)  
    LIMONENE, (+)- (UNII: GFD7C86Q1W)  
    LINALOOL, (+/-)- (UNII: D81QY6I88E)  
    POLYGLYCERYL-2 DIPOLYHYDROXYSTEARATE (UNII: 9229XJ4V12)  
    POLYGLYCERYL-3 DIISOSTEARATE (UNII: 46P231IQV8)  
    POLYHYDROXYSTEARIC ACID (2300 MW) (UNII: YXH47AOU0F)  
    PROPANEDIOL (UNII: 5965N8W85T)  
    SESAME OIL (UNII: QX10HYY4QV)  
    STEARIC ACID (UNII: 4ELV7Z65AP)  
    TOCOPHEROL (UNII: R0ZB2556P8)  
    WATER (UNII: 059QF0KO0R)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:61296-016-001 in 1 BOX01/07/202203/31/2025
    1100 mL in 1 BOTTLE, PUMP; Type 0: Not a Combination Product
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC Monograph DrugM02001/07/202203/31/2025
    Labeler - Pro Vera SA (375713286)
    Registrant - Pro Vera SA (375713286)
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