Label: BIOSOLIS SUNSCREEN BROADSPECTRUM SPF50 KIDS- 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%

    Zinc oxide 13.5%

  • 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 40 minutes 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

    ALOE VERA LEAF JUICE*, ALUMINUM HYDROXIDE,BENZYL ALCOHOL, BISABOLOL*, CAPRYLIC/CAPRICTRIGLYCERIDE, DEHYDROACETIC ACID, DICAPRYLYLCARBONATE, KARANJA TREE SEED EXTRACT,POLYGLYCERYL-2 DIPOLYHYDROXYSTEARATE,POLYGLYCERYL-3 DIISOSTEARATE,POLYHYDROXYSTEARIC ACID, PROPANEDIOL,SESAME OIL*, SODIUM CHLORIDE, STEARIC ACID,TOCOPHEROL, WATER.

  • Questions or comments?

    1-866-853-9427

  • Package Labeling:61296-014-00

    SPF50 KIDS outer levelSPF50 kids front tube

  • INGREDIENTS AND APPEARANCE
    BIOSOLIS SUNSCREEN BROADSPECTRUM SPF50 KIDS 
    titanium dioxide, zinc oxide cream
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:61296-014
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    ZINC OXIDE (UNII: SOI2LOH54Z) (ZINC CATION - UNII:13S1S8SF37) ZINC CATION135 mg  in 1 mL
    TITANIUM DIOXIDE (UNII: 15FIX9V2JP) (TITANIUM DIOXIDE - UNII:15FIX9V2JP) TITANIUM DIOXIDE100 mg  in 1 mL
    Inactive Ingredients
    Ingredient NameStrength
    ALOE VERA LEAF (UNII: ZY81Z83H0X)  
    ALUMINUM HYDROXIDE (UNII: 5QB0T2IUN0)  
    BENZYL ALCOHOL (UNII: LKG8494WBH)  
    LEVOMENOL (UNII: 24WE03BX2T)  
    MEDIUM-CHAIN TRIGLYCERIDES (UNII: C9H2L21V7U)  
    DEHYDROACETIC ACID (UNII: 2KAG279R6R)  
    DICAPRYLYL CARBONATE (UNII: 609A3V1SUA)  
    PONGAMIA PINNATA SEED (UNII: C2BRV53B1V)  
    POLYGLYCERYL-2 DIPOLYHYDROXYSTEARATE (UNII: 9229XJ4V12)  
    POLYGLYCERYL-3 DIISOSTEARATE (UNII: 46P231IQV8)  
    POLYHYDROXYSTEARIC ACID (2300 MW) (UNII: YXH47AOU0F)  
    PROPANEDIOL (UNII: 5965N8W85T)  
    SESAME OIL (UNII: QX10HYY4QV)  
    SODIUM CHLORIDE (UNII: 451W47IQ8X)  
    STEARIC ACID (UNII: 4ELV7Z65AP)  
    TOCOPHEROL (UNII: R0ZB2556P8)  
    WATER (UNII: 059QF0KO0R)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:61296-014-001 in 1 BOX01/07/202204/30/2025
    1100 mL in 1 TUBE; Type 0: Not a Combination Product
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC Monograph DrugM02001/07/202204/30/2025
    Labeler - Pro Vera SA (375713286)
    Registrant - Pro Vera SA (375713286)
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