Label: BIOSOLIS SUNSCREEN BROADSPECTRUM SPF30- zinc oxide cream

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

Drug Label Information

Updated January 10, 2024

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

View All Sections
  • Drug Facts

  • Active ingredients

    Zinc oxide 18.8%

  • 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

    BISABOLOL*, CAPRYLIC/CAPRIC TRIGLYCERIDE,COCONUT OIL*, DICAPRYLYL CARBONATE,FRAGANCE, HYDROGENATED COCONUT OIL**,KARANJA TREE SEED EXTRACT, LIMONENE,LINALOOL, POLYHYDROXYSTEARIC ACID,SESAME OIL*, TOCOPHEROL.

  • Questions or comments?

    1-866-853-9427

  • Package Labeling:61296-015-00

    SPF30 spray outer levelSPF30 spray bottle

  • INGREDIENTS AND APPEARANCE
    BIOSOLIS SUNSCREEN BROADSPECTRUM SPF30 
    zinc oxide cream
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:61296-015
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    ZINC OXIDE (UNII: SOI2LOH54Z) (ZINC CATION - UNII:13S1S8SF37) ZINC CATION188 mg  in 1 mL
    Inactive Ingredients
    Ingredient NameStrength
    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)  
    POLYHYDROXYSTEARIC ACID (2300 MW) (UNII: YXH47AOU0F)  
    SESAME OIL (UNII: QX10HYY4QV)  
    TOCOPHEROL (UNII: R0ZB2556P8)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:61296-015-001 in 1 BOX01/07/202204/30/2025
    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 DrugM02001/07/202204/30/2025
    Labeler - Pro Vera SA (375713286)
    Registrant - 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!