Label: RR SPF30 SUN STICK- spf30 sun stick stick

  • 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 February 2, 2020

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  • ACTIVE INGREDIENT

    Avobenzone 3%

    Homosalate 7.5%

    Octisalate 5%

    Octocrylene 2.5%

    Oxybenzone 6%

  • INSTRUCTIONS FOR USE

    Uses - Helps prevent sunburn

  • WARNINGS

    • For external use only
    • Do not use on damaged or broken skin
    • Stop use and ask a doctor if rash occurs
    • When using this product keep out of eyes. Rinse with water to remove.
    • Keep out of reach of children. If swallowed, get medical help or contact a Poison Control Center right away.
  • INSTRUCTIONS FOR USE

    Directions:

    Apply liberally 15 minutes before sun exposure

    • Use a water resistant sunscreen if swimming or sweating
    • Reapply at least every 2 hours
    • children under 6 months of age: Ask a Doctor

    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 a Broad Spectrum SPF value of 15 or higher and other sun protection measures including:

    • limit time in the sun, especially from 10am - 2pm.
    • wear long sleeved shirts, pants, hats and sunglasses
  • INACTIVE INGREDIENT

    Beeswax, cetyl alcohol, cocoa butter, coconut oil, dimethicone, jojoba oil, ozokerite wax, rosemary extract, vitamin E

  • OTHER SAFETY INFORMATION

    Other Information:

    Protect this product from excessive heat and direct sun.

  • PRINCIPAL DISPLAY PANEL

    BSSPF30SUNSTICK

  • INGREDIENTS AND APPEARANCE
    RR SPF30 SUN STICK 
    spf30 sun stick stick
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:58418-276
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    OCTISALATE (UNII: 4X49Y0596W) (OCTISALATE - UNII:4X49Y0596W) OCTISALATE5 mg  in 1 mL
    OCTOCRYLENE (UNII: 5A68WGF6WM) (OCTOCRYLENE - UNII:5A68WGF6WM) OCTOCRYLENE2.5 mg  in 1 mL
    OXYBENZONE (UNII: 95OOS7VE0Y) (OXYBENZONE - UNII:95OOS7VE0Y) OXYBENZONE6 mg  in 1 mL
    HOMOSALATE (UNII: V06SV4M95S) (HOMOSALATE - UNII:V06SV4M95S) HOMOSALATE7.5 mg  in 1 mL
    AVOBENZONE (UNII: G63QQF2NOX) (AVOBENZONE - UNII:G63QQF2NOX) AVOBENZONE3 mg  in 1 mL
    Inactive Ingredients
    Ingredient NameStrength
    YELLOW WAX (UNII: 2ZA36H0S2V)  
    .ALPHA.-TOCOPHEROL ACETATE (UNII: 9E8X80D2L0)  
    COCOA BUTTER (UNII: 512OYT1CRR)  
    DIMETHICONE CROSSPOLYMER (450000 MPA.S AT 12% IN CYCLOPENTASILOXANE) (UNII: UF7620L1W6)  
    JOJOBA OIL (UNII: 724GKU717M)  
    CETYL ALCOHOL (UNII: 936JST6JCN)  
    COCONUT OIL (UNII: Q9L0O73W7L)  
    CERESIN (UNII: Q1LS2UJO3A)  
    ROSEMARY (UNII: IJ67X351P9)  
    Product Characteristics
    ColorwhiteScore    
    ShapeSize
    FlavorImprint Code
    Contains    
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:58418-276-0515 mL in 1 CANISTER; Type 0: Not a Combination Product08/31/2018
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph not finalpart35208/31/2018
    Labeler - Tropical Enterprises International, Inc (091986179)
    Registrant - Tropical Enterprises International, Inc. (091986179)
    Establishment
    NameAddressID/FEIBusiness Operations
    Tropical Enterprises International, Inc.091986179label(58418-276)
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