RR SPF30 SUN STICK (SPF30 SUN STICK) STICK [TROPICAL ENTERPRISES INTERNATIONAL, INC]

RR SPF30 SUN STICK (SPF30 SUN STICK) STICK [TROPICAL ENTERPRISES INTERNATIONAL, INC]
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NDC 58418-276-05
Set ID 7496c1a5-c31b-10c0-e053-2991aa0aa359
Category HUMAN OTC DRUG LABEL
Packager Tropical Enterprises International, Inc
Generic Name
Product Class
Product Number
Application Number PART352
  • 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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