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

FT SPF30 SUN STICK (SPF30 SUN STICK - FT) STICK [TROPICAL ENTERPRISES INTERNATIONAL, INC]
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NDC 58418-275-05
Set ID 747f1399-7397-3d26-e053-2991aa0a9df3
Category HUMAN OTC DRUG LABEL
Packager Tropical Enterprises International, Inc
Generic Name
Product Class
Product Number
Application Number PART352
  • ACTIVE INGREDIENT

    Avobenzone 2%

    Octyl Salate 5%

    Homosalate 15%

    Octinoxate 7.5%

  • PURPOSE

    Uses * Helps prevent sunburn

  • WARNINGS

    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 produict is 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, reguarly 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 10a.m. - 2p.m.
    • wear long sleeved shirts, pants, hats and sunglasses
  • INACTIVE INGREDIENT

    Inactive Ingredients: Parrafin, Ethylhexyl Palmitate, Oxokerite, Ephorbia Cerifera, Cera Alba, Cutyloctyl Sallicylate, Polyethylene, Polyester-8, Cetyl Alcohol, DL-alpha-Tocopheryl acetate, Butylated hydroxytoluene, Ascorbic Acid

  • OTHER SAFETY INFORMATION

    Other Information

    Protect this product from excessive heat and direct sun.

  • PRINCIPAL DISPLAY PANEL

    SPF30BSSUNSTICK

  • INGREDIENTS AND APPEARANCE
    FT SPF30 SUN STICK 
    spf30 sun stick - ft stick
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:58418-275
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    OCTINOXATE (UNII: 4Y5P7MUD51) (OCTINOXATE - UNII:4Y5P7MUD51) OCTINOXATE7.5 mg  in 1 mL
    HOMOSALATE (UNII: V06SV4M95S) (HOMOSALATE - UNII:V06SV4M95S) HOMOSALATE15 mg  in 1 mL
    OCTISALATE (UNII: 4X49Y0596W) (OCTISALATE - UNII:4X49Y0596W) OCTISALATE5 mg  in 1 mL
    AVOBENZONE (UNII: G63QQF2NOX) (AVOBENZONE - UNII:G63QQF2NOX) AVOBENZONE2 mg  in 1 mL
    Inactive Ingredients
    Ingredient NameStrength
    WHITE WAX (UNII: 7G1J5DA97F)  
    .ALPHA.-TOCOPHEROL ACETATE (UNII: 9E8X80D2L0)  
    PARAFFIN (UNII: I9O0E3H2ZE)  
    ETHYLHEXYL PALMITATE (UNII: 2865993309)  
    BUTYLOCTYL SALICYLATE (UNII: 2EH13UN8D3)  
    POLYESTER-8 (1400 MW, CYANODIPHENYLPROPENOYL CAPPED) (UNII: T9296U138P)  
    BUTYLATED HYDROXYTOLUENE (UNII: 1P9D0Z171K)  
    ASCORBIC ACID (UNII: PQ6CK8PD0R)  
    CANDELILLA WAX (UNII: WL0328HX19)  
    CETYL ALCOHOL (UNII: 936JST6JCN)  
    POLYETHYLENE GLYCOL, UNSPECIFIED (UNII: 3WJQ0SDW1A)  
    CERESIN (UNII: Q1LS2UJO3A)  
    Product Characteristics
    ColorwhiteScore    
    ShapeSize
    FlavorImprint Code
    Contains    
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:58418-275-0515 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(58418-275)

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