Label: ECO SPF30 SUN STICK- spf30 broad spectrum sun stick stick

  • Category: HUMAN OTC DRUG LABEL

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 3, 2020

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  • ACTIVE INGREDIENT

    Avobenzone (1%)

    Octinoxate (7.5%)

    Octisalate (5%)

    Oxybenzone (4%)

  • PURPOSE

    Uses

    • Helps prevent sunburn
    • If used as directed with other sun protection measures (see Cirections), decreases the risk of skin cancer and early skin aging caused by the sun.
  • 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

    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.
    • reapply:
      • after 40 minutes of swimming or sweating
      • immediately after towel drying
      • at least every 2 hours
      • 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 of 15 or higher and other sun protection measures including:
      • limit time in the sun, especially from 10 a.m. - 2 p.m.
      • wear long-sleeved shirts; pants, hats and sunglasses
      • children under 6 months: Ask a doctor.

  • INACTIVE INGREDIENT

    Inactive Ingredients

    *Aloe Barbadenis (Aloe Vera) Leaf Oil, *Cera Flava (Beeswax), *Calendula Officinalis (Calendula) Flower Extract, *Cocos Nucifera (Cocounut) Oil, "Hellanthus Annuus (Sunflower) Seed Oil, *Rosmarinus Officinalis (Rosemary) Leaf Extract, *Theeobroma Cacao (Cocoa) Seed Butter, Mixed Tocopherols (Vitamin E).

    *Organic Ingredients

  • OTHER SAFETY INFORMATION

    Other Information

    Protect this product from excessive heat and direct sunlight.

  • QUESTIONS

    Questions or Comments?

    Call 1.866.326.5477

  • PRINCIPAL DISPLAY PANEL

    SPF30BSSUNSTICK

  • INGREDIENTS AND APPEARANCE
    ECO SPF30 SUN STICK 
    spf30 broad spectrum sun stick stick
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:58418-274
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    OCTISALATE (UNII: 4X49Y0596W) (OCTISALATE - UNII:4X49Y0596W) OCTISALATE5 mg  in 1 mL
    OXYBENZONE (UNII: 95OOS7VE0Y) (OXYBENZONE - UNII:95OOS7VE0Y) OXYBENZONE4 mg  in 1 mL
    OCTINOXATE (UNII: 4Y5P7MUD51) (OCTINOXATE - UNII:4Y5P7MUD51) OCTINOXATE7.5 mg  in 1 mL
    AVOBENZONE (UNII: G63QQF2NOX) (AVOBENZONE - UNII:G63QQF2NOX) AVOBENZONE1 mg  in 1 mL
    Inactive Ingredients
    Ingredient NameStrength
    ALOE VERA LEAF (UNII: ZY81Z83H0X)  
    ROSMARINUS OFFICINALIS FLOWERING TOP OIL (UNII: OXN0D3N28L)  
    SUNFLOWER OIL (UNII: 3W1JG795YI)  
    CALENDULA OFFICINALIS FLOWER (UNII: P0M7O4Y7YD)  
    COCONUT OIL (UNII: Q9L0O73W7L)  
    APIS CERANA WORKER SECRETION (UNII: PRG8653U8K)  
    COCOA BUTTER (UNII: 512OYT1CRR)  
    TOCOPHEROL (UNII: R0ZB2556P8)  
    Product Characteristics
    ColorwhiteScore    
    ShapeSize
    FlavorImprint Code
    Contains    
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:58418-274-0515 mL in 1 CANISTER; Type 0: Not a Combination Product08/27/2018
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph not finalpart35208/01/2014
    Labeler - Tropical Enterprises International, Inc (091986179)
    Registrant - Tropical Enterprises International, Inc. (091986179)
    Establishment
    NameAddressID/FEIBusiness Operations
    Tropical Enterprises International, Inc.091986179label(58418-274)
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