Label: FLORIDA SUNCARE BROAD SPECTRUM SPF 15- avobenzone,octisalate, octocrylene spray

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

Drug Label Information

Updated January 25, 2024

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

View All Sections
  • Active Ingredients

    Avobenzone 2%

    Octisalate 5%

    Octocrylene 2%

  • 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

    Flammable: Do not use in the presence of a flame or spark. Keep away from sources of ignition- No smoking. Contents under pressure. Do not puncture or incinerate. Do not store at temperatures above 120°F.

    Do not use on damaged or broken skin.

    When using this product keep away from face to avoid breathing it. 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 product is swallowed, get medical help or contact a Poison Control Center right away.

  • Directions

    • hold container 4 to 6 inches from the skin to apply.
    • spray liberally and spread evenly by hand 15 minutes before sun exposure.
    • do not spray directly into face. Spray on hands then apply to face.
    • do not apply in windy conditions. Use in a well ventilated area.
    • reapply
    • After 80 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 sleeve shirts, pants, hats & sunglasses
    • children under 6 months: Ask a doctor

  • Inactive ingredients

    Cocos Nucifera (Coconut) Oil, Fragrance, SD Alcohol 40-B, Tocopheryl Acetate, VA/Butyl Maleate/Isobornyl Acrylate Copolymer

  • Other information

    • protect this product from excessive heat and direct sun.
    • avoid spraying on fabrics - could cause discoloration
  • Questions or comments?

    Call 1 (800) 931-9254

  • Florida Glow Broad Spectrum SPF 15

    Principal Display Label

  • INGREDIENTS AND APPEARANCE
    FLORIDA SUNCARE  BROAD SPECTRUM SPF 15
    avobenzone,octisalate, octocrylene spray
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:13630-0235
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    AVOBENZONE (UNII: G63QQF2NOX) (AVOBENZONE - UNII:G63QQF2NOX) AVOBENZONE16.3 mg  in 1 mL
    OCTISALATE (UNII: 4X49Y0596W) (OCTISALATE - UNII:4X49Y0596W) OCTISALATE40.8 mg  in 1 mL
    OCTOCRYLENE (UNII: 5A68WGF6WM) (OCTOCRYLENE - UNII:5A68WGF6WM) OCTOCRYLENE16.3 mg  in 1 mL
    Inactive Ingredients
    Ingredient NameStrength
    .ALPHA.-TOCOPHEROL ACETATE (UNII: 9E8X80D2L0)  
    ALCOHOL (UNII: 3K9958V90M)  
    VINYL ACETATE (UNII: L9MK238N77)  
    DIBUTYL MALEATE (UNII: 4X371TMK9K)  
    ISOBORNYL ACRYLATE (UNII: IX0PRH184P)  
    COCONUT OIL (UNII: Q9L0O73W7L)  
    Product Characteristics
    Coloryellow (very light Yellow) Score    
    ShapeSize
    FlavorImprint Code
    Contains    
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:13630-0235-4191 mL in 1 CAN; Type 0: Not a Combination Product08/18/2017
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC Monograph DrugM02008/18/2017
    Labeler - Prime Packaging, Inc. (805987059)
    Registrant - Prime Packaging, Inc. (805987059)
    Establishment
    NameAddressID/FEIBusiness Operations
    Prime Enterprises, Inc.101946028manufacture(13630-0235) , analysis(13630-0235)
    Establishment
    NameAddressID/FEIBusiness Operations
    Prime Packaging, Inc.805987059pack(13630-0235) , label(13630-0235)
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!