Label: KISS MY FACE COOL SPORT 30 MINERAL SUNSCREEN- titanium dioxide spray

  • NDC Code(s): 74154-016-06
  • Packager: Windmill Health Products, LLC
  • 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 17, 2022

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  • SPL UNCLASSIFIED SECTION

    Drug Facts

  • Active Ingredient

    Titanium Dioxide 7.8%

  • Purpose

    Sunscreen

  • Uses

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

    • Do not puncture or incinerate. Contents under pressure. Do not store at temperature above 120°F.
    • For external use only.
    • Do not use on damaged or broken skin.
    • When using this product, keep out of eyes. Rinse with water to remove.
    • Stop use and ask a doctor if skin rash or irritation develops and lasts.

    • Keep out of reach of children.
    • If swallowed, get medical help or contact a Poison Control Center right away.
    • If pregnant or breast-feeding, ask a health professional before use.
  • Directions

    • Apply liberally 15 minute before sun exposure.
    • Hold 4 to 6 inches away from body when spraying.
    • Do not spray directly on face and avoid breathing mist. Spray on hand and apply to face.
    • Do not apply in windy conditions.
    • Use in well-ventilated areas and avoid inhalation.
    • Reapply:
      • after 80 minutes of swimming or sweating,
      • immediately after towel drying and
      • at least every 2 hours.
    • Children under 6 months: ask a doctor.
    • Sun Protection Measures: Spending time in the sun increases your risk of skin cancer and early skin aging. To decrease risk, regularly use a sunscreen with Broad Spectrum SPF 15 or higher and other sun protection measures including:
      • Limit time in sun, especially from 10am to 2pm.
      • Wear long-sleeved shirts, pants, hats and sunglasses.
  • Inactive Ingredients

    Aloe Barbadensis Leaf Juice, Alumina, Bentonite, Butyloctyl Salicylate, Caprylhydroxamic Acid, Caprylyl Glycol, Carthamus Tinctorius (Safflower) Seed Oil, Cetearyl Alcohol , Coco-Glucoside, Cucumis Sativus (Cucumber) Fruit Extract, Ethylhexylglycerin, Fragrance (Parfum)1, Ginkgo Biloba Leaf Extract, Glycerin, Heptyl Undecylenate, Impatiens Balsamina (Garden Balsam) Leaf Extract, Methyl Dihydroabietate, Persea Gratissima (Avocado) Fruit Extract, Silica, Tocopherol, Water (Aqua)

    1
    Natural fragrance
  • Other Information

    • Protect this product from excessive heat and direct sun.
  • Questions?

    Call 800-822-4320 Or visit www.kissmyface.com

  • PRINCIPAL DISPLAY PANEL - 177 ml Can Label

    KISS
    MY
    FACE®

    30
    cool sport

    mineral sunscreen
    wet & dry skin formula

    broad spectrum SPF30
    water resistant (80 minutes)

    hydrates & protects

    aloe vera
    cucumber

    REEF FRIENDLY*

    6 fl oz (177 ml)

    PRINCIPAL DISPLAY PANEL - 177 ml Can Label
  • INGREDIENTS AND APPEARANCE
    KISS MY FACE COOL SPORT 30 MINERAL SUNSCREEN 
    titanium dioxide spray
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:74154-016
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    Titanium Dioxide (UNII: 15FIX9V2JP) (Titanium Dioxide - UNII:15FIX9V2JP) Titanium Dioxide78 mg  in 1 mL
    Inactive Ingredients
    Ingredient NameStrength
    Aloe Vera Leaf (UNII: ZY81Z83H0X)  
    ALUMINUM OXIDE (UNII: LMI26O6933)  
    BENTONITE (UNII: A3N5ZCN45C)  
    Butyloctyl Salicylate (UNII: 2EH13UN8D3)  
    Caprylhydroxamic Acid (UNII: UPY805K99W)  
    Caprylyl Glycol (UNII: 00YIU5438U)  
    SAFFLOWER OIL (UNII: 65UEH262IS)  
    CETOSTEARYL ALCOHOL (UNII: 2DMT128M1S)  
    Coco Glucoside (UNII: ICS790225B)  
    Cucumber (UNII: YY7C30VXJT)  
    Ethylhexylglycerin (UNII: 147D247K3P)  
    GINKGO (UNII: 19FUJ2C58T)  
    Glycerin (UNII: PDC6A3C0OX)  
    Heptyl Undecylenate (UNII: W77QUB6GXO)  
    Impatiens Balsamina Leaf (UNII: LH9E1X602V)  
    Methyl Dihydroabietate (UNII: 7666FJ0J9F)  
    Avocado (UNII: SDS87L369F)  
    SILICON DIOXIDE (UNII: ETJ7Z6XBU4)  
    Tocopherol (UNII: R0ZB2556P8)  
    Water (UNII: 059QF0KO0R)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:74154-016-06177 mL in 1 CAN; Type 0: Not a Combination Product02/22/2022
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC MONOGRAPH NOT FINALpart35202/22/2022
    Labeler - Windmill Health Products, LLC (831136267)
    Establishment
    NameAddressID/FEIBusiness Operations
    Bell International Laboratories967781555MANUFACTURE(74154-016)
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