Label: KISS MY FACE - OAT PROTEIN COMPLEX SPF 18- titanium dioxide, zinc oxide lotion

  • 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 8, 2017

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

  • SPL UNCLASSIFIED SECTION

    Practice safe sun with this effective formula made with this NATURAL MINERAL SUNBLOCK made with oat protein and betaglucans that moisturize, help reduce irritation and fight the signs of aging.

    Bob and Steve, Founders/Chief Safe Sun-Lovers

    • No parabens
    • No nanoparticles
    • No artificial colors or fragrances
    • No animal ingredients or testing
  • SPL UNCLASSIFIED SECTION

    Drug Facts

  • Active Ingredients

    Titanium Dioxide 4.25%

    Zinc Oxide 3.75%

  • Purpose

    Sunscreens

  • INDICATIONS & USAGE

    Uses

    • Helps prevent sunburn
    • Higher SPF gives more sunburn protection
    • Retains SPF after 40 minutes of activity in water
  • WARNINGS

    Warnings

    For external use only

  • WHEN USING

    When using this product keep out of eyes. Rinse with water to remove.

  • STOP USE

    Stop use and ask a doctor if rash or irritation develops and lasts.

  • 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.

  • DOSAGE & ADMINISTRATION

    Directions

    •  Apply liberally 20 minutes before sun exposure and as needed
    • Children under 6 months of age; ask a doctor
  • SPL UNCLASSIFIED SECTION

    Other information

    • Sun Alert: Limiting sun exposure, wearing protective clothing and using sunscreen may reduce the wish of skin aging, skin cancer and other harmful effects of the sun.
    • You may report a serious adverse event from using this product to Kiss My Face Corp, 144 Main St, Gardiner NY 12525.
  • INACTIVE INGREDIENT

    Inactive ingredients

    Aqua, Aloe Barbadensis (Aloe Vera) Leaf Juice, Helianthus Annuus (Sunflower) Seed Oil, Acrylates Copolymer, Lecithin, Glycerin, Xanthan Gum, Glycine Soja (Soybean) Oil, Cocamidopropyl Betaine, Cocos Nucifera (Coconut) Oil, Avena Sativa (Oat) Protein, Butyrospermum Parkii (Shea) Butter, Camellia Sinensis (Green Tea) Leaf Extract, Daucus Carota Sativa (Carrot) Root Extract, Tocopheryl Acetate (Vitamin E), Olea Europaea (Olive) Oil, Retinyl Palmitate (Vitamin A), Avena Sativa (Oat) Betaglucan, Amygdalus Dulcis (Sweet Almond) Oil, Phenoxyethanol, Ethylhexylglycerin, Mangifera Indica (Mango) Seed Butter



  • SPL UNCLASSIFIED SECTION

    kissmyface.com

    Please recycle

    Dis: Kiss My Face LLC Gardiner NY 12525 Made in USA

  • PRINCIPAL DISPLAY PANEL

    KISS MY FACE

    do what comes

    naturally.

    OAT PROTEIN COMPLEX

    PARABEN FREE

    SPF 18

    UVA/UVB protection water resistant

    4 Fl Oz 118 mL

    KissMyFace


  • INGREDIENTS AND APPEARANCE
    KISS MY FACE - OAT PROTEIN COMPLEX SPF 18 
    titanium dioxide, zinc oxide lotion
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:65364-100
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    TITANIUM DIOXIDE (UNII: 15FIX9V2JP) (TITANIUM DIOXIDE - UNII:15FIX9V2JP) TITANIUM DIOXIDE4.25 g  in 100 mL
    ZINC OXIDE (UNII: SOI2LOH54Z) (ZINC OXIDE - UNII:SOI2LOH54Z) ZINC OXIDE3.75 g  in 100 mL
    Inactive Ingredients
    Ingredient NameStrength
    WATER (UNII: 059QF0KO0R)  
    ALOE VERA LEAF (UNII: ZY81Z83H0X)  
    SUNFLOWER OIL (UNII: 3W1JG795YI)  
    GLYCERIN (UNII: PDC6A3C0OX)  
    XANTHAN GUM (UNII: TTV12P4NEE)  
    SOYBEAN OIL (UNII: 241ATL177A)  
    COCAMIDOPROPYL BETAINE (UNII: 5OCF3O11KX)  
    COCONUT OIL (UNII: Q9L0O73W7L)  
    OAT BRAN (UNII: KQX236OK4U)  
    SHEA BUTTER (UNII: K49155WL9Y)  
    GREEN TEA LEAF (UNII: W2ZU1RY8B0)  
    CARROT (UNII: L56Z1JK48B)  
    ALPHA-TOCOPHEROL (UNII: H4N855PNZ1)  
    OLIVE OIL (UNII: 6UYK2W1W1E)  
    ALMOND OIL (UNII: 66YXD4DKO9)  
    PHENOXYETHANOL (UNII: HIE492ZZ3T)  
    ETHYLHEXYLGLYCERIN (UNII: 147D247K3P)  
    MANGO SEED OIL (UNII: K8LOR30915)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:65364-100-04118 mL in 1 TUBE; Type 0: Not a Combination Product02/08/2017
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph not finalpart35202/09/2011
    Labeler - Kiss My Face LLC (041794279)