KISS MY FACE SPF-50 FACE FACTOR (AVOBENZONE,HOMOSALATE,OCTINOXATE,OCTISALATE,OCTOCRYLENE) CREAM [KISS MY FACE, LLC]

KISS MY FACE SPF-50 FACE FACTOR (AVOBENZONE,HOMOSALATE,OCTINOXATE,OCTISALATE,OCTOCRYLENE) CREAM [KISS MY FACE, LLC]
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NDC 65364-381-03
Set ID f078d514-64f3-4317-8298-755958bce9df
Category HUMAN OTC DRUG LABEL
Packager Kiss My Face, LLC
Generic Name
Product Class
Product Number
Application Number PART352
  • Drug Facts

  • Active Ingredients

    Avobenzone 3%, Homosalate 2%,

    Octinoxate 4%, Octisalate 3%

    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.

    Do not use

    on damaged or broken skin.

    Stop use and ask a doctor

    if rash occurs

    When using this product

    keep out of reach of eyes.  Rinse with water to remove.

    Keep out of reach of children.

    If swallowed, get medical help or contact a Poison Control Center right away.

  • 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 • 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, use Broad Spectrum sunscreen SPF value of 15 or higher and other sun protection measures including: • Limit time in sun, especially from 10 am-2 pm • Wear long-sleeved shirts, pants, hats and sunglasses

  • Inactive Ingredients

    Acetyl Hexapeptide-8, Acrylates Copolymer, Aloe Barbadensis Leaf Juice, alpha-Lipoic ACid, Ascorbyl Palmitate (Vitamin C), Camellia Sinensis (Green Tea) Extract, Caprylic/Capric Triglyceride, carthamus Tinctorius (Safflower) Oleosomes, Cetearyl Olivate, Cetyl Alcohol, Citric Acid, Cucumis Sativus (Cucumber) Extract, Dimethicone, Ethylhexylglycerin, Glycerin, Glyceryl Stearate SE, Glycyrrhiza Glabra (Licorice) Extract, Helianthus Annuus (Sunflower) Oil, Lavandula Angustifolia (Lavender) Oil, Lecithin, Phenoxyethanol, Polysorbate 20, Potassium Hydroxide, Saccharide Isomerate, Sodium Hyaluronate, Sorbitan Olivate, Stearyl Alcohol, Styrene/Acrylates Copolymer, Water, Zemea Propanediol (Corn Derived)

  • Other information

    • Protect product from excessive heat and direct sun
  • Package Labeling

    Facefactor

  • INGREDIENTS AND APPEARANCE
    KISS MY FACE SPF-50 FACE FACTOR 
    avobenzone,homosalate,octinoxate,octisalate,octocrylene cream
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:65364-381
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    AVOBENZONE (UNII: G63QQF2NOX) (AVOBENZONE - UNII:G63QQF2NOX) AVOBENZONE30 mg  in 1 mL
    HOMOSALATE (UNII: V06SV4M95S) (HOMOSALATE - UNII:V06SV4M95S) HOMOSALATE20 mg  in 1 mL
    OCTINOXATE (UNII: 4Y5P7MUD51) (OCTINOXATE - UNII:4Y5P7MUD51) OCTINOXATE75 mg  in 1 mL
    OCTISALATE (UNII: 4X49Y0596W) (OCTISALATE - UNII:4X49Y0596W) OCTISALATE50 mg  in 1 mL
    OCTOCRYLENE (UNII: 5A68WGF6WM) (OCTOCRYLENE - UNII:5A68WGF6WM) OCTOCRYLENE50 mg  in 1 mL
    Inactive Ingredients
    Ingredient NameStrength
    ACETYL HEXAPEPTIDE-8 (UNII: L4EL31FWIL)  
    ACRYLATE/ISOBUTYL METHACRYLATE/N-TERT-OCTYLACRYLAMIDE COPOLYMER (75000 MW) (UNII: JU3XHR8VWK)  
    ALOE VERA LEAF (UNII: ZY81Z83H0X)  
    .ALPHA.-LIPOIC ACID (UNII: 73Y7P0K73Y)  
    ASCORBYL PALMITATE (UNII: QN83US2B0N)  
    GREEN TEA LEAF (UNII: W2ZU1RY8B0)  
    TRICAPRYLIN (UNII: 6P92858988)  
    CARTHAMUS TINCTORIUS SEED OLEOSOMES (UNII: 9S60Q72309)  
    CETEARYL OLIVATE (UNII: 58B69Q84JO)  
    CETYL ALCOHOL (UNII: 936JST6JCN)  
    CITRIC ACID MONOHYDRATE (UNII: 2968PHW8QP)  
    DIMETHICONE (UNII: 92RU3N3Y1O)  
    ETHYLHEXYLGLYCERIN (UNII: 147D247K3P)  
    GLYCERIN (UNII: PDC6A3C0OX)  
    GLYCERYL STEARATE SE (UNII: FCZ5MH785I)  
    GLYCYRRHIZA GLABRA (UNII: 2788Z9758H)  
    SUNFLOWER OIL (UNII: 3W1JG795YI)  
    LAVENDER OIL (UNII: ZBP1YXW0H8)  
    PHENOXYETHANOL (UNII: HIE492ZZ3T)  
    POLYSORBATE 20 (UNII: 7T1F30V5YH)  
    POTASSIUM HYDROXIDE (UNII: WZH3C48M4T)  
    SACCHARIDE ISOMERATE (UNII: W8K377W98I)  
    HYALURONATE SODIUM (UNII: YSE9PPT4TH)  
    SORBITAN OLIVATE (UNII: MDL271E3GR)  
    STEARYL ALCOHOL (UNII: 2KR89I4H1Y)  
    WATER (UNII: 059QF0KO0R)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:65364-381-0359 mL in 1 TUBE; Type 0: Not a Combination Product01/12/2018
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph not finalpart35201/12/2018
    Labeler - Kiss My Face, LLC (041794279)

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