KISS MY FACE ORGANICS SPF-30 MINERAL SUN (TITANIUM DIOXIDE, ZINC OXIDE) LOTION [KISS MY FACE, LLC]

KISS MY FACE ORGANICS SPF-30 MINERAL SUN (TITANIUM DIOXIDE, ZINC OXIDE) LOTION [KISS MY FACE, LLC]
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NDC 65364-382-08
Set ID fb17b09e-b59c-4357-ac2a-90afee76106e
Category HUMAN OTC DRUG LABEL
Packager Kiss My Face, LLC
Generic Name
Product Class
Product Number
Application Number PART352
  • Drug Facts

  • Active Ingredients

    Titanium Dioxide 6%, Zinc Oxide 6%

    Purpose

    Sunscreen

  • Uses

    Helps prevent sunburn

  • 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.

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

  • Directions

    • Apply liberally 15 minutes before sun exposure • Reapply: after 80 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

    Aloe Barbadensis Leaf Extract*, Camellia Sinensis (Green Tea) Leaf Extract*, Caprylic/Capric Triglyceride, Carthamus Tinctorius (Safflower) Oil*, Glycerin*, Caprylyl/Capryl Glucoside, Gluconolactone, Glyceryl Caprylate, Glyceryl Stearate Citrate, Glyceryl Undecylenate, Glycyrrhiza Glabra (Licorice) Extract,* Helianthus Annuus (Sunflower) Seed Oil*, Lecithin, Leuconostoc/ Radish Root Ferment Filtrate, Lonicera Caprifolium (Honeysuckle) Extract, Lonicera Japonica (Honeysuckle) Flower Extract, Polyhydroxystearic Acid, Populus Tremuloides (Aspen) Bark Extract, Punica Granatum (Pomegranate) Extract*, Stearic Acid, Theobroma Cacao (Cocoa) Seed Butter*, Tocopherol (Vitamin E), Xanthan Gum. *CERTIFIED ORGANIC

  • Other information

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

    SunSpray

  • INGREDIENTS AND APPEARANCE
    KISS MY FACE ORGANICS SPF-30 MINERAL SUN 
    titanium dioxide, zinc oxide lotion
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:65364-382
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    TITANIUM DIOXIDE (UNII: 15FIX9V2JP) (TITANIUM DIOXIDE - UNII:15FIX9V2JP) TITANIUM DIOXIDE60 mg  in 1 mL
    ZINC OXIDE (UNII: SOI2LOH54Z) (ZINC CATION - UNII:13S1S8SF37) ZINC CATION60 mg  in 1 mL
    Inactive Ingredients
    Ingredient NameStrength
    ALOE VERA LEAF (UNII: ZY81Z83H0X)  
    GREEN TEA LEAF (UNII: W2ZU1RY8B0)  
    MEDIUM-CHAIN TRIGLYCERIDES (UNII: C9H2L21V7U)  
    SAFFLOWER OIL (UNII: 65UEH262IS)  
    GLYCERIN (UNII: PDC6A3C0OX)  
    CAPRYLYL/CAPRYL OLIGOGLUCOSIDE (UNII: E00JL9G9K0)  
    GLUCONOLACTONE (UNII: WQ29KQ9POT)  
    GLYCERYL CAPRYLATE (UNII: TM2TZD4G4A)  
    GLYCERYL STEARATE CITRATE (UNII: WH8T92A065)  
    LICORICE (UNII: 61ZBX54883)  
    SUNFLOWER OIL (UNII: 3W1JG795YI)  
    LEUCONOSTOC/RADISH ROOT FERMENT FILTRATE (UNII: D2QHA03458)  
    LONICERA CAPRIFOLIUM FLOWER (UNII: 5N1WD9784U)  
    POPULUS TREMULOIDES BARK (UNII: 5543O0CEID)  
    POMEGRANATE (UNII: 56687D1Z4D)  
    STEARIC ACID (UNII: 4ELV7Z65AP)  
    COCOA BUTTER (UNII: 512OYT1CRR)  
    .ALPHA.-TOCOPHEROL (UNII: H4N855PNZ1)  
    XANTHAN GUM (UNII: TTV12P4NEE)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:65364-382-08236 mL in 1 BOTTLE, SPRAY; Type 0: Not a Combination Product01/19/2018
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph not finalpart35201/19/2018
    Labeler - Kiss My Face, LLC (041794279)

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