KYPRIS POT OF SHADE HELIOTROPIC BROAD SPECTRUM SPF 30 SUNSCREEN AND PRIMER (ZINC OXIDE) CREAM [KYPRIS BEAUTY LLC]

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  • KYPRIS POT OF SHADE HELIOTROPIC BROAD SPECTRUM SPF 30 SUNSCREEN AND PRIMER (ZINC OXIDE) CREAM [KYPRIS BEAUTY LLC]

KYPRIS POT OF SHADE HELIOTROPIC BROAD SPECTRUM SPF 30 SUNSCREEN AND PRIMER (ZINC OXIDE) CREAM [KYPRIS BEAUTY LLC]
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NDC 70608-001-01, 70608-001-02
Set ID a5d5f7bd-d7bf-4a5c-8530-b9d5d74754c3
Category HUMAN OTC DRUG LABEL
Packager Kypris Beauty LLC
Generic Name
Product Class
Product Number
Application Number PART352
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  • ​Drug Facts

  • ​Active ingredient

    Zinc Oxide 20%

    ​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

    When using this product

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

  • ​Directions

    • Apply liberally 15 minutes before sun exposure
    • Reapply at least every 2 hours
    • Use a water-resistant sunscreen if swimming or sweating
    • 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 value of 15 or higher and other sun protection measures including:
      • Limit time in the sun, especially from 10am to 2pm
      • Wear long-sleeved shirts, pants, hats, and sunglasses

      Children under 6 months: ask a doctor

  • ​Other information

    Protect the product in this container from excessive heat and direct sun.

  • ​Inactive ingredients

    Water/Aqua, Caprylic/Capric Triglyceride, Isoamyl Laurate, Coconut Alkanes, Glycerin, Polyglyceryl-3 Polyricinoleate, Silica, Glyceryl Caprylate, Lecithin, Rose (Rosa Damascena) Flower Extract, Algae, Aloe (Aloe Barbadensis) Leaf Juice, Isostearic Acid, Polyhydroxystearic Acid, Sunflower (Helianthus Annuus) Seed Oil, Sweet Iris (Iris Pallida) Leaf Cell Extract, Polyglyceryl-6 Polyricinoleate, Sodium Chloride, Coco-Caprylate/Caprate, Kukui (Aleurites Moluccanus) Seed Oil, Pumpkin (Cucurbita Pepo) Seed Oil, Squalane, Xanthan Gum, Tamanu (Calophyllum Inophylum) Seed Oil, Pomegranate (Punica Granatum) Extract, Chaparral (Larrea Tridentata) Extract, Leuconostoc/Radish Root Ferment Filtrate, Bisabolol, Tocopherol, Sodium Hyaluronate, Citric Acid

  • ​Package Labeling:

    General LabelInactive IngredientsJar LabelOuter Label Details 1Outer Label Details 2

  • INGREDIENTS AND APPEARANCE
    KYPRIS POT OF SHADE HELIOTROPIC BROAD SPECTRUM SPF 30 SUNSCREEN AND PRIMER 
    zinc oxide cream
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:70608-001
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    ZINC OXIDE (UNII: SOI2LOH54Z) (ZINC CATION - UNII:13S1S8SF37) ZINC CATION200 mg  in 1 mL
    Inactive Ingredients
    Ingredient NameStrength
    WATER (UNII: 059QF0KO0R)  
    MEDIUM-CHAIN TRIGLYCERIDES (UNII: C9H2L21V7U)  
    ISOAMYL LAURATE (UNII: M1SLX00M3M)  
    COCONUT ALKANES (UNII: 1E5KJY107T)  
    GLYCERIN (UNII: PDC6A3C0OX)  
    SILICON DIOXIDE (UNII: ETJ7Z6XBU4)  
    GLYCERYL CAPRYLATE (UNII: TM2TZD4G4A)  
    ROSA X DAMASCENA FLOWER (UNII: JWB78P295A)  
    ALOE VERA LEAF (UNII: ZY81Z83H0X)  
    ISOSTEARIC ACID (UNII: X33R8U0062)  
    SUNFLOWER OIL (UNII: 3W1JG795YI)  
    SODIUM CHLORIDE (UNII: 451W47IQ8X)  
    COCO-CAPRYLATE/CAPRATE (UNII: 8D9H4QU99H)  
    KUKUI NUT (UNII: J87WJ3E7VW)  
    PUMPKIN SEED OIL (UNII: 6E5QR5USSP)  
    SQUALANE (UNII: GW89575KF9)  
    XANTHAN GUM (UNII: TTV12P4NEE)  
    TAMANU OIL (UNII: JT3LVK84A1)  
    POMEGRANATE (UNII: 56687D1Z4D)  
    LEVOMENOL (UNII: 24WE03BX2T)  
    TOCOPHEROL (UNII: R0ZB2556P8)  
    HYALURONATE SODIUM (UNII: YSE9PPT4TH)  
    CITRIC ACID MONOHYDRATE (UNII: 2968PHW8QP)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:70608-001-011 in 1 CARTON05/25/2016
    127 mL in 1 JAR; Type 0: Not a Combination Product
    2NDC:70608-001-021 in 1 CARTON05/25/2016
    22.5 mL in 1 JAR; Type 0: Not a Combination Product
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph not finalpart35205/25/2016
    Labeler - Kypris Beauty LLC (842161015)
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