DAILY PROTEZIONE BROAD SPECTRUM SPF30 SUNSCREEN (ZINC OXIDE) LOTION [PURE ON PURPOSE, LLC]

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DAILY PROTEZIONE BROAD SPECTRUM SPF30 SUNSCREEN (ZINC OXIDE) LOTION [PURE ON PURPOSE, LLC]
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NDC 71556-100-01
Set ID 7c7d2d4c-0d59-43bc-913d-bbdc6bf96d4d
Category HUMAN OTC DRUG LABEL
Packager Pure on Purpose, LLC
Generic Name
Product Class
Product Number
Application Number PART352
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  • Active Ingredient

    Zinc Oxide (non-nano uncoated) 17.5%

  • 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

    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.

  • DIRECTIONS

    •
    Apply liberally 15 minutes before sun exposure
    •
    Children under 6 months of age—ask a doctor
    •
    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 & other sun protection measures including:
    •
    limit time in the sun, especially from 10am–2pm
    •
    wear long-sleeved shirts, pants, hats & sunglasses
    •
    reapply after 80 minutes of swimming or sweating, immediately after towel drying & at least every 2 hours
  • OTHER INFORMATION

    Protect this product from excessive heat & direct sunlight.

  • INACTIVE INGREDIENTS

    Argania Spinosa Kernel Oil*(Argan), Camellia Sinensis (Green Tea) Seed Oil*, Carthamus Tinctorius (Safflower) Seed Oil*, Cera Alba (Beeswax)*, Glycerin*, Glycyrrhiza Glabra (Licorice) Root Extract, Helianthus Annuus (Sunflower) Seed Oil*, Iron Oxides (CI 77491), (CI 77492) and (CI 77499), Jojoba Esters, Persea Gratissima (Avocado) Oil*, Prunus Armeniaca (Apricot) Kernel Oil*, Rosmarinus Officinalis (Rosemary) Leaf Extract, Rubus Idaeus (Raspberry) Seed Oil, Simmondsia Chinensis (Jojoba) Seed Oil*, Tocopherol (Vitamin E). *denotes certified organic

  • Package/Label Principal Display Panel

    VIVE SANA
    ORGANIC SUNCARE

    DAILY
    PROTEZIONE
    DEEP HYDRATION
    STRONG BARRIER PROTECTION
    POTENT ANTIOXIDANT REPAIR
    BROAD SPECTRUM
    -SPF 30-
    VERY WATER RESISTANT
    SHEER MATTE FINISH
    100% NATURAL

    NET WEIGHT 2 FL. OZ / 59 ML

    image-01

    Label

  • INGREDIENTS AND APPEARANCE
    DAILY PROTEZIONE  BROAD SPECTRUM SPF30 SUNSCREEN
    zinc oxide lotion
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:71556-100
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    ZINC OXIDE (UNII: SOI2LOH54Z) (ZINC OXIDE - UNII:SOI2LOH54Z) ZINC OXIDE17.5 g  in 100 g
    Inactive Ingredients
    Ingredient NameStrength
    ARGAN OIL (UNII: 4V59G5UW9X)  
    CAMELLIA SINENSIS SEED OIL (UNII: O5R6DK2M9K)  
    SAFFLOWER OIL (UNII: 65UEH262IS)  
    GLYCERIN (UNII: PDC6A3C0OX)  
    GLYCYRRHIZA GLABRA (UNII: 2788Z9758H)  
    SUNFLOWER OIL (UNII: 3W1JG795YI)  
    AVOCADO OIL (UNII: 6VNO72PFC1)  
    APRICOT KERNEL OIL (UNII: 54JB35T06A)  
    ROSEMARY (UNII: IJ67X351P9)  
    RASPBERRY SEED OIL (UNII: 9S8867952A)  
    JOJOBA OIL (UNII: 724GKU717M)  
    TOCOPHEROL (UNII: R0ZB2556P8)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:71556-100-011 in 1 CARTON07/10/2017
    159 g in 1 TUBE; Type 0: Not a Combination Product
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph not finalpart35207/10/2017
    Labeler - Pure on Purpose, LLC (080668430)
    Establishment
    NameAddressID/FEIBusiness Operations
    Fragrance Manufacturing, Inc.793406000MANUFACTURE(71556-100)
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