SUNNYSCREEN SPF 50 STICK (ZINC OXIDE) STICK [TAYLOR JAMES, LTD]

SUNNYSCREEN SPF 50 STICK (ZINC OXIDE) STICK [TAYLOR JAMES, LTD]
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NDC 75936-251-01
Set ID 857f7b28-3161-f66b-e053-2991aa0a391b
Category HUMAN OTC DRUG LABEL
Packager TAYLOR JAMES, LTD
Generic Name
Product Class
Product Number
Application Number PART352
  • ACTIVE INGREDIENT

    Active Ingredients Purpose

    Zinc Oxide 21% Sunscreen

  • PURPOSE

    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.
  • KEEP OUT OF REACH OF CHILDREN

    Keep out of reach of children

    If product is swallowed, get medical help or contact a poison Control Center right away

  • INDICATIONS & USAGE

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

  • WARNINGS

    Warnings

    Do not use on damaged or broken skin

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

    For external use only

  • DOSAGE & ADMINISTRATION

    Directions

    • Apply generously and evenly 15 minutes before sun exposure and at least
    every 2 hours.

    • Reapply:
    • after 80 minutes of swimming or sweating • immediately after towel drying
    • at least every 2 hours.
    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 your time in the sun, especially from 10
    a.m. – 2 p.m.

    • wear long-sleeved shirts, pants, hats, and sunglasses

    • Children under 6 months of age: ask a doctor.

  • INACTIVE INGREDIENT

    Inactive Ingredients Beeswax, Bertholletia Excelsa Seed Oil, Bisabolol, Butyloctyl Salicylate, Butyrospermum Parkii (Shea Butter), Euphorbia Cerifera (Candelilla) Wax, Heptyl Undecylenate, Linum Usitassimum (Lineseed) Oil, Olea Europaea (Olive) Fruit Extract, Olea Europaea (Olive) Fruit Oil, Oryzanol, Salvia hispanica (Chia) Seed Oil, SImmondsia Chinensis (Jojoba) Seed Oil, Theobroma Cacao(Cocoa) Seed Butter, Tocopherol, Triethyl Citrate, Vanilla Planifolia Fruit Extract

  • PRINCIPAL DISPLAY PANEL

    Sunnyscreen

    SPF 50 Stick for babies + kiddos

    Broad Spectrum Sunscreen SPF 50

    Water Resistant (80 minutes)

    0.7 oz. / 19.8g

    sunscreen stick

    sunscreen stick drug facts

  • INGREDIENTS AND APPEARANCE
    SUNNYSCREEN SPF 50 STICK 
    zinc oxide stick
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:75936-251
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    ZINC OXIDE (UNII: SOI2LOH54Z) (ZINC OXIDE - UNII:SOI2LOH54Z) ZINC OXIDE21 g  in 100 g
    Inactive Ingredients
    Ingredient NameStrength
    OLIVE OIL (UNII: 6UYK2W1W1E)  
    JOJOBA OIL (UNII: 724GKU717M)  
    COCOA BUTTER (UNII: 512OYT1CRR)  
    TRIETHYL CITRATE (UNII: 8Z96QXD6UM)  
    CHIA SEED OIL (UNII: MC2LH51BO7)  
    YELLOW WAX (UNII: 2ZA36H0S2V)  
    SHEA BUTTER (UNII: K49155WL9Y)  
    ORYZANOL (UNII: SST9XCL51M)  
    HEPTYL UNDECYLENATE (UNII: W77QUB6GXO)  
    LEVOMENOL (UNII: 24WE03BX2T)  
    BUTYLOCTYL SALICYLATE (UNII: 2EH13UN8D3)  
    CANDELILLA WAX (UNII: WL0328HX19)  
    VANILLA (UNII: Q74T35078H)  
    LINSEED OIL (UNII: 84XB4DV00W)  
    BRAZIL NUT OIL (UNII: 0G89T29HO6)  
    TOCOPHEROL (UNII: R0ZB2556P8)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:75936-251-0179.8 g in 1 BOX; Type 0: Not a Combination Product04/01/2019
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph finalpart35204/01/2019
    Labeler - TAYLOR JAMES, LTD (033381850)
    Registrant - TAYLOR JAMES, LTD (033381850)

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