ZINC SCREEN BROAD SPECTRUM SUNSCREEN SPF 40 (ZINC OXIDE) LOTION [TAYLOR JAMES LTD.]

ZINC SCREEN BROAD SPECTRUM SUNSCREEN SPF 40 (ZINC OXIDE) LOTION [TAYLOR JAMES LTD.]
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NDC 75936-223-01
Set ID 87adf142-7560-30d9-e053-2a95a90aca90
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 13% 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
    Use a water-resistant sunscreen if swimming or sweating
    Reapply 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

    Water, Tetradecane, Cetearyl Nonanoate, Ethylhexyl Palmitate, Caprylic/Capric Triglyceride, Isopropyl Myristate, Glycerin, Polyglyceryl-3 Diisostearate, Mica, Propanediol, Disteardimonium Hectorite, Gluconolactone, Polyglyceryl-6 Polyricinoleate, Brassica Campestris/Aleurites Fordi Oil Copolymer, Polyhydrostearic Acid, Sodium Chloride, Magnesium Sulfate, Fructose, Octyldodecyl Oleate, Tocopherol, Cocos Nucifera (Coconut) Fruit Extract, Sodium Benzoate, Iron oxides (CI 77492), Dodecane, Hexadecane, Titanium Dioxide (CI 77891), Withania Somnifera Flower Extract, Iron Oxides (CI 77491), Vaccinium Angustifolia (Blueberry) Fruit Extract, Silica, Calcium Gluconate

  • PRINCIPAL DISPLAY PANEL

    Zinc Screen

    100% Mineral Lotion

    Broad Spectrum SPF 40 PA+++

    1.7 fl. oz. / 50 ml.

    Zincscreen SPF 40 box

    Zincscreen SPF 40 primary

  • INGREDIENTS AND APPEARANCE
    ZINC SCREEN BROAD SPECTRUM SUNSCREEN SPF 40 
    zinc oxide lotion
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:75936-223
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    ZINC OXIDE (UNII: SOI2LOH54Z) (ZINC OXIDE - UNII:SOI2LOH54Z) ZINC OXIDE13 g  in 100 mL
    Inactive Ingredients
    Ingredient NameStrength
    GLUCONOLACTONE (UNII: WQ29KQ9POT)  
    POLYHYDROXYSTEARIC ACID (2300 MW) (UNII: YXH47AOU0F)  
    SODIUM CHLORIDE (UNII: 451W47IQ8X)  
    SILICON DIOXIDE (UNII: ETJ7Z6XBU4)  
    PROPANEDIOL (UNII: 5965N8W85T)  
    OCTYLDODECYL OLEATE (UNII: MCA43PK7MH)  
    CALCIUM GLUCONATE (UNII: SQE6VB453K)  
    ISOPROPYL PALMITATE (UNII: 8CRQ2TH63M)  
    TETRADECANE (UNII: 03LY784Y58)  
    ETHYLHEXYL PALMITATE (UNII: 2865993309)  
    MEDIUM-CHAIN TRIGLYCERIDES (UNII: C9H2L21V7U)  
    ISOPROPYL MYRISTATE (UNII: 0RE8K4LNJS)  
    FRUCTOSE (UNII: 6YSS42VSEV)  
    WATER (UNII: 059QF0KO0R)  
    MAGNESIUM SULFATE ANHYDROUS (UNII: ML30MJ2U7I)  
    WITHANIA SOMNIFERA FLOWER (UNII: 2HZ95R7082)  
    HEXADECANE (UNII: F8Z00SHP6Q)  
    CETEARYL NONANOATE (UNII: F6ZWV2F361)  
    MICA (UNII: V8A1AW0880)  
    TITANIUM DIOXIDE (UNII: 15FIX9V2JP)  
    TOCOPHEROL (UNII: R0ZB2556P8)  
    GLYCERIN (UNII: PDC6A3C0OX)  
    COCONUT (UNII: 3RT3536DHY)  
    SODIUM BENZOATE (UNII: OJ245FE5EU)  
    FERRIC OXIDE YELLOW (UNII: EX438O2MRT)  
    DODECANE (UNII: 11A386X1QH)  
    FERRIC OXIDE RED (UNII: 1K09F3G675)  
    LOWBUSH BLUEBERRY (UNII: G90PX41VP0)  
    POLYGLYCERYL-3 DIISOSTEARATE (UNII: 46P231IQV8)  
    DISTEARDIMONIUM HECTORITE (UNII: X687XDK09L)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:75936-223-0150 mL in 1 BOTTLE; Type 0: Not a Combination Product04/30/2019
    2NDC:75936-223-0210 mL in 1 BOTTLE; Type 0: Not a Combination Product11/19/2020
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph finalpart35204/30/2019
    Labeler - Taylor James Ltd. (033381850)

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