SUNNYSCREEN SPF 50 (TITANIUM DIOXIDE, ZINC OXIDE) SPRAY [TAYLOR JAMES, LTD.]

SUNNYSCREEN SPF 50 (TITANIUM DIOXIDE, ZINC OXIDE) SPRAY [TAYLOR JAMES, LTD.]
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NDC 75936-252-01
Set ID 859461ea-582e-8185-e053-2991aa0a954a
Category HUMAN OTC DRUG LABEL
Packager TAYLOR JAMES, LTD.
Generic Name
Product Class
Product Number
Application Number PART352
  • ACTIVE INGREDIENT

    Active Ingredient Purpose

    Titanium Dioxide 10% Sunscreen

    Zinc Oxide 12% 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

  • WARNINGS

    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.

  • DOSAGE & ADMINISTRATION

    Directions

    • Apply generously and evenly 15 minutes before sun exposure
    • 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

    Aqua (Deionized water), Ascorbyl Palmitate, Butyloctyl Salicylate, Calendula Officinalis Extract, Camellia Sinensis (Green Tea) Extract, Caprylic/Capric Triglyceride, Capryl/Caprylyl Glucoside, Chamomilla Recutita (Chamomile) Extract, Cocos Nucifera (Coconut) Oil, Daucus Carota Sativa (Carrot) Extract, Glycerin, Glyceryl Caprylate, Glyceryl Stearate Citrate, Glyceryl Undecylenate, Helianthus Annuus (Sunflower) Oil, Mangifera Indica (Mango) Butter, Polyhydroxystearic Acid, Punica Granatum (Pomegranate) Extract, Stearic Acid, Tocopherol (Vitamin E), Xanthan Gum, Zemea (Corn) Propanediol.

  • PRINCIPAL DISPLAY PANEL

    Supergoop

    Sunnyscreen SPF 50 spray for babies + kiddos

    Broad Spectrum Sunscreen SPF 50

    Water Resistant (80 minutes)

    3.4 fl oz./100 ml

    sunnyscreen SPF 50 Spray

  • INGREDIENTS AND APPEARANCE
    SUNNYSCREEN SPF 50 
    titanium dioxide, zinc oxide spray
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:75936-252
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    TITANIUM DIOXIDE (UNII: 15FIX9V2JP) (TITANIUM DIOXIDE - UNII:15FIX9V2JP) TITANIUM DIOXIDE10 g  in 100 mL
    ZINC OXIDE (UNII: SOI2LOH54Z) (ZINC OXIDE - UNII:SOI2LOH54Z) ZINC OXIDE12 g  in 100 mL
    Inactive Ingredients
    Ingredient NameStrength
    MATRICARIA CHAMOMILLA (UNII: G0R4UBI2ZZ)  
    COCONUT OIL (UNII: Q9L0O73W7L)  
    WATER (UNII: 059QF0KO0R)  
    ASCORBYL PALMITATE (UNII: QN83US2B0N)  
    GREEN TEA LEAF (UNII: W2ZU1RY8B0)  
    GLYCERYL STEARATE CITRATE (UNII: WH8T92A065)  
    TOCOPHEROL (UNII: R0ZB2556P8)  
    CALENDULA OFFICINALIS FLOWER (UNII: P0M7O4Y7YD)  
    MEDIUM-CHAIN TRIGLYCERIDES (UNII: C9H2L21V7U)  
    GLYCERYL MONOCAPRYLATE (UNII: TM2TZD4G4A)  
    POLYHYDROXYSTEARIC ACID (2300 MW) (UNII: YXH47AOU0F)  
    STEARIC ACID (UNII: 4ELV7Z65AP)  
    XANTHAN GUM (UNII: TTV12P4NEE)  
    PROPANEDIOL (UNII: 5965N8W85T)  
    BUTYLOCTYL SALICYLATE (UNII: 2EH13UN8D3)  
    GLYCERYL 1-UNDECYLENATE (UNII: B68LJT9544)  
    GLYCERIN (UNII: PDC6A3C0OX)  
    PUNICA GRANATUM ROOT BARK (UNII: CLV24I3T1D)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:75936-252-01100 mL in 1 BOTTLE, SPRAY; Type 0: Not a Combination Product04/02/2019
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph finalpart35204/02/2019
    Labeler - TAYLOR JAMES, LTD. (033381850)
    Registrant - TAYLOR JAMES, LTD. (033381850)

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