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

SUNNYSCREEN SPF 50 (TITANIUM DIOXIDE, ZINC OXIDE) LOTION [TAYLOR JAMES, LTD.]
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NDC 75936-250-01
Set ID 857ef2e1-31da-7647-e053-2991aa0a94f5
Category HUMAN OTC DRUG LABEL
Packager TAYLOR JAMES, LTD.
Generic Name
Product Class
Product Number
Application Number PART352
  • ACTIVE INGREDIENT

    Active Ingredients Purpose

    TItanium Dioxide 3.4% Sunscreen

    Zinc Oxide 23.8% 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 liberally and generously 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

    Avena Sativa (Oat) Kernel Flour, Butyloctyl Salicylate, Butyrospermum Parkii (Shea) Butter, C9-12 Alkane, Caesalpinia Spinosa Gum, Calendula Officinalis Flower Extract, Caprylhydroxamic Acid, Caprylic/Capric Triglyceride,Cetearyl Alcohol,Chamomila Recutita (Matricaria) Flower Extract, Coco-Caprylate/Caprate, Ethylhexylglycerin, Glycerin, Glyceryl Caprylate, Glyceryl Stearate, Haematococcus Pluvialis Extract, Helianthus Annuus (Sunflower) Seed Oil, Hydrolyzed Jojoba Esters, Jojoba Esters, Methyl Dihydroabietate, Myrciaria Dubia Fruit Extract, Polyhydroxystearic Acid, Propanediol, Sea Water, Silica, Sodium Phytate, Sorbitan Stearate, Sorbityl Laurate, Stearic Acid, Water

  • PRINCIPAL DISPLAY PANEL

    Sunnyscreen SPF 50 Lotion for babies+ Kiddos

    3 fl. Oz./89ml

    Sunnyscreen lotion 2

  • INGREDIENTS AND APPEARANCE
    SUNNYSCREEN SPF 50 
    titanium dioxide, zinc oxide lotion
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:75936-250
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    TITANIUM DIOXIDE (UNII: 15FIX9V2JP) (TITANIUM DIOXIDE - UNII:15FIX9V2JP) TITANIUM DIOXIDE3.4 g  in 100 mL
    ZINC OXIDE (UNII: SOI2LOH54Z) (ZINC OXIDE - UNII:SOI2LOH54Z) ZINC OXIDE23.8 g  in 100 mL
    Inactive Ingredients
    Ingredient NameStrength
    ETHYLHEXYLGLYCERIN (UNII: 147D247K3P)  
    GLYCERIN (UNII: PDC6A3C0OX)  
    HAEMATOCOCCUS PLUVIALIS (UNII: 31T0FF0472)  
    SUNFLOWER OIL (UNII: 3W1JG795YI)  
    METHYL DIHYDROABIETATE (UNII: 7666FJ0J9F)  
    MYRCIARIA DUBIA FRUIT (UNII: YSW4EM1EKP)  
    POLYHYDROXYSTEARIC ACID (2300 MW) (UNII: YXH47AOU0F)  
    PHYTATE SODIUM (UNII: 88496G1ERL)  
    SORBITYL LAURATE (UNII: 23XPH3M9LR)  
    BUTYLOCTYL SALICYLATE (UNII: 2EH13UN8D3)  
    CAESALPINIA SPINOSA RESIN (UNII: WL3883U2PO)  
    MEDIUM-CHAIN TRIGLYCERIDES (UNII: C9H2L21V7U)  
    COCO-CAPRYLATE/CAPRATE (UNII: 8D9H4QU99H)  
    SHEA BUTTER (UNII: K49155WL9Y)  
    HYDROLYZED JOJOBA ESTERS (ACID FORM) (UNII: UDR641JW8W)  
    PROPANEDIOL (UNII: 5965N8W85T)  
    SODIUM CHLORIDE (UNII: 451W47IQ8X)  
    GLYCERYL CAPRYLATE (UNII: TM2TZD4G4A)  
    SILICON DIOXIDE (UNII: ETJ7Z6XBU4)  
    STEARIC ACID (UNII: 4ELV7Z65AP)  
    WATER (UNII: 059QF0KO0R)  
    OATMEAL (UNII: 8PI54V663Y)  
    CALENDULA OFFICINALIS FLOWER (UNII: P0M7O4Y7YD)  
    CAPRYLHYDROXAMIC ACID (UNII: UPY805K99W)  
    CHAMOMILE (UNII: FGL3685T2X)  
    CETOSTEARYL ALCOHOL (UNII: 2DMT128M1S)  
    GLYCERYL MONOSTEARATE (UNII: 230OU9XXE4)  
    SORBITAN MONOSTEARATE (UNII: NVZ4I0H58X)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:75936-250-0189 mL in 1 BOTTLE; Type 0: Not a Combination Product04/01/2019
    2NDC:75936-250-025 mL in 1 PACKET; Type 0: Not a Combination Product04/01/201905/01/2019
    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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