UNSEEN SUNSCREEN BROAD SPECTRUM SPF 40 (AVOBENZONE, HOMOSALATE, OCTINOXATE, OCTISALATE) CREAM [TAYLOR JAMES, LTD.]

UNSEEN SUNSCREEN BROAD SPECTRUM SPF 40 (AVOBENZONE, HOMOSALATE, OCTINOXATE, OCTISALATE) CREAM [TAYLOR JAMES, LTD.]
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NDC 75936-142-01, 75936-142-02, 75936-142-03, 75936-142-04, 75936-142-05, 75936-142-06
Set ID d8ac12f2-485c-4b28-847b-e12d034ee075
Category HUMAN OTC DRUG LABEL
Packager TAYLOR JAMES, LTD.
Generic Name
Product Class
Product Number
Application Number PART352
  • ACTIVE INGREDIENT

    Active Ingredients        Purpose

    Avobenzone 3%          Sunscreen

    Homosalate 8%          Sunscreen

    Octinoxate 4.5%         Sunscreen

    Octisalate 5%             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

  • DOSAGE & ADMINISTRATION

    Directions

    • apply generously and evenly 15 minutes before sun exposure
    • reapply:

    after 40 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 time in the sun, especially from 10 a.m.-2 p.m.
    • Wear long-sleeved shirts, pants, hats, and sunglasses
    • Children under 6 months: ask a doctor
  • INACTIVE INGREDIENT

    Inactive Ingredients

    Isododecane, Dimethicone Crosspolymer, Dimethicone/Bis-Isobutyl PPG-20 Crosspolymer, Isohexadecane, Dicrapylyl Carbonate, Meadowfoam Estolide, Polyester-8,Polymethylsilsesquioxane, Caprylic/Capric Triglyceride, Lithothamnion Calcareum Extract,Butyrospermum Parkii (Shea) Butter, Jojoba Esters, Diethylhexyl Syringylidenemalonate, Mannitol, Olibanum, Lecithin, Microcrystalline Cellulose, Diatomaceous Earth, Zinc Sulfate, Silica, Tocopherol

  • PRINCIPAL DISPLAY PANEL

    Unseen Sunscreen

    Broad Spectrum SPF 40

    Water and sweat resistant (40 minutes)

    1.7 fl oz/ 50 ml

    carton

    inner

  • INGREDIENTS AND APPEARANCE
    UNSEEN SUNSCREEN BROAD SPECTRUM SPF 40 
    avobenzone, homosalate, octinoxate, octisalate cream
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:75936-142
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    AVOBENZONE (UNII: G63QQF2NOX) (AVOBENZONE - UNII:G63QQF2NOX) AVOBENZONE3 g  in 100 mL
    HOMOSALATE (UNII: V06SV4M95S) (HOMOSALATE - UNII:V06SV4M95S) HOMOSALATE8 g  in 100 mL
    OCTINOXATE (UNII: 4Y5P7MUD51) (OCTINOXATE - UNII:4Y5P7MUD51) OCTINOXATE4.5 g  in 100 mL
    OCTISALATE (UNII: 4X49Y0596W) (OCTISALATE - UNII:4X49Y0596W) OCTISALATE5 g  in 100 mL
    Inactive Ingredients
    Ingredient NameStrength
    ISODODECANE (UNII: A8289P68Y2)  
    DIMETHICONE CROSSPOLYMER (450000 MPA.S AT 12% IN CYCLOPENTASILOXANE) (UNII: UF7620L1W6)  
    DIMETHICONE/BIS-ISOBUTYL PPG-20 CROSSPOLYMER (UNII: O4I3UFO6ZF)  
    ISOHEXADECANE (UNII: 918X1OUF1E)  
    DICAPRYLYL CARBONATE (UNII: 609A3V1SUA)  
    POLYESTER-8 (1400 MW, CYANODIPHENYLPROPENOYL CAPPED) (UNII: T9296U138P)  
    POLYMETHYLSILSESQUIOXANE (11 MICRONS) (UNII: Z570VEV8XK)  
    MEDIUM-CHAIN TRIGLYCERIDES (UNII: C9H2L21V7U)  
    PHYMATOLITHON CALCAREUM (UNII: 6J1M3WA0ZK)  
    SHEA BUTTER (UNII: K49155WL9Y)  
    DIETHYLHEXYL SYRINGYLIDENEMALONATE (UNII: 3V5U97P248)  
    MANNITOL (UNII: 3OWL53L36A)  
    FRANKINCENSE (UNII: R9XLF1R1WM)  
    LECITHIN, SUNFLOWER (UNII: 834K0WOS5G)  
    MICROCRYSTALLINE CELLULOSE (UNII: OP1R32D61U)  
    DIATOMACEOUS EARTH (UNII: 2RF6EJ0M85)  
    ZINC SULFATE (UNII: 89DS0H96TB)  
    SILICON DIOXIDE (UNII: ETJ7Z6XBU4)  
    TOCOPHEROL (UNII: R0ZB2556P8)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:75936-142-021 in 1 CARTON10/12/2017
    1NDC:75936-142-0150 mL in 1 PACKAGE; Type 0: Not a Combination Product
    2NDC:75936-142-0615 mL in 1 TUBE; Type 0: Not a Combination Product10/12/2017
    3NDC:75936-142-0310 mL in 1 PACKAGE; Type 0: Not a Combination Product10/12/2017
    4NDC:75936-142-045 mL in 1 PACKAGE; Type 0: Not a Combination Product10/12/2017
    5NDC:75936-142-051.5 mL in 1 PACKAGE; Type 0: Not a Combination Product10/12/2017
    6NDC:75936-142-0720 mL in 1 CARTON; Type 0: Not a Combination Product01/04/2021
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph finalpart35210/10/2017
    Labeler - TAYLOR JAMES, LTD. (033381850)
    Establishment
    NameAddressID/FEIBusiness Operations
    Cosway Company Inc.052400223manufacture(75936-142)

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