Label: UNSEEN SUNSCREEN BROAD SPECTRUM SPF 40- avobenzone, homosalate, octinoxate, octisalate cream

  • Category: HUMAN OTC DRUG LABEL
  • DEA Schedule: None
  • Marketing Status: OTC monograph final

DISCLAIMER: Most OTC drugs are not reviewed and approved by FDA, however they may be marketed if they comply with applicable regulations and policies. FDA has not evaluated whether this product complies.

Drug Label Information

Updated January 6, 2021

If you are a consumer or patient please visit this version.

View All Sections
  • 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)
View All Sections

Find additional resources

(also available in the left menu)

Safety

Report Adverse Events, FDA Safety Recalls, Presence in Breast Milk

Related Resources

Medline Plus, Clinical Trials, PubMed, Biochemical Data Summary

More Info on this Drug

View Labeling Archives, RxNorm, Get Label RSS Feed, View NDC Code(s)NEW!