Label: SUPERNATURAL PORELESS TINT SPF 15- octisalate, titanium dioxide cream

  • Category: HUMAN OTC DRUG LABEL
  • DEA Schedule: None
  • Marketing Status: OTC monograph not 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 February 11, 2020

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

  • Active Ingredients

    Octisalate (5.0%)

    Titanium Dioxide (4.0%)

  • Purpose

    Sunscreen

  • 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

  • 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.

  • Stop use and ask a doctor

    if rash occurs.

  • Keep out of reach of children.

    If swallowed, get medical help or contact a Poison Control Center right away.

  • Directions

    apply liberally 15 minutes before sun exposure

    reapply at least every 2 hours

    use a water resistant sunscreen if swimming or sweating

    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 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-sleeve shirts, pants, hats and sunglasses

    children under 6 months: ask a doctor

  • Inactive Ingredients

    ingred

  • Other Information

    protect this product from excessive heat and direct sun

  • Questions or Comments?

    Call toll-free 1-800-568-3151 from 6 a.m.-5 p.m. MST (Monday-Friday)

  • PRINCIPAL DISPLAY PANEL

    the

    supernatural

    philosophy: we needed

    a way to "trick" you into

    wearing sunscreen to help

    prevent drive-by wrinkles.

    the first time you apply

    our supernatural poreless,

    flawless tinted spf, you will

    watch the appearance of

    your skin tone magically

    even out, your large pores

    fade, and your fine lines

    and wrinkles go into soft

    focus. who said tricks are

    for kids?

    broad spectrum

    spf 15 sunscreen

    poreless, flawless

    tinted

    1

  • INGREDIENTS AND APPEARANCE
    SUPERNATURAL PORELESS TINT SPF 15 
    octisalate, titanium dioxide cream
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:50184-1066
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    TITANIUM DIOXIDE (UNII: 15FIX9V2JP) (TITANIUM DIOXIDE - UNII:15FIX9V2JP) TITANIUM DIOXIDE4 g  in 100 g
    OCTISALATE (UNII: 4X49Y0596W) (OCTISALATE - UNII:4X49Y0596W) OCTISALATE5 g  in 100 g
    Inactive Ingredients
    Ingredient NameStrength
    SQUALANE (UNII: GW89575KF9)  
    PHENOXYETHANOL (UNII: HIE492ZZ3T)  
    CAPRYLYL GLYCOL (UNII: 00YIU5438U)  
    DIMETHICONE CROSSPOLYMER (450000 MPA.S AT 12% IN CYCLOPENTASILOXANE) (UNII: UF7620L1W6)  
    SQUALENE (UNII: 7QWM220FJH)  
    TRIETHOXYCAPRYLYLSILANE (UNII: LDC331P08E)  
    TOCOTRIENOLS (UNII: KP2MW85SSQ)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:50184-1066-145.4 g in 1 TUBE; Type 0: Not a Combination Product04/09/2019
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph not finalpart35204/09/2019
    Labeler - PHILOSOPHY INC. (948102256)