Label: KEEP THE PEACE BROAD SPECTRUM SPF 20 SUNSCREEN PROTECTIVE COLOR CORRECTOR- titanium dioxide, zinc oxide lotion

  • 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 April 4, 2013

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

  • Active Ingredients

    Titanium Dioxide 4.8%

    Zinc Oxide 3.0%

  • Purpose

    Sunscreen

  • Keep Out of Reach of Children.

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

  • Uses

    • helps prevent sunburn
    • if used as directed with other sun protection measures (see Directions), decreases the risk of skin cancer and early skin againg caused by the sun
  • Warnings

    Do

    For external use only.

    Do not use on damaged or broken skin.

    When using this product keep out of reach of eyes. Rinse with water to remove.

    Stop use and ask a doctor if rsh occurs.

  • Directions

    • apply liberally 15 minutes before sun exposure
    • reapply at least ever 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 of age: ask a doctor
  • Inactive Ingredients

    cyclopentasiloxane, dimethicone crosspolymer, c12-15 alkyl benzoate, caprylic/capric triglyceride, dimethicone/vinyl dimethicone crosspolymer,

  • PRINCIPAL DISPLAY PANEL

    KTP Package Copy

  • INGREDIENTS AND APPEARANCE
    KEEP THE PEACE  BROAD SPECTRUM SPF 20 SUNSCREEN PROTECTIVE COLOR CORRECTOR
    titanium dioxide, zinc oxide lotion
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:50184-1031
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    TITANIUM DIOXIDE (UNII: 15FIX9V2JP) (TITANIUM DIOXIDE - UNII:15FIX9V2JP) TITANIUM DIOXIDE11.52 g  in 60 mL
    Zinc Oxide (UNII: SOI2LOH54Z) (ZINC OXIDE - UNII:SOI2LOH54Z) Zinc Oxide2.772 g  in 60 mL
    Inactive Ingredients
    Ingredient NameStrength
    CYCLOMETHICONE 5 (UNII: 0THT5PCI0R)  
    DIMETHICONE 100 (UNII: RO266O364U)  
    C12-15 ALKYL BENZOATE (UNII: A9EJ3J61HQ)  
    CAPRYLIC/CAPRIC ACID (UNII: DI775RT244)  
    DIMETHICONE/VINYL DIMETHICONE CROSSPOLYMER (HARD PARTICLE) (UNII: H895X08VNQ)  
    TOCOTRIENOLS (UNII: KP2MW85SSQ)  
    TOCOPHEROL (UNII: R0ZB2556P8)  
    RICE BRAN (UNII: R60QEP13IC)  
    SQUALANE (UNII: GW89575KF9)  
    LAVENDER OIL (UNII: ZBP1YXW0H8)  
    SOYBEAN (UNII: L7HT8F1ZOD)  
    DIMETHICONE (UNII: 92RU3N3Y1O)  
    LINOLEIC ACID (UNII: 9KJL21T0QJ)  
    OMEGA-3 FATTY ACIDS (UNII: 71M78END5S)  
    CAPRYLYL GLYCOL (UNII: 00YIU5438U)  
    ALUMINUM OXIDE (UNII: LMI26O6933)  
    PHENOXYETHANOL (UNII: HIE492ZZ3T)  
    TRIETHOXYCAPRYLYLSILANE (UNII: LDC331P08E)  
    FERRIC OXIDE RED (UNII: 1K09F3G675)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:50184-1031-21 in 1 BOX
    1NDC:50184-1031-160 mL in 1 TUBE
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph not finalpart35202/01/2013
    Labeler - Philosophy, Inc. (948102256)
    Establishment
    NameAddressID/FEIBusiness Operations
    Bio Tech Research Labs948102256manufacture(50184-1031)