Label: LBEL- titanium dioxide powder

  • 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 August 9, 2010

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  • SPL UNCLASSIFIED SECTION

    Drug Facts

  • Active Ingredients

    Titanium dioxide 5.0 %

  • Purpose

    sunscreen

  • Uses

    • Helps prevent sunburn
    • Higher SPF gives more sunburn protection
    • Provides minimal protection against sunburn
  • Warnings

    For external use only.

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

    Stop use and ask a doctor if rash or irritation develops and lasts.

    Keep out of reach of children. If swallowed, get medical help or contact a Poison Control Center right away.

  • Directions

    • Apply liberally before sun exposure and as needed.
  • Other information

    • Sun alert: Limiting sun exposure, wearing protective clothing, and using sunscreen may reduce the risk of skin aging, skin cancer, and other harmful effects of the sun.
  • Inactive ingredients

    talc, mica, zinc stearate, octyldodecyl stearoyl stearate, magnesium stearate, dimethicone/vinyl dimethicone crosspolymer, dimethicone, aqua (water), polyperfluoroisopropyl ether, kaolin, glycerin, olea europaea oil unsaponifiables (olea europaea (olive) oil unsaponifiables), lauryl methacrylate/glycol dimethacrylate crosspolymer, calcium carbonate, magnesium silicate, dicaprylyl ether, methylparaben, propylparaben, magnesium myristate, silica, parfum (fragrance), polyethylene, pisum sativum extract (pisum sativum (pea) extract), algae extract, bht, xanthan gum, polyglyceryl-2 dipolyhydroxystearate. May contain: ci 77891 (titanium dioxide), ci 77492 (iron oxides), ci 77491 (iron oxides), ci 77499 (iron oxides).

  • PRINCIPAL DISPLAY PANEL - 11 g Case

    EFFET
    PARFAIT

    double use compact powder: rejuvenating effect spf 7

    11 g e (.38 oz.)

    L'BEL

    Principal Display Panel - 11 g Case
  • INGREDIENTS AND APPEARANCE
    LBEL   EFFET PARFIT
    titanium dioxide powder
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:14783-091
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    Titanium dioxide (UNII: 15FIX9V2JP) (Titanium dioxide - UNII:15FIX9V2JP) Titanium dioxide0.55 g  in 11 g
    Inactive Ingredients
    Ingredient NameStrength
    talc (UNII: 7SEV7J4R1U)  
    mica (UNII: V8A1AW0880)  
    zinc stearate (UNII: H92E6QA4FV)  
    magnesium stearate (UNII: 70097M6I30)  
    kaolin (UNII: 24H4NWX5CO)  
    olive oil (UNII: 6UYK2W1W1E)  
    calcium carbonate (UNII: H0G9379FGK)  
    magnesium silicate (UNII: 9B9691B2N9)  
    dicaprylyl ether (UNII: 77JZM5516Z)  
    methylparaben (UNII: A2I8C7HI9T)  
    propylparaben (UNII: Z8IX2SC1OH)  
    silicon dioxide (UNII: ETJ7Z6XBU4)  
    snow pea (UNII: 84SKC33B1I)  
    butylated hydroxytoluene (UNII: 1P9D0Z171K)  
    xanthan gum (UNII: TTV12P4NEE)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:14783-091-811 in 1 BOX
    1NDC:14783-091-8011 g in 1 CASE
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC MONOGRAPH FINALpart35208/15/2010
    Labeler - Ventura International LTD (603192787)
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