Label: EFFET PARFAIT- octinoxate and titanium dioxide lotion

  • Category: HUMAN OTC DRUG LABEL

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 September 3, 2010

If you are a healthcare professional or from the pharmaceutical industry please visit this version.

View All Sections
  • SPL UNCLASSIFIED SECTION

    Drug Facts

  • ACTIVE INGREDIENT

    Active IngredientPurpose
    Octinoxate 6.5%,Sunscreen
    Titanium Dioxide 1.6%Sunscreen
  • Uses

    • Helps prevent sunburn
    • Higher SPF gives more sunburn protection
    • Provides moderate 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 generously and evently 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

    Aqua(water),Cyclopentasiloxane, Cyclohexasiloxane, Propylene Glycol Dicaprylate/dicaprate, Peg/ppg-18/18 Dimethicone, Trimethylsiloxysilicate , Dimethicone/vinyl Dimethicone Crosspolymer, Xylitylglucoside, Octyldodecanol, Polymethyl methacrylate, Oleth-5, Anhydroxylitol, Glycerin, Linoleic Acid, Peg/ppg-19/19 Dimethicone, Cera Microcristallina (microcrystalline wax), C12-15 Alkyl Benzoote, Xylitol, Diazolidinyl Urea, Alumina, Petrolatum, Tocopheryl Acetate, Triethoxycaprylylsilane, Phospholipids, Ribes Nigrum Seed Oil (ribes nigrum (black currant) seed oil), Silica, Methylparaben, Propylparaben, Copernicia Cerifera Cera (copernicia cerifera (carnauba) wax), Parfum (fragrance), Tribehenin, Colesterol, Methicone, BHT, Menthoxypropanediol, Cetearyl Alcohol, Cera Alba (beeswax), Candelilla Cera (euphorbia cerifera (candelilla) wax), Polyglyceryl-2 dipolyhydroxystearate, Cetearyl Glucoside, Glycosphingolipids, Ceramide 2, Linolenic Acid, Decyl Glucoside, Peg-10 Rapeseed Sterol, Palmitoyl Oligopeptide. May Contain:CI 77891 (Titanium Dioxide), CI 77491, CI 77492, CI 77499 (Iron Oxides)

  • PRINCIPAL DISPLAY PANEL - 30 ml Bottle Carton

    EFFET
    PARFAIT

    natural finish
    moisturizing
    foundation
    SPF 25

    30 ml e (1 fl.oz.)

    L'BEL

    Principal Display Panel - 30 ml Bottle Carton
  • INGREDIENTS AND APPEARANCE
    EFFET PARFAIT   NATURAL FINISH MOISTURIZING FOUNDATION SPF 25
    octinoxate and titanium dioxide lotion
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:14783-170
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    Octinoxate (UNII: 4Y5P7MUD51) (Octinoxate - UNII:4Y5P7MUD51) Octinoxate0.065 mL  in 1 mL
    Titanium Dioxide (UNII: 15FIX9V2JP) (Titanium Dioxide - UNII:15FIX9V2JP) Titanium Dioxide0.016 mL  in 1 mL
    Inactive Ingredients
    Ingredient NameStrength
    water (UNII: 059QF0KO0R)  
    Cyclomethicone 5 (UNII: 0THT5PCI0R)  
    Cyclomethicone 6 (UNII: XHK3U310BA)  
    Propylene Glycol Dicaprylate/Dicaprate (UNII: O4446S9CRA)  
    Octyldodecanol (UNII: 461N1O614Y)  
    Oleth-5 (UNII: 1GH33785AY)  
    Glycerin (UNII: PDC6A3C0OX)  
    Linoleic Acid (UNII: 9KJL21T0QJ)  
    C12-15 Alkyl Benzoate (UNII: A9EJ3J61HQ)  
    Xylitol (UNII: VCQ006KQ1E)  
    Diazolidinyl Urea (UNII: H5RIZ3MPW4)  
    Aluminum Oxide (UNII: LMI26O6933)  
    Petrolatum (UNII: 4T6H12BN9U)  
    Alpha-Tocopherol Acetate (UNII: 9E8X80D2L0)  
    Octyltriethoxysilane (UNII: LDC331P08E)  
    Ribes Nigrum Seed (UNII: EHO0V3IRF5)  
    Silicon Dioxide (UNII: ETJ7Z6XBU4)  
    Methylparaben (UNII: A2I8C7HI9T)  
    Propylparaben (UNII: Z8IX2SC1OH)  
    Carnauba Wax (UNII: R12CBM0EIZ)  
    Tribehenin (UNII: 8OC9U7TQZ0)  
    Cholesterol (UNII: 97C5T2UQ7J)  
    Butylated Hydroxytoluene (UNII: 1P9D0Z171K)  
    Propanediol (UNII: 5965N8W85T)  
    Cetostearyl Alcohol (UNII: 2DMT128M1S)  
    Yellow Wax (UNII: 2ZA36H0S2V)  
    Candelilla Wax (UNII: WL0328HX19)  
    Cetearyl Glucoside (UNII: 09FUA47KNA)  
    Linolenic Acid (UNII: 0RBV727H71)  
    Ferric Oxide Red (UNII: 1K09F3G675)  
    Ferric Oxide Yellow (UNII: EX438O2MRT)  
    Ferrosoferric Oxide (UNII: XM0M87F357)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:14783-170-211 in 1 CARTON
    140.5 mL in 1 BOTTLE
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph not finalpart35209/16/2010
    EFFET PARFAIT   NATURAL FINISH MOISTURIZING FOUNDATION SPF 25
    octinoxate and titanium dioxide lotion
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:14783-160
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    Octinoxate (UNII: 4Y5P7MUD51) (Octinoxate - UNII:4Y5P7MUD51) Octinoxate0.065 mL  in 1 mL
    Titanium Dioxide (UNII: 15FIX9V2JP) (Titanium Dioxide - UNII:15FIX9V2JP) Titanium Dioxide0.016 mL  in 1 mL
    Inactive Ingredients
    Ingredient NameStrength
    water (UNII: 059QF0KO0R)  
    Cyclomethicone 5 (UNII: 0THT5PCI0R)  
    Cyclomethicone 6 (UNII: XHK3U310BA)  
    Propylene Glycol Dicaprylate/Dicaprate (UNII: O4446S9CRA)  
    Octyldodecanol (UNII: 461N1O614Y)  
    Oleth-5 (UNII: 1GH33785AY)  
    Glycerin (UNII: PDC6A3C0OX)  
    Linoleic Acid (UNII: 9KJL21T0QJ)  
    C12-15 Alkyl Benzoate (UNII: A9EJ3J61HQ)  
    Xylitol (UNII: VCQ006KQ1E)  
    Diazolidinyl Urea (UNII: H5RIZ3MPW4)  
    Aluminum Oxide (UNII: LMI26O6933)  
    Petrolatum (UNII: 4T6H12BN9U)  
    Alpha-Tocopherol Acetate (UNII: 9E8X80D2L0)  
    Octyltriethoxysilane (UNII: LDC331P08E)  
    Ribes Nigrum Seed (UNII: EHO0V3IRF5)  
    Silicon Dioxide (UNII: ETJ7Z6XBU4)  
    Methylparaben (UNII: A2I8C7HI9T)  
    Propylparaben (UNII: Z8IX2SC1OH)  
    Carnauba Wax (UNII: R12CBM0EIZ)  
    Tribehenin (UNII: 8OC9U7TQZ0)  
    Cholesterol (UNII: 97C5T2UQ7J)  
    Butylated Hydroxytoluene (UNII: 1P9D0Z171K)  
    Propanediol (UNII: 5965N8W85T)  
    Cetostearyl Alcohol (UNII: 2DMT128M1S)  
    Yellow Wax (UNII: 2ZA36H0S2V)  
    Candelilla Wax (UNII: WL0328HX19)  
    Cetearyl Glucoside (UNII: 09FUA47KNA)  
    Linolenic Acid (UNII: 0RBV727H71)  
    Ferric Oxide Red (UNII: 1K09F3G675)  
    Ferric Oxide Yellow (UNII: EX438O2MRT)  
    Ferrosoferric Oxide (UNII: XM0M87F357)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:14783-160-211 in 1 CARTON
    130 mL in 1 BOTTLE
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph not finalpart35209/16/2010
    EFFET PARFAIT   NATURAL FINISH MOISTURIZING FOUNDATION SPF 25
    octinoxate and titanium dioxide lotion
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:14783-150
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    Octinoxate (UNII: 4Y5P7MUD51) (Octinoxate - UNII:4Y5P7MUD51) Octinoxate0.065 mL  in 1 mL
    Titanium Dioxide (UNII: 15FIX9V2JP) (Titanium Dioxide - UNII:15FIX9V2JP) Titanium Dioxide0.016 mL  in 1 mL
    Inactive Ingredients
    Ingredient NameStrength
    water (UNII: 059QF0KO0R)  
    Cyclomethicone 5 (UNII: 0THT5PCI0R)  
    Cyclomethicone 6 (UNII: XHK3U310BA)  
    Propylene Glycol Dicaprylate/Dicaprate (UNII: O4446S9CRA)  
    Octyldodecanol (UNII: 461N1O614Y)  
    Oleth-5 (UNII: 1GH33785AY)  
    Glycerin (UNII: PDC6A3C0OX)  
    Linoleic Acid (UNII: 9KJL21T0QJ)  
    C12-15 Alkyl Benzoate (UNII: A9EJ3J61HQ)  
    Xylitol (UNII: VCQ006KQ1E)  
    Diazolidinyl Urea (UNII: H5RIZ3MPW4)  
    Aluminum Oxide (UNII: LMI26O6933)  
    Petrolatum (UNII: 4T6H12BN9U)  
    Alpha-Tocopherol Acetate (UNII: 9E8X80D2L0)  
    Octyltriethoxysilane (UNII: LDC331P08E)  
    Ribes Nigrum Seed (UNII: EHO0V3IRF5)  
    Silicon Dioxide (UNII: ETJ7Z6XBU4)  
    Methylparaben (UNII: A2I8C7HI9T)  
    Propylparaben (UNII: Z8IX2SC1OH)  
    Carnauba Wax (UNII: R12CBM0EIZ)  
    Tribehenin (UNII: 8OC9U7TQZ0)  
    Cholesterol (UNII: 97C5T2UQ7J)  
    Butylated Hydroxytoluene (UNII: 1P9D0Z171K)  
    Propanediol (UNII: 5965N8W85T)  
    Cetostearyl Alcohol (UNII: 2DMT128M1S)  
    Yellow Wax (UNII: 2ZA36H0S2V)  
    Candelilla Wax (UNII: WL0328HX19)  
    Cetearyl Glucoside (UNII: 09FUA47KNA)  
    Linolenic Acid (UNII: 0RBV727H71)  
    Ferric Oxide Red (UNII: 1K09F3G675)  
    Ferric Oxide Yellow (UNII: EX438O2MRT)  
    Ferrosoferric Oxide (UNII: XM0M87F357)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:14783-150-211 in 1 CARTON
    14.5 mL in 1 BOTTLE
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph not finalpart35209/16/2010
    EFFET PARFAIT   NATURAL FINISH MOISTURIZING FOUNDATION SPF 25
    octinoxate and titanium dioxide lotion
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:14783-140
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    Octinoxate (UNII: 4Y5P7MUD51) (Octinoxate - UNII:4Y5P7MUD51) Octinoxate0.065 mL  in 1 mL
    Titanium Dioxide (UNII: 15FIX9V2JP) (Titanium Dioxide - UNII:15FIX9V2JP) Titanium Dioxide0.016 mL  in 1 mL
    Inactive Ingredients
    Ingredient NameStrength
    water (UNII: 059QF0KO0R)  
    Cyclomethicone 5 (UNII: 0THT5PCI0R)  
    Cyclomethicone 6 (UNII: XHK3U310BA)  
    Propylene Glycol Dicaprylate/Dicaprate (UNII: O4446S9CRA)  
    Octyldodecanol (UNII: 461N1O614Y)  
    Oleth-5 (UNII: 1GH33785AY)  
    Glycerin (UNII: PDC6A3C0OX)  
    Linoleic Acid (UNII: 9KJL21T0QJ)  
    C12-15 Alkyl Benzoate (UNII: A9EJ3J61HQ)  
    Xylitol (UNII: VCQ006KQ1E)  
    Diazolidinyl Urea (UNII: H5RIZ3MPW4)  
    Aluminum Oxide (UNII: LMI26O6933)  
    Petrolatum (UNII: 4T6H12BN9U)  
    Alpha-Tocopherol Acetate (UNII: 9E8X80D2L0)  
    Octyltriethoxysilane (UNII: LDC331P08E)  
    Ribes Nigrum Seed (UNII: EHO0V3IRF5)  
    Silicon Dioxide (UNII: ETJ7Z6XBU4)  
    Methylparaben (UNII: A2I8C7HI9T)  
    Propylparaben (UNII: Z8IX2SC1OH)  
    Carnauba Wax (UNII: R12CBM0EIZ)  
    Tribehenin (UNII: 8OC9U7TQZ0)  
    Cholesterol (UNII: 97C5T2UQ7J)  
    Butylated Hydroxytoluene (UNII: 1P9D0Z171K)  
    Propanediol (UNII: 5965N8W85T)  
    Cetostearyl Alcohol (UNII: 2DMT128M1S)  
    Yellow Wax (UNII: 2ZA36H0S2V)  
    Candelilla Wax (UNII: WL0328HX19)  
    Cetearyl Glucoside (UNII: 09FUA47KNA)  
    Linolenic Acid (UNII: 0RBV727H71)  
    Ferric Oxide Red (UNII: 1K09F3G675)  
    Ferric Oxide Yellow (UNII: EX438O2MRT)  
    Ferrosoferric Oxide (UNII: XM0M87F357)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:14783-140-211 in 1 CARTON
    13 mL in 1 BOTTLE
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph not finalpart35209/16/2010
    Labeler - VENTURA INTERNATIONAL LTD (603192787)
    Establishment
    NameAddressID/FEIBusiness Operations
    Bel Star, S.A.880160197MANUFACTURE
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

More Info on this Drug

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