EFFET PARFAIT  NATURAL FINISH MOISTURIZING FOUNDATION SPF 25- octinoxate and titanium dioxide lotion 
VENTURA INTERNATIONAL LTD

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.

----------

EFFET
PARFAIT
natural finish
moisturizing
foundation
SPF 25

Drug Facts

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

Uses

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

Other information

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
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

Revised: 9/2010
Document Id: 36f6fbf5-166f-47a3-b864-60de558168e2
Set id: 0595d3ef-634a-43d1-907c-7f30686a820a
Version: 1
Effective Time: 20100903
 
VENTURA INTERNATIONAL LTD