EFFET PARFAIT- octinoxate and titanium dioxide lotion

EFFET PARFAIT by

Drug Labeling and Warnings

EFFET PARFAIT by is a Otc medication manufactured, distributed, or labeled by VENTURA INTERNATIONAL LTD, Bel Star, S.A.. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

SPL UNCLASSIFIED SECTION

Drug Facts

ACTIVE INGREDIENT

• Active Ingredient: Purpose
• 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

INGREDIENTS AND APPEARANCE

EFFET PARFAIT   NATURAL FINISH MOISTURIZING FOUNDATION SPF 25
octinoxate and titanium dioxide lotion

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 14783-170
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
Octinoxate (UNII: 4Y5P7MUD51) (Octinoxate - UNII:4Y5P7MUD51)	Octinoxate	0.065 mL  in 1 mL
Titanium Dioxide (UNII: 15FIX9V2JP) (Titanium Dioxide - UNII:15FIX9V2JP)	Titanium Dioxide	0.016 mL  in 1 mL

Inactive Ingredients
Ingredient Name	Strength
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 Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 14783-170-21	1 in 1 CARTON
1		40.5 mL in 1 BOTTLE

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC monograph not final	part352	09/16/2010

EFFET PARFAIT   NATURAL FINISH MOISTURIZING FOUNDATION SPF 25
octinoxate and titanium dioxide lotion

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 14783-160
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
Octinoxate (UNII: 4Y5P7MUD51) (Octinoxate - UNII:4Y5P7MUD51)	Octinoxate	0.065 mL  in 1 mL
Titanium Dioxide (UNII: 15FIX9V2JP) (Titanium Dioxide - UNII:15FIX9V2JP)	Titanium Dioxide	0.016 mL  in 1 mL

Inactive Ingredients
Ingredient Name	Strength
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 Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 14783-160-21	1 in 1 CARTON
1		30 mL in 1 BOTTLE

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC monograph not final	part352	09/16/2010

EFFET PARFAIT   NATURAL FINISH MOISTURIZING FOUNDATION SPF 25
octinoxate and titanium dioxide lotion

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 14783-150
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
Octinoxate (UNII: 4Y5P7MUD51) (Octinoxate - UNII:4Y5P7MUD51)	Octinoxate	0.065 mL  in 1 mL
Titanium Dioxide (UNII: 15FIX9V2JP) (Titanium Dioxide - UNII:15FIX9V2JP)	Titanium Dioxide	0.016 mL  in 1 mL

Inactive Ingredients
Ingredient Name	Strength
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 Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 14783-150-21	1 in 1 CARTON
1		4.5 mL in 1 BOTTLE

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC monograph not final	part352	09/16/2010

EFFET PARFAIT   NATURAL FINISH MOISTURIZING FOUNDATION SPF 25
octinoxate and titanium dioxide lotion

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 14783-140
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
Octinoxate (UNII: 4Y5P7MUD51) (Octinoxate - UNII:4Y5P7MUD51)	Octinoxate	0.065 mL  in 1 mL
Titanium Dioxide (UNII: 15FIX9V2JP) (Titanium Dioxide - UNII:15FIX9V2JP)	Titanium Dioxide	0.016 mL  in 1 mL

Inactive Ingredients
Ingredient Name	Strength
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 Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 14783-140-21	1 in 1 CARTON
1		3 mL in 1 BOTTLE

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC monograph not final	part352	09/16/2010

Labeler - VENTURA INTERNATIONAL LTD (603192787)

Establishment
Name	Address	ID/FEI	Business Operations
Bel Star, S.A.		880160197	MANUFACTURE