LBEL EFFET PARFAIT MINERAL NATURAL SKIN EFFECT MOUSE FOUNDATION- octinoxate, titanium dioxide, and zinc oxide powder

LBEL Effet Parfait Mineral Natural Skin Effect Mouse Foundation by

Drug Labeling and Warnings

LBEL Effet Parfait Mineral Natural Skin Effect Mouse Foundation by is a Otc medication manufactured, distributed, or labeled by Ventura International, Limited, BelStar, 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 2.4%	Sunscreen
Zinc Oxide 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, waring protective clothing, and using sunscreen may reduce the risk of skin aging, skin cancer, and other harmful effects of the sun.

Inactive ingredients

Cyclopentasiloxane, Mica, Dimethicone Crosspolymer, Dimethicone/Vinyl Dimethicone Crosspolymer, Trimethylsiloxysilicate, Cyclohexasiloxane , Bis-hydroxyethoxypropyl Dimethicone, Octyldodecanol, Phenoxyethanol, Boron nitride, Disteardimonium Hectorite, Alumina, Cetyl peg/ppg-10/1 Dimethicone, Polyglyceryl-4 isostearate, Cera Microcristallina (Microcrystalline Wax), Silica, Hexyl Laurate, Dimethiconol, Caprylyl glycol, Tocopheryl Acetate, Chlorphenesin, Lauroyl Lysine, Petrolatum, Propylene Carbonate, Methicone, Phospholipids,Rhodiola Rosea Root Extract, Cholesterol, BHA, BHT, Carnosine, Triethoxycaprylylsilane, Candelilla Cera (Euphorbia Cerifera (candelilla) wax), Cera alba (Beeswax), Cetearyl Alcohol, Cetearyl Glucoside, Copernicia Cerifera Cera (Copernicia Cerifera (carnauba) wax), Polyglyceryl-2 Dipolyhydroxystearate, Glycosphingolipids, Alanyl Glutamine. May Contain: CI 77891(Titanium Dioxide) , CI 77491, CI 77492, CI 77499 (Iron Oxides).

SPL UNCLASSIFIED SECTION

USA: Dist. by Ventura International Ltd. San Francisco, CA 94111. Made in Colombia. PUERTO RICO: Dist. by Ventura Corporation, Ltd., San Juan, Puerto Rico 00926. Made in Colombia.

PRINCIPAL DISPLAY PANEL - 30 g Carton

EFFET PARFAIT
MINÉRAL

natural skin effect
mousse foundation
SPF 16

30 g e (1 oz.)

L'BEL

INGREDIENTS AND APPEARANCE

LBEL EFFET PARFAIT MINERAL NATURAL SKIN EFFECT MOUSE FOUNDATION 
octinoxate, titanium dioxide, and zinc oxide powder

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 14783-770
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
OCTINOXATE (UNII: 4Y5P7MUD51) (OCTINOXATE - UNII:4Y5P7MUD51)	OCTINOXATE	0.065 g  in 1 g
TITANIUM DIOXIDE (UNII: 15FIX9V2JP) (TITANIUM DIOXIDE - UNII:15FIX9V2JP)	TITANIUM DIOXIDE	0.024 g  in 1 g
ZINC OXIDE (UNII: SOI2LOH54Z) (ZINC OXIDE - UNII:SOI2LOH54Z)	ZINC OXIDE	0.016 g  in 1 g

Inactive Ingredients
Ingredient Name	Strength
CYCLOMETHICONE 5 (UNII: 0THT5PCI0R)
MICA (UNII: V8A1AW0880)
CYCLOMETHICONE 6 (UNII: XHK3U310BA)
OCTYLDODECANOL (UNII: 461N1O614Y)
PHENOXYETHANOL (UNII: HIE492ZZ3T)
ALUMINUM OXIDE (UNII: LMI26O6933)
POLYGLYCERYL-4 ISOSTEARATE (UNII: 820DPX33S7)
MICROCRYSTALLINE WAX (UNII: XOF597Q3KY)
SILICON DIOXIDE (UNII: ETJ7Z6XBU4)
HEXYL LAURATE (UNII: 4CG9F9W01Q)
CAPRYLYL GLYCOL (UNII: 00YIU5438U)
CHLORPHENESIN (UNII: I670DAL4SZ)
LAUROYL LYSINE (UNII: 113171Q70B)
PETROLATUM (UNII: 4T6H12BN9U)
PROPYLENE CARBONATE (UNII: 8D08K3S51E)
CHOLESTEROL (UNII: 97C5T2UQ7J)
BUTYLATED HYDROXYANISOLE (UNII: REK4960K2U)
BUTYLATED HYDROXYTOLUENE (UNII: 1P9D0Z171K)
CARNOSINE (UNII: 8HO6PVN24W)
CANDELILLA WAX (UNII: WL0328HX19)
YELLOW WAX (UNII: 2ZA36H0S2V)
CETOSTEARYL ALCOHOL (UNII: 2DMT128M1S)
CETEARYL GLUCOSIDE (UNII: 09FUA47KNA)
CARNAUBA WAX (UNII: R12CBM0EIZ)
ALANYL-GLUTAMINE (UNII: U5JDO2770Z)
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: 14783-770-31	1 in 1 CARTON
1	NDC: 14783-770-30	30 g in 1 BOTTLE
2	NDC: 14783-770-04	1 in 1 CARTON
2	NDC: 14783-770-03	3 g in 1 BOTTLE

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC MONOGRAPH NOT FINAL	part352	11/26/2010

Labeler - Ventura International, Limited (603192787)

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