LBEL EFFET PARFAIT SIGNS OF AGE APPEARANCE MINIMIZER FOUNDATION SPF 20- octinoxate and titanium dioxide lotion

LBEL EFFET PARFAIT by

Drug Labeling and Warnings

LBEL EFFET PARFAIT by is a Otc medication manufactured, distributed, or labeled by Ventura Corporation LTD., Bel Star S.A. (Colombia), Yobel Supply Chain Management S.A. (Peru). Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

SPL UNCLASSIFIED SECTION

Drug Facts

ACTIVE INGREDIENT

Active Ingredients	Purpose
Octinoxate 7.0 %	Sunscreen
Titanium Dioxide 2.4 %	Sunscreen

Uses

• Helps prevent sunburn

Warnings

• Skin Cancer / Skin Aging Alert; Spending time in the sun increases your risk of skin cancer and early skin aging. This product has been shown only to help prevent sunburn, not skin cancer or early skin aging.

• For external use only.

• Do not use on damage or broken skin.

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

• Stop use and ask a doctor if rash occurs.

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

Directions

• Apply liberally and evenly 15 minutes before sun exposure.
• Children under 6 months of age: Ask a doctor
• Reapply at least every 2 hours
• Use a water resistant sunscreen if swimming or sweating.

Other information

• Protect the product in this container from excessive heat and direct sun.

Inactive ingredients

AQUA (WATER), CYCLOPENTASILOXANE, POLYMETHYL METHACRYLATE, DIMETHICONE, CYCLOHEXASILOXANE, CETYL PEG/PPG-10/1 DIMETHICONE, POLYGLYCERYL-4 ISOSTEARATE, HEXYL LAURATE, TRIMETHYLSILOXYSILICATE, GLYCERIN, SODIUM CHLORIDE, PEG/PPG-19/19 DIMETHICONE, Coffea Arabica (Coffee) Seedcake Extract, PEG/PPG-18/18 DIMETHICONE, PHENOXYETHANOL, ALUMINA, BUTYLENE GLYCOL, DIAZOLIDINYL UREA, OCTYLDODECANOL, METHYLPARABEN, TOCOPHERYL ACETATE, PROPYLPARABEN, METHICONE, BHT, MICROCRISTALLINA CERA (MICROCRYSTALLINE WAX), BENZYL ALCOHOL, PETROLATUM, BUTYLPARABEN, ETHYLPARABEN, PHOSPHOLIPIDS, POTASSIUM SORBATE, CARBOMER, ISOBUTYLPARABEN, CHOLESTEROL, POLYSORBATE 20, CANDELILLA CERA (EUPHORBIA CERIFERA (CANDELILLA) WAX), CERA ALBA (BEESWAX), CETEARYL ALCOHOL, CETEARYL GLUCOSIDE, COPERNICIA CERIFERA CERA (COPERNICIA CERIFERA (CARNAUBA ) WAX), POLYGLYCERYL-2 DIPOLYHYDROXYSTEARATE, GLYCOSPHINGOLIPIDS, PALMITOYL OLIGOPEPTIDE, PALMITOYL TETRAPEPTIDE-7, MAY CONTAIN: CI 77491 (IRON OXIDES), CI 77492 (IRON OXIDES), CI 77499 (IRON OXIDES), CI 77891 (TITANIUM DIOXIDE ), TRIETHOXYCAPRYLYLSILANE

SPL UNCLASSIFIED SECTION

US: Dist. by Ventura International Ltd. DBA Belcorp USA, San Francisco, CA 94111

PRINCIPAL DISPLAY PANEL - 30 ml Bottle Box

L'BEL

EFFET
PARFAIT

signs of age
appearance
minimizer
foundation
SPF 20

30 ml e (1 fl.oz.)

INGREDIENTS AND APPEARANCE

LBEL EFFET PARFAIT   SIGNS OF AGE APPEARANCE MINIMIZER FOUNDATION SPF 20
octinoxate and titanium dioxide lotion

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 13537-434
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
Octinoxate (UNII: 4Y5P7MUD51) (Octinoxate - UNII:4Y5P7MUD51)	Octinoxate	0.07 g  in 1 mL
Titanium Dioxide (UNII: 15FIX9V2JP) (Titanium Dioxide - UNII:15FIX9V2JP)	Titanium Dioxide	0.024 g  in 1 mL

Inactive Ingredients
Ingredient Name	Strength
WATER (UNII: 059QF0KO0R)
CYCLOMETHICONE 5 (UNII: 0THT5PCI0R)
DIMETHICONE (UNII: 92RU3N3Y1O)
CYCLOMETHICONE 6 (UNII: XHK3U310BA)
POLYGLYCERYL-4 ISOSTEARATE (UNII: 820DPX33S7)
HEXYL LAURATE (UNII: 4CG9F9W01Q)
GLYCERIN (UNII: PDC6A3C0OX)
SODIUM CHLORIDE (UNII: 451W47IQ8X)
PEG/PPG-19/19 DIMETHICONE (UNII: EHH90CO7TL)
ARABICA COFFEE BEAN (UNII: 3SW678MX72)
PEG/PPG-18/18 DIMETHICONE (UNII: 9H0AO7T794)
PHENOXYETHANOL (UNII: HIE492ZZ3T)
ALUMINUM OXIDE (UNII: LMI26O6933)
BUTYLENE GLYCOL (UNII: 3XUS85K0RA)
DIAZOLIDINYL UREA (UNII: H5RIZ3MPW4)
OCTYLDODECANOL (UNII: 461N1O614Y)
METHYLPARABEN (UNII: A2I8C7HI9T)
.ALPHA.-TOCOPHEROL ACETATE (UNII: 9E8X80D2L0)
PROPYLPARABEN (UNII: Z8IX2SC1OH)
BUTYLATED HYDROXYTOLUENE (UNII: 1P9D0Z171K)
MICROCRYSTALLINE WAX (UNII: XOF597Q3KY)
BENZYL ALCOHOL (UNII: LKG8494WBH)
PETROLATUM (UNII: 4T6H12BN9U)
BUTYLPARABEN (UNII: 3QPI1U3FV8)
ETHYLPARABEN (UNII: 14255EXE39)
POTASSIUM SORBATE (UNII: 1VPU26JZZ4)
ISOBUTYLPARABEN (UNII: 0QQJ25X58G)
CHOLESTEROL (UNII: 97C5T2UQ7J)
POLYSORBATE 20 (UNII: 7T1F30V5YH)
CANDELILLA WAX (UNII: WL0328HX19)
YELLOW WAX (UNII: 2ZA36H0S2V)
CETOSTEARYL ALCOHOL (UNII: 2DMT128M1S)
CETEARYL GLUCOSIDE (UNII: 09FUA47KNA)
CARNAUBA WAX (UNII: R12CBM0EIZ)
POLYGLYCERYL-2 DIPOLYHYDROXYSTEARATE (UNII: 9229XJ4V12)
PALMITOYL OLIGOPEPTIDE (UNII: HO4ZT5S86C)
PALMITOYL TETRAPEPTIDE-7 (UNII: Q41S464P1R)
FERRIC OXIDE RED (UNII: 1K09F3G675)
FERRIC OXIDE YELLOW (UNII: EX438O2MRT)
FERROSOFERRIC OXIDE (UNII: XM0M87F357)
TRIETHOXYCAPRYLYLSILANE (UNII: LDC331P08E)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 13537-434-02	1 in 1 BOX
1	NDC: 13537-434-01	1 mL in 1 BOTTLE
2	NDC: 13537-434-04	1 in 1 BOX
2	NDC: 13537-434-03	3 mL in 1 BOTTLE
3	NDC: 13537-434-06	1 in 1 BOX
3	NDC: 13537-434-05	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	09/14/2012

Labeler - Ventura Corporation LTD. (602751344)

Establishment
Name	Address	ID/FEI	Business Operations
Bel Star S.A. (Colombia)		880160197	MANUFACTURE(13537-434)

Establishment
Name	Address	ID/FEI	Business Operations
Yobel Supply Chain Management S.A. (Peru)		934116930	MANUFACTURE(13537-434)