Drug Facts

Active Ingredients	Purpose
TITANIUM DIOXIDE 3.54 %	Sunscreen
OCTINOXATE 3.00 %	Sunscreen
OXYBENZONE 3.00 %	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.
Reapply at least every 2 hours.
Use a water resistant sunscreen if swimming or sweating.
Children under 6 months of age: Ask a doctor.

Other information

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

Inactive ingredients

TALC, ZEA MAYS (CORN) STARCH, SILICA, CALCIUM CARBONATE, KAOLIN, ZINC STEARATE, OCTYLDODECANOL, ISOSTEARYL NEOPENTANOATE, GLYCERYL CAPRYLATE, METHYL METHACRYLATE CROSSPOLYMER, MAGNESIUM MYRISTATE, PHENOXYETHANOL, SODIUM POTASSIUM ALUMINUM SILICATE, HYDROGEN DIMETHICONE, TOCOPHERYL ACETATE, ALUMINA, CAPRYLYL GLYCOL, CHLORPHENESIN, MICROCRYSTALLINE WAX, PETROLATUM, PHOSPHOLIPIDS, CHOLESTEROL, EUPHORBIA CERIFERA (CANDELILLA) WAX, BEESWAX, CETEARYL ALCOHOL, CETEARYL GLUCOSIDE, COPERNICIA CERIFERA (CARNAUBA) WAX, POLYGLYCERYL-2 DIPOLYHYDROXYSTEARATE, GLYCOSPHINGOLIPIDS.

MAY CONTAIN:

IRON OXIDES, TITANIUM DIOXIDE

Dist. by Ventura Corp, Ltd., San Juan, Puerto Rico 00926.

PRINCIPAL DISPLAY PANEL - 12 g Case Box - PORCELAINE- BEIGE

L'BEL

EFFET PARFAIT

loose extra-fine portable
powder SPF 15 FM

Net Wt. 0.42 oz. e (12 g)

PRINCIPAL DISPLAY PANEL - 12 g Case Box - PORCELAINE- BEIGE

PRINCIPAL DISPLAY PANEL - 12 g Case Box - TRANSLUCIDE- BEIGE

L'BEL

EFFET PARFAIT

loose extra-fine portable
powder SPF 15 FM

Net Wt. 0.42 oz. e (12 g)

PRINCIPAL DISPLAY PANEL - 12 g Case Box - TRANSLUCIDE- BEIGE

PRINCIPAL DISPLAY PANEL - 12 g Case Box - SANTE- BEIGE

L'BEL

EFFET PARFAIT

loose extra-fine portable
powder SPF 15 FM

Net Wt. 0.42 oz. e (12 g)

PRINCIPAL DISPLAY PANEL - 12 g Case Box - SANTE- BEIGE

LBEL EFFET PARFAIT LOOSE EXTRA-FINE PORTABLE SPF 15 FM PORCELAINE- BEIGE
octinoxate, titanium dioxide, and oxybenzone powder

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC:13537-721
Route of Administration	TOPICAL

Ingredient Name	Basis of Strength	Strength
Active Ingredient/Active Moiety
OCTINOXATE (UNII: 4Y5P7MUD51) (OCTINOXATE - UNII:4Y5P7MUD51)	OCTINOXATE	0.03 g in 1 g
TITANIUM DIOXIDE (UNII: 15FIX9V2JP) (TITANIUM DIOXIDE - UNII:15FIX9V2JP)	TITANIUM DIOXIDE	0.0354 g in 1 g
OXYBENZONE (UNII: 95OOS7VE0Y) (OXYBENZONE - UNII:95OOS7VE0Y)	OXYBENZONE	0.03 g in 1 g

Ingredient Name	Strength
Inactive Ingredients
TALC (UNII: 7SEV7J4R1U)
STARCH, CORN (UNII: O8232NY3SJ)
SILICON DIOXIDE (UNII: ETJ7Z6XBU4)
CALCIUM CARBONATE (UNII: H0G9379FGK)
KAOLIN (UNII: 24H4NWX5CO)
ZINC STEARATE (UNII: H92E6QA4FV)
OCTYLDODECANOL (UNII: 461N1O614Y)
ISOSTEARYL NEOPENTANOATE (UNII: 411THY156Q)
GLYCERYL MONOCAPRYLATE (UNII: TM2TZD4G4A)
MAGNESIUM MYRISTATE (UNII: Z1917F0578)
PHENOXYETHANOL (UNII: HIE492ZZ3T)
.ALPHA.-TOCOPHEROL ACETATE (UNII: 9E8X80D2L0)
ALUMINUM OXIDE (UNII: LMI26O6933)
CAPRYLYL GLYCOL (UNII: 00YIU5438U)
CHLORPHENESIN (UNII: I670DAL4SZ)
MICROCRYSTALLINE WAX (UNII: XOF597Q3KY)
PETROLATUM (UNII: 4T6H12BN9U)
LECITHIN, SOYBEAN (UNII: 1DI56QDM62)
CHOLESTEROL (UNII: 97C5T2UQ7J)
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)
FERRIC OXIDE RED (UNII: 1K09F3G675)

#	Item Code	Package Description	Marketing Start Date
Packaging
1	NDC:13537-721-02	1 in 1 BOX	12/22/2015
1	NDC:13537-721-01	12 g in 1 CASE; Type 0: Not a Combination Product

Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
Marketing Information
OTC MONOGRAPH FINAL	part352	12/22/2015

LBEL EFFET PARFAIT LOOSE EXTRA-FINE PORTABLE SPF 15 FM TRANSLUCIDE- BEIGE
octinoxate, titanium dioxide, and oxybenzone powder

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC:13537-722
Route of Administration	TOPICAL

Ingredient Name	Basis of Strength	Strength
Active Ingredient/Active Moiety
OCTINOXATE (UNII: 4Y5P7MUD51) (OCTINOXATE - UNII:4Y5P7MUD51)	OCTINOXATE	0.03 g in 1 g
TITANIUM DIOXIDE (UNII: 15FIX9V2JP) (TITANIUM DIOXIDE - UNII:15FIX9V2JP)	TITANIUM DIOXIDE	0.0354 g in 1 g
OXYBENZONE (UNII: 95OOS7VE0Y) (OXYBENZONE - UNII:95OOS7VE0Y)	OXYBENZONE	0.03 g in 1 g

Ingredient Name	Strength
Inactive Ingredients
TALC (UNII: 7SEV7J4R1U)
STARCH, CORN (UNII: O8232NY3SJ)
SILICON DIOXIDE (UNII: ETJ7Z6XBU4)
CALCIUM CARBONATE (UNII: H0G9379FGK)
KAOLIN (UNII: 24H4NWX5CO)
ZINC STEARATE (UNII: H92E6QA4FV)
OCTYLDODECANOL (UNII: 461N1O614Y)
ISOSTEARYL NEOPENTANOATE (UNII: 411THY156Q)
GLYCERYL MONOCAPRYLATE (UNII: TM2TZD4G4A)
MAGNESIUM MYRISTATE (UNII: Z1917F0578)
PHENOXYETHANOL (UNII: HIE492ZZ3T)
.ALPHA.-TOCOPHEROL ACETATE (UNII: 9E8X80D2L0)
ALUMINUM OXIDE (UNII: LMI26O6933)
CAPRYLYL GLYCOL (UNII: 00YIU5438U)
CHLORPHENESIN (UNII: I670DAL4SZ)
MICROCRYSTALLINE WAX (UNII: XOF597Q3KY)
PETROLATUM (UNII: 4T6H12BN9U)
LECITHIN, SOYBEAN (UNII: 1DI56QDM62)
CHOLESTEROL (UNII: 97C5T2UQ7J)
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)
FERRIC OXIDE RED (UNII: 1K09F3G675)

#	Item Code	Package Description	Marketing Start Date
Packaging
1	NDC:13537-722-02	1 in 1 BOX	12/22/2015
1	NDC:13537-722-01	12 g in 1 CASE; Type 0: Not a Combination Product

Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
Marketing Information
OTC MONOGRAPH FINAL	part352	12/22/2015

LBEL EFFET PARFAIT LOOSE EXTRA-FINE PORTABLE SPF 15 FM SANTE- BEIGE
octinoxate, titanium dioxide, and oxybenzone powder

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC:13537-723
Route of Administration	TOPICAL

Ingredient Name	Basis of Strength	Strength
Active Ingredient/Active Moiety
OCTINOXATE (UNII: 4Y5P7MUD51) (OCTINOXATE - UNII:4Y5P7MUD51)	OCTINOXATE	0.03 g in 1 g
TITANIUM DIOXIDE (UNII: 15FIX9V2JP) (TITANIUM DIOXIDE - UNII:15FIX9V2JP)	TITANIUM DIOXIDE	0.0354 g in 1 g
OXYBENZONE (UNII: 95OOS7VE0Y) (OXYBENZONE - UNII:95OOS7VE0Y)	OXYBENZONE	0.03 g in 1 g

Ingredient Name	Strength
Inactive Ingredients
TALC (UNII: 7SEV7J4R1U)
STARCH, CORN (UNII: O8232NY3SJ)
SILICON DIOXIDE (UNII: ETJ7Z6XBU4)
CALCIUM CARBONATE (UNII: H0G9379FGK)
KAOLIN (UNII: 24H4NWX5CO)
ZINC STEARATE (UNII: H92E6QA4FV)
OCTYLDODECANOL (UNII: 461N1O614Y)
ISOSTEARYL NEOPENTANOATE (UNII: 411THY156Q)
GLYCERYL MONOCAPRYLATE (UNII: TM2TZD4G4A)
MAGNESIUM MYRISTATE (UNII: Z1917F0578)
PHENOXYETHANOL (UNII: HIE492ZZ3T)
.ALPHA.-TOCOPHEROL ACETATE (UNII: 9E8X80D2L0)
ALUMINUM OXIDE (UNII: LMI26O6933)
CAPRYLYL GLYCOL (UNII: 00YIU5438U)
CHLORPHENESIN (UNII: I670DAL4SZ)
MICROCRYSTALLINE WAX (UNII: XOF597Q3KY)
PETROLATUM (UNII: 4T6H12BN9U)
LECITHIN, SOYBEAN (UNII: 1DI56QDM62)
CHOLESTEROL (UNII: 97C5T2UQ7J)
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)
FERRIC OXIDE RED (UNII: 1K09F3G675)

#	Item Code	Package Description	Marketing Start Date
Packaging
1	NDC:13537-723-02	1 in 1 BOX	12/22/2015
1	NDC:13537-723-01	12 g in 1 CASE; Type 0: Not a Combination Product

Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
Marketing Information
OTC MONOGRAPH FINAL	part352	12/22/2015

Labeler - Ventura Corporation LTD (602751344)

Name	Address	ID/FEI	Business Operations
Establishment
Bel Star S.A. (Colombia)		880160197	MANUFACTURE(13537-721, 13537-722, 13537-723)

L'BEL EFFET PARFAIT Loose extra-fine portable powder SPF 15 FM

Uses

Warnings

Directions

Other information

Inactive ingredients

PRINCIPAL DISPLAY PANEL - 12 g Case Box - PORCELAINE- BEIGE

PRINCIPAL DISPLAY PANEL - 12 g Case Box - TRANSLUCIDE- BEIGE

PRINCIPAL DISPLAY PANEL - 12 g Case Box - SANTE- BEIGE