LBEL EFFET PARFAIT FILLING EFFECT FOUNDATION SPF 10 - CLAIRE 1- octinoxate liquid
LBEL EFFET PARFAIT FILLING EFFECT FOUNDATION SPF 10 - CLAIRE 2- octinoxate liquid
LBEL EFFET PARFAIT FILLING EFFECT FOUNDATION SPF 10 - CLAIRE 3- octinoxate liquid
LBEL EFFET PARFAIT FILLING EFFECT FOUNDATION SPF 10 - CLAIRE 4- octinoxate liquid
LBEL EFFET PARFAIT FILLING EFFECT FOUNDATION SPF 10 - MEDIUM 5- octinoxate liquid
LBEL EFFET PARFAIT FILLING EFFECT FOUNDATION SPF 10 - MEDIUM 6- octinoxate liquid
LBEL EFFET PARFAIT FILLING EFFECT FOUNDATION SPF 10 - MEDIUM 7- octinoxate liquid
LBEL EFFET PARFAIT FILLING EFFECT FOUNDATION SPF 10 - OBSCURE 8- octinoxate liquid
LBEL EFFET PARFAIT FILLING EFFECT FOUNDATION SPF 10 - OBSCURE 9- octinoxate liquid
Ventura Corporation 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.

----------

L'BEL EFFET PARFAIT filling effect foundation SPF 10

Active Ingredients

Octinoxate 7.0 %

Purpose

sunscreen

Uses

Helps prevent sunburn.
Higher SPF gives more sunburn protection.
Provides minimal 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 liberally 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.
Apply to the forehead, nose, chin and both cheeks. Blend with circular motion and spread softly without stretching the skin.

Inactive ingredients

Aqua (water), cyclomethicone, cyclopentasiloxane, cyclohexasiloxane, sodium chloride, peg/ppg-18/18 dimethicone, dimethicone, nylon-12 fluorescent brightener 230 salt, dimethiconol, diazolidinyl urea, methicone, cetearyl dimethicone crosspolymer, methylparaben, parfum (fragrance), propylparaben, polyvinylalcohol crosspolymer, sodium hyaluronate
May contain: CI 77891 (titanium dioxide), CI 77492 (iron oxides), CI 77491 (iron oxides), CI 77499 (iron oxides).

PR: Distributed by Ventura Corporation, Ltd. San Juan, Puerto Rico 00926.

PRINCIPAL DISPLAY PANEL - 30 ml Bottle Box - CLAIRE 1

L'BEL

EFFET
PARFAIT

filling effect
foundation SPF 10

30 ml e (1 fl.oz.)

Principal Display Panel - 30 ml Bottle Box - CLAIRE 1

PRINCIPAL DISPLAY PANEL - 30 ml Bottle Box - CLAIRE 2

L'BEL

EFFET
PARFAIT

filling effect
foundation SPF 10

30 ml e (1 fl.oz.)

Principal Display Panel - 30 ml Bottle Box - CLAIRE 2

PRINCIPAL DISPLAY PANEL - 30 ml Bottle Box - CLAIRE 3

L'BEL

EFFET
PARFAIT

filling effect
foundation SPF 10

30 ml e (1 fl.oz.)

Principal Display Panel - 30 ml Bottle Box - CLAIRE 3

PRINCIPAL DISPLAY PANEL - 30 ml Bottle Box - CLAIRE 4

L'BEL

EFFET
PARFAIT

filling effect
foundation SPF 10

30 ml e (1 fl.oz.)

Principal Display Panel - 30 ml Bottle Box - CLAIRE 4

PRINCIPAL DISPLAY PANEL - 30 ml Bottle Box - MEDIUM 5

L'BEL

EFFET
PARFAIT

filling effect
foundation SPF 10

30 ml e (1 fl.oz.)

Principal Display Panel - 30 ml Bottle Box - MEDIUM 5

PRINCIPAL DISPLAY PANEL - 30 ml Bottle Box - MEDIUM 6

L'BEL

EFFET
PARFAIT

filling effect
foundation SPF 10

30 ml e (1 fl.oz.)

Principal Display Panel - 30 ml Bottle Box - MEDIUM 6

PRINCIPAL DISPLAY PANEL - 30 ml Bottle Box - MEDIUM 7

L'BEL

EFFET
PARFAIT

filling effect
foundation SPF 10

30 ml e (1 fl.oz.)

Principal Display Panel - 30 ml Bottle Box - MEDIUM 7

PRINCIPAL DISPLAY PANEL - 30 ml Bottle Box - OBSCURE 8

L'BEL

EFFET
PARFAIT

filling effect
foundation SPF 10

30 ml e (1 fl.oz.)

Principal Display Panel - 30 ml Bottle Box - OBSCURE 8

PRINCIPAL DISPLAY PANEL - 30 ml Bottle Box - OBSCURE 9

L'BEL

EFFET
PARFAIT

filling effect
foundation SPF 10

30 ml e (1 fl.oz.)

Principal Display Panel - 30 ml Bottle Box - OBSCURE 9

LBEL EFFET PARFAIT FILLING EFFECT FOUNDATION SPF 10 - CLAIRE 1
octinoxate liquid

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC:13537-560
Route of Administration	TOPICAL

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

Ingredient Name	Strength
Inactive Ingredients
water (UNII: 059QF0KO0R)
cyclomethicone (UNII: NMQ347994Z)
cyclomethicone 5 (UNII: 0THT5PCI0R)
cyclomethicone 6 (UNII: XHK3U310BA)
sodium chloride (UNII: 451W47IQ8X)
peg/ppg-18/18 dimethicone (UNII: 9H0AO7T794)
dimethicone (UNII: 92RU3N3Y1O)
diazolidinyl urea (UNII: H5RIZ3MPW4)
methylparaben (UNII: A2I8C7HI9T)
propylparaben (UNII: Z8IX2SC1OH)
hyaluronate sodium (UNII: YSE9PPT4TH)
titanium dioxide (UNII: 15FIX9V2JP)
ferric oxide yellow (UNII: EX438O2MRT)
ferric oxide red (UNII: 1K09F3G675)
ferrosoferric oxide (UNII: XM0M87F357)

#	Item Code	Package Description	Marketing Start Date	Marketing End Date
Packaging
1	NDC:13537-560-02	1 in 1 BOX
1	NDC:13537-560-01	30 mL in 1 BOTTLE

Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
Marketing Information
OTC MONOGRAPH NOT FINAL	part352	05/07/2013

LBEL EFFET PARFAIT FILLING EFFECT FOUNDATION SPF 10 - CLAIRE 2
octinoxate liquid

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC:13537-561
Route of Administration	TOPICAL

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

Ingredient Name	Strength
Inactive Ingredients
water (UNII: 059QF0KO0R)
cyclomethicone (UNII: NMQ347994Z)
cyclomethicone 5 (UNII: 0THT5PCI0R)
cyclomethicone 6 (UNII: XHK3U310BA)
sodium chloride (UNII: 451W47IQ8X)
peg/ppg-18/18 dimethicone (UNII: 9H0AO7T794)
dimethicone (UNII: 92RU3N3Y1O)
diazolidinyl urea (UNII: H5RIZ3MPW4)
methylparaben (UNII: A2I8C7HI9T)
propylparaben (UNII: Z8IX2SC1OH)
hyaluronate sodium (UNII: YSE9PPT4TH)
titanium dioxide (UNII: 15FIX9V2JP)
ferric oxide yellow (UNII: EX438O2MRT)
ferric oxide red (UNII: 1K09F3G675)
ferrosoferric oxide (UNII: XM0M87F357)

#	Item Code	Package Description	Marketing Start Date	Marketing End Date
Packaging
1	NDC:13537-561-02	1 in 1 BOX
1	NDC:13537-561-01	30 mL in 1 BOTTLE

Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
Marketing Information
OTC MONOGRAPH NOT FINAL	part352	05/07/2013

LBEL EFFET PARFAIT FILLING EFFECT FOUNDATION SPF 10 - CLAIRE 3
octinoxate liquid

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC:13537-562
Route of Administration	TOPICAL

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

Ingredient Name	Strength
Inactive Ingredients
water (UNII: 059QF0KO0R)
cyclomethicone (UNII: NMQ347994Z)
cyclomethicone 5 (UNII: 0THT5PCI0R)
cyclomethicone 6 (UNII: XHK3U310BA)
sodium chloride (UNII: 451W47IQ8X)
peg/ppg-18/18 dimethicone (UNII: 9H0AO7T794)
dimethicone (UNII: 92RU3N3Y1O)
diazolidinyl urea (UNII: H5RIZ3MPW4)
methylparaben (UNII: A2I8C7HI9T)
propylparaben (UNII: Z8IX2SC1OH)
hyaluronate sodium (UNII: YSE9PPT4TH)
titanium dioxide (UNII: 15FIX9V2JP)
ferric oxide yellow (UNII: EX438O2MRT)
ferric oxide red (UNII: 1K09F3G675)
ferrosoferric oxide (UNII: XM0M87F357)

#	Item Code	Package Description	Marketing Start Date	Marketing End Date
Packaging
1	NDC:13537-562-02	1 in 1 BOX
1	NDC:13537-562-01	30 mL in 1 BOTTLE

Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
Marketing Information
OTC MONOGRAPH NOT FINAL	part352	05/07/2013

LBEL EFFET PARFAIT FILLING EFFECT FOUNDATION SPF 10 - CLAIRE 4
octinoxate liquid

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC:13537-563
Route of Administration	TOPICAL

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

Ingredient Name	Strength
Inactive Ingredients
water (UNII: 059QF0KO0R)
cyclomethicone (UNII: NMQ347994Z)
cyclomethicone 5 (UNII: 0THT5PCI0R)
cyclomethicone 6 (UNII: XHK3U310BA)
sodium chloride (UNII: 451W47IQ8X)
peg/ppg-18/18 dimethicone (UNII: 9H0AO7T794)
dimethicone (UNII: 92RU3N3Y1O)
diazolidinyl urea (UNII: H5RIZ3MPW4)
methylparaben (UNII: A2I8C7HI9T)
propylparaben (UNII: Z8IX2SC1OH)
hyaluronate sodium (UNII: YSE9PPT4TH)
titanium dioxide (UNII: 15FIX9V2JP)
ferric oxide yellow (UNII: EX438O2MRT)
ferric oxide red (UNII: 1K09F3G675)
ferrosoferric oxide (UNII: XM0M87F357)

#	Item Code	Package Description	Marketing Start Date	Marketing End Date
Packaging
1	NDC:13537-563-02	1 in 1 BOX
1	NDC:13537-563-01	30 mL in 1 BOTTLE

Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
Marketing Information
OTC MONOGRAPH NOT FINAL	part352	05/07/2013

LBEL EFFET PARFAIT FILLING EFFECT FOUNDATION SPF 10 - MEDIUM 5
octinoxate liquid

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC:13537-564
Route of Administration	TOPICAL

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

Ingredient Name	Strength
Inactive Ingredients
water (UNII: 059QF0KO0R)
cyclomethicone (UNII: NMQ347994Z)
cyclomethicone 5 (UNII: 0THT5PCI0R)
cyclomethicone 6 (UNII: XHK3U310BA)
sodium chloride (UNII: 451W47IQ8X)
peg/ppg-18/18 dimethicone (UNII: 9H0AO7T794)
dimethicone (UNII: 92RU3N3Y1O)
diazolidinyl urea (UNII: H5RIZ3MPW4)
methylparaben (UNII: A2I8C7HI9T)
propylparaben (UNII: Z8IX2SC1OH)
hyaluronate sodium (UNII: YSE9PPT4TH)
titanium dioxide (UNII: 15FIX9V2JP)
ferric oxide yellow (UNII: EX438O2MRT)
ferric oxide red (UNII: 1K09F3G675)
ferrosoferric oxide (UNII: XM0M87F357)

#	Item Code	Package Description	Marketing Start Date	Marketing End Date
Packaging
1	NDC:13537-564-02	1 in 1 BOX
1	NDC:13537-564-01	30 mL in 1 BOTTLE

Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
Marketing Information
OTC MONOGRAPH NOT FINAL	part352	05/07/2013

LBEL EFFET PARFAIT FILLING EFFECT FOUNDATION SPF 10 - MEDIUM 6
octinoxate liquid

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC:13537-565
Route of Administration	TOPICAL

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

Ingredient Name	Strength
Inactive Ingredients
water (UNII: 059QF0KO0R)
cyclomethicone (UNII: NMQ347994Z)
cyclomethicone 5 (UNII: 0THT5PCI0R)
cyclomethicone 6 (UNII: XHK3U310BA)
sodium chloride (UNII: 451W47IQ8X)
peg/ppg-18/18 dimethicone (UNII: 9H0AO7T794)
dimethicone (UNII: 92RU3N3Y1O)
diazolidinyl urea (UNII: H5RIZ3MPW4)
methylparaben (UNII: A2I8C7HI9T)
propylparaben (UNII: Z8IX2SC1OH)
hyaluronate sodium (UNII: YSE9PPT4TH)
titanium dioxide (UNII: 15FIX9V2JP)
ferric oxide yellow (UNII: EX438O2MRT)
ferric oxide red (UNII: 1K09F3G675)
ferrosoferric oxide (UNII: XM0M87F357)

#	Item Code	Package Description	Marketing Start Date	Marketing End Date
Packaging
1	NDC:13537-565-02	1 in 1 BOX
1	NDC:13537-565-01	30 mL in 1 BOTTLE

Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
Marketing Information
OTC MONOGRAPH NOT FINAL	part352	05/07/2013

LBEL EFFET PARFAIT FILLING EFFECT FOUNDATION SPF 10 - MEDIUM 7
octinoxate liquid

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC:13537-566
Route of Administration	TOPICAL

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

Ingredient Name	Strength
Inactive Ingredients
water (UNII: 059QF0KO0R)
cyclomethicone (UNII: NMQ347994Z)
cyclomethicone 5 (UNII: 0THT5PCI0R)
cyclomethicone 6 (UNII: XHK3U310BA)
sodium chloride (UNII: 451W47IQ8X)
peg/ppg-18/18 dimethicone (UNII: 9H0AO7T794)
dimethicone (UNII: 92RU3N3Y1O)
diazolidinyl urea (UNII: H5RIZ3MPW4)
methylparaben (UNII: A2I8C7HI9T)
propylparaben (UNII: Z8IX2SC1OH)
hyaluronate sodium (UNII: YSE9PPT4TH)
titanium dioxide (UNII: 15FIX9V2JP)
ferric oxide yellow (UNII: EX438O2MRT)
ferric oxide red (UNII: 1K09F3G675)
ferrosoferric oxide (UNII: XM0M87F357)

#	Item Code	Package Description	Marketing Start Date	Marketing End Date
Packaging
1	NDC:13537-566-02	1 in 1 BOX
1	NDC:13537-566-01	30 mL in 1 BOTTLE

Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
Marketing Information
OTC MONOGRAPH NOT FINAL	part352	05/07/2013

LBEL EFFET PARFAIT FILLING EFFECT FOUNDATION SPF 10 - OBSCURE 8
octinoxate liquid

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC:13537-567
Route of Administration	TOPICAL

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

Ingredient Name	Strength
Inactive Ingredients
water (UNII: 059QF0KO0R)
cyclomethicone (UNII: NMQ347994Z)
cyclomethicone 5 (UNII: 0THT5PCI0R)
cyclomethicone 6 (UNII: XHK3U310BA)
sodium chloride (UNII: 451W47IQ8X)
peg/ppg-18/18 dimethicone (UNII: 9H0AO7T794)
dimethicone (UNII: 92RU3N3Y1O)
diazolidinyl urea (UNII: H5RIZ3MPW4)
methylparaben (UNII: A2I8C7HI9T)
propylparaben (UNII: Z8IX2SC1OH)
hyaluronate sodium (UNII: YSE9PPT4TH)
titanium dioxide (UNII: 15FIX9V2JP)
ferric oxide yellow (UNII: EX438O2MRT)
ferric oxide red (UNII: 1K09F3G675)
ferrosoferric oxide (UNII: XM0M87F357)

#	Item Code	Package Description	Marketing Start Date	Marketing End Date
Packaging
1	NDC:13537-567-02	1 in 1 BOX
1	NDC:13537-567-01	30 mL in 1 BOTTLE

Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
Marketing Information
OTC MONOGRAPH NOT FINAL	part352	05/07/2013

LBEL EFFET PARFAIT FILLING EFFECT FOUNDATION SPF 10 - OBSCURE 9
octinoxate liquid

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC:13537-568
Route of Administration	TOPICAL

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

Ingredient Name	Strength
Inactive Ingredients
water (UNII: 059QF0KO0R)
cyclomethicone (UNII: NMQ347994Z)
cyclomethicone 5 (UNII: 0THT5PCI0R)
cyclomethicone 6 (UNII: XHK3U310BA)
sodium chloride (UNII: 451W47IQ8X)
peg/ppg-18/18 dimethicone (UNII: 9H0AO7T794)
dimethicone (UNII: 92RU3N3Y1O)
diazolidinyl urea (UNII: H5RIZ3MPW4)
methylparaben (UNII: A2I8C7HI9T)
propylparaben (UNII: Z8IX2SC1OH)
hyaluronate sodium (UNII: YSE9PPT4TH)
titanium dioxide (UNII: 15FIX9V2JP)
ferric oxide yellow (UNII: EX438O2MRT)
ferric oxide red (UNII: 1K09F3G675)
ferrosoferric oxide (UNII: XM0M87F357)

#	Item Code	Package Description	Marketing Start Date	Marketing End Date
Packaging
1	NDC:13537-568-02	1 in 1 BOX
1	NDC:13537-568-01	30 mL in 1 BOTTLE

Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
Marketing Information
OTC MONOGRAPH NOT FINAL	part352	05/07/2013

Labeler - Ventura Corporation LTD. (602751344)

Name	Address	ID/FEI	Business Operations
Establishment
Bel Star S.A. (Colombia)		880160197	MANUFACTURE(13537-560, 13537-561, 13537-562, 13537-563, 13537-564, 13537-565, 13537-566, 13537-567, 13537-568)

Revised: 5/2013

Document Id: 430fc14d-555e-4bbe-8ba7-c5a43361b62b

Set id: 80374fb9-59f8-46c8-b993-325d72f1a60a

Version: 1

Effective Time: 20130509

Ventura Corporation LTD.