LBEL FILLING EFFECT FOUNDATION SPF 10 (CLAIRE 1) - BEIGE- octinoxate liquid
LBEL FILLING EFFECT FOUNDATION SPF 10 (CLAIRE 2) - BEIGE- octinoxate liquid
LBEL FILLING EFFECT FOUNDATION SPF 10 (CLAIRE 3) - BEIGE- octinoxate liquid
LBEL FILLING EFFECT FOUNDATION SPF 10 (CLAIRE 4) - BEIGE- octinoxate liquid
LBEL FILLING EFFECT FOUNDATION SPF 10 (MEDIUM 5) - BROWN- octinoxate liquid
LBEL FILLING EFFECT FOUNDATION SPF 10 (MEDIUM 6) - BROWN- octinoxate liquid
LBEL FILLING EFFECT FOUNDATION SPF 10 (MEDIUM 7) - BROWN- octinoxate liquid
LBEL FILLING EFFECT FOUNDATION SPF 10 (OBSCURE 8) - BROWN- octinoxate liquid
LBEL FILLING EFFECT FOUNDATION SPF 10 (OBSCURE 9) - BROWN- octinoxate liquid
Ventura International 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 FILLING EFFECT FOUNDATION SPF 10

Drug Facts

Active Ingredients

Octinoxate 7 %

Purpose

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 damaged 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

AQUA (WATER), CYCLOMETHICONE, CYCLOPENTASILOXANE, CYCLOHEXASILOXANE, SODIUM CHLORIDE, PEG/PPG-18/18 DIMETHICONE, DIMETHICONE, NYLON-12 FLUORESCENT BRIGHTENER 230 SALT, DIMETHICONOL, DIAZOLIDINYL UREA, CETEARYL DIMETHICONE CROSSPOLYMER, METHYLPARABEN, PARFUM (FRAGRANCE), PROPYLPARABEN, POLYVINYLALCOHOL CROSSPOLYMER, SODIUM HYALURONATE.

MAY CONTAIN

TITANIUM DIOXIDE (CI 77891), IRON OXIDES (CI 77492), IRON OXIDES (CI 77499), IRON OXIDES (CI 77491), METHICONE

Distributed by Ventura International Ltd. DBA Belcorp USA, San Francisco, CA 94111

PRINCIPAL DISPLAY PANEL - 30 ml Bottle Box - (Claire 1) - Beige

L'BEL

EFFET
PARFAIT

filling effect
foundation SPF 10

30 ml e (1 fl.oz.)

Principal Display Panel - 30 ml Bottle Box - (Claire 1) - Beige

PRINCIPAL DISPLAY PANEL - 30 ml Bottle Box - (Claire 2) - Beige

L'BEL

EFFET
PARFAIT

filling effect
foundation SPF 10

30 ml e (1 fl.oz.)

Principal Display Panel - 30 ml Bottle Box - (Claire 2) - Beige

PRINCIPAL DISPLAY PANEL - 30 ml Bottle Box - (Claire 3) - Beige

L'BEL

EFFET
PARFAIT

filling effect
foundation SPF 10

30 ml e (1 fl.oz.)

Principal Display Panel - 30 ml Bottle Box - (Claire 3) - Beige

PRINCIPAL DISPLAY PANEL - 30 ml Bottle Box - (Claire 4) - Beige

L'BEL

EFFET
PARFAIT

filling effect
foundation SPF 10

30 ml e (1 fl.oz.)

Principal Display Panel - 30 ml Bottle Box - (Claire 4) - Beige

PRINCIPAL DISPLAY PANEL - 30 ml Bottle Box - (Medium 5) - Brown

L'BEL

EFFET
PARFAIT

filling effect
foundation SPF 10

30 ml e (1 fl.oz.)

Principal Display Panel - 30 ml Bottle Box - (Medium 5) - Brown

PRINCIPAL DISPLAY PANEL - 30 ml Bottle Box - (Medium 6) - Brown

L'BEL

EFFET
PARFAIT

filling effect
foundation SPF 10

30 ml e (1 fl.oz.)

Principal Display Panel - 30 ml Bottle Box - (Medium 6) - Brown

PRINCIPAL DISPLAY PANEL - 30 ml Bottle Box - (Medium 7) - Brown

L'BEL

EFFET
PARFAIT

filling effect
foundation SPF 10

30 ml e (1 fl.oz.)

Principal Display Panel - 30 ml Bottle Box - (Medium 7) - Brown

PRINCIPAL DISPLAY PANEL - 30 ml Bottle Box - (Obscure 8) - Brown

L'BEL

EFFET
PARFAIT

filling effect
foundation SPF 10

30 ml e (1 fl.oz.)

Principal Display Panel - 30 ml Bottle Box - (Obscure 8) - Brown

PRINCIPAL DISPLAY PANEL - 30 ml Bottle Box - (Obscure 9) - Brown

L'BEL

EFFET
PARFAIT

filling effect
foundation SPF 10

30 ml e (1 fl.oz.)

Principal Display Panel - 30 ml Bottle Box - (Obscure 9) - Brown

LBEL FILLING EFFECT FOUNDATION SPF 10 (CLAIRE 1) - BEIGE
octinoxate liquid

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC:14783-200
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)
ferrosoferric oxide (UNII: XM0M87F357)
ferric oxide red (UNII: 1K09F3G675)

#	Item Code	Package Description	Marketing Start Date	Marketing End Date
Packaging
1	NDC:14783-200-02	1 in 1 BOX
1	NDC:14783-200-01	30 mL in 1 BOTTLE
2	NDC:14783-200-04	1 in 1 BOX
2	NDC:14783-200-03	3 mL in 1 TUBE

Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
Marketing Information
OTC MONOGRAPH NOT FINAL	part352	12/16/2013

LBEL FILLING EFFECT FOUNDATION SPF 10 (CLAIRE 2) - BEIGE
octinoxate liquid

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC:14783-201
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)
ferrosoferric oxide (UNII: XM0M87F357)
ferric oxide red (UNII: 1K09F3G675)

#	Item Code	Package Description	Marketing Start Date	Marketing End Date
Packaging
1	NDC:14783-201-06	1 in 1 BOX
1	NDC:14783-201-05	30 mL in 1 BOTTLE
2	NDC:14783-201-08	1 in 1 BOX
2	NDC:14783-201-07	3 mL in 1 TUBE

Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
Marketing Information
OTC MONOGRAPH NOT FINAL	part352	12/16/2013

LBEL FILLING EFFECT FOUNDATION SPF 10 (CLAIRE 3) - BEIGE
octinoxate liquid

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC:14783-202
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)
ferrosoferric oxide (UNII: XM0M87F357)
ferric oxide red (UNII: 1K09F3G675)

#	Item Code	Package Description	Marketing Start Date	Marketing End Date
Packaging
1	NDC:14783-202-10	1 in 1 BOX
1	NDC:14783-202-09	30 mL in 1 BOTTLE
2	NDC:14783-202-12	1 in 1 BOX
2	NDC:14783-202-11	3 mL in 1 TUBE

Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
Marketing Information
OTC MONOGRAPH NOT FINAL	part352	12/16/2013

LBEL FILLING EFFECT FOUNDATION SPF 10 (CLAIRE 4) - BEIGE
octinoxate liquid

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC:14783-203
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)
ferrosoferric oxide (UNII: XM0M87F357)
ferric oxide red (UNII: 1K09F3G675)

#	Item Code	Package Description	Marketing Start Date	Marketing End Date
Packaging
1	NDC:14783-203-14	1 in 1 BOX
1	NDC:14783-203-13	30 mL in 1 BOTTLE
2	NDC:14783-203-16	1 in 1 BOX
2	NDC:14783-203-15	3 mL in 1 TUBE

Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
Marketing Information
OTC MONOGRAPH NOT FINAL	part352	12/16/2013

LBEL FILLING EFFECT FOUNDATION SPF 10 (MEDIUM 5) - BROWN
octinoxate liquid

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC:14783-204
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)
ferrosoferric oxide (UNII: XM0M87F357)
ferric oxide red (UNII: 1K09F3G675)

#	Item Code	Package Description	Marketing Start Date	Marketing End Date
Packaging
1	NDC:14783-204-18	1 in 1 BOX
1	NDC:14783-204-17	30 mL in 1 BOTTLE
2	NDC:14783-204-20	1 in 1 BOX
2	NDC:14783-204-19	3 mL in 1 TUBE

Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
Marketing Information
OTC MONOGRAPH NOT FINAL	part352	12/16/2013

LBEL FILLING EFFECT FOUNDATION SPF 10 (MEDIUM 6) - BROWN
octinoxate liquid

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC:14783-205
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)
ferrosoferric oxide (UNII: XM0M87F357)
ferric oxide red (UNII: 1K09F3G675)

#	Item Code	Package Description	Marketing Start Date	Marketing End Date
Packaging
1	NDC:14783-205-22	1 in 1 BOX
1	NDC:14783-205-21	30 mL in 1 BOTTLE
2	NDC:14783-205-24	1 in 1 BOX
2	NDC:14783-205-23	3 mL in 1 TUBE

Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
Marketing Information
OTC MONOGRAPH NOT FINAL	part352	12/16/2013

LBEL FILLING EFFECT FOUNDATION SPF 10 (MEDIUM 7) - BROWN
octinoxate liquid

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC:14783-206
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)
ferrosoferric oxide (UNII: XM0M87F357)
ferric oxide red (UNII: 1K09F3G675)

#	Item Code	Package Description	Marketing Start Date	Marketing End Date
Packaging
1	NDC:14783-206-26	1 in 1 BOX
1	NDC:14783-206-25	30 mL in 1 BOTTLE
2	NDC:14783-206-28	1 in 1 BOX
2	NDC:14783-206-27	3 mL in 1 TUBE

Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
Marketing Information
OTC MONOGRAPH NOT FINAL	part352	12/16/2013

LBEL FILLING EFFECT FOUNDATION SPF 10 (OBSCURE 8) - BROWN
octinoxate liquid

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC:14783-207
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)
ferrosoferric oxide (UNII: XM0M87F357)
ferric oxide red (UNII: 1K09F3G675)

#	Item Code	Package Description	Marketing Start Date	Marketing End Date
Packaging
1	NDC:14783-207-30	1 in 1 BOX
1	NDC:14783-207-29	30 mL in 1 BOTTLE
2	NDC:14783-207-32	1 in 1 BOX
2	NDC:14783-207-31	3 mL in 1 TUBE

Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
Marketing Information
OTC MONOGRAPH NOT FINAL	part352	12/16/2013

LBEL FILLING EFFECT FOUNDATION SPF 10 (OBSCURE 9) - BROWN
octinoxate liquid

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC:14783-208
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)
ferrosoferric oxide (UNII: XM0M87F357)
ferric oxide red (UNII: 1K09F3G675)

#	Item Code	Package Description	Marketing Start Date	Marketing End Date
Packaging
1	NDC:14783-208-34	1 in 1 BOX
1	NDC:14783-208-33	30 mL in 1 BOTTLE
2	NDC:14783-208-36	1 in 1 BOX
2	NDC:14783-208-35	3 mL in 1 TUBE

Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
Marketing Information
OTC MONOGRAPH NOT FINAL	part352	12/16/2013

Labeler - Ventura International LTD (603192787)

Name	Address	ID/FEI	Business Operations
Establishment
Bel Star S.A. (Colombia)		880160197	MANUFACTURE(14783-200, 14783-201, 14783-202, 14783-203, 14783-204, 14783-205, 14783-206, 14783-207, 14783-208)

Revised: 12/2013

Document Id: 8ef66f04-ff18-4da3-b355-2cdb4ea2f86c

Set id: ef3f31f2-506f-4797-8303-702a33d72d05

Version: 1

Effective Time: 20131219

Ventura International LTD