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

LBEL FILLING EFFECT FOUNDATION SPF 10 by

Drug Labeling and Warnings

LBEL FILLING EFFECT FOUNDATION SPF 10 by is a Otc medication manufactured, distributed, or labeled by Ventura Corporation LTD, Bel Star S.A. (Colombia). Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

SPL UNCLASSIFIED SECTION

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

SPL UNCLASSIFIED SECTION

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

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 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 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 4) - Beige

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

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

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

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

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

L'BEL

EFFET
PARFAIT

filling effect
foundation SPF 10

30 ml e (1 fl.oz.)

INGREDIENTS AND APPEARANCE

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

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 13537-200
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

Inactive Ingredients
Ingredient Name	Strength
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)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 13537-200-02	1 in 1 BOX
1	NDC: 13537-200-01	30 mL in 1 BOTTLE
2	NDC: 13537-200-04	1 in 1 BOX
2	NDC: 13537-200-03	3 mL in 1 TUBE

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
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: 13537-201
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

Inactive Ingredients
Ingredient Name	Strength
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)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 13537-201-06	1 in 1 BOX
1	NDC: 13537-201-05	30 mL in 1 BOTTLE
2	NDC: 13537-201-08	1 in 1 BOX
2	NDC: 13537-201-07	3 mL in 1 TUBE

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
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: 13537-202
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

Inactive Ingredients
Ingredient Name	Strength
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)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 13537-202-10	1 in 1 BOX
1	NDC: 13537-202-09	30 mL in 1 BOTTLE
2	NDC: 13537-202-12	1 in 1 BOX
2	NDC: 13537-202-11	3 mL in 1 TUBE

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
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: 13537-203
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

Inactive Ingredients
Ingredient Name	Strength
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)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 13537-203-14	1 in 1 BOX
1	NDC: 13537-203-13	30 mL in 1 BOTTLE
2	NDC: 13537-203-16	1 in 1 BOX
2	NDC: 13537-203-15	3 mL in 1 TUBE

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
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: 13537-204
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

Inactive Ingredients
Ingredient Name	Strength
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)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 13537-204-18	1 in 1 BOX
1	NDC: 13537-204-17	30 mL in 1 BOTTLE
2	NDC: 13537-204-20	1 in 1 BOX
2	NDC: 13537-204-19	3 mL in 1 TUBE

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
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: 13537-205
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

Inactive Ingredients
Ingredient Name	Strength
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)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 13537-205-22	1 in 1 BOX
1	NDC: 13537-205-21	30 mL in 1 BOTTLE
2	NDC: 13537-205-24	1 in 1 BOX
2	NDC: 13537-205-23	3 mL in 1 TUBE

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
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: 13537-206
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

Inactive Ingredients
Ingredient Name	Strength
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)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 13537-206-26	1 in 1 BOX
1	NDC: 13537-206-25	30 mL in 1 BOTTLE
2	NDC: 13537-206-28	1 in 1 BOX
2	NDC: 13537-206-27	3 mL in 1 TUBE

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
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: 13537-207
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

Inactive Ingredients
Ingredient Name	Strength
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)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 13537-207-30	1 in 1 BOX
1	NDC: 13537-207-29	30 mL in 1 BOTTLE
2	NDC: 13537-207-32	1 in 1 BOX
2	NDC: 13537-207-31	3 mL in 1 TUBE

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
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: 13537-208
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

Inactive Ingredients
Ingredient Name	Strength
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)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 13537-208-34	1 in 1 BOX
1	NDC: 13537-208-33	30 mL in 1 BOTTLE
2	NDC: 13537-208-36	1 in 1 BOX
2	NDC: 13537-208-35	3 mL in 1 TUBE

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

Labeler - Ventura Corporation LTD (602751344)

Establishment
Name	Address	ID/FEI	Business Operations
Bel Star S.A. (Colombia)		880160197	MANUFACTURE(13537-200, 13537-201, 13537-202, 13537-203, 13537-204, 13537-205, 13537-206, 13537-207, 13537-208)