LBEL REPLENISHING FOUNDATION SPF 14 (CLAIRE 1) - BEIGE- octinoxate liquid
LBEL REPLENISHING FOUNDATION SPF 14 (CLAIRE 2) - BEIGE- octinoxate liquid
LBEL REPLENISHING FOUNDATION SPF 14 (CLAIRE 3) - BEIGE- octinoxate liquid
LBEL REPLENISHING FOUNDATION SPF 14 (CLAIRE 4) - BEIGE- octinoxate liquid
LBEL REPLENISHING FOUNDATION SPF 14 (MEDIUM 5) - BROWN- octinoxate liquid
LBEL REPLENISHING FOUNDATION SPF 14 (MEDIUM 6) - BROWN- octinoxate liquid
LBEL REPLENISHING FOUNDATION SPF 14 (MEDIUM 7) - BROWN- octinoxate liquid
LBEL REPLENISHING FOUNDATION SPF 14 (OBSCURE 8) - BROWN- octinoxate liquid
LBEL REPLENISHING FOUNDATION SPF 14 (OBSCURE 9) - BROWN- 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 REPLENISHING FOUNDATION SPF 14

Drug Facts

Active Ingredients

Octinoxate (4.5 %)

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
Apply to the forehead, nose, chin and both cheeks.
Blend with CIrcular motion and spread softly without stretching the skin.

Other information

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

Inactive ingredients

Water, cyclopentasiloxane, butylene glycol, cyclohexasiloxane, phenyl trimethicone, cetyl peg/ppg-10/1 dimethicone, polyglyceryl-4 isostearate, nylon-12 fluorescent brightener 230 salt, hexyl laurate, mannitol, glycerin, ethylene/acrylic acid copolymer, glycine soja (soybean) protein, peg/ppg-18/18 dimethicone, disteardimonium hectorite, sodium chloride, dimethicone, propylene glycol, dimethicone crosspolymer, dimethicone/vinyl dimethicone crosspolymer, diazolidinyl urea, hydrolyzed keratin, dimethiconol, sucrose, methylparaben, serine, fragrance, arginine, cyclodextrin, polyvinylalcohol crosspolymer, pca, bht, macrocystis pyrifera extract, yeast extract, alanine, propylparaben, hydrolyzed wheat protein, carbomer, pvp, threonine, polysorbate 20, disodium succinate, mourera fluviatilis extract, palmitoyl pentapeptide-4.

May contain: titanium dioxide, iron oxides, iron oxides, iron oxides,methicone.

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

PRINCIPAL DISPLAY PANEL - 30 g Bottle Box - Claire 1 - BEIGE

L'BEL

replenishing foundation SPF 14

Net Weight 1 oz. (30 g)

Principal Display Panel - 30 g Bottle Box - Claire 1 - BEIGE

PRINCIPAL DISPLAY PANEL - 30 g Bottle Box - Claire 2 - BEIGE

L'BEL

replenishing foundation SPF 14

Net Weight 1 oz. (30 g)

Principal Display Panel - 30 g Bottle Box - Claire 2 - BEIGE

PRINCIPAL DISPLAY PANEL - 30 g Bottle Box - Claire 3 - BEIGE

L'BEL

replenishing foundation SPF 14

Net Weight 1 oz. (30 g)

Principal Display Panel - 30 g Bottle Box - Claire 3 - BEIGE

PRINCIPAL DISPLAY PANEL - 30 g Bottle Box - Claire 4 - BEIGE

L'BEL

replenishing foundation SPF 14

Net Weight 1 oz. (30 g)

Principal Display Panel - 30 g Bottle Box - Claire 4 - BEIGE

PRINCIPAL DISPLAY PANEL - 30 g Bottle Box - Medium 5 - BROWN

L'BEL

replenishing foundation SPF 14

Net Weight 1 oz. (30 g)

Principal Display Panel - 30 g Bottle Box - Medium 5 - BROWN

PRINCIPAL DISPLAY PANEL - 30 g Bottle Box - Medium 6 - BROWN

L'BEL

replenishing foundation SPF 14

Net Weight 1 oz. (30 g)

Principal Display Panel - 30 g Bottle Box - Medium 6 - BROWN

PRINCIPAL DISPLAY PANEL - 30 g Bottle Box - Medium 7 - BROWN

L'BEL

replenishing foundation SPF 14

Net Weight 1 oz. (30 g)

Principal Display Panel - 30 g Bottle Box - Medium 7 - BROWN

PRINCIPAL DISPLAY PANEL - 30 g Bottle Box - Obscure 8 - BROWN

L'BEL

replenishing foundation SPF 14

Net Weight 1 oz. (30 g)

Principal Display Panel - 30 g Bottle Box - Obscure 8 - BROWN

PRINCIPAL DISPLAY PANEL - 30 g Bottle Box - Obscure 9 - BROWN

L'BEL

replenishing foundation SPF 14

Net Weight 1 oz. (30 g)

Principal Display Panel - 30 g Bottle Box - Obscure 9 - BROWN

LBEL REPLENISHING FOUNDATION SPF 14 (CLAIRE 1) - BEIGE
octinoxate liquid

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC:13537-257
Route of Administration	TOPICAL

Ingredient Name	Basis of Strength	Strength
Active Ingredient/Active Moiety
Octinoxate (UNII: 4Y5P7MUD51) (Octinoxate - UNII:4Y5P7MUD51)	Octinoxate	0.045 g in 1 g

Ingredient Name	Strength
Inactive Ingredients
WATER (UNII: 059QF0KO0R)
CYCLOMETHICONE 5 (UNII: 0THT5PCI0R)
BUTYLENE GLYCOL (UNII: 3XUS85K0RA)
CYCLOMETHICONE 6 (UNII: XHK3U310BA)
PHENYL TRIMETHICONE (UNII: DR0K5NOJ4R)
POLYGLYCERYL-4 ISOSTEARATE (UNII: 820DPX33S7)
HEXYL LAURATE (UNII: 4CG9F9W01Q)
MANNITOL (UNII: 3OWL53L36A)
GLYCERIN (UNII: PDC6A3C0OX)
PEG/PPG-18/18 DIMETHICONE (UNII: 9H0AO7T794)
DISTEARDIMONIUM HECTORITE (UNII: X687XDK09L)
SODIUM CHLORIDE (UNII: 451W47IQ8X)
DIMETHICONE (UNII: 92RU3N3Y1O)
PROPYLENE GLYCOL (UNII: 6DC9Q167V3)
DIAZOLIDINYL UREA (UNII: H5RIZ3MPW4)
SUCROSE (UNII: C151H8M554)
METHYLPARABEN (UNII: A2I8C7HI9T)
SERINE (UNII: 452VLY9402)
ARGININE (UNII: 94ZLA3W45F)
PIDOLIC ACID (UNII: SZB83O1W42)
BUTYLATED HYDROXYTOLUENE (UNII: 1P9D0Z171K)
MACROCYSTIS PYRIFERA (UNII: K31S3OG5C4)
YEAST (UNII: 3NY3SM6B8U)
ALANINE (UNII: OF5P57N2ZX)
PROPYLPARABEN (UNII: Z8IX2SC1OH)
THREONINE (UNII: 2ZD004190S)
POLYSORBATE 20 (UNII: 7T1F30V5YH)
SODIUM SUCCINATE ANHYDROUS (UNII: V8ZGC8ISR3)
PALMITOYL PENTAPEPTIDE-4 (UNII: KK181SM5JG)
TITANIUM DIOXIDE (UNII: 15FIX9V2JP)
FERRIC OXIDE RED (UNII: 1K09F3G675)

#	Item Code	Package Description	Marketing Start Date	Marketing End Date
Packaging
1	NDC:13537-257-02	1 in 1 BOX
1	NDC:13537-257-01	30 g in 1 BOTTLE

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

LBEL REPLENISHING FOUNDATION SPF 14 (CLAIRE 2) - BEIGE
octinoxate liquid

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC:13537-258
Route of Administration	TOPICAL

Ingredient Name	Basis of Strength	Strength
Active Ingredient/Active Moiety
Octinoxate (UNII: 4Y5P7MUD51) (Octinoxate - UNII:4Y5P7MUD51)	Octinoxate	0.045 g in 1 g

Ingredient Name	Strength
Inactive Ingredients
WATER (UNII: 059QF0KO0R)
CYCLOMETHICONE 5 (UNII: 0THT5PCI0R)
BUTYLENE GLYCOL (UNII: 3XUS85K0RA)
CYCLOMETHICONE 6 (UNII: XHK3U310BA)
PHENYL TRIMETHICONE (UNII: DR0K5NOJ4R)
POLYGLYCERYL-4 ISOSTEARATE (UNII: 820DPX33S7)
HEXYL LAURATE (UNII: 4CG9F9W01Q)
MANNITOL (UNII: 3OWL53L36A)
GLYCERIN (UNII: PDC6A3C0OX)
PEG/PPG-18/18 DIMETHICONE (UNII: 9H0AO7T794)
DISTEARDIMONIUM HECTORITE (UNII: X687XDK09L)
SODIUM CHLORIDE (UNII: 451W47IQ8X)
DIMETHICONE (UNII: 92RU3N3Y1O)
PROPYLENE GLYCOL (UNII: 6DC9Q167V3)
DIAZOLIDINYL UREA (UNII: H5RIZ3MPW4)
SUCROSE (UNII: C151H8M554)
METHYLPARABEN (UNII: A2I8C7HI9T)
SERINE (UNII: 452VLY9402)
ARGININE (UNII: 94ZLA3W45F)
PIDOLIC ACID (UNII: SZB83O1W42)
BUTYLATED HYDROXYTOLUENE (UNII: 1P9D0Z171K)
MACROCYSTIS PYRIFERA (UNII: K31S3OG5C4)
YEAST (UNII: 3NY3SM6B8U)
ALANINE (UNII: OF5P57N2ZX)
PROPYLPARABEN (UNII: Z8IX2SC1OH)
THREONINE (UNII: 2ZD004190S)
POLYSORBATE 20 (UNII: 7T1F30V5YH)
SODIUM SUCCINATE ANHYDROUS (UNII: V8ZGC8ISR3)
PALMITOYL PENTAPEPTIDE-4 (UNII: KK181SM5JG)
TITANIUM DIOXIDE (UNII: 15FIX9V2JP)
FERRIC OXIDE RED (UNII: 1K09F3G675)

#	Item Code	Package Description	Marketing Start Date	Marketing End Date
Packaging
1	NDC:13537-258-04	1 in 1 BOX
1	NDC:13537-258-03	30 g in 1 BOTTLE

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

LBEL REPLENISHING FOUNDATION SPF 14 (CLAIRE 3) - BEIGE
octinoxate liquid

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC:13537-259
Route of Administration	TOPICAL

Ingredient Name	Basis of Strength	Strength
Active Ingredient/Active Moiety
Octinoxate (UNII: 4Y5P7MUD51) (Octinoxate - UNII:4Y5P7MUD51)	Octinoxate	0.045 g in 1 g

Ingredient Name	Strength
Inactive Ingredients
WATER (UNII: 059QF0KO0R)
CYCLOMETHICONE 5 (UNII: 0THT5PCI0R)
BUTYLENE GLYCOL (UNII: 3XUS85K0RA)
CYCLOMETHICONE 6 (UNII: XHK3U310BA)
PHENYL TRIMETHICONE (UNII: DR0K5NOJ4R)
POLYGLYCERYL-4 ISOSTEARATE (UNII: 820DPX33S7)
HEXYL LAURATE (UNII: 4CG9F9W01Q)
MANNITOL (UNII: 3OWL53L36A)
GLYCERIN (UNII: PDC6A3C0OX)
PEG/PPG-18/18 DIMETHICONE (UNII: 9H0AO7T794)
DISTEARDIMONIUM HECTORITE (UNII: X687XDK09L)
SODIUM CHLORIDE (UNII: 451W47IQ8X)
DIMETHICONE (UNII: 92RU3N3Y1O)
PROPYLENE GLYCOL (UNII: 6DC9Q167V3)
DIAZOLIDINYL UREA (UNII: H5RIZ3MPW4)
SUCROSE (UNII: C151H8M554)
METHYLPARABEN (UNII: A2I8C7HI9T)
SERINE (UNII: 452VLY9402)
ARGININE (UNII: 94ZLA3W45F)
PIDOLIC ACID (UNII: SZB83O1W42)
BUTYLATED HYDROXYTOLUENE (UNII: 1P9D0Z171K)
MACROCYSTIS PYRIFERA (UNII: K31S3OG5C4)
YEAST (UNII: 3NY3SM6B8U)
ALANINE (UNII: OF5P57N2ZX)
PROPYLPARABEN (UNII: Z8IX2SC1OH)
THREONINE (UNII: 2ZD004190S)
POLYSORBATE 20 (UNII: 7T1F30V5YH)
SODIUM SUCCINATE ANHYDROUS (UNII: V8ZGC8ISR3)
PALMITOYL PENTAPEPTIDE-4 (UNII: KK181SM5JG)
TITANIUM DIOXIDE (UNII: 15FIX9V2JP)
FERRIC OXIDE RED (UNII: 1K09F3G675)

#	Item Code	Package Description	Marketing Start Date	Marketing End Date
Packaging
1	NDC:13537-259-06	1 in 1 BOX
1	NDC:13537-259-05	30 g in 1 BOTTLE

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

LBEL REPLENISHING FOUNDATION SPF 14 (CLAIRE 4) - BEIGE
octinoxate liquid

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC:13537-260
Route of Administration	TOPICAL

Ingredient Name	Basis of Strength	Strength
Active Ingredient/Active Moiety
Octinoxate (UNII: 4Y5P7MUD51) (Octinoxate - UNII:4Y5P7MUD51)	Octinoxate	0.045 g in 1 g

Ingredient Name	Strength
Inactive Ingredients
WATER (UNII: 059QF0KO0R)
CYCLOMETHICONE 5 (UNII: 0THT5PCI0R)
BUTYLENE GLYCOL (UNII: 3XUS85K0RA)
CYCLOMETHICONE 6 (UNII: XHK3U310BA)
PHENYL TRIMETHICONE (UNII: DR0K5NOJ4R)
POLYGLYCERYL-4 ISOSTEARATE (UNII: 820DPX33S7)
HEXYL LAURATE (UNII: 4CG9F9W01Q)
MANNITOL (UNII: 3OWL53L36A)
GLYCERIN (UNII: PDC6A3C0OX)
PEG/PPG-18/18 DIMETHICONE (UNII: 9H0AO7T794)
DISTEARDIMONIUM HECTORITE (UNII: X687XDK09L)
SODIUM CHLORIDE (UNII: 451W47IQ8X)
DIMETHICONE (UNII: 92RU3N3Y1O)
PROPYLENE GLYCOL (UNII: 6DC9Q167V3)
DIAZOLIDINYL UREA (UNII: H5RIZ3MPW4)
SUCROSE (UNII: C151H8M554)
METHYLPARABEN (UNII: A2I8C7HI9T)
SERINE (UNII: 452VLY9402)
ARGININE (UNII: 94ZLA3W45F)
PIDOLIC ACID (UNII: SZB83O1W42)
BUTYLATED HYDROXYTOLUENE (UNII: 1P9D0Z171K)
MACROCYSTIS PYRIFERA (UNII: K31S3OG5C4)
YEAST (UNII: 3NY3SM6B8U)
ALANINE (UNII: OF5P57N2ZX)
PROPYLPARABEN (UNII: Z8IX2SC1OH)
THREONINE (UNII: 2ZD004190S)
POLYSORBATE 20 (UNII: 7T1F30V5YH)
SODIUM SUCCINATE ANHYDROUS (UNII: V8ZGC8ISR3)
PALMITOYL PENTAPEPTIDE-4 (UNII: KK181SM5JG)
TITANIUM DIOXIDE (UNII: 15FIX9V2JP)
FERRIC OXIDE RED (UNII: 1K09F3G675)

#	Item Code	Package Description	Marketing Start Date	Marketing End Date
Packaging
1	NDC:13537-260-08	1 in 1 BOX
1	NDC:13537-260-07	30 g in 1 BOTTLE

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

LBEL REPLENISHING FOUNDATION SPF 14 (MEDIUM 5) - BROWN
octinoxate liquid

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC:13537-298
Route of Administration	TOPICAL

Ingredient Name	Basis of Strength	Strength
Active Ingredient/Active Moiety
Octinoxate (UNII: 4Y5P7MUD51) (Octinoxate - UNII:4Y5P7MUD51)	Octinoxate	0.045 g in 1 g

Ingredient Name	Strength
Inactive Ingredients
WATER (UNII: 059QF0KO0R)
CYCLOMETHICONE 5 (UNII: 0THT5PCI0R)
BUTYLENE GLYCOL (UNII: 3XUS85K0RA)
CYCLOMETHICONE 6 (UNII: XHK3U310BA)
PHENYL TRIMETHICONE (UNII: DR0K5NOJ4R)
POLYGLYCERYL-4 ISOSTEARATE (UNII: 820DPX33S7)
HEXYL LAURATE (UNII: 4CG9F9W01Q)
MANNITOL (UNII: 3OWL53L36A)
GLYCERIN (UNII: PDC6A3C0OX)
PEG/PPG-18/18 DIMETHICONE (UNII: 9H0AO7T794)
DISTEARDIMONIUM HECTORITE (UNII: X687XDK09L)
SODIUM CHLORIDE (UNII: 451W47IQ8X)
DIMETHICONE (UNII: 92RU3N3Y1O)
PROPYLENE GLYCOL (UNII: 6DC9Q167V3)
DIAZOLIDINYL UREA (UNII: H5RIZ3MPW4)
SUCROSE (UNII: C151H8M554)
METHYLPARABEN (UNII: A2I8C7HI9T)
SERINE (UNII: 452VLY9402)
ARGININE (UNII: 94ZLA3W45F)
PIDOLIC ACID (UNII: SZB83O1W42)
BUTYLATED HYDROXYTOLUENE (UNII: 1P9D0Z171K)
MACROCYSTIS PYRIFERA (UNII: K31S3OG5C4)
YEAST (UNII: 3NY3SM6B8U)
ALANINE (UNII: OF5P57N2ZX)
PROPYLPARABEN (UNII: Z8IX2SC1OH)
THREONINE (UNII: 2ZD004190S)
POLYSORBATE 20 (UNII: 7T1F30V5YH)
SODIUM SUCCINATE ANHYDROUS (UNII: V8ZGC8ISR3)
PALMITOYL PENTAPEPTIDE-4 (UNII: KK181SM5JG)
TITANIUM DIOXIDE (UNII: 15FIX9V2JP)
FERRIC OXIDE RED (UNII: 1K09F3G675)

#	Item Code	Package Description	Marketing Start Date	Marketing End Date
Packaging
1	NDC:13537-298-10	1 in 1 BOX
1	NDC:13537-298-09	30 g in 1 BOTTLE

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

LBEL REPLENISHING FOUNDATION SPF 14 (MEDIUM 6) - BROWN
octinoxate liquid

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC:13537-262
Route of Administration	TOPICAL

Ingredient Name	Basis of Strength	Strength
Active Ingredient/Active Moiety
Octinoxate (UNII: 4Y5P7MUD51) (Octinoxate - UNII:4Y5P7MUD51)	Octinoxate	0.045 g in 1 g

Ingredient Name	Strength
Inactive Ingredients
WATER (UNII: 059QF0KO0R)
CYCLOMETHICONE 5 (UNII: 0THT5PCI0R)
BUTYLENE GLYCOL (UNII: 3XUS85K0RA)
CYCLOMETHICONE 6 (UNII: XHK3U310BA)
PHENYL TRIMETHICONE (UNII: DR0K5NOJ4R)
POLYGLYCERYL-4 ISOSTEARATE (UNII: 820DPX33S7)
HEXYL LAURATE (UNII: 4CG9F9W01Q)
MANNITOL (UNII: 3OWL53L36A)
GLYCERIN (UNII: PDC6A3C0OX)
PEG/PPG-18/18 DIMETHICONE (UNII: 9H0AO7T794)
DISTEARDIMONIUM HECTORITE (UNII: X687XDK09L)
SODIUM CHLORIDE (UNII: 451W47IQ8X)
DIMETHICONE (UNII: 92RU3N3Y1O)
PROPYLENE GLYCOL (UNII: 6DC9Q167V3)
DIAZOLIDINYL UREA (UNII: H5RIZ3MPW4)
SUCROSE (UNII: C151H8M554)
METHYLPARABEN (UNII: A2I8C7HI9T)
SERINE (UNII: 452VLY9402)
ARGININE (UNII: 94ZLA3W45F)
PIDOLIC ACID (UNII: SZB83O1W42)
BUTYLATED HYDROXYTOLUENE (UNII: 1P9D0Z171K)
MACROCYSTIS PYRIFERA (UNII: K31S3OG5C4)
YEAST (UNII: 3NY3SM6B8U)
ALANINE (UNII: OF5P57N2ZX)
PROPYLPARABEN (UNII: Z8IX2SC1OH)
THREONINE (UNII: 2ZD004190S)
POLYSORBATE 20 (UNII: 7T1F30V5YH)
SODIUM SUCCINATE ANHYDROUS (UNII: V8ZGC8ISR3)
PALMITOYL PENTAPEPTIDE-4 (UNII: KK181SM5JG)
TITANIUM DIOXIDE (UNII: 15FIX9V2JP)
FERRIC OXIDE RED (UNII: 1K09F3G675)

#	Item Code	Package Description	Marketing Start Date	Marketing End Date
Packaging
1	NDC:13537-262-12	1 in 1 BOX
1	NDC:13537-262-11	30 g in 1 BOTTLE

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

LBEL REPLENISHING FOUNDATION SPF 14 (MEDIUM 7) - BROWN
octinoxate liquid

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC:13537-263
Route of Administration	TOPICAL

Ingredient Name	Basis of Strength	Strength
Active Ingredient/Active Moiety
Octinoxate (UNII: 4Y5P7MUD51) (Octinoxate - UNII:4Y5P7MUD51)	Octinoxate	0.045 g in 1 g

Ingredient Name	Strength
Inactive Ingredients
WATER (UNII: 059QF0KO0R)
CYCLOMETHICONE 5 (UNII: 0THT5PCI0R)
BUTYLENE GLYCOL (UNII: 3XUS85K0RA)
CYCLOMETHICONE 6 (UNII: XHK3U310BA)
PHENYL TRIMETHICONE (UNII: DR0K5NOJ4R)
POLYGLYCERYL-4 ISOSTEARATE (UNII: 820DPX33S7)
HEXYL LAURATE (UNII: 4CG9F9W01Q)
MANNITOL (UNII: 3OWL53L36A)
GLYCERIN (UNII: PDC6A3C0OX)
PEG/PPG-18/18 DIMETHICONE (UNII: 9H0AO7T794)
DISTEARDIMONIUM HECTORITE (UNII: X687XDK09L)
SODIUM CHLORIDE (UNII: 451W47IQ8X)
DIMETHICONE (UNII: 92RU3N3Y1O)
PROPYLENE GLYCOL (UNII: 6DC9Q167V3)
DIAZOLIDINYL UREA (UNII: H5RIZ3MPW4)
SUCROSE (UNII: C151H8M554)
METHYLPARABEN (UNII: A2I8C7HI9T)
SERINE (UNII: 452VLY9402)
ARGININE (UNII: 94ZLA3W45F)
PIDOLIC ACID (UNII: SZB83O1W42)
BUTYLATED HYDROXYTOLUENE (UNII: 1P9D0Z171K)
MACROCYSTIS PYRIFERA (UNII: K31S3OG5C4)
YEAST (UNII: 3NY3SM6B8U)
ALANINE (UNII: OF5P57N2ZX)
PROPYLPARABEN (UNII: Z8IX2SC1OH)
THREONINE (UNII: 2ZD004190S)
POLYSORBATE 20 (UNII: 7T1F30V5YH)
SODIUM SUCCINATE ANHYDROUS (UNII: V8ZGC8ISR3)
PALMITOYL PENTAPEPTIDE-4 (UNII: KK181SM5JG)
TITANIUM DIOXIDE (UNII: 15FIX9V2JP)
FERRIC OXIDE RED (UNII: 1K09F3G675)

#	Item Code	Package Description	Marketing Start Date	Marketing End Date
Packaging
1	NDC:13537-263-14	1 in 1 BOX
1	NDC:13537-263-13	30 g in 1 BOTTLE

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

LBEL REPLENISHING FOUNDATION SPF 14 (OBSCURE 8) - BROWN
octinoxate liquid

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC:13537-264
Route of Administration	TOPICAL

Ingredient Name	Basis of Strength	Strength
Active Ingredient/Active Moiety
Octinoxate (UNII: 4Y5P7MUD51) (Octinoxate - UNII:4Y5P7MUD51)	Octinoxate	0.045 g in 1 g

Ingredient Name	Strength
Inactive Ingredients
WATER (UNII: 059QF0KO0R)
CYCLOMETHICONE 5 (UNII: 0THT5PCI0R)
BUTYLENE GLYCOL (UNII: 3XUS85K0RA)
CYCLOMETHICONE 6 (UNII: XHK3U310BA)
PHENYL TRIMETHICONE (UNII: DR0K5NOJ4R)
POLYGLYCERYL-4 ISOSTEARATE (UNII: 820DPX33S7)
HEXYL LAURATE (UNII: 4CG9F9W01Q)
MANNITOL (UNII: 3OWL53L36A)
GLYCERIN (UNII: PDC6A3C0OX)
PEG/PPG-18/18 DIMETHICONE (UNII: 9H0AO7T794)
DISTEARDIMONIUM HECTORITE (UNII: X687XDK09L)
SODIUM CHLORIDE (UNII: 451W47IQ8X)
DIMETHICONE (UNII: 92RU3N3Y1O)
PROPYLENE GLYCOL (UNII: 6DC9Q167V3)
DIAZOLIDINYL UREA (UNII: H5RIZ3MPW4)
SUCROSE (UNII: C151H8M554)
METHYLPARABEN (UNII: A2I8C7HI9T)
SERINE (UNII: 452VLY9402)
ARGININE (UNII: 94ZLA3W45F)
PIDOLIC ACID (UNII: SZB83O1W42)
BUTYLATED HYDROXYTOLUENE (UNII: 1P9D0Z171K)
MACROCYSTIS PYRIFERA (UNII: K31S3OG5C4)
YEAST (UNII: 3NY3SM6B8U)
ALANINE (UNII: OF5P57N2ZX)
PROPYLPARABEN (UNII: Z8IX2SC1OH)
THREONINE (UNII: 2ZD004190S)
POLYSORBATE 20 (UNII: 7T1F30V5YH)
SODIUM SUCCINATE ANHYDROUS (UNII: V8ZGC8ISR3)
PALMITOYL PENTAPEPTIDE-4 (UNII: KK181SM5JG)
TITANIUM DIOXIDE (UNII: 15FIX9V2JP)
FERRIC OXIDE RED (UNII: 1K09F3G675)

#	Item Code	Package Description	Marketing Start Date	Marketing End Date
Packaging
1	NDC:13537-264-16	1 in 1 BOX
1	NDC:13537-264-15	30 g in 1 BOTTLE

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

LBEL REPLENISHING FOUNDATION SPF 14 (OBSCURE 9) - BROWN
octinoxate liquid

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC:13537-265
Route of Administration	TOPICAL

Ingredient Name	Basis of Strength	Strength
Active Ingredient/Active Moiety
Octinoxate (UNII: 4Y5P7MUD51) (Octinoxate - UNII:4Y5P7MUD51)	Octinoxate	0.045 g in 1 g

Ingredient Name	Strength
Inactive Ingredients
WATER (UNII: 059QF0KO0R)
CYCLOMETHICONE 5 (UNII: 0THT5PCI0R)
BUTYLENE GLYCOL (UNII: 3XUS85K0RA)
CYCLOMETHICONE 6 (UNII: XHK3U310BA)
PHENYL TRIMETHICONE (UNII: DR0K5NOJ4R)
POLYGLYCERYL-4 ISOSTEARATE (UNII: 820DPX33S7)
HEXYL LAURATE (UNII: 4CG9F9W01Q)
MANNITOL (UNII: 3OWL53L36A)
GLYCERIN (UNII: PDC6A3C0OX)
PEG/PPG-18/18 DIMETHICONE (UNII: 9H0AO7T794)
DISTEARDIMONIUM HECTORITE (UNII: X687XDK09L)
SODIUM CHLORIDE (UNII: 451W47IQ8X)
DIMETHICONE (UNII: 92RU3N3Y1O)
PROPYLENE GLYCOL (UNII: 6DC9Q167V3)
DIAZOLIDINYL UREA (UNII: H5RIZ3MPW4)
SUCROSE (UNII: C151H8M554)
METHYLPARABEN (UNII: A2I8C7HI9T)
SERINE (UNII: 452VLY9402)
ARGININE (UNII: 94ZLA3W45F)
PIDOLIC ACID (UNII: SZB83O1W42)
BUTYLATED HYDROXYTOLUENE (UNII: 1P9D0Z171K)
MACROCYSTIS PYRIFERA (UNII: K31S3OG5C4)
YEAST (UNII: 3NY3SM6B8U)
ALANINE (UNII: OF5P57N2ZX)
PROPYLPARABEN (UNII: Z8IX2SC1OH)
THREONINE (UNII: 2ZD004190S)
POLYSORBATE 20 (UNII: 7T1F30V5YH)
SODIUM SUCCINATE ANHYDROUS (UNII: V8ZGC8ISR3)
PALMITOYL PENTAPEPTIDE-4 (UNII: KK181SM5JG)
TITANIUM DIOXIDE (UNII: 15FIX9V2JP)
FERRIC OXIDE RED (UNII: 1K09F3G675)

#	Item Code	Package Description	Marketing Start Date	Marketing End Date
Packaging
1	NDC:13537-265-18	1 in 1 BOX
1	NDC:13537-265-17	30 g in 1 BOTTLE

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 Corporation LTD (602751344)

Name	Address	ID/FEI	Business Operations
Establishment
Bel Star S.A. (Colombia)		880160197	MANUFACTURE(13537-257, 13537-258, 13537-259, 13537-260, 13537-298, 13537-262, 13537-263, 13537-264, 13537-265)

Revised: 12/2013

Document Id: 5a7e90d6-5692-4e0f-99c1-94f311dad88a

Set id: a6a4ec83-ee52-4140-9f2f-8e9e12738ab3

Version: 1

Effective Time: 20131217

Ventura Corporation LTD