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

LBEL REPLENISHING FOUNDATION SPF 14 by

Drug Labeling and Warnings

LBEL REPLENISHING FOUNDATION SPF 14 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 (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.

SPL UNCLASSIFIED SECTION

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 2 - BEIGE

L'BEL

replenishing foundation SPF 14

Net Weight 1 oz. (30 g)

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 4 - BEIGE

L'BEL

replenishing foundation SPF 14

Net Weight 1 oz. (30 g)

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 6 - BROWN

L'BEL

replenishing foundation SPF 14

Net Weight 1 oz. (30 g)

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 - Obscure 8 - BROWN

L'BEL

replenishing foundation SPF 14

Net Weight 1 oz. (30 g)

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

L'BEL

replenishing foundation SPF 14

Net Weight 1 oz. (30 g)

INGREDIENTS AND APPEARANCE

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

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

Inactive Ingredients
Ingredient Name	Strength
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)

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

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
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

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

Inactive Ingredients
Ingredient Name	Strength
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)

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

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
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

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

Inactive Ingredients
Ingredient Name	Strength
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)

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

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
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

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

Inactive Ingredients
Ingredient Name	Strength
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)

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

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
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

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

Inactive Ingredients
Ingredient Name	Strength
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)

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

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
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

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

Inactive Ingredients
Ingredient Name	Strength
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)

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

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
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

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

Inactive Ingredients
Ingredient Name	Strength
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)

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

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
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

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

Inactive Ingredients
Ingredient Name	Strength
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)

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

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
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

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

Inactive Ingredients
Ingredient Name	Strength
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)

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

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(13537-257, 13537-258, 13537-259, 13537-260, 13537-298, 13537-262, 13537-263, 13537-264, 13537-265)