LBEL MAXIMUM COMFORT AND LONG-LASTING FOUNDATION SPF 10 (CLAIRE 1) - BEIGE- zinc oxide liquid
LBEL MAXIMUM COMFORT AND LONG-LASTING FOUNDATION SPF 10 (CLAIRE 2) - BEIGE- zinc oxide liquid
LBEL MAXIMUM COMFORT AND LONG-LASTING FOUNDATION SPF 10 (CLAIRE 3) - BEIGE- zinc oxide liquid
LBEL MAXIMUM COMFORT AND LONG-LASTING FOUNDATION SPF 10 (CLAIRE 4) - BEIGE- zinc oxide liquid
LBEL MAXIMUM COMFORT AND LONG-LASTING FOUNDATION SPF 10 (MEDIUM 5) - BROWN- zinc oxide liquid
LBEL MAXIMUM COMFORT AND LONG-LASTING FOUNDATION SPF 10 (MEDIUM 6) - BROWN- zinc oxide liquid
LBEL MAXIMUM COMFORT AND LONG-LASTING FOUNDATION SPF 10 (MEDIUM 7) - BROWN- zinc oxide liquid
LBEL MAXIMUM COMFORT AND LONG-LASTING FOUNDATION SPF 10 (OBSCURE 8) - BROWN- zinc oxide liquid
LBEL MAXIMUM COMFORT AND LONG-LASTING FOUNDATION SPF 10 (OBSCURE 9) - BROWN- zinc oxide 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 MAXIMUM COMFORT AND LONG-LASTING FOUNDATION SPF 10

Drug Facts

Active Ingredients

Zinc oxide 1.6%

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

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, trimethylsiloxysilicate, dimethicone, polymethyl methacrylate, peg/ppg-18/18 dimethicone, cyclohexasiloxane, methyl methacrylate crosspolymer, sodium chloride, bis-hydroxyethoxypropyl dimethicone, bis-peg-18 methyl ether dimethyl silane, peg/ppg-19/19 dimethicone, glycerin, oleth-5, phenyl trimethicone, hydrolyzed soy protein, propylene glycol, silica silylate, mica, methylparaben, triethoxycaprylylsilane, propylparaben, tocopheryl acetate, phenoxyethanol, fragrance, butylparaben, ethylparaben, silica, isobutylparaben.

May contain

Titanium dioxide, iron oxides, iron oxides, iron oxides, bismuth oxychloride.

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

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

EFFET
PARFAIT

maximum comfort
and long-lasting
foundation
SPF 10

30 ml e (1 fl.oz.)

L'BEL

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

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

EFFET
PARFAIT

maximum comfort
and long-lasting
foundation
SPF 10

30 ml e (1 fl.oz.)

L'BEL

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

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

EFFET
PARFAIT

maximum comfort
and long-lasting
foundation
SPF 10

30 ml e (1 fl.oz.)

L'BEL

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

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

EFFET
PARFAIT

maximum comfort
and long-lasting
foundation
SPF 10

30 ml e (1 fl.oz.)

L'BEL

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

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

EFFET
PARFAIT

maximum comfort
and long-lasting
foundation
SPF 10

30 ml e (1 fl.oz.)

L'BEL

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

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

EFFET
PARFAIT

maximum comfort
and long-lasting
foundation
SPF 10

30 ml e (1 fl.oz.)

L'BEL

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

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

EFFET
PARFAIT

maximum comfort
and long-lasting
foundation
SPF 10

30 ml e (1 fl.oz.)

L'BEL

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

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

EFFET
PARFAIT

maximum comfort
and long-lasting
foundation
SPF 10

30 ml e (1 fl.oz.)

L'BEL

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

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

EFFET
PARFAIT

maximum comfort
and long-lasting
foundation
SPF 10

30 ml e (1 fl.oz.)

L'BEL

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

LBEL MAXIMUM COMFORT AND LONG-LASTING FOUNDATION SPF 10 (CLAIRE 1) - BEIGE
zinc oxide liquid

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC:14783-266
Route of Administration	TOPICAL

Ingredient Name	Basis of Strength	Strength
Active Ingredient/Active Moiety
Zinc oxide (UNII: SOI2LOH54Z) (Zinc oxide - UNII:SOI2LOH54Z)	Zinc oxide	.016 g in 1 mL

Ingredient Name	Strength
Inactive Ingredients
water (UNII: 059QF0KO0R)
cyclomethicone 5 (UNII: 0THT5PCI0R)
dimethicone (UNII: 92RU3N3Y1O)
peg/ppg-18/18 dimethicone (UNII: 9H0AO7T794)
cyclomethicone 6 (UNII: XHK3U310BA)
sodium chloride (UNII: 451W47IQ8X)
bis-peg-18 methyl ether dimethyl silane (UNII: OEB4R3WW9C)
peg/ppg-19/19 dimethicone (UNII: EHH90CO7TL)
glycerin (UNII: PDC6A3C0OX)
oleth-5 (UNII: 1GH33785AY)
phenyl trimethicone (UNII: DR0K5NOJ4R)
propylene glycol (UNII: 6DC9Q167V3)
mica (UNII: V8A1AW0880)
methylparaben (UNII: A2I8C7HI9T)
triethoxycaprylylsilane (UNII: LDC331P08E)
propylparaben (UNII: Z8IX2SC1OH)
.alpha.-tocopherol acetate (UNII: 9E8X80D2L0)
phenoxyethanol (UNII: HIE492ZZ3T)
butylparaben (UNII: 3QPI1U3FV8)
ethylparaben (UNII: 14255EXE39)
silicon dioxide (UNII: ETJ7Z6XBU4)
isobutylparaben (UNII: 0QQJ25X58G)
titanium dioxide (UNII: 15FIX9V2JP)
FERRIC OXIDE RED (UNII: 1K09F3G675)
bismuth oxychloride (UNII: 4ZR792I587)

#	Item Code	Package Description	Marketing Start Date	Marketing End Date
Packaging
1	NDC:14783-266-02	1 in 1 BOX
1	NDC:14783-266-01	30 mL in 1 BOTTLE, PLASTIC
2	NDC:14783-266-04	1 in 1 BOX
2	NDC:14783-266-03	3 mL in 1 TUBE

Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
Marketing Information
OTC MONOGRAPH FINAL	part352	12/16/2013

LBEL MAXIMUM COMFORT AND LONG-LASTING FOUNDATION SPF 10 (CLAIRE 2) - BEIGE
zinc oxide liquid

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC:14783-267
Route of Administration	TOPICAL

Ingredient Name	Basis of Strength	Strength
Active Ingredient/Active Moiety
Zinc oxide (UNII: SOI2LOH54Z) (Zinc oxide - UNII:SOI2LOH54Z)	Zinc oxide	.016 g in 1 mL

Ingredient Name	Strength
Inactive Ingredients
water (UNII: 059QF0KO0R)
cyclomethicone 5 (UNII: 0THT5PCI0R)
dimethicone (UNII: 92RU3N3Y1O)
peg/ppg-18/18 dimethicone (UNII: 9H0AO7T794)
cyclomethicone 6 (UNII: XHK3U310BA)
sodium chloride (UNII: 451W47IQ8X)
bis-peg-18 methyl ether dimethyl silane (UNII: OEB4R3WW9C)
peg/ppg-19/19 dimethicone (UNII: EHH90CO7TL)
glycerin (UNII: PDC6A3C0OX)
oleth-5 (UNII: 1GH33785AY)
phenyl trimethicone (UNII: DR0K5NOJ4R)
propylene glycol (UNII: 6DC9Q167V3)
mica (UNII: V8A1AW0880)
methylparaben (UNII: A2I8C7HI9T)
triethoxycaprylylsilane (UNII: LDC331P08E)
propylparaben (UNII: Z8IX2SC1OH)
.alpha.-tocopherol acetate (UNII: 9E8X80D2L0)
phenoxyethanol (UNII: HIE492ZZ3T)
butylparaben (UNII: 3QPI1U3FV8)
ethylparaben (UNII: 14255EXE39)
silicon dioxide (UNII: ETJ7Z6XBU4)
isobutylparaben (UNII: 0QQJ25X58G)
titanium dioxide (UNII: 15FIX9V2JP)
FERRIC OXIDE RED (UNII: 1K09F3G675)
bismuth oxychloride (UNII: 4ZR792I587)

#	Item Code	Package Description	Marketing Start Date	Marketing End Date
Packaging
1	NDC:14783-267-06	1 in 1 BOX
1	NDC:14783-267-05	30 mL in 1 BOTTLE, PLASTIC
2	NDC:14783-267-08	1 in 1 BOX
2	NDC:14783-267-07	3 mL in 1 TUBE

Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
Marketing Information
OTC MONOGRAPH FINAL	part352	12/16/2013

LBEL MAXIMUM COMFORT AND LONG-LASTING FOUNDATION SPF 10 (CLAIRE 3) - BEIGE
zinc oxide liquid

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC:14783-268
Route of Administration	TOPICAL

Ingredient Name	Basis of Strength	Strength
Active Ingredient/Active Moiety
Zinc oxide (UNII: SOI2LOH54Z) (Zinc oxide - UNII:SOI2LOH54Z)	Zinc oxide	.016 g in 1 mL

Ingredient Name	Strength
Inactive Ingredients
water (UNII: 059QF0KO0R)
cyclomethicone 5 (UNII: 0THT5PCI0R)
dimethicone (UNII: 92RU3N3Y1O)
peg/ppg-18/18 dimethicone (UNII: 9H0AO7T794)
cyclomethicone 6 (UNII: XHK3U310BA)
sodium chloride (UNII: 451W47IQ8X)
bis-peg-18 methyl ether dimethyl silane (UNII: OEB4R3WW9C)
peg/ppg-19/19 dimethicone (UNII: EHH90CO7TL)
glycerin (UNII: PDC6A3C0OX)
oleth-5 (UNII: 1GH33785AY)
phenyl trimethicone (UNII: DR0K5NOJ4R)
propylene glycol (UNII: 6DC9Q167V3)
mica (UNII: V8A1AW0880)
methylparaben (UNII: A2I8C7HI9T)
triethoxycaprylylsilane (UNII: LDC331P08E)
propylparaben (UNII: Z8IX2SC1OH)
.alpha.-tocopherol acetate (UNII: 9E8X80D2L0)
phenoxyethanol (UNII: HIE492ZZ3T)
butylparaben (UNII: 3QPI1U3FV8)
ethylparaben (UNII: 14255EXE39)
silicon dioxide (UNII: ETJ7Z6XBU4)
isobutylparaben (UNII: 0QQJ25X58G)
titanium dioxide (UNII: 15FIX9V2JP)
FERRIC OXIDE RED (UNII: 1K09F3G675)
bismuth oxychloride (UNII: 4ZR792I587)

#	Item Code	Package Description	Marketing Start Date	Marketing End Date
Packaging
1	NDC:14783-268-10	1 in 1 BOX
1	NDC:14783-268-09	30 mL in 1 BOTTLE, PLASTIC
2	NDC:14783-268-12	1 in 1 BOX
2	NDC:14783-268-11	3 mL in 1 TUBE

Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
Marketing Information
OTC MONOGRAPH FINAL	part352	12/16/2013

LBEL MAXIMUM COMFORT AND LONG-LASTING FOUNDATION SPF 10 (CLAIRE 4) - BEIGE
zinc oxide liquid

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC:14783-269
Route of Administration	TOPICAL

Ingredient Name	Basis of Strength	Strength
Active Ingredient/Active Moiety
Zinc oxide (UNII: SOI2LOH54Z) (Zinc oxide - UNII:SOI2LOH54Z)	Zinc oxide	.016 g in 1 mL

Ingredient Name	Strength
Inactive Ingredients
water (UNII: 059QF0KO0R)
cyclomethicone 5 (UNII: 0THT5PCI0R)
dimethicone (UNII: 92RU3N3Y1O)
peg/ppg-18/18 dimethicone (UNII: 9H0AO7T794)
cyclomethicone 6 (UNII: XHK3U310BA)
sodium chloride (UNII: 451W47IQ8X)
bis-peg-18 methyl ether dimethyl silane (UNII: OEB4R3WW9C)
peg/ppg-19/19 dimethicone (UNII: EHH90CO7TL)
glycerin (UNII: PDC6A3C0OX)
oleth-5 (UNII: 1GH33785AY)
phenyl trimethicone (UNII: DR0K5NOJ4R)
propylene glycol (UNII: 6DC9Q167V3)
mica (UNII: V8A1AW0880)
methylparaben (UNII: A2I8C7HI9T)
triethoxycaprylylsilane (UNII: LDC331P08E)
propylparaben (UNII: Z8IX2SC1OH)
.alpha.-tocopherol acetate (UNII: 9E8X80D2L0)
phenoxyethanol (UNII: HIE492ZZ3T)
butylparaben (UNII: 3QPI1U3FV8)
ethylparaben (UNII: 14255EXE39)
silicon dioxide (UNII: ETJ7Z6XBU4)
isobutylparaben (UNII: 0QQJ25X58G)
titanium dioxide (UNII: 15FIX9V2JP)
FERRIC OXIDE RED (UNII: 1K09F3G675)
bismuth oxychloride (UNII: 4ZR792I587)

#	Item Code	Package Description	Marketing Start Date	Marketing End Date
Packaging
1	NDC:14783-269-14	1 in 1 BOX
1	NDC:14783-269-13	30 mL in 1 BOTTLE, PLASTIC
2	NDC:14783-269-16	1 in 1 BOX
2	NDC:14783-269-15	3 mL in 1 TUBE

Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
Marketing Information
OTC MONOGRAPH FINAL	part352	12/16/2013

LBEL MAXIMUM COMFORT AND LONG-LASTING FOUNDATION SPF 10 (MEDIUM 5) - BROWN
zinc oxide liquid

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC:14783-270
Route of Administration	TOPICAL

Ingredient Name	Basis of Strength	Strength
Active Ingredient/Active Moiety
Zinc oxide (UNII: SOI2LOH54Z) (Zinc oxide - UNII:SOI2LOH54Z)	Zinc oxide	.016 g in 1 mL

Ingredient Name	Strength
Inactive Ingredients
water (UNII: 059QF0KO0R)
cyclomethicone 5 (UNII: 0THT5PCI0R)
dimethicone (UNII: 92RU3N3Y1O)
peg/ppg-18/18 dimethicone (UNII: 9H0AO7T794)
cyclomethicone 6 (UNII: XHK3U310BA)
sodium chloride (UNII: 451W47IQ8X)
bis-peg-18 methyl ether dimethyl silane (UNII: OEB4R3WW9C)
peg/ppg-19/19 dimethicone (UNII: EHH90CO7TL)
glycerin (UNII: PDC6A3C0OX)
oleth-5 (UNII: 1GH33785AY)
phenyl trimethicone (UNII: DR0K5NOJ4R)
propylene glycol (UNII: 6DC9Q167V3)
mica (UNII: V8A1AW0880)
methylparaben (UNII: A2I8C7HI9T)
triethoxycaprylylsilane (UNII: LDC331P08E)
propylparaben (UNII: Z8IX2SC1OH)
.alpha.-tocopherol acetate (UNII: 9E8X80D2L0)
phenoxyethanol (UNII: HIE492ZZ3T)
butylparaben (UNII: 3QPI1U3FV8)
ethylparaben (UNII: 14255EXE39)
silicon dioxide (UNII: ETJ7Z6XBU4)
isobutylparaben (UNII: 0QQJ25X58G)
titanium dioxide (UNII: 15FIX9V2JP)
FERRIC OXIDE RED (UNII: 1K09F3G675)
bismuth oxychloride (UNII: 4ZR792I587)

#	Item Code	Package Description	Marketing Start Date	Marketing End Date
Packaging
1	NDC:14783-270-18	1 in 1 BOX
1	NDC:14783-270-17	30 mL in 1 BOTTLE, PLASTIC
2	NDC:14783-270-20	1 in 1 BOX
2	NDC:14783-270-19	3 mL in 1 TUBE

Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
Marketing Information
OTC MONOGRAPH FINAL	part352	12/16/2013

LBEL MAXIMUM COMFORT AND LONG-LASTING FOUNDATION SPF 10 (MEDIUM 6) - BROWN
zinc oxide liquid

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC:14783-271
Route of Administration	TOPICAL

Ingredient Name	Basis of Strength	Strength
Active Ingredient/Active Moiety
Zinc oxide (UNII: SOI2LOH54Z) (Zinc oxide - UNII:SOI2LOH54Z)	Zinc oxide	.016 g in 1 mL

Ingredient Name	Strength
Inactive Ingredients
water (UNII: 059QF0KO0R)
cyclomethicone 5 (UNII: 0THT5PCI0R)
dimethicone (UNII: 92RU3N3Y1O)
peg/ppg-18/18 dimethicone (UNII: 9H0AO7T794)
cyclomethicone 6 (UNII: XHK3U310BA)
sodium chloride (UNII: 451W47IQ8X)
bis-peg-18 methyl ether dimethyl silane (UNII: OEB4R3WW9C)
peg/ppg-19/19 dimethicone (UNII: EHH90CO7TL)
glycerin (UNII: PDC6A3C0OX)
oleth-5 (UNII: 1GH33785AY)
phenyl trimethicone (UNII: DR0K5NOJ4R)
propylene glycol (UNII: 6DC9Q167V3)
mica (UNII: V8A1AW0880)
methylparaben (UNII: A2I8C7HI9T)
triethoxycaprylylsilane (UNII: LDC331P08E)
propylparaben (UNII: Z8IX2SC1OH)
.alpha.-tocopherol acetate (UNII: 9E8X80D2L0)
phenoxyethanol (UNII: HIE492ZZ3T)
butylparaben (UNII: 3QPI1U3FV8)
ethylparaben (UNII: 14255EXE39)
silicon dioxide (UNII: ETJ7Z6XBU4)
isobutylparaben (UNII: 0QQJ25X58G)
titanium dioxide (UNII: 15FIX9V2JP)
FERRIC OXIDE RED (UNII: 1K09F3G675)
bismuth oxychloride (UNII: 4ZR792I587)

#	Item Code	Package Description	Marketing Start Date	Marketing End Date
Packaging
1	NDC:14783-271-22	1 in 1 BOX
1	NDC:14783-271-21	30 mL in 1 BOTTLE, PLASTIC
2	NDC:14783-271-24	1 in 1 BOX
2	NDC:14783-271-23	3 mL in 1 TUBE

Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
Marketing Information
OTC MONOGRAPH FINAL	part352	12/16/2013

LBEL MAXIMUM COMFORT AND LONG-LASTING FOUNDATION SPF 10 (MEDIUM 7) - BROWN
zinc oxide liquid

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC:14783-272
Route of Administration	TOPICAL

Ingredient Name	Basis of Strength	Strength
Active Ingredient/Active Moiety
Zinc oxide (UNII: SOI2LOH54Z) (Zinc oxide - UNII:SOI2LOH54Z)	Zinc oxide	.016 g in 1 mL

Ingredient Name	Strength
Inactive Ingredients
water (UNII: 059QF0KO0R)
cyclomethicone 5 (UNII: 0THT5PCI0R)
dimethicone (UNII: 92RU3N3Y1O)
peg/ppg-18/18 dimethicone (UNII: 9H0AO7T794)
cyclomethicone 6 (UNII: XHK3U310BA)
sodium chloride (UNII: 451W47IQ8X)
bis-peg-18 methyl ether dimethyl silane (UNII: OEB4R3WW9C)
peg/ppg-19/19 dimethicone (UNII: EHH90CO7TL)
glycerin (UNII: PDC6A3C0OX)
oleth-5 (UNII: 1GH33785AY)
phenyl trimethicone (UNII: DR0K5NOJ4R)
propylene glycol (UNII: 6DC9Q167V3)
mica (UNII: V8A1AW0880)
methylparaben (UNII: A2I8C7HI9T)
triethoxycaprylylsilane (UNII: LDC331P08E)
propylparaben (UNII: Z8IX2SC1OH)
.alpha.-tocopherol acetate (UNII: 9E8X80D2L0)
phenoxyethanol (UNII: HIE492ZZ3T)
butylparaben (UNII: 3QPI1U3FV8)
ethylparaben (UNII: 14255EXE39)
silicon dioxide (UNII: ETJ7Z6XBU4)
isobutylparaben (UNII: 0QQJ25X58G)
titanium dioxide (UNII: 15FIX9V2JP)
FERRIC OXIDE RED (UNII: 1K09F3G675)
bismuth oxychloride (UNII: 4ZR792I587)

#	Item Code	Package Description	Marketing Start Date	Marketing End Date
Packaging
1	NDC:14783-272-26	1 in 1 BOX
1	NDC:14783-272-25	30 mL in 1 BOTTLE, PLASTIC
2	NDC:14783-272-28	1 in 1 BOX
2	NDC:14783-272-27	3 mL in 1 TUBE

Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
Marketing Information
OTC MONOGRAPH FINAL	part352	12/16/2013

LBEL MAXIMUM COMFORT AND LONG-LASTING FOUNDATION SPF 10 (OBSCURE 8) - BROWN
zinc oxide liquid

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC:14783-273
Route of Administration	TOPICAL

Ingredient Name	Basis of Strength	Strength
Active Ingredient/Active Moiety
Zinc oxide (UNII: SOI2LOH54Z) (Zinc oxide - UNII:SOI2LOH54Z)	Zinc oxide	.016 g in 1 mL

Ingredient Name	Strength
Inactive Ingredients
water (UNII: 059QF0KO0R)
cyclomethicone 5 (UNII: 0THT5PCI0R)
dimethicone (UNII: 92RU3N3Y1O)
peg/ppg-18/18 dimethicone (UNII: 9H0AO7T794)
cyclomethicone 6 (UNII: XHK3U310BA)
sodium chloride (UNII: 451W47IQ8X)
bis-peg-18 methyl ether dimethyl silane (UNII: OEB4R3WW9C)
peg/ppg-19/19 dimethicone (UNII: EHH90CO7TL)
glycerin (UNII: PDC6A3C0OX)
oleth-5 (UNII: 1GH33785AY)
phenyl trimethicone (UNII: DR0K5NOJ4R)
propylene glycol (UNII: 6DC9Q167V3)
mica (UNII: V8A1AW0880)
methylparaben (UNII: A2I8C7HI9T)
triethoxycaprylylsilane (UNII: LDC331P08E)
propylparaben (UNII: Z8IX2SC1OH)
.alpha.-tocopherol acetate (UNII: 9E8X80D2L0)
phenoxyethanol (UNII: HIE492ZZ3T)
butylparaben (UNII: 3QPI1U3FV8)
ethylparaben (UNII: 14255EXE39)
silicon dioxide (UNII: ETJ7Z6XBU4)
isobutylparaben (UNII: 0QQJ25X58G)
titanium dioxide (UNII: 15FIX9V2JP)
FERRIC OXIDE RED (UNII: 1K09F3G675)
bismuth oxychloride (UNII: 4ZR792I587)

#	Item Code	Package Description	Marketing Start Date	Marketing End Date
Packaging
1	NDC:14783-273-30	1 in 1 BOX
1	NDC:14783-273-29	30 mL in 1 BOTTLE, PLASTIC
2	NDC:14783-273-32	1 in 1 BOX
2	NDC:14783-273-31	3 mL in 1 TUBE

Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
Marketing Information
OTC MONOGRAPH FINAL	part352	12/16/2013

LBEL MAXIMUM COMFORT AND LONG-LASTING FOUNDATION SPF 10 (OBSCURE 9) - BROWN
zinc oxide liquid

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC:14783-274
Route of Administration	TOPICAL

Ingredient Name	Basis of Strength	Strength
Active Ingredient/Active Moiety
Zinc oxide (UNII: SOI2LOH54Z) (Zinc oxide - UNII:SOI2LOH54Z)	Zinc oxide	.016 g in 1 mL

Ingredient Name	Strength
Inactive Ingredients
water (UNII: 059QF0KO0R)
cyclomethicone 5 (UNII: 0THT5PCI0R)
dimethicone (UNII: 92RU3N3Y1O)
peg/ppg-18/18 dimethicone (UNII: 9H0AO7T794)
cyclomethicone 6 (UNII: XHK3U310BA)
sodium chloride (UNII: 451W47IQ8X)
bis-peg-18 methyl ether dimethyl silane (UNII: OEB4R3WW9C)
peg/ppg-19/19 dimethicone (UNII: EHH90CO7TL)
glycerin (UNII: PDC6A3C0OX)
oleth-5 (UNII: 1GH33785AY)
phenyl trimethicone (UNII: DR0K5NOJ4R)
propylene glycol (UNII: 6DC9Q167V3)
mica (UNII: V8A1AW0880)
methylparaben (UNII: A2I8C7HI9T)
triethoxycaprylylsilane (UNII: LDC331P08E)
propylparaben (UNII: Z8IX2SC1OH)
.alpha.-tocopherol acetate (UNII: 9E8X80D2L0)
phenoxyethanol (UNII: HIE492ZZ3T)
butylparaben (UNII: 3QPI1U3FV8)
ethylparaben (UNII: 14255EXE39)
silicon dioxide (UNII: ETJ7Z6XBU4)
isobutylparaben (UNII: 0QQJ25X58G)
titanium dioxide (UNII: 15FIX9V2JP)
FERRIC OXIDE RED (UNII: 1K09F3G675)
bismuth oxychloride (UNII: 4ZR792I587)

#	Item Code	Package Description	Marketing Start Date	Marketing End Date
Packaging
1	NDC:14783-274-34	1 in 1 BOX
1	NDC:14783-274-33	30 mL in 1 BOTTLE, PLASTIC
2	NDC:14783-274-36	1 in 1 BOX
2	NDC:14783-274-35	3 mL in 1 TUBE

Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
Marketing Information
OTC MONOGRAPH FINAL	part352	12/16/2013

Labeler - Ventura International LTD (603192787)

Name	Address	ID/FEI	Business Operations
Establishment
Bel Star S.A. (Colombia)		880160197	MANUFACTURE(14783-266, 14783-267, 14783-268, 14783-269, 14783-270, 14783-271, 14783-272, 14783-273, 14783-274)

Revised: 12/2013

Document Id: c4ffde81-0367-4c19-b79c-e8d255c53798

Set id: a0e147ab-76dd-4438-a8f4-29b01289a0cc

Version: 1

Effective Time: 20131218

Ventura International LTD