LBEL NATURAL FINISH MOISTURIZING FOUNDATION SPF 25 (CLAIRE 1) - BEIGE- octinoxate and titanium dioxide liquid LBEL NATURAL FINISH MOISTURIZING FOUNDATION SPF 25 (CLAIRE 2) - BEIGE- octinoxate and titanium dioxide liquid LBEL NATURAL FINISH MOISTURIZING FOUNDATION SPF 25 (CLAIRE 3) - BEIGE- octinoxate and titanium dioxide liquid LBEL NATURAL FINISH .......tanium dioxide) liquid LBEL NATURAL FINISH MOISTURIZING FOUNDATION SPF 25 (OBSCURE 8C) - BROWN- octinoxate and titanium dioxide liquid LBEL NATURAL FINISH MOISTURIZING FOUNDATION SPF 25 (OBSCURE 10) - BROWN- octinoxate and titanium dioxide liquid LBEL NATURAL FINISH MOISTURIZING FOUNDATION SPF 25 (DORE 6) - BEIGE- octinoxate and titanium dioxide liquid

LBEL NATURAL FINISH MOISTURIZING FOUNDATION SPF 25 by

Drug Labeling and Warnings

LBEL NATURAL FINISH MOISTURIZING FOUNDATION SPF 25 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 INGREDIENT

Active Ingredients	Purpose
Octinoxate 6.5 %	Sunscreen
Titanium Dioxide 1.6%	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

Water, cyclopentasiloxane, cyclohexasiloxane, propylene glycol dicaprylate/dicaprate, peg/ppg-18/18 dimethicone, trimethylsiloxysilicate, dimethicone/vinyl dimethicone crosspolymer, xylitylglucoside, octyldodecanol, oleth-5, polymethyl methacrylate, anhydroxylitol, glycerin, linoleic acid, peg/ppg-19/19 dimethicone, microcrystalline wax, c12-15 alkyl benzoate, xylitol, diazolidinyl urea, alumina, petrolatum, tocopheryl acetate, triethoxycaprylylsilane, phospholipids, ribes nigrum (black currant) seed oil, silica, methylparaben, propylparaben, fragrance, copernicia cerifera (carnauba) wax, tribehenin, cholesterol, methicone, bht, menthoxypropanediol, euphorbia cerifera (candelilla) wax, beeswax, cetearyl alcohol, cetearyl glucoside, polyglyceryl-2 dipolyhydroxystearate, glycosphingolipids, ceramide 2, decyl glucoside, linolenic acid, peg-10 rapeseed sterol, palmitoyl oligopeptide.

May contain:

Titanium dioxide, iron oxides , iron oxides, iron oxides.

SPL UNCLASSIFIED SECTION

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

PRINCIPAL DISPLAY PANEL - 30 mL Tube Carton - (Claire 1) - Beige

EFFET
PARFAIT

natural finish
moisturizing
foundation
SPF 25

30 ml e (1 fl.oz.)

L'BEL

PRINCIPAL DISPLAY PANEL - 30 mL Tube Carton - (Claire 2) - Beige

EFFET
PARFAIT

natural finish
moisturizing
foundation
SPF 25

30 ml e (1 fl.oz.)

L'BEL

PRINCIPAL DISPLAY PANEL - 30 mL Tube Carton - (Claire 3) - Beige

EFFET
PARFAIT

natural finish
moisturizing
foundation
SPF 25

30 ml e (1 fl.oz.)

L'BEL

PRINCIPAL DISPLAY PANEL - 30 mL Tube Carton - (Claire 4) - Beige

EFFET
PARFAIT

natural finish
moisturizing
foundation
SPF 25

30 ml e (1 fl.oz.)

L'BEL

PRINCIPAL DISPLAY PANEL - 30 mL Tube Carton - (Medium 5) - Brown

EFFET
PARFAIT

natural finish
moisturizing
foundation
SPF 25

30 ml e (1 fl.oz.)

L'BEL

PRINCIPAL DISPLAY PANEL - 30 mL Tube Carton - (Medium 6) - Brown

EFFET
PARFAIT

natural finish
moisturizing
foundation
SPF 25

30 ml e (1 fl.oz.)

L'BEL

PRINCIPAL DISPLAY PANEL - 30 mL Tube Carton - (Medium 7) - Brown

EFFET
PARFAIT

natural finish
moisturizing
foundation
SPF 25

30 ml e (1 fl.oz.)

L'BEL

PRINCIPAL DISPLAY PANEL - 30 mL Tube Carton - (Obscure 8) - Brown

EFFET
PARFAIT

natural finish
moisturizing
foundation
SPF 25

30 ml e (1 fl.oz.)

L'BEL

PRINCIPAL DISPLAY PANEL - 30 mL Tube Carton - (Obscure 9) - Brown

EFFET
PARFAIT

natural finish
moisturizing
foundation
SPF 25

30 ml e (1 fl.oz.)

L'BEL

PRINCIPAL DISPLAY PANEL - 30 mL Tube Carton - (Medium 6A) - Brown

EFFET
PARFAIT

natural finish
moisturizing
foundation
SPF 25

30 ml e (1 fl.oz.)

L'BEL

PRINCIPAL DISPLAY PANEL - 30 mL Tube Carton - (Medium 6B) - Brown

EFFET
PARFAIT

natural finish
moisturizing
foundation
SPF 25

30 ml e (1 fl.oz.)

L'BEL

PRINCIPAL DISPLAY PANEL - 30 mL Tube Carton - (Obscure 8A) - Brown

EFFET
PARFAIT

natural finish
moisturizing
foundation
SPF 25

30 ml e (1 fl.oz.)

L'BEL

PRINCIPAL DISPLAY PANEL - 30 mL Tube Carton - (Obscure 8B) - Brown

EFFET
PARFAIT

natural finish
moisturizing
foundation
SPF 25

30 ml e (1 fl.oz.)

L'BEL

PRINCIPAL DISPLAY PANEL - 30 mL Tube Carton - (Obscure 8C) - Brown

EFFET
PARFAIT

natural finish
moisturizing
foundation
SPF 25

30 ml e (1 fl.oz.)

L'BEL

PRINCIPAL DISPLAY PANEL - 30 mL Tube Carton - (Obscure 10) - Brown

EFFET
PARFAIT

natural finish
moisturizing
foundation
SPF 25

30 ml e (1 fl.oz.)

L'BEL

PRINCIPAL DISPLAY PANEL - 30 mL Tube Carton - (Dore 6) - Beige

EFFET
PARFAIT

natural finish
moisturizing
foundation
SPF 25

30 ml e (1 fl.oz.)

L'BEL

INGREDIENTS AND APPEARANCE

LBEL NATURAL FINISH MOISTURIZING FOUNDATION SPF 25   (CLAIRE 1) - BEIGE
octinoxate and titanium dioxide liquid

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 13537-241
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
Octinoxate (UNII: 4Y5P7MUD51) (Octinoxate - UNII:4Y5P7MUD51)	Octinoxate	0.065 g  in 1 mL
Titanium Dioxide (UNII: 15FIX9V2JP) (Titanium Dioxide - UNII:15FIX9V2JP)	Titanium Dioxide	0.016 g  in 1 mL

Inactive Ingredients
Ingredient Name	Strength
water (UNII: 059QF0KO0R)
cyclomethicone 5 (UNII: 0THT5PCI0R)
cyclomethicone 6 (UNII: XHK3U310BA)
propylene glycol dicaprylate/dicaprate (UNII: O4446S9CRA)
peg/ppg-18/18 dimethicone (UNII: 9H0AO7T794)
xylitylglucoside (UNII: O0IEZ166FB)
octyldodecanol (UNII: 461N1O614Y)
oleth-5 (UNII: 1GH33785AY)
anhydroxylitol (UNII: 8XWR7NN42F)
glycerin (UNII: PDC6A3C0OX)
linoleic acid (UNII: 9KJL21T0QJ)
peg/ppg-19/19 dimethicone (UNII: EHH90CO7TL)
microcrystalline wax (UNII: XOF597Q3KY)
alkyl (c12-15) benzoate (UNII: A9EJ3J61HQ)
xylitol (UNII: VCQ006KQ1E)
diazolidinyl urea (UNII: H5RIZ3MPW4)
aluminum oxide (UNII: LMI26O6933)
petrolatum (UNII: 4T6H12BN9U)
.alpha.-tocopherol acetate (UNII: 9E8X80D2L0)
triethoxycaprylylsilane (UNII: LDC331P08E)
ribes nigrum seed oil (UNII: GKE1188837)
silicon dioxide (UNII: ETJ7Z6XBU4)
methylparaben (UNII: A2I8C7HI9T)
propylparaben (UNII: Z8IX2SC1OH)
carnauba wax (UNII: R12CBM0EIZ)
tribehenin (UNII: 8OC9U7TQZ0)
cholesterol (UNII: 97C5T2UQ7J)
butylated hydroxytoluene (UNII: 1P9D0Z171K)
3-((l-menthyl)oxy)propane-1,2-diol (UNII: KD6TZ2QICH)
candelilla wax (UNII: WL0328HX19)
yellow wax (UNII: 2ZA36H0S2V)
cetostearyl alcohol (UNII: 2DMT128M1S)
cetearyl glucoside (UNII: 09FUA47KNA)
polyglyceryl-2 dipolyhydroxystearate (UNII: 9229XJ4V12)
ceramide 2 (UNII: C04977SRJ5)
decyl glucoside (UNII: Z17H97EA6Y)
linolenic acid (UNII: 0RBV727H71)
peg-10 rapeseed sterol (UNII: 258O76T85M)
palmitoyl oligopeptide (UNII: HO4ZT5S86C)
ferric oxide red (UNII: 1K09F3G675)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 13537-241-02	1 in 1 BOX
1	NDC: 13537-241-01	30 mL in 1 BOTTLE, PLASTIC
2	NDC: 13537-241-04	1 in 1 BOX
2	NDC: 13537-241-03	27 mL in 1 BOTTLE, PLASTIC
3	NDC: 13537-241-06	1 in 1 BOX
3	NDC: 13537-241-05	4.5 mL in 1 BOTTLE, PLASTIC
4	NDC: 13537-241-08	1 in 1 BOX
4	NDC: 13537-241-07	3 mL in 1 TUBE

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

LBEL NATURAL FINISH MOISTURIZING FOUNDATION SPF 25   (CLAIRE 2) - BEIGE
octinoxate and titanium dioxide liquid

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 13537-242
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
Octinoxate (UNII: 4Y5P7MUD51) (Octinoxate - UNII:4Y5P7MUD51)	Octinoxate	0.065 g  in 1 mL
Titanium Dioxide (UNII: 15FIX9V2JP) (Titanium Dioxide - UNII:15FIX9V2JP)	Titanium Dioxide	0.016 g  in 1 mL

Inactive Ingredients
Ingredient Name	Strength
water (UNII: 059QF0KO0R)
cyclomethicone 5 (UNII: 0THT5PCI0R)
cyclomethicone 6 (UNII: XHK3U310BA)
propylene glycol dicaprylate/dicaprate (UNII: O4446S9CRA)
peg/ppg-18/18 dimethicone (UNII: 9H0AO7T794)
xylitylglucoside (UNII: O0IEZ166FB)
octyldodecanol (UNII: 461N1O614Y)
oleth-5 (UNII: 1GH33785AY)
anhydroxylitol (UNII: 8XWR7NN42F)
glycerin (UNII: PDC6A3C0OX)
linoleic acid (UNII: 9KJL21T0QJ)
peg/ppg-19/19 dimethicone (UNII: EHH90CO7TL)
microcrystalline wax (UNII: XOF597Q3KY)
alkyl (c12-15) benzoate (UNII: A9EJ3J61HQ)
xylitol (UNII: VCQ006KQ1E)
diazolidinyl urea (UNII: H5RIZ3MPW4)
aluminum oxide (UNII: LMI26O6933)
petrolatum (UNII: 4T6H12BN9U)
.alpha.-tocopherol acetate (UNII: 9E8X80D2L0)
triethoxycaprylylsilane (UNII: LDC331P08E)
ribes nigrum seed oil (UNII: GKE1188837)
silicon dioxide (UNII: ETJ7Z6XBU4)
methylparaben (UNII: A2I8C7HI9T)
propylparaben (UNII: Z8IX2SC1OH)
carnauba wax (UNII: R12CBM0EIZ)
tribehenin (UNII: 8OC9U7TQZ0)
cholesterol (UNII: 97C5T2UQ7J)
butylated hydroxytoluene (UNII: 1P9D0Z171K)
3-((l-menthyl)oxy)propane-1,2-diol (UNII: KD6TZ2QICH)
candelilla wax (UNII: WL0328HX19)
yellow wax (UNII: 2ZA36H0S2V)
cetostearyl alcohol (UNII: 2DMT128M1S)
cetearyl glucoside (UNII: 09FUA47KNA)
polyglyceryl-2 dipolyhydroxystearate (UNII: 9229XJ4V12)
ceramide 2 (UNII: C04977SRJ5)
decyl glucoside (UNII: Z17H97EA6Y)
linolenic acid (UNII: 0RBV727H71)
peg-10 rapeseed sterol (UNII: 258O76T85M)
palmitoyl oligopeptide (UNII: HO4ZT5S86C)
ferric oxide red (UNII: 1K09F3G675)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 13537-242-02	1 in 1 BOX
1	NDC: 13537-242-01	30 mL in 1 BOTTLE, PLASTIC
2	NDC: 13537-242-04	1 in 1 BOX
2	NDC: 13537-242-03	27 mL in 1 BOTTLE, PLASTIC
3	NDC: 13537-242-06	1 in 1 BOX
3	NDC: 13537-242-05	4.5 mL in 1 BOTTLE, PLASTIC
4	NDC: 13537-242-08	1 in 1 BOX
4	NDC: 13537-242-07	3 mL in 1 TUBE

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

LBEL NATURAL FINISH MOISTURIZING FOUNDATION SPF 25   (CLAIRE 3) - BEIGE
octinoxate and titanium dioxide liquid

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 13537-243
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
Octinoxate (UNII: 4Y5P7MUD51) (Octinoxate - UNII:4Y5P7MUD51)	Octinoxate	0.065 g  in 1 mL
Titanium Dioxide (UNII: 15FIX9V2JP) (Titanium Dioxide - UNII:15FIX9V2JP)	Titanium Dioxide	0.016 g  in 1 mL

Inactive Ingredients
Ingredient Name	Strength
water (UNII: 059QF0KO0R)
cyclomethicone 5 (UNII: 0THT5PCI0R)
cyclomethicone 6 (UNII: XHK3U310BA)
propylene glycol dicaprylate/dicaprate (UNII: O4446S9CRA)
peg/ppg-18/18 dimethicone (UNII: 9H0AO7T794)
xylitylglucoside (UNII: O0IEZ166FB)
octyldodecanol (UNII: 461N1O614Y)
oleth-5 (UNII: 1GH33785AY)
anhydroxylitol (UNII: 8XWR7NN42F)
glycerin (UNII: PDC6A3C0OX)
linoleic acid (UNII: 9KJL21T0QJ)
peg/ppg-19/19 dimethicone (UNII: EHH90CO7TL)
microcrystalline wax (UNII: XOF597Q3KY)
alkyl (c12-15) benzoate (UNII: A9EJ3J61HQ)
xylitol (UNII: VCQ006KQ1E)
diazolidinyl urea (UNII: H5RIZ3MPW4)
aluminum oxide (UNII: LMI26O6933)
petrolatum (UNII: 4T6H12BN9U)
.alpha.-tocopherol acetate (UNII: 9E8X80D2L0)
triethoxycaprylylsilane (UNII: LDC331P08E)
ribes nigrum seed oil (UNII: GKE1188837)
silicon dioxide (UNII: ETJ7Z6XBU4)
methylparaben (UNII: A2I8C7HI9T)
propylparaben (UNII: Z8IX2SC1OH)
carnauba wax (UNII: R12CBM0EIZ)
tribehenin (UNII: 8OC9U7TQZ0)
cholesterol (UNII: 97C5T2UQ7J)
butylated hydroxytoluene (UNII: 1P9D0Z171K)
3-((l-menthyl)oxy)propane-1,2-diol (UNII: KD6TZ2QICH)
candelilla wax (UNII: WL0328HX19)
yellow wax (UNII: 2ZA36H0S2V)
cetostearyl alcohol (UNII: 2DMT128M1S)
cetearyl glucoside (UNII: 09FUA47KNA)
polyglyceryl-2 dipolyhydroxystearate (UNII: 9229XJ4V12)
ceramide 2 (UNII: C04977SRJ5)
decyl glucoside (UNII: Z17H97EA6Y)
linolenic acid (UNII: 0RBV727H71)
peg-10 rapeseed sterol (UNII: 258O76T85M)
palmitoyl oligopeptide (UNII: HO4ZT5S86C)
ferric oxide red (UNII: 1K09F3G675)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 13537-243-02	1 in 1 BOX
1	NDC: 13537-243-01	30 mL in 1 BOTTLE, PLASTIC
2	NDC: 13537-243-04	1 in 1 BOX
2	NDC: 13537-243-03	27 mL in 1 BOTTLE, PLASTIC
3	NDC: 13537-243-06	1 in 1 BOX
3	NDC: 13537-243-05	4.5 mL in 1 BOTTLE, PLASTIC
4	NDC: 13537-243-08	1 in 1 BOX
4	NDC: 13537-243-07	3 mL in 1 TUBE

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

LBEL NATURAL FINISH MOISTURIZING FOUNDATION SPF 25   (CLAIRE 4) - BEIGE
octinoxate and titanium dioxide liquid

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 13537-244
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
Octinoxate (UNII: 4Y5P7MUD51) (Octinoxate - UNII:4Y5P7MUD51)	Octinoxate	0.065 g  in 1 mL
Titanium Dioxide (UNII: 15FIX9V2JP) (Titanium Dioxide - UNII:15FIX9V2JP)	Titanium Dioxide	0.016 g  in 1 mL

Inactive Ingredients
Ingredient Name	Strength
water (UNII: 059QF0KO0R)
cyclomethicone 5 (UNII: 0THT5PCI0R)
cyclomethicone 6 (UNII: XHK3U310BA)
propylene glycol dicaprylate/dicaprate (UNII: O4446S9CRA)
peg/ppg-18/18 dimethicone (UNII: 9H0AO7T794)
xylitylglucoside (UNII: O0IEZ166FB)
octyldodecanol (UNII: 461N1O614Y)
oleth-5 (UNII: 1GH33785AY)
anhydroxylitol (UNII: 8XWR7NN42F)
glycerin (UNII: PDC6A3C0OX)
linoleic acid (UNII: 9KJL21T0QJ)
peg/ppg-19/19 dimethicone (UNII: EHH90CO7TL)
microcrystalline wax (UNII: XOF597Q3KY)
alkyl (c12-15) benzoate (UNII: A9EJ3J61HQ)
xylitol (UNII: VCQ006KQ1E)
diazolidinyl urea (UNII: H5RIZ3MPW4)
aluminum oxide (UNII: LMI26O6933)
petrolatum (UNII: 4T6H12BN9U)
.alpha.-tocopherol acetate (UNII: 9E8X80D2L0)
triethoxycaprylylsilane (UNII: LDC331P08E)
ribes nigrum seed oil (UNII: GKE1188837)
silicon dioxide (UNII: ETJ7Z6XBU4)
methylparaben (UNII: A2I8C7HI9T)
propylparaben (UNII: Z8IX2SC1OH)
carnauba wax (UNII: R12CBM0EIZ)
tribehenin (UNII: 8OC9U7TQZ0)
cholesterol (UNII: 97C5T2UQ7J)
butylated hydroxytoluene (UNII: 1P9D0Z171K)
3-((l-menthyl)oxy)propane-1,2-diol (UNII: KD6TZ2QICH)
candelilla wax (UNII: WL0328HX19)
yellow wax (UNII: 2ZA36H0S2V)
cetostearyl alcohol (UNII: 2DMT128M1S)
cetearyl glucoside (UNII: 09FUA47KNA)
polyglyceryl-2 dipolyhydroxystearate (UNII: 9229XJ4V12)
ceramide 2 (UNII: C04977SRJ5)
decyl glucoside (UNII: Z17H97EA6Y)
linolenic acid (UNII: 0RBV727H71)
peg-10 rapeseed sterol (UNII: 258O76T85M)
palmitoyl oligopeptide (UNII: HO4ZT5S86C)
ferric oxide red (UNII: 1K09F3G675)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 13537-244-02	1 in 1 BOX
1	NDC: 13537-244-01	30 mL in 1 BOTTLE, PLASTIC
2	NDC: 13537-244-04	1 in 1 BOX
2	NDC: 13537-244-03	27 mL in 1 BOTTLE, PLASTIC
3	NDC: 13537-244-06	1 in 1 BOX
3	NDC: 13537-244-05	4.5 mL in 1 BOTTLE, PLASTIC
4	NDC: 13537-244-08	1 in 1 BOX
4	NDC: 13537-244-07	3 mL in 1 TUBE

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

LBEL NATURAL FINISH MOISTURIZING FOUNDATION SPF 25   (MEDIUM 5) - BROWN
octinoxate and titanium dioxide liquid

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 13537-245
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
Octinoxate (UNII: 4Y5P7MUD51) (Octinoxate - UNII:4Y5P7MUD51)	Octinoxate	0.065 g  in 1 mL
Titanium Dioxide (UNII: 15FIX9V2JP) (Titanium Dioxide - UNII:15FIX9V2JP)	Titanium Dioxide	0.016 g  in 1 mL

Inactive Ingredients
Ingredient Name	Strength
water (UNII: 059QF0KO0R)
cyclomethicone 5 (UNII: 0THT5PCI0R)
cyclomethicone 6 (UNII: XHK3U310BA)
propylene glycol dicaprylate/dicaprate (UNII: O4446S9CRA)
peg/ppg-18/18 dimethicone (UNII: 9H0AO7T794)
xylitylglucoside (UNII: O0IEZ166FB)
octyldodecanol (UNII: 461N1O614Y)
oleth-5 (UNII: 1GH33785AY)
anhydroxylitol (UNII: 8XWR7NN42F)
glycerin (UNII: PDC6A3C0OX)
linoleic acid (UNII: 9KJL21T0QJ)
peg/ppg-19/19 dimethicone (UNII: EHH90CO7TL)
microcrystalline wax (UNII: XOF597Q3KY)
alkyl (c12-15) benzoate (UNII: A9EJ3J61HQ)
xylitol (UNII: VCQ006KQ1E)
diazolidinyl urea (UNII: H5RIZ3MPW4)
aluminum oxide (UNII: LMI26O6933)
petrolatum (UNII: 4T6H12BN9U)
.alpha.-tocopherol acetate (UNII: 9E8X80D2L0)
triethoxycaprylylsilane (UNII: LDC331P08E)
ribes nigrum seed oil (UNII: GKE1188837)
silicon dioxide (UNII: ETJ7Z6XBU4)
methylparaben (UNII: A2I8C7HI9T)
propylparaben (UNII: Z8IX2SC1OH)
carnauba wax (UNII: R12CBM0EIZ)
tribehenin (UNII: 8OC9U7TQZ0)
cholesterol (UNII: 97C5T2UQ7J)
butylated hydroxytoluene (UNII: 1P9D0Z171K)
3-((l-menthyl)oxy)propane-1,2-diol (UNII: KD6TZ2QICH)
candelilla wax (UNII: WL0328HX19)
yellow wax (UNII: 2ZA36H0S2V)
cetostearyl alcohol (UNII: 2DMT128M1S)
cetearyl glucoside (UNII: 09FUA47KNA)
polyglyceryl-2 dipolyhydroxystearate (UNII: 9229XJ4V12)
ceramide 2 (UNII: C04977SRJ5)
decyl glucoside (UNII: Z17H97EA6Y)
linolenic acid (UNII: 0RBV727H71)
peg-10 rapeseed sterol (UNII: 258O76T85M)
palmitoyl oligopeptide (UNII: HO4ZT5S86C)
ferric oxide red (UNII: 1K09F3G675)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 13537-245-02	1 in 1 BOX
1	NDC: 13537-245-01	30 mL in 1 BOTTLE, PLASTIC
2	NDC: 13537-245-04	1 in 1 BOX
2	NDC: 13537-245-03	27 mL in 1 BOTTLE, PLASTIC
3	NDC: 13537-245-06	1 in 1 BOX
3	NDC: 13537-245-05	4.5 mL in 1 BOTTLE, PLASTIC
4	NDC: 13537-245-08	1 in 1 BOX
4	NDC: 13537-245-07	3 mL in 1 TUBE

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

LBEL NATURAL FINISH MOISTURIZING FOUNDATION SPF 25   (MEDIUM 6) - BROWN
octinoxate and titanium dioxide liquid

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 13537-246
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
Octinoxate (UNII: 4Y5P7MUD51) (Octinoxate - UNII:4Y5P7MUD51)	Octinoxate	0.065 g  in 1 mL
Titanium Dioxide (UNII: 15FIX9V2JP) (Titanium Dioxide - UNII:15FIX9V2JP)	Titanium Dioxide	0.016 g  in 1 mL

Inactive Ingredients
Ingredient Name	Strength
water (UNII: 059QF0KO0R)
cyclomethicone 5 (UNII: 0THT5PCI0R)
cyclomethicone 6 (UNII: XHK3U310BA)
propylene glycol dicaprylate/dicaprate (UNII: O4446S9CRA)
peg/ppg-18/18 dimethicone (UNII: 9H0AO7T794)
xylitylglucoside (UNII: O0IEZ166FB)
octyldodecanol (UNII: 461N1O614Y)
oleth-5 (UNII: 1GH33785AY)
anhydroxylitol (UNII: 8XWR7NN42F)
glycerin (UNII: PDC6A3C0OX)
linoleic acid (UNII: 9KJL21T0QJ)
peg/ppg-19/19 dimethicone (UNII: EHH90CO7TL)
microcrystalline wax (UNII: XOF597Q3KY)
alkyl (c12-15) benzoate (UNII: A9EJ3J61HQ)
xylitol (UNII: VCQ006KQ1E)
diazolidinyl urea (UNII: H5RIZ3MPW4)
aluminum oxide (UNII: LMI26O6933)
petrolatum (UNII: 4T6H12BN9U)
.alpha.-tocopherol acetate (UNII: 9E8X80D2L0)
triethoxycaprylylsilane (UNII: LDC331P08E)
ribes nigrum seed oil (UNII: GKE1188837)
silicon dioxide (UNII: ETJ7Z6XBU4)
methylparaben (UNII: A2I8C7HI9T)
propylparaben (UNII: Z8IX2SC1OH)
carnauba wax (UNII: R12CBM0EIZ)
tribehenin (UNII: 8OC9U7TQZ0)
cholesterol (UNII: 97C5T2UQ7J)
butylated hydroxytoluene (UNII: 1P9D0Z171K)
3-((l-menthyl)oxy)propane-1,2-diol (UNII: KD6TZ2QICH)
candelilla wax (UNII: WL0328HX19)
yellow wax (UNII: 2ZA36H0S2V)
cetostearyl alcohol (UNII: 2DMT128M1S)
cetearyl glucoside (UNII: 09FUA47KNA)
polyglyceryl-2 dipolyhydroxystearate (UNII: 9229XJ4V12)
ceramide 2 (UNII: C04977SRJ5)
decyl glucoside (UNII: Z17H97EA6Y)
linolenic acid (UNII: 0RBV727H71)
peg-10 rapeseed sterol (UNII: 258O76T85M)
palmitoyl oligopeptide (UNII: HO4ZT5S86C)
ferric oxide red (UNII: 1K09F3G675)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 13537-246-02	1 in 1 BOX
1	NDC: 13537-246-01	30 mL in 1 BOTTLE, PLASTIC
2	NDC: 13537-246-04	1 in 1 BOX
2	NDC: 13537-246-03	27 mL in 1 BOTTLE, PLASTIC
3	NDC: 13537-246-06	1 in 1 BOX
3	NDC: 13537-246-05	4.5 mL in 1 BOTTLE, PLASTIC
4	NDC: 13537-246-08	1 in 1 BOX
4	NDC: 13537-246-07	3 mL in 1 TUBE

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

LBEL NATURAL FINISH MOISTURIZING FOUNDATION SPF 25   (MEDIUM 7) - BROWN
octinoxate and titanium dioxide liquid

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 13537-247
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
Octinoxate (UNII: 4Y5P7MUD51) (Octinoxate - UNII:4Y5P7MUD51)	Octinoxate	0.065 g  in 1 mL
Titanium Dioxide (UNII: 15FIX9V2JP) (Titanium Dioxide - UNII:15FIX9V2JP)	Titanium Dioxide	0.016 g  in 1 mL

Inactive Ingredients
Ingredient Name	Strength
water (UNII: 059QF0KO0R)
cyclomethicone 5 (UNII: 0THT5PCI0R)
cyclomethicone 6 (UNII: XHK3U310BA)
propylene glycol dicaprylate/dicaprate (UNII: O4446S9CRA)
peg/ppg-18/18 dimethicone (UNII: 9H0AO7T794)
xylitylglucoside (UNII: O0IEZ166FB)
octyldodecanol (UNII: 461N1O614Y)
oleth-5 (UNII: 1GH33785AY)
anhydroxylitol (UNII: 8XWR7NN42F)
glycerin (UNII: PDC6A3C0OX)
linoleic acid (UNII: 9KJL21T0QJ)
peg/ppg-19/19 dimethicone (UNII: EHH90CO7TL)
microcrystalline wax (UNII: XOF597Q3KY)
alkyl (c12-15) benzoate (UNII: A9EJ3J61HQ)
xylitol (UNII: VCQ006KQ1E)
diazolidinyl urea (UNII: H5RIZ3MPW4)
aluminum oxide (UNII: LMI26O6933)
petrolatum (UNII: 4T6H12BN9U)
.alpha.-tocopherol acetate (UNII: 9E8X80D2L0)
triethoxycaprylylsilane (UNII: LDC331P08E)
ribes nigrum seed oil (UNII: GKE1188837)
silicon dioxide (UNII: ETJ7Z6XBU4)
methylparaben (UNII: A2I8C7HI9T)
propylparaben (UNII: Z8IX2SC1OH)
carnauba wax (UNII: R12CBM0EIZ)
tribehenin (UNII: 8OC9U7TQZ0)
cholesterol (UNII: 97C5T2UQ7J)
butylated hydroxytoluene (UNII: 1P9D0Z171K)
3-((l-menthyl)oxy)propane-1,2-diol (UNII: KD6TZ2QICH)
candelilla wax (UNII: WL0328HX19)
yellow wax (UNII: 2ZA36H0S2V)
cetostearyl alcohol (UNII: 2DMT128M1S)
cetearyl glucoside (UNII: 09FUA47KNA)
polyglyceryl-2 dipolyhydroxystearate (UNII: 9229XJ4V12)
ceramide 2 (UNII: C04977SRJ5)
decyl glucoside (UNII: Z17H97EA6Y)
linolenic acid (UNII: 0RBV727H71)
peg-10 rapeseed sterol (UNII: 258O76T85M)
palmitoyl oligopeptide (UNII: HO4ZT5S86C)
ferric oxide red (UNII: 1K09F3G675)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 13537-247-02	1 in 1 BOX
1	NDC: 13537-247-01	30 mL in 1 BOTTLE, PLASTIC
2	NDC: 13537-247-04	1 in 1 BOX
2	NDC: 13537-247-03	27 mL in 1 BOTTLE, PLASTIC
3	NDC: 13537-247-06	1 in 1 BOX
3	NDC: 13537-247-05	4.5 mL in 1 BOTTLE, PLASTIC
4	NDC: 13537-247-08	1 in 1 BOX
4	NDC: 13537-247-07	3 mL in 1 TUBE

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

LBEL NATURAL FINISH MOISTURIZING FOUNDATION SPF 25   (OBSCURE 8) - BROWN
octinoxate and titanium dioxide liquid

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 13537-248
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
Octinoxate (UNII: 4Y5P7MUD51) (Octinoxate - UNII:4Y5P7MUD51)	Octinoxate	0.065 g  in 1 mL
Titanium Dioxide (UNII: 15FIX9V2JP) (Titanium Dioxide - UNII:15FIX9V2JP)	Titanium Dioxide	0.016 g  in 1 mL

Inactive Ingredients
Ingredient Name	Strength
water (UNII: 059QF0KO0R)
cyclomethicone 5 (UNII: 0THT5PCI0R)
cyclomethicone 6 (UNII: XHK3U310BA)
propylene glycol dicaprylate/dicaprate (UNII: O4446S9CRA)
peg/ppg-18/18 dimethicone (UNII: 9H0AO7T794)
xylitylglucoside (UNII: O0IEZ166FB)
octyldodecanol (UNII: 461N1O614Y)
oleth-5 (UNII: 1GH33785AY)
anhydroxylitol (UNII: 8XWR7NN42F)
glycerin (UNII: PDC6A3C0OX)
linoleic acid (UNII: 9KJL21T0QJ)
peg/ppg-19/19 dimethicone (UNII: EHH90CO7TL)
microcrystalline wax (UNII: XOF597Q3KY)
alkyl (c12-15) benzoate (UNII: A9EJ3J61HQ)
xylitol (UNII: VCQ006KQ1E)
diazolidinyl urea (UNII: H5RIZ3MPW4)
aluminum oxide (UNII: LMI26O6933)
petrolatum (UNII: 4T6H12BN9U)
.alpha.-tocopherol acetate (UNII: 9E8X80D2L0)
triethoxycaprylylsilane (UNII: LDC331P08E)
ribes nigrum seed oil (UNII: GKE1188837)
silicon dioxide (UNII: ETJ7Z6XBU4)
methylparaben (UNII: A2I8C7HI9T)
propylparaben (UNII: Z8IX2SC1OH)
carnauba wax (UNII: R12CBM0EIZ)
tribehenin (UNII: 8OC9U7TQZ0)
cholesterol (UNII: 97C5T2UQ7J)
butylated hydroxytoluene (UNII: 1P9D0Z171K)
3-((l-menthyl)oxy)propane-1,2-diol (UNII: KD6TZ2QICH)
candelilla wax (UNII: WL0328HX19)
yellow wax (UNII: 2ZA36H0S2V)
cetostearyl alcohol (UNII: 2DMT128M1S)
cetearyl glucoside (UNII: 09FUA47KNA)
polyglyceryl-2 dipolyhydroxystearate (UNII: 9229XJ4V12)
ceramide 2 (UNII: C04977SRJ5)
decyl glucoside (UNII: Z17H97EA6Y)
linolenic acid (UNII: 0RBV727H71)
peg-10 rapeseed sterol (UNII: 258O76T85M)
palmitoyl oligopeptide (UNII: HO4ZT5S86C)
ferric oxide red (UNII: 1K09F3G675)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 13537-248-02	1 in 1 BOX
1	NDC: 13537-248-01	30 mL in 1 BOTTLE, PLASTIC
2	NDC: 13537-248-04	1 in 1 BOX
2	NDC: 13537-248-03	27 mL in 1 BOTTLE, PLASTIC
3	NDC: 13537-248-06	1 in 1 BOX
3	NDC: 13537-248-05	4.5 mL in 1 BOTTLE, PLASTIC
4	NDC: 13537-248-08	1 in 1 BOX
4	NDC: 13537-248-07	3 mL in 1 TUBE

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

LBEL NATURAL FINISH MOISTURIZING FOUNDATION SPF 25   (OBSCURE 9) - BROWN
octinoxate and titanium dioxide liquid

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 13537-249
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
Octinoxate (UNII: 4Y5P7MUD51) (Octinoxate - UNII:4Y5P7MUD51)	Octinoxate	0.065 g  in 1 mL
Titanium Dioxide (UNII: 15FIX9V2JP) (Titanium Dioxide - UNII:15FIX9V2JP)	Titanium Dioxide	0.016 g  in 1 mL

Inactive Ingredients
Ingredient Name	Strength
water (UNII: 059QF0KO0R)
cyclomethicone 5 (UNII: 0THT5PCI0R)
cyclomethicone 6 (UNII: XHK3U310BA)
propylene glycol dicaprylate/dicaprate (UNII: O4446S9CRA)
peg/ppg-18/18 dimethicone (UNII: 9H0AO7T794)
xylitylglucoside (UNII: O0IEZ166FB)
octyldodecanol (UNII: 461N1O614Y)
oleth-5 (UNII: 1GH33785AY)
anhydroxylitol (UNII: 8XWR7NN42F)
glycerin (UNII: PDC6A3C0OX)
linoleic acid (UNII: 9KJL21T0QJ)
peg/ppg-19/19 dimethicone (UNII: EHH90CO7TL)
microcrystalline wax (UNII: XOF597Q3KY)
alkyl (c12-15) benzoate (UNII: A9EJ3J61HQ)
xylitol (UNII: VCQ006KQ1E)
diazolidinyl urea (UNII: H5RIZ3MPW4)
aluminum oxide (UNII: LMI26O6933)
petrolatum (UNII: 4T6H12BN9U)
.alpha.-tocopherol acetate (UNII: 9E8X80D2L0)
triethoxycaprylylsilane (UNII: LDC331P08E)
ribes nigrum seed oil (UNII: GKE1188837)
silicon dioxide (UNII: ETJ7Z6XBU4)
methylparaben (UNII: A2I8C7HI9T)
propylparaben (UNII: Z8IX2SC1OH)
carnauba wax (UNII: R12CBM0EIZ)
tribehenin (UNII: 8OC9U7TQZ0)
cholesterol (UNII: 97C5T2UQ7J)
butylated hydroxytoluene (UNII: 1P9D0Z171K)
3-((l-menthyl)oxy)propane-1,2-diol (UNII: KD6TZ2QICH)
candelilla wax (UNII: WL0328HX19)
yellow wax (UNII: 2ZA36H0S2V)
cetostearyl alcohol (UNII: 2DMT128M1S)
cetearyl glucoside (UNII: 09FUA47KNA)
polyglyceryl-2 dipolyhydroxystearate (UNII: 9229XJ4V12)
ceramide 2 (UNII: C04977SRJ5)
decyl glucoside (UNII: Z17H97EA6Y)
linolenic acid (UNII: 0RBV727H71)
peg-10 rapeseed sterol (UNII: 258O76T85M)
palmitoyl oligopeptide (UNII: HO4ZT5S86C)
ferric oxide red (UNII: 1K09F3G675)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 13537-249-02	1 in 1 BOX
1	NDC: 13537-249-01	30 mL in 1 BOTTLE, PLASTIC
2	NDC: 13537-249-04	1 in 1 BOX
2	NDC: 13537-249-03	27 mL in 1 BOTTLE, PLASTIC
3	NDC: 13537-249-06	1 in 1 BOX
3	NDC: 13537-249-05	4.5 mL in 1 BOTTLE, PLASTIC
4	NDC: 13537-249-08	1 in 1 BOX
4	NDC: 13537-249-07	3 mL in 1 TUBE

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

LBEL NATURAL FINISH MOISTURIZING FOUNDATION SPF 25   (MEDIUM 6A) - BROWN
octinoxate and titanium dioxide liquid

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 13537-299
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
Octinoxate (UNII: 4Y5P7MUD51) (Octinoxate - UNII:4Y5P7MUD51)	Octinoxate	0.065 g  in 1 mL
Titanium Dioxide (UNII: 15FIX9V2JP) (Titanium Dioxide - UNII:15FIX9V2JP)	Titanium Dioxide	0.016 g  in 1 mL

Inactive Ingredients
Ingredient Name	Strength
water (UNII: 059QF0KO0R)
cyclomethicone 5 (UNII: 0THT5PCI0R)
cyclomethicone 6 (UNII: XHK3U310BA)
propylene glycol dicaprylate/dicaprate (UNII: O4446S9CRA)
peg/ppg-18/18 dimethicone (UNII: 9H0AO7T794)
xylitylglucoside (UNII: O0IEZ166FB)
octyldodecanol (UNII: 461N1O614Y)
oleth-5 (UNII: 1GH33785AY)
anhydroxylitol (UNII: 8XWR7NN42F)
glycerin (UNII: PDC6A3C0OX)
linoleic acid (UNII: 9KJL21T0QJ)
peg/ppg-19/19 dimethicone (UNII: EHH90CO7TL)
microcrystalline wax (UNII: XOF597Q3KY)
alkyl (c12-15) benzoate (UNII: A9EJ3J61HQ)
xylitol (UNII: VCQ006KQ1E)
diazolidinyl urea (UNII: H5RIZ3MPW4)
aluminum oxide (UNII: LMI26O6933)
petrolatum (UNII: 4T6H12BN9U)
.alpha.-tocopherol acetate (UNII: 9E8X80D2L0)
triethoxycaprylylsilane (UNII: LDC331P08E)
ribes nigrum seed oil (UNII: GKE1188837)
silicon dioxide (UNII: ETJ7Z6XBU4)
methylparaben (UNII: A2I8C7HI9T)
propylparaben (UNII: Z8IX2SC1OH)
carnauba wax (UNII: R12CBM0EIZ)
tribehenin (UNII: 8OC9U7TQZ0)
cholesterol (UNII: 97C5T2UQ7J)
butylated hydroxytoluene (UNII: 1P9D0Z171K)
3-((l-menthyl)oxy)propane-1,2-diol (UNII: KD6TZ2QICH)
candelilla wax (UNII: WL0328HX19)
yellow wax (UNII: 2ZA36H0S2V)
cetostearyl alcohol (UNII: 2DMT128M1S)
cetearyl glucoside (UNII: 09FUA47KNA)
polyglyceryl-2 dipolyhydroxystearate (UNII: 9229XJ4V12)
ceramide 2 (UNII: C04977SRJ5)
decyl glucoside (UNII: Z17H97EA6Y)
linolenic acid (UNII: 0RBV727H71)
peg-10 rapeseed sterol (UNII: 258O76T85M)
palmitoyl oligopeptide (UNII: HO4ZT5S86C)
ferric oxide red (UNII: 1K09F3G675)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 13537-299-02	1 in 1 BOX
1	NDC: 13537-299-01	30 mL in 1 BOTTLE, PLASTIC
2	NDC: 13537-299-04	1 in 1 BOX
2	NDC: 13537-299-03	27 mL in 1 BOTTLE, PLASTIC
3	NDC: 13537-299-06	1 in 1 BOX
3	NDC: 13537-299-05	4.5 mL in 1 BOTTLE, PLASTIC
4	NDC: 13537-299-08	1 in 1 BOX
4	NDC: 13537-299-07	3 mL in 1 TUBE

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

LBEL NATURAL FINISH MOISTURIZING FOUNDATION SPF 25   (MEDIUM 6B) - BROWN
octinoxate and titanium dioxide liquid

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 13537-251
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
Octinoxate (UNII: 4Y5P7MUD51) (Octinoxate - UNII:4Y5P7MUD51)	Octinoxate	0.065 g  in 1 mL
Titanium Dioxide (UNII: 15FIX9V2JP) (Titanium Dioxide - UNII:15FIX9V2JP)	Titanium Dioxide	0.016 g  in 1 mL

Inactive Ingredients
Ingredient Name	Strength
water (UNII: 059QF0KO0R)
cyclomethicone 5 (UNII: 0THT5PCI0R)
cyclomethicone 6 (UNII: XHK3U310BA)
propylene glycol dicaprylate/dicaprate (UNII: O4446S9CRA)
peg/ppg-18/18 dimethicone (UNII: 9H0AO7T794)
xylitylglucoside (UNII: O0IEZ166FB)
octyldodecanol (UNII: 461N1O614Y)
oleth-5 (UNII: 1GH33785AY)
anhydroxylitol (UNII: 8XWR7NN42F)
glycerin (UNII: PDC6A3C0OX)
linoleic acid (UNII: 9KJL21T0QJ)
peg/ppg-19/19 dimethicone (UNII: EHH90CO7TL)
microcrystalline wax (UNII: XOF597Q3KY)
alkyl (c12-15) benzoate (UNII: A9EJ3J61HQ)
xylitol (UNII: VCQ006KQ1E)
diazolidinyl urea (UNII: H5RIZ3MPW4)
aluminum oxide (UNII: LMI26O6933)
petrolatum (UNII: 4T6H12BN9U)
.alpha.-tocopherol acetate (UNII: 9E8X80D2L0)
triethoxycaprylylsilane (UNII: LDC331P08E)
ribes nigrum seed oil (UNII: GKE1188837)
silicon dioxide (UNII: ETJ7Z6XBU4)
methylparaben (UNII: A2I8C7HI9T)
propylparaben (UNII: Z8IX2SC1OH)
carnauba wax (UNII: R12CBM0EIZ)
tribehenin (UNII: 8OC9U7TQZ0)
cholesterol (UNII: 97C5T2UQ7J)
butylated hydroxytoluene (UNII: 1P9D0Z171K)
3-((l-menthyl)oxy)propane-1,2-diol (UNII: KD6TZ2QICH)
candelilla wax (UNII: WL0328HX19)
yellow wax (UNII: 2ZA36H0S2V)
cetostearyl alcohol (UNII: 2DMT128M1S)
cetearyl glucoside (UNII: 09FUA47KNA)
polyglyceryl-2 dipolyhydroxystearate (UNII: 9229XJ4V12)
ceramide 2 (UNII: C04977SRJ5)
decyl glucoside (UNII: Z17H97EA6Y)
linolenic acid (UNII: 0RBV727H71)
peg-10 rapeseed sterol (UNII: 258O76T85M)
palmitoyl oligopeptide (UNII: HO4ZT5S86C)
ferric oxide red (UNII: 1K09F3G675)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 13537-251-02	1 in 1 BOX
1	NDC: 13537-251-01	30 mL in 1 BOTTLE, PLASTIC
2	NDC: 13537-251-04	1 in 1 BOX
2	NDC: 13537-251-03	27 mL in 1 BOTTLE, PLASTIC
3	NDC: 13537-251-06	1 in 1 BOX
3	NDC: 13537-251-05	4.5 mL in 1 BOTTLE, PLASTIC
4	NDC: 13537-251-08	1 in 1 BOX
4	NDC: 13537-251-07	3 mL in 1 TUBE

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

LBEL NATURAL FINISH MOISTURIZING FOUNDATION SPF 25   (OBSCURE 8A) - BROWN
octinoxate and titanium dioxide liquid

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 13537-252
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
Octinoxate (UNII: 4Y5P7MUD51) (Octinoxate - UNII:4Y5P7MUD51)	Octinoxate	0.065 g  in 1 mL
Titanium Dioxide (UNII: 15FIX9V2JP) (Titanium Dioxide - UNII:15FIX9V2JP)	Titanium Dioxide	0.016 g  in 1 mL

Inactive Ingredients
Ingredient Name	Strength
water (UNII: 059QF0KO0R)
cyclomethicone 5 (UNII: 0THT5PCI0R)
cyclomethicone 6 (UNII: XHK3U310BA)
propylene glycol dicaprylate/dicaprate (UNII: O4446S9CRA)
peg/ppg-18/18 dimethicone (UNII: 9H0AO7T794)
xylitylglucoside (UNII: O0IEZ166FB)
octyldodecanol (UNII: 461N1O614Y)
oleth-5 (UNII: 1GH33785AY)
anhydroxylitol (UNII: 8XWR7NN42F)
glycerin (UNII: PDC6A3C0OX)
linoleic acid (UNII: 9KJL21T0QJ)
peg/ppg-19/19 dimethicone (UNII: EHH90CO7TL)
microcrystalline wax (UNII: XOF597Q3KY)
alkyl (c12-15) benzoate (UNII: A9EJ3J61HQ)
xylitol (UNII: VCQ006KQ1E)
diazolidinyl urea (UNII: H5RIZ3MPW4)
aluminum oxide (UNII: LMI26O6933)
petrolatum (UNII: 4T6H12BN9U)
.alpha.-tocopherol acetate (UNII: 9E8X80D2L0)
triethoxycaprylylsilane (UNII: LDC331P08E)
ribes nigrum seed oil (UNII: GKE1188837)
silicon dioxide (UNII: ETJ7Z6XBU4)
methylparaben (UNII: A2I8C7HI9T)
propylparaben (UNII: Z8IX2SC1OH)
carnauba wax (UNII: R12CBM0EIZ)
tribehenin (UNII: 8OC9U7TQZ0)
cholesterol (UNII: 97C5T2UQ7J)
butylated hydroxytoluene (UNII: 1P9D0Z171K)
3-((l-menthyl)oxy)propane-1,2-diol (UNII: KD6TZ2QICH)
candelilla wax (UNII: WL0328HX19)
yellow wax (UNII: 2ZA36H0S2V)
cetostearyl alcohol (UNII: 2DMT128M1S)
cetearyl glucoside (UNII: 09FUA47KNA)
polyglyceryl-2 dipolyhydroxystearate (UNII: 9229XJ4V12)
ceramide 2 (UNII: C04977SRJ5)
decyl glucoside (UNII: Z17H97EA6Y)
linolenic acid (UNII: 0RBV727H71)
peg-10 rapeseed sterol (UNII: 258O76T85M)
palmitoyl oligopeptide (UNII: HO4ZT5S86C)
ferric oxide red (UNII: 1K09F3G675)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 13537-252-02	1 in 1 BOX
1	NDC: 13537-252-01	30 mL in 1 BOTTLE, PLASTIC
2	NDC: 13537-252-04	1 in 1 BOX
2	NDC: 13537-252-03	27 mL in 1 BOTTLE, PLASTIC
3	NDC: 13537-252-06	1 in 1 BOX
3	NDC: 13537-252-05	4.5 mL in 1 BOTTLE, PLASTIC
4	NDC: 13537-252-08	1 in 1 BOX
4	NDC: 13537-252-07	3 mL in 1 TUBE

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

LBEL NATURAL FINISH MOISTURIZING FOUNDATION SPF 25   (OBSCURE 8B) - BROWN
octinoxate and titanium dioxide liquid

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 13537-253
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
Octinoxate (UNII: 4Y5P7MUD51) (Octinoxate - UNII:4Y5P7MUD51)	Octinoxate	0.065 g  in 1 mL
Titanium Dioxide (UNII: 15FIX9V2JP) (Titanium Dioxide - UNII:15FIX9V2JP)	Titanium Dioxide	0.016 g  in 1 mL

Inactive Ingredients
Ingredient Name	Strength
water (UNII: 059QF0KO0R)
cyclomethicone 5 (UNII: 0THT5PCI0R)
cyclomethicone 6 (UNII: XHK3U310BA)
propylene glycol dicaprylate/dicaprate (UNII: O4446S9CRA)
peg/ppg-18/18 dimethicone (UNII: 9H0AO7T794)
xylitylglucoside (UNII: O0IEZ166FB)
octyldodecanol (UNII: 461N1O614Y)
oleth-5 (UNII: 1GH33785AY)
anhydroxylitol (UNII: 8XWR7NN42F)
glycerin (UNII: PDC6A3C0OX)
linoleic acid (UNII: 9KJL21T0QJ)
peg/ppg-19/19 dimethicone (UNII: EHH90CO7TL)
microcrystalline wax (UNII: XOF597Q3KY)
alkyl (c12-15) benzoate (UNII: A9EJ3J61HQ)
xylitol (UNII: VCQ006KQ1E)
diazolidinyl urea (UNII: H5RIZ3MPW4)
aluminum oxide (UNII: LMI26O6933)
petrolatum (UNII: 4T6H12BN9U)
.alpha.-tocopherol acetate (UNII: 9E8X80D2L0)
triethoxycaprylylsilane (UNII: LDC331P08E)
ribes nigrum seed oil (UNII: GKE1188837)
silicon dioxide (UNII: ETJ7Z6XBU4)
methylparaben (UNII: A2I8C7HI9T)
propylparaben (UNII: Z8IX2SC1OH)
carnauba wax (UNII: R12CBM0EIZ)
tribehenin (UNII: 8OC9U7TQZ0)
cholesterol (UNII: 97C5T2UQ7J)
butylated hydroxytoluene (UNII: 1P9D0Z171K)
3-((l-menthyl)oxy)propane-1,2-diol (UNII: KD6TZ2QICH)
candelilla wax (UNII: WL0328HX19)
yellow wax (UNII: 2ZA36H0S2V)
cetostearyl alcohol (UNII: 2DMT128M1S)
cetearyl glucoside (UNII: 09FUA47KNA)
polyglyceryl-2 dipolyhydroxystearate (UNII: 9229XJ4V12)
ceramide 2 (UNII: C04977SRJ5)
decyl glucoside (UNII: Z17H97EA6Y)
linolenic acid (UNII: 0RBV727H71)
peg-10 rapeseed sterol (UNII: 258O76T85M)
palmitoyl oligopeptide (UNII: HO4ZT5S86C)
ferric oxide red (UNII: 1K09F3G675)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 13537-253-02	1 in 1 BOX
1	NDC: 13537-253-01	30 mL in 1 BOTTLE, PLASTIC
2	NDC: 13537-253-04	1 in 1 BOX
2	NDC: 13537-253-03	27 mL in 1 BOTTLE, PLASTIC
3	NDC: 13537-253-06	1 in 1 BOX
3	NDC: 13537-253-05	4.5 mL in 1 BOTTLE, PLASTIC
4	NDC: 13537-253-08	1 in 1 BOX
4	NDC: 13537-253-07	3 mL in 1 TUBE

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

LBEL NATURAL FINISH MOISTURIZING FOUNDATION SPF 25   (OBSCURE 8C) - BROWN
octinoxate and titanium dioxide liquid

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 13537-254
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
Octinoxate (UNII: 4Y5P7MUD51) (Octinoxate - UNII:4Y5P7MUD51)	Octinoxate	0.065 g  in 1 mL
Titanium Dioxide (UNII: 15FIX9V2JP) (Titanium Dioxide - UNII:15FIX9V2JP)	Titanium Dioxide	0.016 g  in 1 mL

Inactive Ingredients
Ingredient Name	Strength
water (UNII: 059QF0KO0R)
cyclomethicone 5 (UNII: 0THT5PCI0R)
cyclomethicone 6 (UNII: XHK3U310BA)
propylene glycol dicaprylate/dicaprate (UNII: O4446S9CRA)
peg/ppg-18/18 dimethicone (UNII: 9H0AO7T794)
xylitylglucoside (UNII: O0IEZ166FB)
octyldodecanol (UNII: 461N1O614Y)
oleth-5 (UNII: 1GH33785AY)
anhydroxylitol (UNII: 8XWR7NN42F)
glycerin (UNII: PDC6A3C0OX)
linoleic acid (UNII: 9KJL21T0QJ)
peg/ppg-19/19 dimethicone (UNII: EHH90CO7TL)
microcrystalline wax (UNII: XOF597Q3KY)
alkyl (c12-15) benzoate (UNII: A9EJ3J61HQ)
xylitol (UNII: VCQ006KQ1E)
diazolidinyl urea (UNII: H5RIZ3MPW4)
aluminum oxide (UNII: LMI26O6933)
petrolatum (UNII: 4T6H12BN9U)
.alpha.-tocopherol acetate (UNII: 9E8X80D2L0)
triethoxycaprylylsilane (UNII: LDC331P08E)
ribes nigrum seed oil (UNII: GKE1188837)
silicon dioxide (UNII: ETJ7Z6XBU4)
methylparaben (UNII: A2I8C7HI9T)
propylparaben (UNII: Z8IX2SC1OH)
carnauba wax (UNII: R12CBM0EIZ)
tribehenin (UNII: 8OC9U7TQZ0)
cholesterol (UNII: 97C5T2UQ7J)
butylated hydroxytoluene (UNII: 1P9D0Z171K)
3-((l-menthyl)oxy)propane-1,2-diol (UNII: KD6TZ2QICH)
candelilla wax (UNII: WL0328HX19)
yellow wax (UNII: 2ZA36H0S2V)
cetostearyl alcohol (UNII: 2DMT128M1S)
cetearyl glucoside (UNII: 09FUA47KNA)
polyglyceryl-2 dipolyhydroxystearate (UNII: 9229XJ4V12)
ceramide 2 (UNII: C04977SRJ5)
decyl glucoside (UNII: Z17H97EA6Y)
linolenic acid (UNII: 0RBV727H71)
peg-10 rapeseed sterol (UNII: 258O76T85M)
palmitoyl oligopeptide (UNII: HO4ZT5S86C)
ferric oxide red (UNII: 1K09F3G675)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 13537-254-02	1 in 1 BOX
1	NDC: 13537-254-01	30 mL in 1 BOTTLE, PLASTIC
2	NDC: 13537-254-04	1 in 1 BOX
2	NDC: 13537-254-03	27 mL in 1 BOTTLE, PLASTIC
3	NDC: 13537-254-06	1 in 1 BOX
3	NDC: 13537-254-05	4.5 mL in 1 BOTTLE, PLASTIC
4	NDC: 13537-254-08	1 in 1 BOX
4	NDC: 13537-254-07	3 mL in 1 TUBE

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

LBEL NATURAL FINISH MOISTURIZING FOUNDATION SPF 25   (OBSCURE 10) - BROWN
octinoxate and titanium dioxide liquid

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 13537-255
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
Octinoxate (UNII: 4Y5P7MUD51) (Octinoxate - UNII:4Y5P7MUD51)	Octinoxate	0.065 g  in 1 mL
Titanium Dioxide (UNII: 15FIX9V2JP) (Titanium Dioxide - UNII:15FIX9V2JP)	Titanium Dioxide	0.016 g  in 1 mL

Inactive Ingredients
Ingredient Name	Strength
water (UNII: 059QF0KO0R)
cyclomethicone 5 (UNII: 0THT5PCI0R)
cyclomethicone 6 (UNII: XHK3U310BA)
propylene glycol dicaprylate/dicaprate (UNII: O4446S9CRA)
peg/ppg-18/18 dimethicone (UNII: 9H0AO7T794)
xylitylglucoside (UNII: O0IEZ166FB)
octyldodecanol (UNII: 461N1O614Y)
oleth-5 (UNII: 1GH33785AY)
anhydroxylitol (UNII: 8XWR7NN42F)
glycerin (UNII: PDC6A3C0OX)
linoleic acid (UNII: 9KJL21T0QJ)
peg/ppg-19/19 dimethicone (UNII: EHH90CO7TL)
microcrystalline wax (UNII: XOF597Q3KY)
alkyl (c12-15) benzoate (UNII: A9EJ3J61HQ)
xylitol (UNII: VCQ006KQ1E)
diazolidinyl urea (UNII: H5RIZ3MPW4)
aluminum oxide (UNII: LMI26O6933)
petrolatum (UNII: 4T6H12BN9U)
.alpha.-tocopherol acetate (UNII: 9E8X80D2L0)
triethoxycaprylylsilane (UNII: LDC331P08E)
ribes nigrum seed oil (UNII: GKE1188837)
silicon dioxide (UNII: ETJ7Z6XBU4)
methylparaben (UNII: A2I8C7HI9T)
propylparaben (UNII: Z8IX2SC1OH)
carnauba wax (UNII: R12CBM0EIZ)
tribehenin (UNII: 8OC9U7TQZ0)
cholesterol (UNII: 97C5T2UQ7J)
butylated hydroxytoluene (UNII: 1P9D0Z171K)
3-((l-menthyl)oxy)propane-1,2-diol (UNII: KD6TZ2QICH)
candelilla wax (UNII: WL0328HX19)
yellow wax (UNII: 2ZA36H0S2V)
cetostearyl alcohol (UNII: 2DMT128M1S)
cetearyl glucoside (UNII: 09FUA47KNA)
polyglyceryl-2 dipolyhydroxystearate (UNII: 9229XJ4V12)
ceramide 2 (UNII: C04977SRJ5)
decyl glucoside (UNII: Z17H97EA6Y)
linolenic acid (UNII: 0RBV727H71)
peg-10 rapeseed sterol (UNII: 258O76T85M)
palmitoyl oligopeptide (UNII: HO4ZT5S86C)
ferric oxide red (UNII: 1K09F3G675)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 13537-255-02	1 in 1 BOX
1	NDC: 13537-255-01	30 mL in 1 BOTTLE, PLASTIC
2	NDC: 13537-255-04	1 in 1 BOX
2	NDC: 13537-255-03	27 mL in 1 BOTTLE, PLASTIC
3	NDC: 13537-255-06	1 in 1 BOX
3	NDC: 13537-255-05	4.5 mL in 1 BOTTLE, PLASTIC
4	NDC: 13537-255-08	1 in 1 BOX
4	NDC: 13537-255-07	3 mL in 1 TUBE

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

LBEL NATURAL FINISH MOISTURIZING FOUNDATION SPF 25   (DORE 6) - BEIGE
octinoxate and titanium dioxide liquid

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 13537-256
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
Octinoxate (UNII: 4Y5P7MUD51) (Octinoxate - UNII:4Y5P7MUD51)	Octinoxate	0.065 g  in 1 mL
Titanium Dioxide (UNII: 15FIX9V2JP) (Titanium Dioxide - UNII:15FIX9V2JP)	Titanium Dioxide	0.016 g  in 1 mL

Inactive Ingredients
Ingredient Name	Strength
water (UNII: 059QF0KO0R)
cyclomethicone 5 (UNII: 0THT5PCI0R)
cyclomethicone 6 (UNII: XHK3U310BA)
propylene glycol dicaprylate/dicaprate (UNII: O4446S9CRA)
peg/ppg-18/18 dimethicone (UNII: 9H0AO7T794)
xylitylglucoside (UNII: O0IEZ166FB)
octyldodecanol (UNII: 461N1O614Y)
oleth-5 (UNII: 1GH33785AY)
anhydroxylitol (UNII: 8XWR7NN42F)
glycerin (UNII: PDC6A3C0OX)
linoleic acid (UNII: 9KJL21T0QJ)
peg/ppg-19/19 dimethicone (UNII: EHH90CO7TL)
microcrystalline wax (UNII: XOF597Q3KY)
alkyl (c12-15) benzoate (UNII: A9EJ3J61HQ)
xylitol (UNII: VCQ006KQ1E)
diazolidinyl urea (UNII: H5RIZ3MPW4)
aluminum oxide (UNII: LMI26O6933)
petrolatum (UNII: 4T6H12BN9U)
.alpha.-tocopherol acetate (UNII: 9E8X80D2L0)
triethoxycaprylylsilane (UNII: LDC331P08E)
ribes nigrum seed oil (UNII: GKE1188837)
silicon dioxide (UNII: ETJ7Z6XBU4)
methylparaben (UNII: A2I8C7HI9T)
propylparaben (UNII: Z8IX2SC1OH)
carnauba wax (UNII: R12CBM0EIZ)
tribehenin (UNII: 8OC9U7TQZ0)
cholesterol (UNII: 97C5T2UQ7J)
butylated hydroxytoluene (UNII: 1P9D0Z171K)
3-((l-menthyl)oxy)propane-1,2-diol (UNII: KD6TZ2QICH)
candelilla wax (UNII: WL0328HX19)
yellow wax (UNII: 2ZA36H0S2V)
cetostearyl alcohol (UNII: 2DMT128M1S)
cetearyl glucoside (UNII: 09FUA47KNA)
polyglyceryl-2 dipolyhydroxystearate (UNII: 9229XJ4V12)
ceramide 2 (UNII: C04977SRJ5)
decyl glucoside (UNII: Z17H97EA6Y)
linolenic acid (UNII: 0RBV727H71)
peg-10 rapeseed sterol (UNII: 258O76T85M)
palmitoyl oligopeptide (UNII: HO4ZT5S86C)
ferric oxide red (UNII: 1K09F3G675)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 13537-256-02	1 in 1 BOX
1	NDC: 13537-256-01	30 mL in 1 BOTTLE, PLASTIC
2	NDC: 13537-256-04	1 in 1 BOX
2	NDC: 13537-256-03	27 mL in 1 BOTTLE, PLASTIC
3	NDC: 13537-256-06	1 in 1 BOX
3	NDC: 13537-256-05	4.5 mL in 1 BOTTLE, PLASTIC
4	NDC: 13537-256-08	1 in 1 BOX
4	NDC: 13537-256-07	3 mL in 1 TUBE

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

Labeler - Ventura Corporation LTD (602751344)

Establishment
Name	Address	ID/FEI	Business Operations
Bel Star S.A. (Colombia)		880160197	MANUFACTURE(13537-241, 13537-242, 13537-243, 13537-244, 13537-245, 13537-246, 13537-247, 13537-248, 13537-249, 13537-299, 13537-251, 13537-252, 13537-253, 13537-254, 13537-255, 13537-256)