NARS FOUNDATION BARCELONA- octinoxate and titanium dioxide powder NARS FOUNDATION BENARES- octinoxate and titanium dioxide powder NARS FOUNDATION CADIZ- octinoxate and titanium dioxide powder NARS FOUNDATION DEAUVILLE- octinoxate and titanium dioxide powder NARS FOUNDATION FIJI- octinoxate and titanium dioxide powder NARS FOUNDATION MONT BLANC- octinoxate and titanium dioxide powder NARS FOUNDATION NEW ORLEANS- octinoxate and titanium dioxide powder NARS FOUNDATION PUNJAB- octinoxate and titanium dioxide powder NARS FOUNDATION SANTA FE- octinoxate and titanium dioxide powder NARS FOUNDATION SIBERIA- octinoxate and titanium dioxide powder NARS FOUNDATION STROMBOLI- octinoxate and titanium dioxide powder NARS FOUNDATION SYRACUSE- octinoxate and titanium dioxide powder NARS FOUNDATION TAHOE- octinoxate and titanium dioxide powder

NARS FOUNDATION by

Drug Labeling and Warnings

NARS FOUNDATION by is a Otc medication manufactured, distributed, or labeled by NARS Cosmetics, SHISEIDO AMERICA INC., Davlyn Industries Inc. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

SPL UNCLASSIFIED SECTION

Drug Facts

ACTIVE INGREDIENT

Active ingredients	Purpose
OCTINOXATE 4.9%	Sunscreen
TITANIUM DIOXIDE 6.6%	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 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 product is swallowed, get medical help or contact a Poison Control Center right away.

Directions

• apply liberally 15 minutes before sun exposure
• use a water resistant sunscreen if swimming or sweating
• reapply at least every 2 hours
• children under 6 months: Ask a doctor

Inactive Ingredients

NYLON-12 , CALCIUM STEARATE , SILICA , DIMETHICONE , JOJOBA ALCOHOL , ISOPROPYL JOJOBATE , JOJOBA ESTERS , HYDROGENATED LECITHIN , TRIMETHYLSILOXYSILICATE , LAUROYL LYSINE , METHICONE , SORBITAN SESQUIOLEATE , METHYLPARABEN , PROPYLPARABEN , BHT , TOCOPHEROL , [(MAY CONTAIN): MICA , TITANIUM DIOXIDE , IRON OXIDES , IRON OXIDES , IRON OXIDES] ,

Other information

protect this product in this container from excessive heat and direct sun

Questions or comments?

Call toll free 1-888-788-NARS

PRINCIPAL DISPLAY PANEL - 12 g Tray Carton - BARCELONA

NARS

POWDER FOUNDATION BROAD SPECTRUM
SPF 12 SUNSCREEN

NET WT. 0.42 Oz. 12 g

PRINCIPAL DISPLAY PANEL - 12 g Tray Carton - BENARES

NARS

POWDER FOUNDATION BROAD SPECTRUM
SPF 12 SUNSCREEN

NET WT. 0.42 Oz. 12 g

PRINCIPAL DISPLAY PANEL - 12 g Tray Carton - CÁDIZ

NARS

POWDER FOUNDATION BROAD SPECTRUM
SPF 12 SUNSCREEN

NET WT. 0.42 Oz. 12 g

PRINCIPAL DISPLAY PANEL - 12 g Tray Carton - DEAUVILLE

NARS

POWDER FOUNDATION BROAD SPECTRUM
SPF 12 SUNSCREEN

NET WT. 0.42 Oz. 12 g

PRINCIPAL DISPLAY PANEL - 12 g Tray Carton - FIJI

NARS

POWDER FOUNDATION BROAD SPECTRUM
SPF 12 SUNSCREEN

NET WT. 0.42 Oz. 12 g

PRINCIPAL DISPLAY PANEL - 12 g Tray Carton - MONT BLANC

NARS

POWDER FOUNDATION BROAD SPECTRUM
SPF 12 SUNSCREEN

NET WT. 0.42 Oz. 12 g

PRINCIPAL DISPLAY PANEL - 12 g Tray Carton - NEW ORLEANS

NARS

POWDER FOUNDATION BROAD SPECTRUM
SPF 12 SUNSCREEN

NET WT. 0.42 Oz. 12 g

PRINCIPAL DISPLAY PANEL - 12 g Tray Carton - PUNJAB

NARS

POWDER FOUNDATION BROAD SPECTRUM
SPF 12 SUNSCREEN

NET WT. 0.42 Oz. 12 g

PRINCIPAL DISPLAY PANEL - 12 g Tray Carton - SANTA FE

NARS

POWDER FOUNDATION BROAD SPECTRUM
SPF 12 SUNSCREEN

NET WT. 0.42 Oz. 12 g

PRINCIPAL DISPLAY PANEL - 12 g Tray Carton - SIBERIA

NARS

POWDER FOUNDATION BROAD SPECTRUM
SPF 12 SUNSCREEN

NET WT. 0.42 Oz. 12 g

PRINCIPAL DISPLAY PANEL - 12 g Tray Carton - STROMBOLI

NARS

POWDER FOUNDATION BROAD SPECTRUM
SPF 12 SUNSCREEN

NET WT. 0.42 Oz. 12 g

PRINCIPAL DISPLAY PANEL - 12 g Tray Carton - SYRACUSE

NARS

POWDER FOUNDATION BROAD SPECTRUM
SPF 12 SUNSCREEN

NET WT. 0.42 Oz. 12 g

PRINCIPAL DISPLAY PANEL - 12 g Tray Carton - TAHOE

NARS

POWDER FOUNDATION BROAD SPECTRUM
SPF 12 SUNSCREEN

NET WT. 0.42 Oz. 12 g

INGREDIENTS AND APPEARANCE

NARS FOUNDATION   BARCELONA
octinoxate and titanium dioxide powder

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 13734-114
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
OCTINOXATE (UNII: 4Y5P7MUD51) (OCTINOXATE - UNII:4Y5P7MUD51)	OCTINOXATE	588 mg  in 12 g
TITANIUM DIOXIDE (UNII: 15FIX9V2JP) (TITANIUM DIOXIDE - UNII:15FIX9V2JP)	TITANIUM DIOXIDE	792 mg  in 12 g

Inactive Ingredients
Ingredient Name	Strength
NYLON-12 (UNII: 446U8J075B)
CALCIUM STEARATE (UNII: 776XM7047L)
SILICON DIOXIDE (UNII: ETJ7Z6XBU4)
DIMETHICONE (UNII: 92RU3N3Y1O)
TRIMETHYLSILOXYSILICATE (M/Q 0.6-0.8) (UNII: 5041RX63GN)
LAUROYL LYSINE (UNII: 113171Q70B)
METHICONE (20 CST) (UNII: 6777U11MKT)
SORBITAN SESQUIOLEATE (UNII: 0W8RRI5W5A)
METHYLPARABEN (UNII: A2I8C7HI9T)
PROPYLPARABEN (UNII: Z8IX2SC1OH)
BUTYLATED HYDROXYTOLUENE (UNII: 1P9D0Z171K)
.ALPHA.-TOCOPHEROL (UNII: H4N855PNZ1)
MICA (UNII: V8A1AW0880)
TITANIUM DIOXIDE (UNII: 15FIX9V2JP)
FERRIC OXIDE RED (UNII: 1K09F3G675)
FERRIC OXIDE YELLOW (UNII: EX438O2MRT)
FERROSOFERRIC OXIDE (UNII: XM0M87F357)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 13734-114-30	1 in 1 CARTON
1		12 g in 1 TRAY

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC MONOGRAPH NOT FINAL	part352	12/01/2012

NARS FOUNDATION   BENARES
octinoxate and titanium dioxide powder

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 13734-115
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
OCTINOXATE (UNII: 4Y5P7MUD51) (OCTINOXATE - UNII:4Y5P7MUD51)	OCTINOXATE	588 mg  in 12 g
TITANIUM DIOXIDE (UNII: 15FIX9V2JP) (TITANIUM DIOXIDE - UNII:15FIX9V2JP)	TITANIUM DIOXIDE	792 mg  in 12 g

Inactive Ingredients
Ingredient Name	Strength
NYLON-12 (UNII: 446U8J075B)
CALCIUM STEARATE (UNII: 776XM7047L)
SILICON DIOXIDE (UNII: ETJ7Z6XBU4)
DIMETHICONE (UNII: 92RU3N3Y1O)
TRIMETHYLSILOXYSILICATE (M/Q 0.6-0.8) (UNII: 5041RX63GN)
LAUROYL LYSINE (UNII: 113171Q70B)
METHICONE (20 CST) (UNII: 6777U11MKT)
SORBITAN SESQUIOLEATE (UNII: 0W8RRI5W5A)
METHYLPARABEN (UNII: A2I8C7HI9T)
PROPYLPARABEN (UNII: Z8IX2SC1OH)
BUTYLATED HYDROXYTOLUENE (UNII: 1P9D0Z171K)
.ALPHA.-TOCOPHEROL (UNII: H4N855PNZ1)
MICA (UNII: V8A1AW0880)
TITANIUM DIOXIDE (UNII: 15FIX9V2JP)
FERRIC OXIDE RED (UNII: 1K09F3G675)
FERRIC OXIDE YELLOW (UNII: EX438O2MRT)
FERROSOFERRIC OXIDE (UNII: XM0M87F357)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 13734-115-30	1 in 1 CARTON
1		12 g in 1 TRAY

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC MONOGRAPH NOT FINAL	part352	12/01/2012

NARS FOUNDATION   CADIZ
octinoxate and titanium dioxide powder

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 13734-116
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
OCTINOXATE (UNII: 4Y5P7MUD51) (OCTINOXATE - UNII:4Y5P7MUD51)	OCTINOXATE	588 mg  in 12 g
TITANIUM DIOXIDE (UNII: 15FIX9V2JP) (TITANIUM DIOXIDE - UNII:15FIX9V2JP)	TITANIUM DIOXIDE	792 mg  in 12 g

Inactive Ingredients
Ingredient Name	Strength
NYLON-12 (UNII: 446U8J075B)
CALCIUM STEARATE (UNII: 776XM7047L)
SILICON DIOXIDE (UNII: ETJ7Z6XBU4)
DIMETHICONE (UNII: 92RU3N3Y1O)
TRIMETHYLSILOXYSILICATE (M/Q 0.6-0.8) (UNII: 5041RX63GN)
LAUROYL LYSINE (UNII: 113171Q70B)
METHICONE (20 CST) (UNII: 6777U11MKT)
SORBITAN SESQUIOLEATE (UNII: 0W8RRI5W5A)
METHYLPARABEN (UNII: A2I8C7HI9T)
PROPYLPARABEN (UNII: Z8IX2SC1OH)
BUTYLATED HYDROXYTOLUENE (UNII: 1P9D0Z171K)
.ALPHA.-TOCOPHEROL (UNII: H4N855PNZ1)
MICA (UNII: V8A1AW0880)
TITANIUM DIOXIDE (UNII: 15FIX9V2JP)
FERRIC OXIDE RED (UNII: 1K09F3G675)
FERRIC OXIDE YELLOW (UNII: EX438O2MRT)
FERROSOFERRIC OXIDE (UNII: XM0M87F357)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 13734-116-30	1 in 1 CARTON
1		12 g in 1 TRAY

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC MONOGRAPH NOT FINAL	part352	12/01/2012

NARS FOUNDATION   DEAUVILLE
octinoxate and titanium dioxide powder

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 13734-117
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
OCTINOXATE (UNII: 4Y5P7MUD51) (OCTINOXATE - UNII:4Y5P7MUD51)	OCTINOXATE	588 mg  in 12 g
TITANIUM DIOXIDE (UNII: 15FIX9V2JP) (TITANIUM DIOXIDE - UNII:15FIX9V2JP)	TITANIUM DIOXIDE	792 mg  in 12 g

Inactive Ingredients
Ingredient Name	Strength
NYLON-12 (UNII: 446U8J075B)
CALCIUM STEARATE (UNII: 776XM7047L)
SILICON DIOXIDE (UNII: ETJ7Z6XBU4)
DIMETHICONE (UNII: 92RU3N3Y1O)
TRIMETHYLSILOXYSILICATE (M/Q 0.6-0.8) (UNII: 5041RX63GN)
LAUROYL LYSINE (UNII: 113171Q70B)
METHICONE (20 CST) (UNII: 6777U11MKT)
SORBITAN SESQUIOLEATE (UNII: 0W8RRI5W5A)
METHYLPARABEN (UNII: A2I8C7HI9T)
PROPYLPARABEN (UNII: Z8IX2SC1OH)
BUTYLATED HYDROXYTOLUENE (UNII: 1P9D0Z171K)
.ALPHA.-TOCOPHEROL (UNII: H4N855PNZ1)
MICA (UNII: V8A1AW0880)
TITANIUM DIOXIDE (UNII: 15FIX9V2JP)
FERRIC OXIDE RED (UNII: 1K09F3G675)
FERRIC OXIDE YELLOW (UNII: EX438O2MRT)
FERROSOFERRIC OXIDE (UNII: XM0M87F357)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 13734-117-30	1 in 1 CARTON
1		12 g in 1 TRAY

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC MONOGRAPH NOT FINAL	part352	12/01/2012

NARS FOUNDATION   FIJI
octinoxate and titanium dioxide powder

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 13734-118
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
OCTINOXATE (UNII: 4Y5P7MUD51) (OCTINOXATE - UNII:4Y5P7MUD51)	OCTINOXATE	588 mg  in 12 g
TITANIUM DIOXIDE (UNII: 15FIX9V2JP) (TITANIUM DIOXIDE - UNII:15FIX9V2JP)	TITANIUM DIOXIDE	792 mg  in 12 g

Inactive Ingredients
Ingredient Name	Strength
NYLON-12 (UNII: 446U8J075B)
CALCIUM STEARATE (UNII: 776XM7047L)
SILICON DIOXIDE (UNII: ETJ7Z6XBU4)
DIMETHICONE (UNII: 92RU3N3Y1O)
TRIMETHYLSILOXYSILICATE (M/Q 0.6-0.8) (UNII: 5041RX63GN)
LAUROYL LYSINE (UNII: 113171Q70B)
METHICONE (20 CST) (UNII: 6777U11MKT)
SORBITAN SESQUIOLEATE (UNII: 0W8RRI5W5A)
METHYLPARABEN (UNII: A2I8C7HI9T)
PROPYLPARABEN (UNII: Z8IX2SC1OH)
BUTYLATED HYDROXYTOLUENE (UNII: 1P9D0Z171K)
.ALPHA.-TOCOPHEROL (UNII: H4N855PNZ1)
MICA (UNII: V8A1AW0880)
TITANIUM DIOXIDE (UNII: 15FIX9V2JP)
FERRIC OXIDE RED (UNII: 1K09F3G675)
FERRIC OXIDE YELLOW (UNII: EX438O2MRT)
FERROSOFERRIC OXIDE (UNII: XM0M87F357)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 13734-118-30	1 in 1 CARTON
1		12 g in 1 TRAY

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC MONOGRAPH NOT FINAL	part352	12/01/2012

NARS FOUNDATION   MONT BLANC
octinoxate and titanium dioxide powder

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 13734-119
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
OCTINOXATE (UNII: 4Y5P7MUD51) (OCTINOXATE - UNII:4Y5P7MUD51)	OCTINOXATE	588 mg  in 12 g
TITANIUM DIOXIDE (UNII: 15FIX9V2JP) (TITANIUM DIOXIDE - UNII:15FIX9V2JP)	TITANIUM DIOXIDE	792 mg  in 12 g

Inactive Ingredients
Ingredient Name	Strength
NYLON-12 (UNII: 446U8J075B)
CALCIUM STEARATE (UNII: 776XM7047L)
SILICON DIOXIDE (UNII: ETJ7Z6XBU4)
DIMETHICONE (UNII: 92RU3N3Y1O)
TRIMETHYLSILOXYSILICATE (M/Q 0.6-0.8) (UNII: 5041RX63GN)
LAUROYL LYSINE (UNII: 113171Q70B)
METHICONE (20 CST) (UNII: 6777U11MKT)
SORBITAN SESQUIOLEATE (UNII: 0W8RRI5W5A)
METHYLPARABEN (UNII: A2I8C7HI9T)
PROPYLPARABEN (UNII: Z8IX2SC1OH)
BUTYLATED HYDROXYTOLUENE (UNII: 1P9D0Z171K)
.ALPHA.-TOCOPHEROL (UNII: H4N855PNZ1)
MICA (UNII: V8A1AW0880)
TITANIUM DIOXIDE (UNII: 15FIX9V2JP)
FERRIC OXIDE RED (UNII: 1K09F3G675)
FERRIC OXIDE YELLOW (UNII: EX438O2MRT)
FERROSOFERRIC OXIDE (UNII: XM0M87F357)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 13734-119-30	1 in 1 CARTON
1		12 g in 1 TRAY

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC MONOGRAPH NOT FINAL	part352	12/01/2012

NARS FOUNDATION   NEW ORLEANS
octinoxate and titanium dioxide powder

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 13734-120
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
OCTINOXATE (UNII: 4Y5P7MUD51) (OCTINOXATE - UNII:4Y5P7MUD51)	OCTINOXATE	588 mg  in 12 g
TITANIUM DIOXIDE (UNII: 15FIX9V2JP) (TITANIUM DIOXIDE - UNII:15FIX9V2JP)	TITANIUM DIOXIDE	792 mg  in 12 g

Inactive Ingredients
Ingredient Name	Strength
NYLON-12 (UNII: 446U8J075B)
CALCIUM STEARATE (UNII: 776XM7047L)
SILICON DIOXIDE (UNII: ETJ7Z6XBU4)
DIMETHICONE (UNII: 92RU3N3Y1O)
TRIMETHYLSILOXYSILICATE (M/Q 0.6-0.8) (UNII: 5041RX63GN)
LAUROYL LYSINE (UNII: 113171Q70B)
METHICONE (20 CST) (UNII: 6777U11MKT)
SORBITAN SESQUIOLEATE (UNII: 0W8RRI5W5A)
METHYLPARABEN (UNII: A2I8C7HI9T)
PROPYLPARABEN (UNII: Z8IX2SC1OH)
BUTYLATED HYDROXYTOLUENE (UNII: 1P9D0Z171K)
.ALPHA.-TOCOPHEROL (UNII: H4N855PNZ1)
MICA (UNII: V8A1AW0880)
TITANIUM DIOXIDE (UNII: 15FIX9V2JP)
FERRIC OXIDE RED (UNII: 1K09F3G675)
FERRIC OXIDE YELLOW (UNII: EX438O2MRT)
FERROSOFERRIC OXIDE (UNII: XM0M87F357)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 13734-120-30	1 in 1 CARTON
1		12 g in 1 TRAY

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC MONOGRAPH NOT FINAL	part352	12/01/2012

NARS FOUNDATION   PUNJAB
octinoxate and titanium dioxide powder

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 13734-121
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
OCTINOXATE (UNII: 4Y5P7MUD51) (OCTINOXATE - UNII:4Y5P7MUD51)	OCTINOXATE	588 mg  in 12 g
TITANIUM DIOXIDE (UNII: 15FIX9V2JP) (TITANIUM DIOXIDE - UNII:15FIX9V2JP)	TITANIUM DIOXIDE	792 mg  in 12 g

Inactive Ingredients
Ingredient Name	Strength
NYLON-12 (UNII: 446U8J075B)
CALCIUM STEARATE (UNII: 776XM7047L)
SILICON DIOXIDE (UNII: ETJ7Z6XBU4)
DIMETHICONE (UNII: 92RU3N3Y1O)
TRIMETHYLSILOXYSILICATE (M/Q 0.6-0.8) (UNII: 5041RX63GN)
LAUROYL LYSINE (UNII: 113171Q70B)
METHICONE (20 CST) (UNII: 6777U11MKT)
SORBITAN SESQUIOLEATE (UNII: 0W8RRI5W5A)
METHYLPARABEN (UNII: A2I8C7HI9T)
PROPYLPARABEN (UNII: Z8IX2SC1OH)
BUTYLATED HYDROXYTOLUENE (UNII: 1P9D0Z171K)
.ALPHA.-TOCOPHEROL (UNII: H4N855PNZ1)
MICA (UNII: V8A1AW0880)
TITANIUM DIOXIDE (UNII: 15FIX9V2JP)
FERRIC OXIDE RED (UNII: 1K09F3G675)
FERRIC OXIDE YELLOW (UNII: EX438O2MRT)
FERROSOFERRIC OXIDE (UNII: XM0M87F357)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 13734-121-30	1 in 1 CARTON
1		12 g in 1 TRAY

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC MONOGRAPH NOT FINAL	part352	12/01/2012

NARS FOUNDATION   SANTA FE
octinoxate and titanium dioxide powder

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 13734-122
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
OCTINOXATE (UNII: 4Y5P7MUD51) (OCTINOXATE - UNII:4Y5P7MUD51)	OCTINOXATE	588 mg  in 12 g
TITANIUM DIOXIDE (UNII: 15FIX9V2JP) (TITANIUM DIOXIDE - UNII:15FIX9V2JP)	TITANIUM DIOXIDE	792 mg  in 12 g

Inactive Ingredients
Ingredient Name	Strength
NYLON-12 (UNII: 446U8J075B)
CALCIUM STEARATE (UNII: 776XM7047L)
SILICON DIOXIDE (UNII: ETJ7Z6XBU4)
DIMETHICONE (UNII: 92RU3N3Y1O)
TRIMETHYLSILOXYSILICATE (M/Q 0.6-0.8) (UNII: 5041RX63GN)
LAUROYL LYSINE (UNII: 113171Q70B)
METHICONE (20 CST) (UNII: 6777U11MKT)
SORBITAN SESQUIOLEATE (UNII: 0W8RRI5W5A)
METHYLPARABEN (UNII: A2I8C7HI9T)
PROPYLPARABEN (UNII: Z8IX2SC1OH)
BUTYLATED HYDROXYTOLUENE (UNII: 1P9D0Z171K)
.ALPHA.-TOCOPHEROL (UNII: H4N855PNZ1)
MICA (UNII: V8A1AW0880)
TITANIUM DIOXIDE (UNII: 15FIX9V2JP)
FERRIC OXIDE RED (UNII: 1K09F3G675)
FERRIC OXIDE YELLOW (UNII: EX438O2MRT)
FERROSOFERRIC OXIDE (UNII: XM0M87F357)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 13734-122-30	1 in 1 CARTON
1		12 g in 1 TRAY

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC MONOGRAPH NOT FINAL	part352	12/01/2012

NARS FOUNDATION   SIBERIA
octinoxate and titanium dioxide powder

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 13734-123
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
OCTINOXATE (UNII: 4Y5P7MUD51) (OCTINOXATE - UNII:4Y5P7MUD51)	OCTINOXATE	588 mg  in 12 g
TITANIUM DIOXIDE (UNII: 15FIX9V2JP) (TITANIUM DIOXIDE - UNII:15FIX9V2JP)	TITANIUM DIOXIDE	792 mg  in 12 g

Inactive Ingredients
Ingredient Name	Strength
NYLON-12 (UNII: 446U8J075B)
CALCIUM STEARATE (UNII: 776XM7047L)
SILICON DIOXIDE (UNII: ETJ7Z6XBU4)
DIMETHICONE (UNII: 92RU3N3Y1O)
TRIMETHYLSILOXYSILICATE (M/Q 0.6-0.8) (UNII: 5041RX63GN)
LAUROYL LYSINE (UNII: 113171Q70B)
METHICONE (20 CST) (UNII: 6777U11MKT)
SORBITAN SESQUIOLEATE (UNII: 0W8RRI5W5A)
METHYLPARABEN (UNII: A2I8C7HI9T)
PROPYLPARABEN (UNII: Z8IX2SC1OH)
BUTYLATED HYDROXYTOLUENE (UNII: 1P9D0Z171K)
.ALPHA.-TOCOPHEROL (UNII: H4N855PNZ1)
MICA (UNII: V8A1AW0880)
TITANIUM DIOXIDE (UNII: 15FIX9V2JP)
FERRIC OXIDE RED (UNII: 1K09F3G675)
FERRIC OXIDE YELLOW (UNII: EX438O2MRT)
FERROSOFERRIC OXIDE (UNII: XM0M87F357)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 13734-123-30	1 in 1 CARTON
1		12 g in 1 TRAY

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC MONOGRAPH NOT FINAL	part352	12/01/2012

NARS FOUNDATION   STROMBOLI
octinoxate and titanium dioxide powder

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 13734-124
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
OCTINOXATE (UNII: 4Y5P7MUD51) (OCTINOXATE - UNII:4Y5P7MUD51)	OCTINOXATE	588 mg  in 12 g
TITANIUM DIOXIDE (UNII: 15FIX9V2JP) (TITANIUM DIOXIDE - UNII:15FIX9V2JP)	TITANIUM DIOXIDE	792 mg  in 12 g

Inactive Ingredients
Ingredient Name	Strength
NYLON-12 (UNII: 446U8J075B)
CALCIUM STEARATE (UNII: 776XM7047L)
SILICON DIOXIDE (UNII: ETJ7Z6XBU4)
DIMETHICONE (UNII: 92RU3N3Y1O)
TRIMETHYLSILOXYSILICATE (M/Q 0.6-0.8) (UNII: 5041RX63GN)
LAUROYL LYSINE (UNII: 113171Q70B)
METHICONE (20 CST) (UNII: 6777U11MKT)
SORBITAN SESQUIOLEATE (UNII: 0W8RRI5W5A)
METHYLPARABEN (UNII: A2I8C7HI9T)
PROPYLPARABEN (UNII: Z8IX2SC1OH)
BUTYLATED HYDROXYTOLUENE (UNII: 1P9D0Z171K)
.ALPHA.-TOCOPHEROL (UNII: H4N855PNZ1)
MICA (UNII: V8A1AW0880)
TITANIUM DIOXIDE (UNII: 15FIX9V2JP)
FERRIC OXIDE RED (UNII: 1K09F3G675)
FERRIC OXIDE YELLOW (UNII: EX438O2MRT)
FERROSOFERRIC OXIDE (UNII: XM0M87F357)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 13734-124-30	1 in 1 CARTON
1		12 g in 1 TRAY

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC MONOGRAPH NOT FINAL	part352	12/01/2012

NARS FOUNDATION   SYRACUSE
octinoxate and titanium dioxide powder

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 13734-125
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
OCTINOXATE (UNII: 4Y5P7MUD51) (OCTINOXATE - UNII:4Y5P7MUD51)	OCTINOXATE	588 mg  in 12 g
TITANIUM DIOXIDE (UNII: 15FIX9V2JP) (TITANIUM DIOXIDE - UNII:15FIX9V2JP)	TITANIUM DIOXIDE	792 mg  in 12 g

Inactive Ingredients
Ingredient Name	Strength
NYLON-12 (UNII: 446U8J075B)
CALCIUM STEARATE (UNII: 776XM7047L)
SILICON DIOXIDE (UNII: ETJ7Z6XBU4)
DIMETHICONE (UNII: 92RU3N3Y1O)
TRIMETHYLSILOXYSILICATE (M/Q 0.6-0.8) (UNII: 5041RX63GN)
LAUROYL LYSINE (UNII: 113171Q70B)
METHICONE (20 CST) (UNII: 6777U11MKT)
SORBITAN SESQUIOLEATE (UNII: 0W8RRI5W5A)
METHYLPARABEN (UNII: A2I8C7HI9T)
PROPYLPARABEN (UNII: Z8IX2SC1OH)
BUTYLATED HYDROXYTOLUENE (UNII: 1P9D0Z171K)
.ALPHA.-TOCOPHEROL (UNII: H4N855PNZ1)
MICA (UNII: V8A1AW0880)
TITANIUM DIOXIDE (UNII: 15FIX9V2JP)
FERRIC OXIDE RED (UNII: 1K09F3G675)
FERRIC OXIDE YELLOW (UNII: EX438O2MRT)
FERROSOFERRIC OXIDE (UNII: XM0M87F357)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 13734-125-30	1 in 1 CARTON
1		12 g in 1 TRAY

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC MONOGRAPH NOT FINAL	part352	12/01/2012

NARS FOUNDATION   TAHOE
octinoxate and titanium dioxide powder

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 13734-126
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
OCTINOXATE (UNII: 4Y5P7MUD51) (OCTINOXATE - UNII:4Y5P7MUD51)	OCTINOXATE	588 mg  in 12 g
TITANIUM DIOXIDE (UNII: 15FIX9V2JP) (TITANIUM DIOXIDE - UNII:15FIX9V2JP)	TITANIUM DIOXIDE	792 mg  in 12 g

Inactive Ingredients
Ingredient Name	Strength
NYLON-12 (UNII: 446U8J075B)
CALCIUM STEARATE (UNII: 776XM7047L)
SILICON DIOXIDE (UNII: ETJ7Z6XBU4)
DIMETHICONE (UNII: 92RU3N3Y1O)
TRIMETHYLSILOXYSILICATE (M/Q 0.6-0.8) (UNII: 5041RX63GN)
LAUROYL LYSINE (UNII: 113171Q70B)
METHICONE (20 CST) (UNII: 6777U11MKT)
SORBITAN SESQUIOLEATE (UNII: 0W8RRI5W5A)
METHYLPARABEN (UNII: A2I8C7HI9T)
PROPYLPARABEN (UNII: Z8IX2SC1OH)
BUTYLATED HYDROXYTOLUENE (UNII: 1P9D0Z171K)
.ALPHA.-TOCOPHEROL (UNII: H4N855PNZ1)
MICA (UNII: V8A1AW0880)
TITANIUM DIOXIDE (UNII: 15FIX9V2JP)
FERRIC OXIDE RED (UNII: 1K09F3G675)
FERRIC OXIDE YELLOW (UNII: EX438O2MRT)
FERROSOFERRIC OXIDE (UNII: XM0M87F357)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 13734-126-30	1 in 1 CARTON
1		12 g in 1 TRAY

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC MONOGRAPH NOT FINAL	part352	12/01/2012

Labeler - NARS Cosmetics (837363571)

Establishment
Name	Address	ID/FEI	Business Operations
SHISEIDO AMERICA INC.		782677132	MANUFACTURE(13734-114, 13734-115, 13734-116, 13734-117, 13734-118, 13734-119, 13734-120, 13734-121, 13734-122, 13734-123, 13734-124, 13734-125, 13734-126) , ANALYSIS(13734-114, 13734-115, 13734-116, 13734-117, 13734-118, 13734-119, 13734-120, 13734-121, 13734-122, 13734-123, 13734-124, 13734-125, 13734-126)

Establishment
Name	Address	ID/FEI	Business Operations
Davlyn Industries Inc		624436254	MANUFACTURE(13734-114, 13734-115, 13734-116, 13734-117, 13734-118, 13734-119, 13734-120, 13734-121, 13734-122, 13734-123, 13734-124, 13734-125, 13734-126)