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 Cosmetics

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.

----------

NARS POWDER FOUNDATION

Drug Facts

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?

PRINCIPAL DISPLAY PANEL - 12 g Tray Carton - SYRACUSE

PRINCIPAL DISPLAY PANEL - 12 g Tray Carton - TAHOE

NARS

POWDER FOUNDATION BROAD SPECTRUM
SPF 12 SUNSCREEN

NET WT. 0.42 Oz. 12 g

PRINCIPAL DISPLAY PANEL - 12 g Tray Carton - TAHOE

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

Ingredient Name	Basis of Strength	Strength
Active Ingredient/Active Moiety
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

Ingredient Name	Strength
Inactive Ingredients
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)
FERRIC OXIDE RED (UNII: 1K09F3G675)
FERRIC OXIDE YELLOW (UNII: EX438O2MRT)
FERROSOFERRIC OXIDE (UNII: XM0M87F357)

#	Item Code	Package Description	Marketing Start Date	Marketing End Date
Packaging
1	NDC:13734-114-30	1 in 1 CARTON	12/01/2012	06/30/2017
1		12 g in 1 TRAY; Type 0: Not a Combination Product

Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
Marketing Information
OTC MONOGRAPH NOT FINAL	part352	12/01/2012	06/30/2017

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

Ingredient Name	Basis of Strength	Strength
Active Ingredient/Active Moiety
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

Ingredient Name	Strength
Inactive Ingredients
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)
FERRIC OXIDE RED (UNII: 1K09F3G675)
FERRIC OXIDE YELLOW (UNII: EX438O2MRT)
FERROSOFERRIC OXIDE (UNII: XM0M87F357)

#	Item Code	Package Description	Marketing Start Date	Marketing End Date
Packaging
1	NDC:13734-115-30	1 in 1 CARTON	12/01/2012	07/31/2017
1		12 g in 1 TRAY; Type 0: Not a Combination Product

Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
Marketing Information
OTC MONOGRAPH NOT FINAL	part352	12/01/2012	07/31/2017

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

Ingredient Name	Basis of Strength	Strength
Active Ingredient/Active Moiety
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

Ingredient Name	Strength
Inactive Ingredients
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)
FERRIC OXIDE RED (UNII: 1K09F3G675)
FERRIC OXIDE YELLOW (UNII: EX438O2MRT)
FERROSOFERRIC OXIDE (UNII: XM0M87F357)

#	Item Code	Package Description	Marketing Start Date	Marketing End Date
Packaging
1	NDC:13734-116-30	1 in 1 CARTON	12/01/2012	06/30/2017
1		12 g in 1 TRAY; Type 0: Not a Combination Product

Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
Marketing Information
OTC MONOGRAPH NOT FINAL	part352	12/01/2012	06/30/2017

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

Ingredient Name	Basis of Strength	Strength
Active Ingredient/Active Moiety
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

Ingredient Name	Strength
Inactive Ingredients
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)
FERRIC OXIDE RED (UNII: 1K09F3G675)
FERRIC OXIDE YELLOW (UNII: EX438O2MRT)
FERROSOFERRIC OXIDE (UNII: XM0M87F357)

#	Item Code	Package Description	Marketing Start Date	Marketing End Date
Packaging
1	NDC:13734-117-30	1 in 1 CARTON	12/01/2012	06/30/2017
1		12 g in 1 TRAY; Type 0: Not a Combination Product

Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
Marketing Information
OTC MONOGRAPH NOT FINAL	part352	12/01/2012	06/30/2017

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

Ingredient Name	Basis of Strength	Strength
Active Ingredient/Active Moiety
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

Ingredient Name	Strength
Inactive Ingredients
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)
FERRIC OXIDE RED (UNII: 1K09F3G675)
FERRIC OXIDE YELLOW (UNII: EX438O2MRT)
FERROSOFERRIC OXIDE (UNII: XM0M87F357)

#	Item Code	Package Description	Marketing Start Date	Marketing End Date
Packaging
1	NDC:13734-118-30	1 in 1 CARTON	12/01/2012	06/30/2017
1		12 g in 1 TRAY; Type 0: Not a Combination Product

Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
Marketing Information
OTC MONOGRAPH NOT FINAL	part352	12/01/2012	06/30/2017

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

Ingredient Name	Basis of Strength	Strength
Active Ingredient/Active Moiety
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

Ingredient Name	Strength
Inactive Ingredients
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)
FERRIC OXIDE RED (UNII: 1K09F3G675)
FERRIC OXIDE YELLOW (UNII: EX438O2MRT)
FERROSOFERRIC OXIDE (UNII: XM0M87F357)

#	Item Code	Package Description	Marketing Start Date	Marketing End Date
Packaging
1	NDC:13734-119-30	1 in 1 CARTON	12/01/2012	07/31/2017
1		12 g in 1 TRAY; Type 0: Not a Combination Product

Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
Marketing Information
OTC MONOGRAPH NOT FINAL	part352	12/01/2012	07/31/2017

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

Ingredient Name	Basis of Strength	Strength
Active Ingredient/Active Moiety
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

Ingredient Name	Strength
Inactive Ingredients
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)
FERRIC OXIDE RED (UNII: 1K09F3G675)
FERRIC OXIDE YELLOW (UNII: EX438O2MRT)
FERROSOFERRIC OXIDE (UNII: XM0M87F357)

#	Item Code	Package Description	Marketing Start Date	Marketing End Date
Packaging
1	NDC:13734-120-30	1 in 1 CARTON	12/01/2012	06/30/2017
1		12 g in 1 TRAY; Type 0: Not a Combination Product

Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
Marketing Information
OTC MONOGRAPH NOT FINAL	part352	12/01/2012	06/30/2017

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

Ingredient Name	Basis of Strength	Strength
Active Ingredient/Active Moiety
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

Ingredient Name	Strength
Inactive Ingredients
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)
FERRIC OXIDE RED (UNII: 1K09F3G675)
FERRIC OXIDE YELLOW (UNII: EX438O2MRT)
FERROSOFERRIC OXIDE (UNII: XM0M87F357)

#	Item Code	Package Description	Marketing Start Date	Marketing End Date
Packaging
1	NDC:13734-121-30	1 in 1 CARTON	12/01/2012	06/30/2017
1		12 g in 1 TRAY; Type 0: Not a Combination Product

Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
Marketing Information
OTC MONOGRAPH NOT FINAL	part352	12/01/2012	06/30/2017

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

Ingredient Name	Basis of Strength	Strength
Active Ingredient/Active Moiety
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

Ingredient Name	Strength
Inactive Ingredients
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)
FERRIC OXIDE RED (UNII: 1K09F3G675)
FERRIC OXIDE YELLOW (UNII: EX438O2MRT)
FERROSOFERRIC OXIDE (UNII: XM0M87F357)

#	Item Code	Package Description	Marketing Start Date	Marketing End Date
Packaging
1	NDC:13734-122-30	1 in 1 CARTON	12/01/2012	06/30/2017
1		12 g in 1 TRAY; Type 0: Not a Combination Product

Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
Marketing Information
OTC MONOGRAPH NOT FINAL	part352	12/01/2012	06/30/2017

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

Ingredient Name	Basis of Strength	Strength
Active Ingredient/Active Moiety
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

Ingredient Name	Strength
Inactive Ingredients
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)
FERRIC OXIDE RED (UNII: 1K09F3G675)
FERRIC OXIDE YELLOW (UNII: EX438O2MRT)
FERROSOFERRIC OXIDE (UNII: XM0M87F357)

#	Item Code	Package Description	Marketing Start Date	Marketing End Date
Packaging
1	NDC:13734-123-30	1 in 1 CARTON	12/01/2012	06/30/2017
1		12 g in 1 TRAY; Type 0: Not a Combination Product

Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
Marketing Information
OTC MONOGRAPH NOT FINAL	part352	12/01/2012	06/30/2017

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

Ingredient Name	Basis of Strength	Strength
Active Ingredient/Active Moiety
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

Ingredient Name	Strength
Inactive Ingredients
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)
FERRIC OXIDE RED (UNII: 1K09F3G675)
FERRIC OXIDE YELLOW (UNII: EX438O2MRT)
FERROSOFERRIC OXIDE (UNII: XM0M87F357)

#	Item Code	Package Description	Marketing Start Date	Marketing End Date
Packaging
1	NDC:13734-124-30	1 in 1 CARTON	12/01/2012	07/31/2017
1		12 g in 1 TRAY; Type 0: Not a Combination Product

Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
Marketing Information
OTC MONOGRAPH NOT FINAL	part352	12/01/2012	07/31/2017

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

Ingredient Name	Basis of Strength	Strength
Active Ingredient/Active Moiety
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

Ingredient Name	Strength
Inactive Ingredients
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)
FERRIC OXIDE RED (UNII: 1K09F3G675)
FERRIC OXIDE YELLOW (UNII: EX438O2MRT)
FERROSOFERRIC OXIDE (UNII: XM0M87F357)

#	Item Code	Package Description	Marketing Start Date	Marketing End Date
Packaging
1	NDC:13734-125-30	1 in 1 CARTON	12/01/2012	06/30/2017
1		12 g in 1 TRAY; Type 0: Not a Combination Product

Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
Marketing Information
OTC MONOGRAPH NOT FINAL	part352	12/01/2012	06/30/2017

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

Ingredient Name	Basis of Strength	Strength
Active Ingredient/Active Moiety
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

Ingredient Name	Strength
Inactive Ingredients
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)
FERRIC OXIDE RED (UNII: 1K09F3G675)
FERRIC OXIDE YELLOW (UNII: EX438O2MRT)
FERROSOFERRIC OXIDE (UNII: XM0M87F357)

#	Item Code	Package Description	Marketing Start Date	Marketing End Date
Packaging
1	NDC:13734-126-30	1 in 1 CARTON	12/01/2012	06/30/2017
1		12 g in 1 TRAY; Type 0: Not a Combination Product

Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
Marketing Information
OTC MONOGRAPH NOT FINAL	part352	12/01/2012	06/30/2017

Labeler - NARS Cosmetics (837363571)

Name	Address	ID/FEI	Business Operations
Establishment
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)

Name	Address	ID/FEI	Business Operations
Establishment
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)

Revised: 9/2023

Document Id: 84a12536-f9fe-4088-a1d0-28aa69b795c2

Set id: 5034b928-2bd9-4350-976b-14811b68886d

Version: 2

Effective Time: 20230911

NARS Cosmetics