NARS VELVET MATTE SKIN TINT TERRE-NEUVE- octinoxate and octisalate cream NARS VELVET MATTE SKIN TINT FINLAND- octinoxate and octisalate cream NARS VELVET MATTE SKIN TINT ALASKA- octinoxate and octisalate cream NARS VELVET MATTE SKIN TINT GROENLAND- octinoxate and octisalate cream NARS VELVET MATTE SKIN TINT ST. MORITZ- octinoxate and octisalate cream NARS VELVET MATTE SKIN TINT CUZCO- octinoxate and octisalate cream NARS VELVET MATTE SKIN TINT ANNAPURNA- octinoxate and octisalate cream NARS VELVET MATTE SKIN TINT CUBA- octinoxate and octisalate cream NARS VELVET MATTE SKIN TINT MALAGA- octinoxate and octisalate cream NARS VELVET MATTE SKIN TINT SEYCHELLES- octinoxate and octisalate cream NARS VELVET MATTE SKIN TINT MARTINIQUE- octinoxate and octisalate cream NARS VELVET MATTE SKIN TINT POLYNESIA- octinoxate and octisalate cream

NARS VELVET MATTE SKIN TINT by

Drug Labeling and Warnings

NARS VELVET MATTE SKIN TINT by is a Otc medication manufactured, distributed, or labeled by NARS Cosmetics. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

SPL UNCLASSIFIED SECTION

Drug Facts

Active ingredients

Octinoxate 7.5%
Octisalate 3%

Purpose

Sunscreen

Uses

• helps prevent sunburn
• if used as directed with other sun protection measures (see Directions), decreases the risk of skin cancer and early skin aging caused by the sun

Warnings

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.

Flammable until dry. Avoid fire, flame and heat during application.

Directions

For sunscreen use:

• apply liberally 15 minutes before sun exposure
• use a water resistant sunscreen if swimming or sweating
• reapply at least every 2 hours
• Sun Protection Measures. Spending time in the sun increases your risk of skin cancer and early skin aging. To decrease this risk, regularly use a sunscreen with a broad spectrum SPF of 15 or higher and other sun protection measures including:
  • limit time in the sun, especially from 10 a.m. – 2 p.m.
  • wear long-sleeve shirts, pants, hats, and sunglasses
• children under 6 months: Ask a doctor

Inactive Ingredients

Methyl Trimethicone ∙ Alcohol ∙ Water ∙ Adipic Acid/Neopentyl Glycol Crosspolymer ∙ Isononyl Isononanoate ∙ Lauryl PEG-9 Polydimethylsiloxyethyl Dimethicone ∙ Dimethicone ∙ Trimethylsiloxysilicate ∙ Disteardimonium Hectorite ∙ Isododecane ∙ Dimethicone/PEG-10/15 Crosspolymer ∙ Calcium Carbonate ∙ Fragrance ∙ Sodium Chloride ∙ Triethoxycaprylylsilane ∙ Aluminum Hydroxide ∙ Trimethylsiloxysilylcarbamoyl Pullulan ∙ Hydroxyapatite ∙ Tocopheryl Acetate ∙ Rosa Multiflora Fruit Extract ∙ Ascorbyl Tetraisopalmitate ∙ [+/- (May Contain): Titanium Dioxide ∙ 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 - 50 mL Tube Carton - TERRE-NEUVE

NARS

VELVET MATTE SKIN TINT
BROAD SPECTRUM
SPF 30 SUNSCREEN

NET WT.
1.7 Oz. 50 mL

PRINCIPAL DISPLAY PANEL - 50 mL Tube Carton - FINLAND

NARS

VELVET MATTE SKIN TINT
BROAD SPECTRUM
SPF 30 SUNSCREEN

NET WT.
1.7 Oz. 50 mL

PRINCIPAL DISPLAY PANEL - 50 mL Tube Carton - ALASKA

NARS

VELVET MATTE SKIN TINT
BROAD SPECTRUM
SPF 30 SUNSCREEN

NET WT.
1.7 Oz. 50 mL

PRINCIPAL DISPLAY PANEL - 50 mL Tube Carton - GROENLAND

NARS

VELVET MATTE SKIN TINT
BROAD SPECTRUM
SPF 30 SUNSCREEN

NET WT.
1.7 Oz. 50 mL

PRINCIPAL DISPLAY PANEL - 50 mL Tube Carton - ST. MORITZ

NARS

VELVET MATTE SKIN TINT
BROAD SPECTRUM
SPF 30 SUNSCREEN

NET WT.
1.7 Oz. 50 mL

PRINCIPAL DISPLAY PANEL - 50 mL Tube Carton - CUZCO

NARS

VELVET MATTE SKIN TINT
BROAD SPECTRUM
SPF 30 SUNSCREEN

NET WT.
1.7 Oz. 50 mL

PRINCIPAL DISPLAY PANEL - 50 mL Tube Carton - ANNAPURNA

NARS

VELVET MATTE SKIN TINT
BROAD SPECTRUM
SPF 30 SUNSCREEN

NET WT.
1.7 Oz. 50 mL

PRINCIPAL DISPLAY PANEL - 50 mL Tube Carton - CUBA

NARS

VELVET MATTE SKIN TINT
BROAD SPECTRUM
SPF 30 SUNSCREEN

NET WT.
1.7 Oz. 50 mL

PRINCIPAL DISPLAY PANEL - 50 mL Tube Carton - MALAGA

NARS

VELVET MATTE SKIN TINT
BROAD SPECTRUM
SPF 30 SUNSCREEN

NET WT.
1.7 Oz. 50 mL

PRINCIPAL DISPLAY PANEL - 50 mL Tube Carton - SEYCHELLES

NARS

VELVET MATTE SKIN TINT
BROAD SPECTRUM
SPF 30 SUNSCREEN

NET WT.
1.7 Oz. 50 mL

PRINCIPAL DISPLAY PANEL - 50 mL Tube Carton - MARTINIQUE

NARS

VELVET MATTE SKIN TINT
BROAD SPECTRUM
SPF 30 SUNSCREEN

NET WT.
1.7 Oz. 50 mL

PRINCIPAL DISPLAY PANEL - 50 mL Tube Carton - POLYNESIA

NARS

VELVET MATTE SKIN TINT
BROAD SPECTRUM
SPF 30 SUNSCREEN

NET WT.
1.7 Oz. 50 mL

INGREDIENTS AND APPEARANCE

NARS VELVET MATTE SKIN TINT   TERRE-NEUVE
octinoxate and octisalate cream

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 13734-144
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
OCTINOXATE (UNII: 4Y5P7MUD51) (OCTINOXATE - UNII:4Y5P7MUD51)	OCTINOXATE	3712.5 mg  in 50 mL
OCTISALATE (UNII: 4X49Y0596W) (OCTISALATE - UNII:4X49Y0596W)	OCTISALATE	1485 mg  in 50 mL

Inactive Ingredients
Ingredient Name	Strength
METHYL TRIMETHICONE (UNII: S73ZQI0GXM)
WATER (UNII: 059QF0KO0R)
ALCOHOL (UNII: 3K9958V90M)
TITANIUM DIOXIDE (UNII: 15FIX9V2JP)
ISONONYL ISONONANOATE (UNII: S4V5BS6GCX)
LAURYL PEG-9 POLYDIMETHYLSILOXYETHYL DIMETHICONE (UNII: 25G622K2RA)
FERRIC OXIDE RED (UNII: 1K09F3G675)
DIMETHICONE (UNII: 92RU3N3Y1O)
TRIMETHYLSILOXYSILICATE (M/Q 0.6-0.8) (UNII: 5041RX63GN)
DISTEARDIMONIUM HECTORITE (UNII: X687XDK09L)
ISODODECANE (UNII: A8289P68Y2)
CALCIUM CARBONATE (UNII: H0G9379FGK)
FERRIC OXIDE YELLOW (UNII: EX438O2MRT)
FERROSOFERRIC OXIDE (UNII: XM0M87F357)
TRIETHOXYCAPRYLYLSILANE (UNII: LDC331P08E)
SODIUM CHLORIDE (UNII: 451W47IQ8X)
ALUMINUM HYDROXIDE (UNII: 5QB0T2IUN0)
.ALPHA.-TOCOPHEROL ACETATE, DL- (UNII: WR1WPI7EW8)
TRIBASIC CALCIUM PHOSPHATE (UNII: 91D9GV0Z28)
ROSA MULTIFLORA FRUIT (UNII: EZ5DSL4T27)
ASCORBYL TETRAISOPALMITATE (UNII: 47143LT58A)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 13734-144-60	1 in 1 CARTON	02/01/2016
1		50 mL in 1 TUBE; Type 0: Not a Combination Product

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC MONOGRAPH NOT FINAL	part352	02/01/2016

NARS VELVET MATTE SKIN TINT   FINLAND
octinoxate and octisalate cream

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 13734-145
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
OCTINOXATE (UNII: 4Y5P7MUD51) (OCTINOXATE - UNII:4Y5P7MUD51)	OCTINOXATE	3712.5 mg  in 50 mL
OCTISALATE (UNII: 4X49Y0596W) (OCTISALATE - UNII:4X49Y0596W)	OCTISALATE	1485 mg  in 50 mL

Inactive Ingredients
Ingredient Name	Strength
METHYL TRIMETHICONE (UNII: S73ZQI0GXM)
WATER (UNII: 059QF0KO0R)
ALCOHOL (UNII: 3K9958V90M)
TITANIUM DIOXIDE (UNII: 15FIX9V2JP)
ISONONYL ISONONANOATE (UNII: S4V5BS6GCX)
LAURYL PEG-9 POLYDIMETHYLSILOXYETHYL DIMETHICONE (UNII: 25G622K2RA)
FERRIC OXIDE RED (UNII: 1K09F3G675)
DIMETHICONE (UNII: 92RU3N3Y1O)
TRIMETHYLSILOXYSILICATE (M/Q 0.6-0.8) (UNII: 5041RX63GN)
DISTEARDIMONIUM HECTORITE (UNII: X687XDK09L)
ISODODECANE (UNII: A8289P68Y2)
CALCIUM CARBONATE (UNII: H0G9379FGK)
FERRIC OXIDE YELLOW (UNII: EX438O2MRT)
FERROSOFERRIC OXIDE (UNII: XM0M87F357)
TRIETHOXYCAPRYLYLSILANE (UNII: LDC331P08E)
SODIUM CHLORIDE (UNII: 451W47IQ8X)
ALUMINUM HYDROXIDE (UNII: 5QB0T2IUN0)
.ALPHA.-TOCOPHEROL ACETATE, DL- (UNII: WR1WPI7EW8)
TRIBASIC CALCIUM PHOSPHATE (UNII: 91D9GV0Z28)
ROSA MULTIFLORA FRUIT (UNII: EZ5DSL4T27)
ASCORBYL TETRAISOPALMITATE (UNII: 47143LT58A)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 13734-145-60	1 in 1 CARTON	02/01/2016
1		50 mL in 1 TUBE; Type 0: Not a Combination Product

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC MONOGRAPH NOT FINAL	part352	02/01/2016

NARS VELVET MATTE SKIN TINT   ALASKA
octinoxate and octisalate cream

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 13734-146
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
OCTINOXATE (UNII: 4Y5P7MUD51) (OCTINOXATE - UNII:4Y5P7MUD51)	OCTINOXATE	3712.5 mg  in 50 mL
OCTISALATE (UNII: 4X49Y0596W) (OCTISALATE - UNII:4X49Y0596W)	OCTISALATE	1485 mg  in 50 mL

Inactive Ingredients
Ingredient Name	Strength
METHYL TRIMETHICONE (UNII: S73ZQI0GXM)
WATER (UNII: 059QF0KO0R)
ALCOHOL (UNII: 3K9958V90M)
TITANIUM DIOXIDE (UNII: 15FIX9V2JP)
ISONONYL ISONONANOATE (UNII: S4V5BS6GCX)
LAURYL PEG-9 POLYDIMETHYLSILOXYETHYL DIMETHICONE (UNII: 25G622K2RA)
FERRIC OXIDE RED (UNII: 1K09F3G675)
DIMETHICONE (UNII: 92RU3N3Y1O)
TRIMETHYLSILOXYSILICATE (M/Q 0.6-0.8) (UNII: 5041RX63GN)
DISTEARDIMONIUM HECTORITE (UNII: X687XDK09L)
ISODODECANE (UNII: A8289P68Y2)
CALCIUM CARBONATE (UNII: H0G9379FGK)
FERRIC OXIDE YELLOW (UNII: EX438O2MRT)
FERROSOFERRIC OXIDE (UNII: XM0M87F357)
TRIETHOXYCAPRYLYLSILANE (UNII: LDC331P08E)
SODIUM CHLORIDE (UNII: 451W47IQ8X)
ALUMINUM HYDROXIDE (UNII: 5QB0T2IUN0)
.ALPHA.-TOCOPHEROL ACETATE, DL- (UNII: WR1WPI7EW8)
TRIBASIC CALCIUM PHOSPHATE (UNII: 91D9GV0Z28)
ROSA MULTIFLORA FRUIT (UNII: EZ5DSL4T27)
ASCORBYL TETRAISOPALMITATE (UNII: 47143LT58A)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 13734-146-60	1 in 1 CARTON	02/01/2016
1		50 mL in 1 TUBE; Type 0: Not a Combination Product

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC MONOGRAPH NOT FINAL	part352	02/01/2016

NARS VELVET MATTE SKIN TINT   GROENLAND
octinoxate and octisalate cream

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 13734-147
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
OCTINOXATE (UNII: 4Y5P7MUD51) (OCTINOXATE - UNII:4Y5P7MUD51)	OCTINOXATE	3712.5 mg  in 50 mL
OCTISALATE (UNII: 4X49Y0596W) (OCTISALATE - UNII:4X49Y0596W)	OCTISALATE	1485 mg  in 50 mL

Inactive Ingredients
Ingredient Name	Strength
METHYL TRIMETHICONE (UNII: S73ZQI0GXM)
WATER (UNII: 059QF0KO0R)
ALCOHOL (UNII: 3K9958V90M)
TITANIUM DIOXIDE (UNII: 15FIX9V2JP)
ISONONYL ISONONANOATE (UNII: S4V5BS6GCX)
LAURYL PEG-9 POLYDIMETHYLSILOXYETHYL DIMETHICONE (UNII: 25G622K2RA)
FERRIC OXIDE RED (UNII: 1K09F3G675)
DIMETHICONE (UNII: 92RU3N3Y1O)
TRIMETHYLSILOXYSILICATE (M/Q 0.6-0.8) (UNII: 5041RX63GN)
DISTEARDIMONIUM HECTORITE (UNII: X687XDK09L)
ISODODECANE (UNII: A8289P68Y2)
CALCIUM CARBONATE (UNII: H0G9379FGK)
FERRIC OXIDE YELLOW (UNII: EX438O2MRT)
FERROSOFERRIC OXIDE (UNII: XM0M87F357)
TRIETHOXYCAPRYLYLSILANE (UNII: LDC331P08E)
SODIUM CHLORIDE (UNII: 451W47IQ8X)
ALUMINUM HYDROXIDE (UNII: 5QB0T2IUN0)
.ALPHA.-TOCOPHEROL ACETATE, DL- (UNII: WR1WPI7EW8)
TRIBASIC CALCIUM PHOSPHATE (UNII: 91D9GV0Z28)
ROSA MULTIFLORA FRUIT (UNII: EZ5DSL4T27)
ASCORBYL TETRAISOPALMITATE (UNII: 47143LT58A)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 13734-147-60	1 in 1 CARTON	02/01/2016
1		50 mL in 1 TUBE; Type 0: Not a Combination Product
2	NDC: 13734-147-80	1 mL in 1 PACKET; Type 0: Not a Combination Product	02/01/2016

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC MONOGRAPH NOT FINAL	part352	02/01/2016

NARS VELVET MATTE SKIN TINT   ST. MORITZ
octinoxate and octisalate cream

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 13734-148
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
OCTINOXATE (UNII: 4Y5P7MUD51) (OCTINOXATE - UNII:4Y5P7MUD51)	OCTINOXATE	3712.5 mg  in 50 mL
OCTISALATE (UNII: 4X49Y0596W) (OCTISALATE - UNII:4X49Y0596W)	OCTISALATE	1485 mg  in 50 mL

Inactive Ingredients
Ingredient Name	Strength
METHYL TRIMETHICONE (UNII: S73ZQI0GXM)
WATER (UNII: 059QF0KO0R)
ALCOHOL (UNII: 3K9958V90M)
TITANIUM DIOXIDE (UNII: 15FIX9V2JP)
ISONONYL ISONONANOATE (UNII: S4V5BS6GCX)
LAURYL PEG-9 POLYDIMETHYLSILOXYETHYL DIMETHICONE (UNII: 25G622K2RA)
FERRIC OXIDE RED (UNII: 1K09F3G675)
DIMETHICONE (UNII: 92RU3N3Y1O)
TRIMETHYLSILOXYSILICATE (M/Q 0.6-0.8) (UNII: 5041RX63GN)
DISTEARDIMONIUM HECTORITE (UNII: X687XDK09L)
ISODODECANE (UNII: A8289P68Y2)
CALCIUM CARBONATE (UNII: H0G9379FGK)
FERRIC OXIDE YELLOW (UNII: EX438O2MRT)
FERROSOFERRIC OXIDE (UNII: XM0M87F357)
TRIETHOXYCAPRYLYLSILANE (UNII: LDC331P08E)
SODIUM CHLORIDE (UNII: 451W47IQ8X)
ALUMINUM HYDROXIDE (UNII: 5QB0T2IUN0)
.ALPHA.-TOCOPHEROL ACETATE, DL- (UNII: WR1WPI7EW8)
TRIBASIC CALCIUM PHOSPHATE (UNII: 91D9GV0Z28)
ROSA MULTIFLORA FRUIT (UNII: EZ5DSL4T27)
ASCORBYL TETRAISOPALMITATE (UNII: 47143LT58A)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 13734-148-60	1 in 1 CARTON	02/01/2016
1		50 mL in 1 TUBE; Type 0: Not a Combination Product
2	NDC: 13734-148-80	1 mL in 1 PACKET; Type 0: Not a Combination Product	02/01/2016

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC MONOGRAPH NOT FINAL	part352	02/01/2016

NARS VELVET MATTE SKIN TINT   CUZCO
octinoxate and octisalate cream

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 13734-149
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
OCTINOXATE (UNII: 4Y5P7MUD51) (OCTINOXATE - UNII:4Y5P7MUD51)	OCTINOXATE	3712.5 mg  in 50 mL
OCTISALATE (UNII: 4X49Y0596W) (OCTISALATE - UNII:4X49Y0596W)	OCTISALATE	1485 mg  in 50 mL

Inactive Ingredients
Ingredient Name	Strength
METHYL TRIMETHICONE (UNII: S73ZQI0GXM)
WATER (UNII: 059QF0KO0R)
ALCOHOL (UNII: 3K9958V90M)
TITANIUM DIOXIDE (UNII: 15FIX9V2JP)
ISONONYL ISONONANOATE (UNII: S4V5BS6GCX)
LAURYL PEG-9 POLYDIMETHYLSILOXYETHYL DIMETHICONE (UNII: 25G622K2RA)
FERRIC OXIDE RED (UNII: 1K09F3G675)
DIMETHICONE (UNII: 92RU3N3Y1O)
TRIMETHYLSILOXYSILICATE (M/Q 0.6-0.8) (UNII: 5041RX63GN)
DISTEARDIMONIUM HECTORITE (UNII: X687XDK09L)
ISODODECANE (UNII: A8289P68Y2)
CALCIUM CARBONATE (UNII: H0G9379FGK)
FERRIC OXIDE YELLOW (UNII: EX438O2MRT)
FERROSOFERRIC OXIDE (UNII: XM0M87F357)
TRIETHOXYCAPRYLYLSILANE (UNII: LDC331P08E)
SODIUM CHLORIDE (UNII: 451W47IQ8X)
ALUMINUM HYDROXIDE (UNII: 5QB0T2IUN0)
.ALPHA.-TOCOPHEROL ACETATE, DL- (UNII: WR1WPI7EW8)
TRIBASIC CALCIUM PHOSPHATE (UNII: 91D9GV0Z28)
ROSA MULTIFLORA FRUIT (UNII: EZ5DSL4T27)
ASCORBYL TETRAISOPALMITATE (UNII: 47143LT58A)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 13734-149-60	1 in 1 CARTON	02/01/2016
1		50 mL in 1 TUBE; Type 0: Not a Combination Product

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC MONOGRAPH NOT FINAL	part352	02/01/2016

NARS VELVET MATTE SKIN TINT   ANNAPURNA
octinoxate and octisalate cream

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 13734-150
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
OCTINOXATE (UNII: 4Y5P7MUD51) (OCTINOXATE - UNII:4Y5P7MUD51)	OCTINOXATE	3712.5 mg  in 50 mL
OCTISALATE (UNII: 4X49Y0596W) (OCTISALATE - UNII:4X49Y0596W)	OCTISALATE	1485 mg  in 50 mL

Inactive Ingredients
Ingredient Name	Strength
METHYL TRIMETHICONE (UNII: S73ZQI0GXM)
WATER (UNII: 059QF0KO0R)
ALCOHOL (UNII: 3K9958V90M)
TITANIUM DIOXIDE (UNII: 15FIX9V2JP)
ISONONYL ISONONANOATE (UNII: S4V5BS6GCX)
LAURYL PEG-9 POLYDIMETHYLSILOXYETHYL DIMETHICONE (UNII: 25G622K2RA)
FERRIC OXIDE RED (UNII: 1K09F3G675)
DIMETHICONE (UNII: 92RU3N3Y1O)
TRIMETHYLSILOXYSILICATE (M/Q 0.6-0.8) (UNII: 5041RX63GN)
DISTEARDIMONIUM HECTORITE (UNII: X687XDK09L)
ISODODECANE (UNII: A8289P68Y2)
CALCIUM CARBONATE (UNII: H0G9379FGK)
FERRIC OXIDE YELLOW (UNII: EX438O2MRT)
FERROSOFERRIC OXIDE (UNII: XM0M87F357)
TRIETHOXYCAPRYLYLSILANE (UNII: LDC331P08E)
SODIUM CHLORIDE (UNII: 451W47IQ8X)
ALUMINUM HYDROXIDE (UNII: 5QB0T2IUN0)
.ALPHA.-TOCOPHEROL ACETATE, DL- (UNII: WR1WPI7EW8)
TRIBASIC CALCIUM PHOSPHATE (UNII: 91D9GV0Z28)
ROSA MULTIFLORA FRUIT (UNII: EZ5DSL4T27)
ASCORBYL TETRAISOPALMITATE (UNII: 47143LT58A)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 13734-150-60	1 in 1 CARTON	02/01/2016
1		50 mL in 1 TUBE; Type 0: Not a Combination Product

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC MONOGRAPH NOT FINAL	part352	02/01/2016

NARS VELVET MATTE SKIN TINT   CUBA
octinoxate and octisalate cream

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 13734-151
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
OCTINOXATE (UNII: 4Y5P7MUD51) (OCTINOXATE - UNII:4Y5P7MUD51)	OCTINOXATE	3712.5 mg  in 50 mL
OCTISALATE (UNII: 4X49Y0596W) (OCTISALATE - UNII:4X49Y0596W)	OCTISALATE	1485 mg  in 50 mL

Inactive Ingredients
Ingredient Name	Strength
METHYL TRIMETHICONE (UNII: S73ZQI0GXM)
WATER (UNII: 059QF0KO0R)
ALCOHOL (UNII: 3K9958V90M)
TITANIUM DIOXIDE (UNII: 15FIX9V2JP)
ISONONYL ISONONANOATE (UNII: S4V5BS6GCX)
LAURYL PEG-9 POLYDIMETHYLSILOXYETHYL DIMETHICONE (UNII: 25G622K2RA)
FERRIC OXIDE RED (UNII: 1K09F3G675)
DIMETHICONE (UNII: 92RU3N3Y1O)
TRIMETHYLSILOXYSILICATE (M/Q 0.6-0.8) (UNII: 5041RX63GN)
DISTEARDIMONIUM HECTORITE (UNII: X687XDK09L)
ISODODECANE (UNII: A8289P68Y2)
CALCIUM CARBONATE (UNII: H0G9379FGK)
FERRIC OXIDE YELLOW (UNII: EX438O2MRT)
FERROSOFERRIC OXIDE (UNII: XM0M87F357)
TRIETHOXYCAPRYLYLSILANE (UNII: LDC331P08E)
SODIUM CHLORIDE (UNII: 451W47IQ8X)
ALUMINUM HYDROXIDE (UNII: 5QB0T2IUN0)
.ALPHA.-TOCOPHEROL ACETATE, DL- (UNII: WR1WPI7EW8)
TRIBASIC CALCIUM PHOSPHATE (UNII: 91D9GV0Z28)
ROSA MULTIFLORA FRUIT (UNII: EZ5DSL4T27)
ASCORBYL TETRAISOPALMITATE (UNII: 47143LT58A)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 13734-151-60	1 in 1 CARTON	02/01/2016
1		50 mL in 1 TUBE; Type 0: Not a Combination Product
2	NDC: 13734-151-80	1 mL in 1 PACKET; Type 0: Not a Combination Product	02/01/2016

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC MONOGRAPH NOT FINAL	part352	02/01/2016

NARS VELVET MATTE SKIN TINT   MALAGA
octinoxate and octisalate cream

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 13734-152
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
OCTINOXATE (UNII: 4Y5P7MUD51) (OCTINOXATE - UNII:4Y5P7MUD51)	OCTINOXATE	3712.5 mg  in 50 mL
OCTISALATE (UNII: 4X49Y0596W) (OCTISALATE - UNII:4X49Y0596W)	OCTISALATE	1485 mg  in 50 mL

Inactive Ingredients
Ingredient Name	Strength
METHYL TRIMETHICONE (UNII: S73ZQI0GXM)
WATER (UNII: 059QF0KO0R)
ALCOHOL (UNII: 3K9958V90M)
TITANIUM DIOXIDE (UNII: 15FIX9V2JP)
ISONONYL ISONONANOATE (UNII: S4V5BS6GCX)
LAURYL PEG-9 POLYDIMETHYLSILOXYETHYL DIMETHICONE (UNII: 25G622K2RA)
FERRIC OXIDE RED (UNII: 1K09F3G675)
DIMETHICONE (UNII: 92RU3N3Y1O)
TRIMETHYLSILOXYSILICATE (M/Q 0.6-0.8) (UNII: 5041RX63GN)
DISTEARDIMONIUM HECTORITE (UNII: X687XDK09L)
ISODODECANE (UNII: A8289P68Y2)
CALCIUM CARBONATE (UNII: H0G9379FGK)
FERRIC OXIDE YELLOW (UNII: EX438O2MRT)
FERROSOFERRIC OXIDE (UNII: XM0M87F357)
TRIETHOXYCAPRYLYLSILANE (UNII: LDC331P08E)
SODIUM CHLORIDE (UNII: 451W47IQ8X)
ALUMINUM HYDROXIDE (UNII: 5QB0T2IUN0)
.ALPHA.-TOCOPHEROL ACETATE, DL- (UNII: WR1WPI7EW8)
TRIBASIC CALCIUM PHOSPHATE (UNII: 91D9GV0Z28)
ROSA MULTIFLORA FRUIT (UNII: EZ5DSL4T27)
ASCORBYL TETRAISOPALMITATE (UNII: 47143LT58A)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 13734-152-60	1 in 1 CARTON	02/01/2016
1		50 mL in 1 TUBE; Type 0: Not a Combination Product

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC MONOGRAPH NOT FINAL	part352	02/01/2016

NARS VELVET MATTE SKIN TINT   SEYCHELLES
octinoxate and octisalate cream

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 13734-153
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
OCTINOXATE (UNII: 4Y5P7MUD51) (OCTINOXATE - UNII:4Y5P7MUD51)	OCTINOXATE	3712.5 mg  in 50 mL
OCTISALATE (UNII: 4X49Y0596W) (OCTISALATE - UNII:4X49Y0596W)	OCTISALATE	1485 mg  in 50 mL

Inactive Ingredients
Ingredient Name	Strength
METHYL TRIMETHICONE (UNII: S73ZQI0GXM)
WATER (UNII: 059QF0KO0R)
ALCOHOL (UNII: 3K9958V90M)
TITANIUM DIOXIDE (UNII: 15FIX9V2JP)
ISONONYL ISONONANOATE (UNII: S4V5BS6GCX)
LAURYL PEG-9 POLYDIMETHYLSILOXYETHYL DIMETHICONE (UNII: 25G622K2RA)
FERRIC OXIDE RED (UNII: 1K09F3G675)
DIMETHICONE (UNII: 92RU3N3Y1O)
TRIMETHYLSILOXYSILICATE (M/Q 0.6-0.8) (UNII: 5041RX63GN)
DISTEARDIMONIUM HECTORITE (UNII: X687XDK09L)
ISODODECANE (UNII: A8289P68Y2)
CALCIUM CARBONATE (UNII: H0G9379FGK)
FERRIC OXIDE YELLOW (UNII: EX438O2MRT)
FERROSOFERRIC OXIDE (UNII: XM0M87F357)
TRIETHOXYCAPRYLYLSILANE (UNII: LDC331P08E)
SODIUM CHLORIDE (UNII: 451W47IQ8X)
ALUMINUM HYDROXIDE (UNII: 5QB0T2IUN0)
.ALPHA.-TOCOPHEROL ACETATE, DL- (UNII: WR1WPI7EW8)
TRIBASIC CALCIUM PHOSPHATE (UNII: 91D9GV0Z28)
ROSA MULTIFLORA FRUIT (UNII: EZ5DSL4T27)
ASCORBYL TETRAISOPALMITATE (UNII: 47143LT58A)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 13734-153-60	1 in 1 CARTON	02/01/2016
1		50 mL in 1 TUBE; Type 0: Not a Combination Product

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC MONOGRAPH NOT FINAL	part352	02/01/2016

NARS VELVET MATTE SKIN TINT   MARTINIQUE
octinoxate and octisalate cream

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 13734-154
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
OCTINOXATE (UNII: 4Y5P7MUD51) (OCTINOXATE - UNII:4Y5P7MUD51)	OCTINOXATE	3712.5 mg  in 50 mL
OCTISALATE (UNII: 4X49Y0596W) (OCTISALATE - UNII:4X49Y0596W)	OCTISALATE	1485 mg  in 50 mL

Inactive Ingredients
Ingredient Name	Strength
METHYL TRIMETHICONE (UNII: S73ZQI0GXM)
WATER (UNII: 059QF0KO0R)
ALCOHOL (UNII: 3K9958V90M)
TITANIUM DIOXIDE (UNII: 15FIX9V2JP)
ISONONYL ISONONANOATE (UNII: S4V5BS6GCX)
LAURYL PEG-9 POLYDIMETHYLSILOXYETHYL DIMETHICONE (UNII: 25G622K2RA)
FERRIC OXIDE RED (UNII: 1K09F3G675)
DIMETHICONE (UNII: 92RU3N3Y1O)
TRIMETHYLSILOXYSILICATE (M/Q 0.6-0.8) (UNII: 5041RX63GN)
DISTEARDIMONIUM HECTORITE (UNII: X687XDK09L)
ISODODECANE (UNII: A8289P68Y2)
CALCIUM CARBONATE (UNII: H0G9379FGK)
FERRIC OXIDE YELLOW (UNII: EX438O2MRT)
FERROSOFERRIC OXIDE (UNII: XM0M87F357)
TRIETHOXYCAPRYLYLSILANE (UNII: LDC331P08E)
SODIUM CHLORIDE (UNII: 451W47IQ8X)
ALUMINUM HYDROXIDE (UNII: 5QB0T2IUN0)
.ALPHA.-TOCOPHEROL ACETATE, DL- (UNII: WR1WPI7EW8)
TRIBASIC CALCIUM PHOSPHATE (UNII: 91D9GV0Z28)
ROSA MULTIFLORA FRUIT (UNII: EZ5DSL4T27)
ASCORBYL TETRAISOPALMITATE (UNII: 47143LT58A)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 13734-154-60	1 in 1 CARTON	02/01/2016
1		50 mL in 1 TUBE; Type 0: Not a Combination Product

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC MONOGRAPH NOT FINAL	part352	02/01/2016

NARS VELVET MATTE SKIN TINT   POLYNESIA
octinoxate and octisalate cream

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 13734-155
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
OCTINOXATE (UNII: 4Y5P7MUD51) (OCTINOXATE - UNII:4Y5P7MUD51)	OCTINOXATE	3712.5 mg  in 50 mL
OCTISALATE (UNII: 4X49Y0596W) (OCTISALATE - UNII:4X49Y0596W)	OCTISALATE	1485 mg  in 50 mL

Inactive Ingredients
Ingredient Name	Strength
METHYL TRIMETHICONE (UNII: S73ZQI0GXM)
WATER (UNII: 059QF0KO0R)
ALCOHOL (UNII: 3K9958V90M)
TITANIUM DIOXIDE (UNII: 15FIX9V2JP)
ISONONYL ISONONANOATE (UNII: S4V5BS6GCX)
LAURYL PEG-9 POLYDIMETHYLSILOXYETHYL DIMETHICONE (UNII: 25G622K2RA)
FERRIC OXIDE RED (UNII: 1K09F3G675)
DIMETHICONE (UNII: 92RU3N3Y1O)
TRIMETHYLSILOXYSILICATE (M/Q 0.6-0.8) (UNII: 5041RX63GN)
DISTEARDIMONIUM HECTORITE (UNII: X687XDK09L)
ISODODECANE (UNII: A8289P68Y2)
CALCIUM CARBONATE (UNII: H0G9379FGK)
FERRIC OXIDE YELLOW (UNII: EX438O2MRT)
FERROSOFERRIC OXIDE (UNII: XM0M87F357)
TRIETHOXYCAPRYLYLSILANE (UNII: LDC331P08E)
SODIUM CHLORIDE (UNII: 451W47IQ8X)
ALUMINUM HYDROXIDE (UNII: 5QB0T2IUN0)
.ALPHA.-TOCOPHEROL ACETATE, DL- (UNII: WR1WPI7EW8)
TRIBASIC CALCIUM PHOSPHATE (UNII: 91D9GV0Z28)
ROSA MULTIFLORA FRUIT (UNII: EZ5DSL4T27)
ASCORBYL TETRAISOPALMITATE (UNII: 47143LT58A)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 13734-155-60	1 in 1 CARTON	02/01/2016
1		50 mL in 1 TUBE; Type 0: Not a Combination Product

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC MONOGRAPH NOT FINAL	part352	02/01/2016

Labeler - NARS Cosmetics (837363571)