NARS PURE RADIANT TINTED MOISTURIZER FINLAND- octinoxate and titanium dioxide cream NARS PURE RADIANT TINTED MOISTURIZER ALASKA- octinoxate and titanium dioxide cream NARS PURE RADIANT TINTED MOISTURIZER ST. MORITZ- octinoxate and titanium dioxide cream NARS PURE RADIANT TINTED MOISTURIZER TERRE-NEUVE- octinoxate and titanium dioxide cream NARS PURE RADIANT TINTED MOISTURIZER GROENLAND- octinoxate and titanium dioxide cream NARS PURE RADIANT TINTED MOISTURIZER CUZCO- octinoxate and titanium dioxide cream NARS PURE RADIANT TINTED MOISTURIZER GOTLAND- octinoxate and titanium dioxide cream NARS PURE RADIANT TINTED MOISTURIZER NORWICH- octinoxate and titanium dioxide cream NARS PURE RADIANT TINTED MOISTURIZER MYKONOS- octinoxate and titanium dioxide cream NARS PURE RADIANT TINTED MOISTURIZER SYDNEY- octinoxate and titanium dioxide cream NARS PURE RADIANT TINTED MOISTURIZER AUCKLAND- octinoxate and titanium dioxide cream NARS PURE RADIANT TINTED MOISTURIZER SANTIAGO- octinoxate and titanium dioxide cream NARS PURE RADIANT TINTED MOISTURIZER MARRAKESH- octinoxate and titanium dioxide cream NARS PURE RADIANT TINTED MOISTURIZER HAVANA- octinoxate and titanium dioxide cream NARS PURE RADIANT TINTED MOISTURIZER GUERNSEY- octinoxate and titanium dioxide cream NARS PURE RADIANT TINTED MOISTURIZER GRANADA- octinoxate and titanium dioxide cream

NARS PURE RADIANT TINTED MOISTURIZER GRANADA by

Drug Labeling and Warnings

NARS PURE RADIANT TINTED MOISTURIZER GRANADA by is a Otc medication manufactured, distributed, or labeled by NARS Cosmetics, SHISEIDO AMERICA INC.. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

SPL UNCLASSIFIED SECTION

Drug Facts

ACTIVE INGREDIENT

Active ingredients	Purpose
Octinoxate 7.49%	Sunscreen
Titanium Dioxide 6.25%	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.

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

Water ∙ Dimethicone ∙ Butylene Glycol ∙ Propanediol ∙ Glycerin ∙ Diethylhexyl Succinate ∙ Nylon-12 ∙ PEG-9 Polydimethylsiloxyethyl Dimethicone ∙ PEG-10 Dimethicone ∙ Aluminum Hydroxide ∙ Diphenylsiloxy Phenyl Trimethicone ∙ Sorbitan Sesquiisostearate ∙ Disteardimonium Hectorite ∙ Vibrio Alginolyticus Ferment Filtrate ∙ Alteromonas Ferment Filtrate ∙ Curcuma Longa (Turmeric) Root Extract ∙ Stearic Acid ∙ Dimethicone/Vinyl Dimethicone Crosspolymer ∙ Polymethylsilsesquioxane ∙ Trisodium EDTA ∙ Ascorbyl Glucoside ∙ Polysilicone-2 ∙ Talc ∙ Tocopherol ∙ Sea Salt ∙ BHT ∙ Hydrogen Dimethicone ∙ Fragrance ∙ Phenoxyethanol ∙ Sodium Metabisulfite ∙ Potassium Sorbate ∙ [(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 - LIGHT 1 - FINLAND

NARS

PURE RADIANT
TINTED MOISTURIZER
BROAD SPECTRUM
SPF 30 SUNSCREEN

NET WT.
1.9 Oz. 50 mL

PRINCIPAL DISPLAY PANEL - 50 mL Tube Carton - LIGHT 2 - ALASKA

NARS

PURE RADIANT
TINTED MOISTURIZER
BROAD SPECTRUM
SPF 30 SUNSCREEN

NET WT.
1.9 Oz. 50 mL

PRINCIPAL DISPLAY PANEL - 50 mL Tube Carton - MEDIUM 1 - ST. MORITZ

NARS

PURE RADIANT
TINTED MOISTURIZER
BROAD SPECTRUM
SPF 30 SUNSCREEN

NET WT.
1.9 Oz. 50 mL

PRINCIPAL DISPLAY PANEL - 50 mL Tube Carton - LIGHT 0 - TERRE-NEUVE

NARS

PURE RADIANT
TINTED MOISTURIZER
BROAD SPECTRUM
SPF 30 SUNSCREEN

NET WT.
1.9 Oz. 50 mL

PRINCIPAL DISPLAY PANEL - 50 mL Tube Carton - LIGHT 3 - GROENLAND

NARS

PURE RADIANT
TINTED MOISTURIZER
BROAD SPECTRUM
SPF 30 SUNSCREEN

NET WT.
1.9 Oz. 50 mL

PRINCIPAL DISPLAY PANEL - 50 mL Tube Carton - MEDIUM 1.5 - CUZCO

NARS

PURE RADIANT
TINTED MOISTURIZER
BROAD SPECTRUM
SPF 30 SUNSCREEN

NET WT.
1.9 Oz. 50 mL

PRINCIPAL DISPLAY PANEL - 50 mL Tube Carton - LIGHT 1.2 - GOTLAND

NARS

PURE RADIANT
TINTED MOISTURIZER
BROAD SPECTRUM
SPF 30 SUNSCREEN

NET WT.
1.9 Oz. 50 mL

PRINCIPAL DISPLAY PANEL - 50 mL Tube Carton - LIGHT 1.5 - NORWICH

NARS

PURE RADIANT
TINTED MOISTURIZER
BROAD SPECTRUM
SPF 30 SUNSCREEN

NET WT.
1.9 Oz. 50 mL

PRINCIPAL DISPLAY PANEL - 50 mL Tube Carton - MEDIUM 0 - MYKONOS

NARS

PURE RADIANT
TINTED MOISTURIZER
BROAD SPECTRUM
SPF 30 SUNSCREEN

NET WT.
1.9 Oz. 50 mL

PRINCIPAL DISPLAY PANEL - 50 mL Tube Carton - MEDIUM 1.2 - SYDNEY

NARS

PURE RADIANT
TINTED MOISTURIZER
BROAD SPECTRUM
SPF 30 SUNSCREEN

NET WT.
1.9 Oz. 50 mL

PRINCIPAL DISPLAY PANEL - 50 mL Tube Carton - MEDIUM 2 - AUCKLAND

NARS

PURE RADIANT
TINTED MOISTURIZER
BROAD SPECTRUM
SPF 30 SUNSCREEN

NET WT.
1.9 Oz. 50 mL

PRINCIPAL DISPLAY PANEL - 50 mL Tube Carton - MEDIUM-DEEP 1 - SANTIAGO

NARS

PURE RADIANT
TINTED MOISTURIZER
BROAD SPECTRUM
SPF 30 SUNSCREEN

NET WT.
1.9 Oz. 50 mL

PRINCIPAL DISPLAY PANEL - 50 mL Tube Carton - MEDIUM-DEEP 2 - MARRAKESH

NARS

PURE RADIANT
TINTED MOISTURIZER
BROAD SPECTRUM
SPF 30 SUNSCREEN

NET WT.
1.9 Oz. 50 mL

PRINCIPAL DISPLAY PANEL - 50 mL Tube Carton - MEDIUM-DEEP 3 - HAVANA

NARS

PURE RADIANT
TINTED MOISTURIZER
BROAD SPECTRUM
SPF 30 SUNSCREEN

NET WT.
1.9 Oz. 50 mL

PRINCIPAL DISPLAY PANEL - 50 mL Tube Carton - DEEP 1 - GUERNSEY

NARS

PURE RADIANT
TINTED MOISTURIZER
BROAD SPECTRUM
SPF 30 SUNSCREEN

NET WT.
1.9 Oz. 50 mL

PRINCIPAL DISPLAY PANEL - 50 mL Tube Carton - DEEP 2 - GRANADA

NARS

PURE RADIANT
TINTED MOISTURIZER
BROAD SPECTRUM
SPF 30 SUNSCREEN

NET WT.
1.9 Oz. 50 mL

INGREDIENTS AND APPEARANCE

NARS PURE RADIANT TINTED MOISTURIZER FINLAND 
octinoxate and titanium dioxide cream

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 13734-171
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
OCTINOXATE (UNII: 4Y5P7MUD51) (OCTINOXATE - UNII:4Y5P7MUD51)	OCTINOXATE	3.745 g  in 50 mL
TITANIUM DIOXIDE (UNII: 15FIX9V2JP) (TITANIUM DIOXIDE - UNII:15FIX9V2JP)	TITANIUM DIOXIDE	3.125 g  in 50 mL

Inactive Ingredients
Ingredient Name	Strength
WATER (UNII: 059QF0KO0R)
DIMETHICONE (UNII: 92RU3N3Y1O)
BUTYLENE GLYCOL (UNII: 3XUS85K0RA)
PROPANEDIOL (UNII: 5965N8W85T)
GLYCERIN (UNII: PDC6A3C0OX)
DIETHYLHEXYL SUCCINATE (UNII: 69W9UMG3P8)
NYLON-12 (UNII: 446U8J075B)
FERRIC OXIDE RED (UNII: 1K09F3G675)
PEG-9 POLYDIMETHYLSILOXYETHYL DIMETHICONE (UNII: TYP81E471F)
PEG-10 DIMETHICONE (600 CST) (UNII: 8PR7V1SVM0)
ALUMINUM HYDROXIDE (UNII: 5QB0T2IUN0)
DIPHENYLSILOXY PHENYL TRIMETHICONE (UNII: I445L28B12)
SORBITAN SESQUIISOSTEARATE (UNII: VU97D01BF9)
DISTEARDIMONIUM HECTORITE (UNII: X687XDK09L)
STEARIC ACID (UNII: 4ELV7Z65AP)
DIMETHICONE/VINYL DIMETHICONE CROSSPOLYMER (SOFT PARTICLE) (UNII: 9E4CO0W6C5)
PHENOXYETHANOL (UNII: HIE492ZZ3T)
FERRIC OXIDE YELLOW (UNII: EX438O2MRT)
POLYMETHYLSILSESQUIOXANE (4.5 MICRONS) (UNII: 59Z907ZB69)
FERROSOFERRIC OXIDE (UNII: XM0M87F357)
EDETATE TRISODIUM (UNII: 420IP921MB)
TALC (UNII: 7SEV7J4R1U)
ASCORBYL GLUCOSIDE (UNII: 2V52R0NHXW)
.ALPHA.-TOCOPHEROL (UNII: H4N855PNZ1)
ALTEROMONAS MACLEODII POLYSACCHARIDES (UNII: AP6XG2GR8Z)
SEA SALT (UNII: 87GE52P74G)
HYDROGEN DIMETHICONE (13 CST) (UNII: 4QGR4P2YOI)
BUTYLATED HYDROXYTOLUENE (UNII: 1P9D0Z171K)
SODIUM METABISULFITE (UNII: 4VON5FNS3C)
TURMERIC (UNII: 856YO1Z64F)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 13734-171-60	1 in 1 CARTON	04/01/2021
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	04/01/2021

NARS PURE RADIANT TINTED MOISTURIZER ALASKA 
octinoxate and titanium dioxide cream

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 13734-172
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
OCTINOXATE (UNII: 4Y5P7MUD51) (OCTINOXATE - UNII:4Y5P7MUD51)	OCTINOXATE	3.745 g  in 50 mL
TITANIUM DIOXIDE (UNII: 15FIX9V2JP) (TITANIUM DIOXIDE - UNII:15FIX9V2JP)	TITANIUM DIOXIDE	3.125 g  in 50 mL

Inactive Ingredients
Ingredient Name	Strength
WATER (UNII: 059QF0KO0R)
DIMETHICONE (UNII: 92RU3N3Y1O)
BUTYLENE GLYCOL (UNII: 3XUS85K0RA)
PROPANEDIOL (UNII: 5965N8W85T)
GLYCERIN (UNII: PDC6A3C0OX)
DIETHYLHEXYL SUCCINATE (UNII: 69W9UMG3P8)
NYLON-12 (UNII: 446U8J075B)
FERRIC OXIDE RED (UNII: 1K09F3G675)
PEG-9 POLYDIMETHYLSILOXYETHYL DIMETHICONE (UNII: TYP81E471F)
PEG-10 DIMETHICONE (600 CST) (UNII: 8PR7V1SVM0)
ALUMINUM HYDROXIDE (UNII: 5QB0T2IUN0)
DIPHENYLSILOXY PHENYL TRIMETHICONE (UNII: I445L28B12)
SORBITAN SESQUIISOSTEARATE (UNII: VU97D01BF9)
DISTEARDIMONIUM HECTORITE (UNII: X687XDK09L)
STEARIC ACID (UNII: 4ELV7Z65AP)
DIMETHICONE/VINYL DIMETHICONE CROSSPOLYMER (SOFT PARTICLE) (UNII: 9E4CO0W6C5)
PHENOXYETHANOL (UNII: HIE492ZZ3T)
FERRIC OXIDE YELLOW (UNII: EX438O2MRT)
POLYMETHYLSILSESQUIOXANE (4.5 MICRONS) (UNII: 59Z907ZB69)
FERROSOFERRIC OXIDE (UNII: XM0M87F357)
EDETATE TRISODIUM (UNII: 420IP921MB)
TALC (UNII: 7SEV7J4R1U)
ASCORBYL GLUCOSIDE (UNII: 2V52R0NHXW)
.ALPHA.-TOCOPHEROL (UNII: H4N855PNZ1)
ALTEROMONAS MACLEODII POLYSACCHARIDES (UNII: AP6XG2GR8Z)
SEA SALT (UNII: 87GE52P74G)
HYDROGEN DIMETHICONE (13 CST) (UNII: 4QGR4P2YOI)
BUTYLATED HYDROXYTOLUENE (UNII: 1P9D0Z171K)
SODIUM METABISULFITE (UNII: 4VON5FNS3C)
TURMERIC (UNII: 856YO1Z64F)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 13734-172-60	1 in 1 CARTON	04/01/2021
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	04/01/2021

NARS PURE RADIANT TINTED MOISTURIZER ST. MORITZ 
octinoxate and titanium dioxide cream

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 13734-173
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
OCTINOXATE (UNII: 4Y5P7MUD51) (OCTINOXATE - UNII:4Y5P7MUD51)	OCTINOXATE	3.745 g  in 50 mL
TITANIUM DIOXIDE (UNII: 15FIX9V2JP) (TITANIUM DIOXIDE - UNII:15FIX9V2JP)	TITANIUM DIOXIDE	3.125 g  in 50 mL

Inactive Ingredients
Ingredient Name	Strength
WATER (UNII: 059QF0KO0R)
DIMETHICONE (UNII: 92RU3N3Y1O)
BUTYLENE GLYCOL (UNII: 3XUS85K0RA)
PROPANEDIOL (UNII: 5965N8W85T)
GLYCERIN (UNII: PDC6A3C0OX)
DIETHYLHEXYL SUCCINATE (UNII: 69W9UMG3P8)
NYLON-12 (UNII: 446U8J075B)
FERRIC OXIDE RED (UNII: 1K09F3G675)
PEG-9 POLYDIMETHYLSILOXYETHYL DIMETHICONE (UNII: TYP81E471F)
PEG-10 DIMETHICONE (600 CST) (UNII: 8PR7V1SVM0)
ALUMINUM HYDROXIDE (UNII: 5QB0T2IUN0)
DIPHENYLSILOXY PHENYL TRIMETHICONE (UNII: I445L28B12)
SORBITAN SESQUIISOSTEARATE (UNII: VU97D01BF9)
DISTEARDIMONIUM HECTORITE (UNII: X687XDK09L)
STEARIC ACID (UNII: 4ELV7Z65AP)
DIMETHICONE/VINYL DIMETHICONE CROSSPOLYMER (SOFT PARTICLE) (UNII: 9E4CO0W6C5)
PHENOXYETHANOL (UNII: HIE492ZZ3T)
FERRIC OXIDE YELLOW (UNII: EX438O2MRT)
POLYMETHYLSILSESQUIOXANE (4.5 MICRONS) (UNII: 59Z907ZB69)
FERROSOFERRIC OXIDE (UNII: XM0M87F357)
EDETATE TRISODIUM (UNII: 420IP921MB)
TALC (UNII: 7SEV7J4R1U)
ASCORBYL GLUCOSIDE (UNII: 2V52R0NHXW)
.ALPHA.-TOCOPHEROL (UNII: H4N855PNZ1)
ALTEROMONAS MACLEODII POLYSACCHARIDES (UNII: AP6XG2GR8Z)
SEA SALT (UNII: 87GE52P74G)
HYDROGEN DIMETHICONE (13 CST) (UNII: 4QGR4P2YOI)
BUTYLATED HYDROXYTOLUENE (UNII: 1P9D0Z171K)
SODIUM METABISULFITE (UNII: 4VON5FNS3C)
TURMERIC (UNII: 856YO1Z64F)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 13734-173-60	1 in 1 CARTON	04/01/2021
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	04/01/2021

NARS PURE RADIANT TINTED MOISTURIZER TERRE-NEUVE 
octinoxate and titanium dioxide cream

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 13734-174
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
OCTINOXATE (UNII: 4Y5P7MUD51) (OCTINOXATE - UNII:4Y5P7MUD51)	OCTINOXATE	3.745 g  in 50 mL
TITANIUM DIOXIDE (UNII: 15FIX9V2JP) (TITANIUM DIOXIDE - UNII:15FIX9V2JP)	TITANIUM DIOXIDE	3.125 g  in 50 mL

Inactive Ingredients
Ingredient Name	Strength
WATER (UNII: 059QF0KO0R)
DIMETHICONE (UNII: 92RU3N3Y1O)
BUTYLENE GLYCOL (UNII: 3XUS85K0RA)
PROPANEDIOL (UNII: 5965N8W85T)
GLYCERIN (UNII: PDC6A3C0OX)
DIETHYLHEXYL SUCCINATE (UNII: 69W9UMG3P8)
NYLON-12 (UNII: 446U8J075B)
FERRIC OXIDE RED (UNII: 1K09F3G675)
PEG-9 POLYDIMETHYLSILOXYETHYL DIMETHICONE (UNII: TYP81E471F)
PEG-10 DIMETHICONE (600 CST) (UNII: 8PR7V1SVM0)
ALUMINUM HYDROXIDE (UNII: 5QB0T2IUN0)
DIPHENYLSILOXY PHENYL TRIMETHICONE (UNII: I445L28B12)
SORBITAN SESQUIISOSTEARATE (UNII: VU97D01BF9)
DISTEARDIMONIUM HECTORITE (UNII: X687XDK09L)
STEARIC ACID (UNII: 4ELV7Z65AP)
DIMETHICONE/VINYL DIMETHICONE CROSSPOLYMER (SOFT PARTICLE) (UNII: 9E4CO0W6C5)
PHENOXYETHANOL (UNII: HIE492ZZ3T)
FERRIC OXIDE YELLOW (UNII: EX438O2MRT)
POLYMETHYLSILSESQUIOXANE (4.5 MICRONS) (UNII: 59Z907ZB69)
FERROSOFERRIC OXIDE (UNII: XM0M87F357)
EDETATE TRISODIUM (UNII: 420IP921MB)
TALC (UNII: 7SEV7J4R1U)
ASCORBYL GLUCOSIDE (UNII: 2V52R0NHXW)
.ALPHA.-TOCOPHEROL (UNII: H4N855PNZ1)
ALTEROMONAS MACLEODII POLYSACCHARIDES (UNII: AP6XG2GR8Z)
SEA SALT (UNII: 87GE52P74G)
HYDROGEN DIMETHICONE (13 CST) (UNII: 4QGR4P2YOI)
BUTYLATED HYDROXYTOLUENE (UNII: 1P9D0Z171K)
SODIUM METABISULFITE (UNII: 4VON5FNS3C)
TURMERIC (UNII: 856YO1Z64F)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 13734-174-60	1 in 1 CARTON	04/01/2021
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	04/01/2021

NARS PURE RADIANT TINTED MOISTURIZER GROENLAND 
octinoxate and titanium dioxide cream

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 13734-175
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
OCTINOXATE (UNII: 4Y5P7MUD51) (OCTINOXATE - UNII:4Y5P7MUD51)	OCTINOXATE	3.745 g  in 50 mL
TITANIUM DIOXIDE (UNII: 15FIX9V2JP) (TITANIUM DIOXIDE - UNII:15FIX9V2JP)	TITANIUM DIOXIDE	3.125 g  in 50 mL

Inactive Ingredients
Ingredient Name	Strength
WATER (UNII: 059QF0KO0R)
DIMETHICONE (UNII: 92RU3N3Y1O)
BUTYLENE GLYCOL (UNII: 3XUS85K0RA)
PROPANEDIOL (UNII: 5965N8W85T)
GLYCERIN (UNII: PDC6A3C0OX)
DIETHYLHEXYL SUCCINATE (UNII: 69W9UMG3P8)
NYLON-12 (UNII: 446U8J075B)
FERRIC OXIDE RED (UNII: 1K09F3G675)
PEG-9 POLYDIMETHYLSILOXYETHYL DIMETHICONE (UNII: TYP81E471F)
PEG-10 DIMETHICONE (600 CST) (UNII: 8PR7V1SVM0)
ALUMINUM HYDROXIDE (UNII: 5QB0T2IUN0)
DIPHENYLSILOXY PHENYL TRIMETHICONE (UNII: I445L28B12)
SORBITAN SESQUIISOSTEARATE (UNII: VU97D01BF9)
DISTEARDIMONIUM HECTORITE (UNII: X687XDK09L)
STEARIC ACID (UNII: 4ELV7Z65AP)
DIMETHICONE/VINYL DIMETHICONE CROSSPOLYMER (SOFT PARTICLE) (UNII: 9E4CO0W6C5)
PHENOXYETHANOL (UNII: HIE492ZZ3T)
FERRIC OXIDE YELLOW (UNII: EX438O2MRT)
POLYMETHYLSILSESQUIOXANE (4.5 MICRONS) (UNII: 59Z907ZB69)
FERROSOFERRIC OXIDE (UNII: XM0M87F357)
EDETATE TRISODIUM (UNII: 420IP921MB)
TALC (UNII: 7SEV7J4R1U)
ASCORBYL GLUCOSIDE (UNII: 2V52R0NHXW)
.ALPHA.-TOCOPHEROL (UNII: H4N855PNZ1)
ALTEROMONAS MACLEODII POLYSACCHARIDES (UNII: AP6XG2GR8Z)
SEA SALT (UNII: 87GE52P74G)
HYDROGEN DIMETHICONE (13 CST) (UNII: 4QGR4P2YOI)
BUTYLATED HYDROXYTOLUENE (UNII: 1P9D0Z171K)
SODIUM METABISULFITE (UNII: 4VON5FNS3C)
TURMERIC (UNII: 856YO1Z64F)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 13734-175-60	1 in 1 CARTON	04/01/2021
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	04/01/2021

NARS PURE RADIANT TINTED MOISTURIZER CUZCO 
octinoxate and titanium dioxide cream

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 13734-176
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
OCTINOXATE (UNII: 4Y5P7MUD51) (OCTINOXATE - UNII:4Y5P7MUD51)	OCTINOXATE	3.745 g  in 50 mL
TITANIUM DIOXIDE (UNII: 15FIX9V2JP) (TITANIUM DIOXIDE - UNII:15FIX9V2JP)	TITANIUM DIOXIDE	3.125 g  in 50 mL

Inactive Ingredients
Ingredient Name	Strength
WATER (UNII: 059QF0KO0R)
DIMETHICONE (UNII: 92RU3N3Y1O)
BUTYLENE GLYCOL (UNII: 3XUS85K0RA)
PROPANEDIOL (UNII: 5965N8W85T)
GLYCERIN (UNII: PDC6A3C0OX)
DIETHYLHEXYL SUCCINATE (UNII: 69W9UMG3P8)
NYLON-12 (UNII: 446U8J075B)
FERRIC OXIDE RED (UNII: 1K09F3G675)
PEG-9 POLYDIMETHYLSILOXYETHYL DIMETHICONE (UNII: TYP81E471F)
PEG-10 DIMETHICONE (600 CST) (UNII: 8PR7V1SVM0)
ALUMINUM HYDROXIDE (UNII: 5QB0T2IUN0)
DIPHENYLSILOXY PHENYL TRIMETHICONE (UNII: I445L28B12)
SORBITAN SESQUIISOSTEARATE (UNII: VU97D01BF9)
DISTEARDIMONIUM HECTORITE (UNII: X687XDK09L)
STEARIC ACID (UNII: 4ELV7Z65AP)
DIMETHICONE/VINYL DIMETHICONE CROSSPOLYMER (SOFT PARTICLE) (UNII: 9E4CO0W6C5)
PHENOXYETHANOL (UNII: HIE492ZZ3T)
FERRIC OXIDE YELLOW (UNII: EX438O2MRT)
POLYMETHYLSILSESQUIOXANE (4.5 MICRONS) (UNII: 59Z907ZB69)
FERROSOFERRIC OXIDE (UNII: XM0M87F357)
EDETATE TRISODIUM (UNII: 420IP921MB)
TALC (UNII: 7SEV7J4R1U)
ASCORBYL GLUCOSIDE (UNII: 2V52R0NHXW)
.ALPHA.-TOCOPHEROL (UNII: H4N855PNZ1)
ALTEROMONAS MACLEODII POLYSACCHARIDES (UNII: AP6XG2GR8Z)
SEA SALT (UNII: 87GE52P74G)
HYDROGEN DIMETHICONE (13 CST) (UNII: 4QGR4P2YOI)
BUTYLATED HYDROXYTOLUENE (UNII: 1P9D0Z171K)
SODIUM METABISULFITE (UNII: 4VON5FNS3C)
TURMERIC (UNII: 856YO1Z64F)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 13734-176-60	1 in 1 CARTON	04/01/2021
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	04/01/2021

NARS PURE RADIANT TINTED MOISTURIZER GOTLAND 
octinoxate and titanium dioxide cream

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 13734-161
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
OCTINOXATE (UNII: 4Y5P7MUD51) (OCTINOXATE - UNII:4Y5P7MUD51)	OCTINOXATE	3.745 g  in 50 mL
TITANIUM DIOXIDE (UNII: 15FIX9V2JP) (TITANIUM DIOXIDE - UNII:15FIX9V2JP)	TITANIUM DIOXIDE	3.125 g  in 50 mL

Inactive Ingredients
Ingredient Name	Strength
WATER (UNII: 059QF0KO0R)
DIMETHICONE (UNII: 92RU3N3Y1O)
BUTYLENE GLYCOL (UNII: 3XUS85K0RA)
PROPANEDIOL (UNII: 5965N8W85T)
GLYCERIN (UNII: PDC6A3C0OX)
DIETHYLHEXYL SUCCINATE (UNII: 69W9UMG3P8)
NYLON-12 (UNII: 446U8J075B)
FERRIC OXIDE RED (UNII: 1K09F3G675)
PEG-9 POLYDIMETHYLSILOXYETHYL DIMETHICONE (UNII: TYP81E471F)
PEG-10 DIMETHICONE (600 CST) (UNII: 8PR7V1SVM0)
ALUMINUM HYDROXIDE (UNII: 5QB0T2IUN0)
DIPHENYLSILOXY PHENYL TRIMETHICONE (UNII: I445L28B12)
SORBITAN SESQUIISOSTEARATE (UNII: VU97D01BF9)
DISTEARDIMONIUM HECTORITE (UNII: X687XDK09L)
STEARIC ACID (UNII: 4ELV7Z65AP)
DIMETHICONE/VINYL DIMETHICONE CROSSPOLYMER (SOFT PARTICLE) (UNII: 9E4CO0W6C5)
PHENOXYETHANOL (UNII: HIE492ZZ3T)
FERRIC OXIDE YELLOW (UNII: EX438O2MRT)
POLYMETHYLSILSESQUIOXANE (4.5 MICRONS) (UNII: 59Z907ZB69)
FERROSOFERRIC OXIDE (UNII: XM0M87F357)
EDETATE TRISODIUM (UNII: 420IP921MB)
TALC (UNII: 7SEV7J4R1U)
ASCORBYL GLUCOSIDE (UNII: 2V52R0NHXW)
.ALPHA.-TOCOPHEROL (UNII: H4N855PNZ1)
ALTEROMONAS MACLEODII POLYSACCHARIDES (UNII: AP6XG2GR8Z)
SEA SALT (UNII: 87GE52P74G)
HYDROGEN DIMETHICONE (13 CST) (UNII: 4QGR4P2YOI)
BUTYLATED HYDROXYTOLUENE (UNII: 1P9D0Z171K)
SODIUM METABISULFITE (UNII: 4VON5FNS3C)
TURMERIC (UNII: 856YO1Z64F)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 13734-161-60	1 in 1 CARTON	04/01/2021
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	04/01/2021

NARS PURE RADIANT TINTED MOISTURIZER NORWICH 
octinoxate and titanium dioxide cream

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 13734-162
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
OCTINOXATE (UNII: 4Y5P7MUD51) (OCTINOXATE - UNII:4Y5P7MUD51)	OCTINOXATE	3.745 g  in 50 mL
TITANIUM DIOXIDE (UNII: 15FIX9V2JP) (TITANIUM DIOXIDE - UNII:15FIX9V2JP)	TITANIUM DIOXIDE	3.125 g  in 50 mL

Inactive Ingredients
Ingredient Name	Strength
WATER (UNII: 059QF0KO0R)
DIMETHICONE (UNII: 92RU3N3Y1O)
BUTYLENE GLYCOL (UNII: 3XUS85K0RA)
PROPANEDIOL (UNII: 5965N8W85T)
GLYCERIN (UNII: PDC6A3C0OX)
DIETHYLHEXYL SUCCINATE (UNII: 69W9UMG3P8)
NYLON-12 (UNII: 446U8J075B)
FERRIC OXIDE RED (UNII: 1K09F3G675)
PEG-9 POLYDIMETHYLSILOXYETHYL DIMETHICONE (UNII: TYP81E471F)
PEG-10 DIMETHICONE (600 CST) (UNII: 8PR7V1SVM0)
ALUMINUM HYDROXIDE (UNII: 5QB0T2IUN0)
DIPHENYLSILOXY PHENYL TRIMETHICONE (UNII: I445L28B12)
SORBITAN SESQUIISOSTEARATE (UNII: VU97D01BF9)
DISTEARDIMONIUM HECTORITE (UNII: X687XDK09L)
STEARIC ACID (UNII: 4ELV7Z65AP)
DIMETHICONE/VINYL DIMETHICONE CROSSPOLYMER (SOFT PARTICLE) (UNII: 9E4CO0W6C5)
PHENOXYETHANOL (UNII: HIE492ZZ3T)
FERRIC OXIDE YELLOW (UNII: EX438O2MRT)
POLYMETHYLSILSESQUIOXANE (4.5 MICRONS) (UNII: 59Z907ZB69)
FERROSOFERRIC OXIDE (UNII: XM0M87F357)
EDETATE TRISODIUM (UNII: 420IP921MB)
TALC (UNII: 7SEV7J4R1U)
ASCORBYL GLUCOSIDE (UNII: 2V52R0NHXW)
.ALPHA.-TOCOPHEROL (UNII: H4N855PNZ1)
ALTEROMONAS MACLEODII POLYSACCHARIDES (UNII: AP6XG2GR8Z)
SEA SALT (UNII: 87GE52P74G)
HYDROGEN DIMETHICONE (13 CST) (UNII: 4QGR4P2YOI)
BUTYLATED HYDROXYTOLUENE (UNII: 1P9D0Z171K)
SODIUM METABISULFITE (UNII: 4VON5FNS3C)
TURMERIC (UNII: 856YO1Z64F)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 13734-162-60	1 in 1 CARTON	04/01/2021
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	04/01/2021

NARS PURE RADIANT TINTED MOISTURIZER MYKONOS 
octinoxate and titanium dioxide cream

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 13734-163
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
OCTINOXATE (UNII: 4Y5P7MUD51) (OCTINOXATE - UNII:4Y5P7MUD51)	OCTINOXATE	3.745 g  in 50 mL
TITANIUM DIOXIDE (UNII: 15FIX9V2JP) (TITANIUM DIOXIDE - UNII:15FIX9V2JP)	TITANIUM DIOXIDE	3.125 g  in 50 mL

Inactive Ingredients
Ingredient Name	Strength
WATER (UNII: 059QF0KO0R)
DIMETHICONE (UNII: 92RU3N3Y1O)
BUTYLENE GLYCOL (UNII: 3XUS85K0RA)
PROPANEDIOL (UNII: 5965N8W85T)
GLYCERIN (UNII: PDC6A3C0OX)
DIETHYLHEXYL SUCCINATE (UNII: 69W9UMG3P8)
NYLON-12 (UNII: 446U8J075B)
FERRIC OXIDE RED (UNII: 1K09F3G675)
PEG-9 POLYDIMETHYLSILOXYETHYL DIMETHICONE (UNII: TYP81E471F)
PEG-10 DIMETHICONE (600 CST) (UNII: 8PR7V1SVM0)
ALUMINUM HYDROXIDE (UNII: 5QB0T2IUN0)
DIPHENYLSILOXY PHENYL TRIMETHICONE (UNII: I445L28B12)
SORBITAN SESQUIISOSTEARATE (UNII: VU97D01BF9)
DISTEARDIMONIUM HECTORITE (UNII: X687XDK09L)
STEARIC ACID (UNII: 4ELV7Z65AP)
DIMETHICONE/VINYL DIMETHICONE CROSSPOLYMER (SOFT PARTICLE) (UNII: 9E4CO0W6C5)
PHENOXYETHANOL (UNII: HIE492ZZ3T)
FERRIC OXIDE YELLOW (UNII: EX438O2MRT)
POLYMETHYLSILSESQUIOXANE (4.5 MICRONS) (UNII: 59Z907ZB69)
FERROSOFERRIC OXIDE (UNII: XM0M87F357)
EDETATE TRISODIUM (UNII: 420IP921MB)
TALC (UNII: 7SEV7J4R1U)
ASCORBYL GLUCOSIDE (UNII: 2V52R0NHXW)
.ALPHA.-TOCOPHEROL (UNII: H4N855PNZ1)
ALTEROMONAS MACLEODII POLYSACCHARIDES (UNII: AP6XG2GR8Z)
SEA SALT (UNII: 87GE52P74G)
HYDROGEN DIMETHICONE (13 CST) (UNII: 4QGR4P2YOI)
BUTYLATED HYDROXYTOLUENE (UNII: 1P9D0Z171K)
SODIUM METABISULFITE (UNII: 4VON5FNS3C)
TURMERIC (UNII: 856YO1Z64F)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 13734-163-60	1 in 1 CARTON	04/01/2021
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	04/01/2021

NARS PURE RADIANT TINTED MOISTURIZER SYDNEY 
octinoxate and titanium dioxide cream

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 13734-164
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
OCTINOXATE (UNII: 4Y5P7MUD51) (OCTINOXATE - UNII:4Y5P7MUD51)	OCTINOXATE	3.745 g  in 50 mL
TITANIUM DIOXIDE (UNII: 15FIX9V2JP) (TITANIUM DIOXIDE - UNII:15FIX9V2JP)	TITANIUM DIOXIDE	3.125 g  in 50 mL

Inactive Ingredients
Ingredient Name	Strength
WATER (UNII: 059QF0KO0R)
DIMETHICONE (UNII: 92RU3N3Y1O)
BUTYLENE GLYCOL (UNII: 3XUS85K0RA)
PROPANEDIOL (UNII: 5965N8W85T)
GLYCERIN (UNII: PDC6A3C0OX)
DIETHYLHEXYL SUCCINATE (UNII: 69W9UMG3P8)
NYLON-12 (UNII: 446U8J075B)
FERRIC OXIDE RED (UNII: 1K09F3G675)
PEG-9 POLYDIMETHYLSILOXYETHYL DIMETHICONE (UNII: TYP81E471F)
PEG-10 DIMETHICONE (600 CST) (UNII: 8PR7V1SVM0)
ALUMINUM HYDROXIDE (UNII: 5QB0T2IUN0)
DIPHENYLSILOXY PHENYL TRIMETHICONE (UNII: I445L28B12)
SORBITAN SESQUIISOSTEARATE (UNII: VU97D01BF9)
DISTEARDIMONIUM HECTORITE (UNII: X687XDK09L)
STEARIC ACID (UNII: 4ELV7Z65AP)
DIMETHICONE/VINYL DIMETHICONE CROSSPOLYMER (SOFT PARTICLE) (UNII: 9E4CO0W6C5)
PHENOXYETHANOL (UNII: HIE492ZZ3T)
FERRIC OXIDE YELLOW (UNII: EX438O2MRT)
POLYMETHYLSILSESQUIOXANE (4.5 MICRONS) (UNII: 59Z907ZB69)
FERROSOFERRIC OXIDE (UNII: XM0M87F357)
EDETATE TRISODIUM (UNII: 420IP921MB)
TALC (UNII: 7SEV7J4R1U)
ASCORBYL GLUCOSIDE (UNII: 2V52R0NHXW)
.ALPHA.-TOCOPHEROL (UNII: H4N855PNZ1)
ALTEROMONAS MACLEODII POLYSACCHARIDES (UNII: AP6XG2GR8Z)
SEA SALT (UNII: 87GE52P74G)
HYDROGEN DIMETHICONE (13 CST) (UNII: 4QGR4P2YOI)
BUTYLATED HYDROXYTOLUENE (UNII: 1P9D0Z171K)
SODIUM METABISULFITE (UNII: 4VON5FNS3C)
TURMERIC (UNII: 856YO1Z64F)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 13734-164-60	1 in 1 CARTON	04/01/2021
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	04/01/2021

NARS PURE RADIANT TINTED MOISTURIZER AUCKLAND 
octinoxate and titanium dioxide cream

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 13734-165
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
OCTINOXATE (UNII: 4Y5P7MUD51) (OCTINOXATE - UNII:4Y5P7MUD51)	OCTINOXATE	3.745 g  in 50 mL
TITANIUM DIOXIDE (UNII: 15FIX9V2JP) (TITANIUM DIOXIDE - UNII:15FIX9V2JP)	TITANIUM DIOXIDE	3.125 g  in 50 mL

Inactive Ingredients
Ingredient Name	Strength
WATER (UNII: 059QF0KO0R)
DIMETHICONE (UNII: 92RU3N3Y1O)
BUTYLENE GLYCOL (UNII: 3XUS85K0RA)
PROPANEDIOL (UNII: 5965N8W85T)
GLYCERIN (UNII: PDC6A3C0OX)
DIETHYLHEXYL SUCCINATE (UNII: 69W9UMG3P8)
NYLON-12 (UNII: 446U8J075B)
FERRIC OXIDE RED (UNII: 1K09F3G675)
PEG-9 POLYDIMETHYLSILOXYETHYL DIMETHICONE (UNII: TYP81E471F)
PEG-10 DIMETHICONE (600 CST) (UNII: 8PR7V1SVM0)
ALUMINUM HYDROXIDE (UNII: 5QB0T2IUN0)
DIPHENYLSILOXY PHENYL TRIMETHICONE (UNII: I445L28B12)
SORBITAN SESQUIISOSTEARATE (UNII: VU97D01BF9)
DISTEARDIMONIUM HECTORITE (UNII: X687XDK09L)
STEARIC ACID (UNII: 4ELV7Z65AP)
DIMETHICONE/VINYL DIMETHICONE CROSSPOLYMER (SOFT PARTICLE) (UNII: 9E4CO0W6C5)
PHENOXYETHANOL (UNII: HIE492ZZ3T)
FERRIC OXIDE YELLOW (UNII: EX438O2MRT)
POLYMETHYLSILSESQUIOXANE (4.5 MICRONS) (UNII: 59Z907ZB69)
FERROSOFERRIC OXIDE (UNII: XM0M87F357)
EDETATE TRISODIUM (UNII: 420IP921MB)
TALC (UNII: 7SEV7J4R1U)
ASCORBYL GLUCOSIDE (UNII: 2V52R0NHXW)
.ALPHA.-TOCOPHEROL (UNII: H4N855PNZ1)
ALTEROMONAS MACLEODII POLYSACCHARIDES (UNII: AP6XG2GR8Z)
SEA SALT (UNII: 87GE52P74G)
HYDROGEN DIMETHICONE (13 CST) (UNII: 4QGR4P2YOI)
BUTYLATED HYDROXYTOLUENE (UNII: 1P9D0Z171K)
SODIUM METABISULFITE (UNII: 4VON5FNS3C)
TURMERIC (UNII: 856YO1Z64F)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 13734-165-60	1 in 1 CARTON	04/01/2021
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	04/01/2021

NARS PURE RADIANT TINTED MOISTURIZER SANTIAGO 
octinoxate and titanium dioxide cream

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 13734-166
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
OCTINOXATE (UNII: 4Y5P7MUD51) (OCTINOXATE - UNII:4Y5P7MUD51)	OCTINOXATE	3.745 g  in 50 mL
TITANIUM DIOXIDE (UNII: 15FIX9V2JP) (TITANIUM DIOXIDE - UNII:15FIX9V2JP)	TITANIUM DIOXIDE	3.125 g  in 50 mL

Inactive Ingredients
Ingredient Name	Strength
WATER (UNII: 059QF0KO0R)
DIMETHICONE (UNII: 92RU3N3Y1O)
BUTYLENE GLYCOL (UNII: 3XUS85K0RA)
PROPANEDIOL (UNII: 5965N8W85T)
GLYCERIN (UNII: PDC6A3C0OX)
DIETHYLHEXYL SUCCINATE (UNII: 69W9UMG3P8)
NYLON-12 (UNII: 446U8J075B)
FERRIC OXIDE RED (UNII: 1K09F3G675)
PEG-9 POLYDIMETHYLSILOXYETHYL DIMETHICONE (UNII: TYP81E471F)
PEG-10 DIMETHICONE (600 CST) (UNII: 8PR7V1SVM0)
ALUMINUM HYDROXIDE (UNII: 5QB0T2IUN0)
DIPHENYLSILOXY PHENYL TRIMETHICONE (UNII: I445L28B12)
SORBITAN SESQUIISOSTEARATE (UNII: VU97D01BF9)
DISTEARDIMONIUM HECTORITE (UNII: X687XDK09L)
STEARIC ACID (UNII: 4ELV7Z65AP)
DIMETHICONE/VINYL DIMETHICONE CROSSPOLYMER (SOFT PARTICLE) (UNII: 9E4CO0W6C5)
PHENOXYETHANOL (UNII: HIE492ZZ3T)
FERRIC OXIDE YELLOW (UNII: EX438O2MRT)
POLYMETHYLSILSESQUIOXANE (4.5 MICRONS) (UNII: 59Z907ZB69)
FERROSOFERRIC OXIDE (UNII: XM0M87F357)
EDETATE TRISODIUM (UNII: 420IP921MB)
TALC (UNII: 7SEV7J4R1U)
ASCORBYL GLUCOSIDE (UNII: 2V52R0NHXW)
.ALPHA.-TOCOPHEROL (UNII: H4N855PNZ1)
ALTEROMONAS MACLEODII POLYSACCHARIDES (UNII: AP6XG2GR8Z)
SEA SALT (UNII: 87GE52P74G)
HYDROGEN DIMETHICONE (13 CST) (UNII: 4QGR4P2YOI)
BUTYLATED HYDROXYTOLUENE (UNII: 1P9D0Z171K)
SODIUM METABISULFITE (UNII: 4VON5FNS3C)
TURMERIC (UNII: 856YO1Z64F)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 13734-166-60	1 in 1 CARTON	04/01/2021
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	04/01/2021

NARS PURE RADIANT TINTED MOISTURIZER MARRAKESH 
octinoxate and titanium dioxide cream

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 13734-167
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
OCTINOXATE (UNII: 4Y5P7MUD51) (OCTINOXATE - UNII:4Y5P7MUD51)	OCTINOXATE	3.745 g  in 50 mL
TITANIUM DIOXIDE (UNII: 15FIX9V2JP) (TITANIUM DIOXIDE - UNII:15FIX9V2JP)	TITANIUM DIOXIDE	3.125 g  in 50 mL

Inactive Ingredients
Ingredient Name	Strength
WATER (UNII: 059QF0KO0R)
DIMETHICONE (UNII: 92RU3N3Y1O)
BUTYLENE GLYCOL (UNII: 3XUS85K0RA)
PROPANEDIOL (UNII: 5965N8W85T)
GLYCERIN (UNII: PDC6A3C0OX)
DIETHYLHEXYL SUCCINATE (UNII: 69W9UMG3P8)
NYLON-12 (UNII: 446U8J075B)
FERRIC OXIDE RED (UNII: 1K09F3G675)
PEG-9 POLYDIMETHYLSILOXYETHYL DIMETHICONE (UNII: TYP81E471F)
PEG-10 DIMETHICONE (600 CST) (UNII: 8PR7V1SVM0)
ALUMINUM HYDROXIDE (UNII: 5QB0T2IUN0)
DIPHENYLSILOXY PHENYL TRIMETHICONE (UNII: I445L28B12)
SORBITAN SESQUIISOSTEARATE (UNII: VU97D01BF9)
DISTEARDIMONIUM HECTORITE (UNII: X687XDK09L)
STEARIC ACID (UNII: 4ELV7Z65AP)
DIMETHICONE/VINYL DIMETHICONE CROSSPOLYMER (SOFT PARTICLE) (UNII: 9E4CO0W6C5)
PHENOXYETHANOL (UNII: HIE492ZZ3T)
FERRIC OXIDE YELLOW (UNII: EX438O2MRT)
POLYMETHYLSILSESQUIOXANE (4.5 MICRONS) (UNII: 59Z907ZB69)
FERROSOFERRIC OXIDE (UNII: XM0M87F357)
EDETATE TRISODIUM (UNII: 420IP921MB)
TALC (UNII: 7SEV7J4R1U)
ASCORBYL GLUCOSIDE (UNII: 2V52R0NHXW)
.ALPHA.-TOCOPHEROL (UNII: H4N855PNZ1)
ALTEROMONAS MACLEODII POLYSACCHARIDES (UNII: AP6XG2GR8Z)
SEA SALT (UNII: 87GE52P74G)
HYDROGEN DIMETHICONE (13 CST) (UNII: 4QGR4P2YOI)
BUTYLATED HYDROXYTOLUENE (UNII: 1P9D0Z171K)
SODIUM METABISULFITE (UNII: 4VON5FNS3C)
TURMERIC (UNII: 856YO1Z64F)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 13734-167-60	1 in 1 CARTON	04/01/2021
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	04/01/2021

NARS PURE RADIANT TINTED MOISTURIZER HAVANA 
octinoxate and titanium dioxide cream

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 13734-168
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
OCTINOXATE (UNII: 4Y5P7MUD51) (OCTINOXATE - UNII:4Y5P7MUD51)	OCTINOXATE	3.745 g  in 50 mL
TITANIUM DIOXIDE (UNII: 15FIX9V2JP) (TITANIUM DIOXIDE - UNII:15FIX9V2JP)	TITANIUM DIOXIDE	3.125 g  in 50 mL

Inactive Ingredients
Ingredient Name	Strength
WATER (UNII: 059QF0KO0R)
DIMETHICONE (UNII: 92RU3N3Y1O)
BUTYLENE GLYCOL (UNII: 3XUS85K0RA)
PROPANEDIOL (UNII: 5965N8W85T)
GLYCERIN (UNII: PDC6A3C0OX)
DIETHYLHEXYL SUCCINATE (UNII: 69W9UMG3P8)
NYLON-12 (UNII: 446U8J075B)
FERRIC OXIDE RED (UNII: 1K09F3G675)
PEG-9 POLYDIMETHYLSILOXYETHYL DIMETHICONE (UNII: TYP81E471F)
PEG-10 DIMETHICONE (600 CST) (UNII: 8PR7V1SVM0)
ALUMINUM HYDROXIDE (UNII: 5QB0T2IUN0)
DIPHENYLSILOXY PHENYL TRIMETHICONE (UNII: I445L28B12)
SORBITAN SESQUIISOSTEARATE (UNII: VU97D01BF9)
DISTEARDIMONIUM HECTORITE (UNII: X687XDK09L)
STEARIC ACID (UNII: 4ELV7Z65AP)
DIMETHICONE/VINYL DIMETHICONE CROSSPOLYMER (SOFT PARTICLE) (UNII: 9E4CO0W6C5)
PHENOXYETHANOL (UNII: HIE492ZZ3T)
FERRIC OXIDE YELLOW (UNII: EX438O2MRT)
POLYMETHYLSILSESQUIOXANE (4.5 MICRONS) (UNII: 59Z907ZB69)
FERROSOFERRIC OXIDE (UNII: XM0M87F357)
EDETATE TRISODIUM (UNII: 420IP921MB)
TALC (UNII: 7SEV7J4R1U)
ASCORBYL GLUCOSIDE (UNII: 2V52R0NHXW)
.ALPHA.-TOCOPHEROL (UNII: H4N855PNZ1)
ALTEROMONAS MACLEODII POLYSACCHARIDES (UNII: AP6XG2GR8Z)
SEA SALT (UNII: 87GE52P74G)
HYDROGEN DIMETHICONE (13 CST) (UNII: 4QGR4P2YOI)
BUTYLATED HYDROXYTOLUENE (UNII: 1P9D0Z171K)
SODIUM METABISULFITE (UNII: 4VON5FNS3C)
TURMERIC (UNII: 856YO1Z64F)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 13734-168-60	1 in 1 CARTON	04/01/2021
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	04/01/2021

NARS PURE RADIANT TINTED MOISTURIZER GUERNSEY 
octinoxate and titanium dioxide cream

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 13734-169
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
OCTINOXATE (UNII: 4Y5P7MUD51) (OCTINOXATE - UNII:4Y5P7MUD51)	OCTINOXATE	3.745 g  in 50 mL
TITANIUM DIOXIDE (UNII: 15FIX9V2JP) (TITANIUM DIOXIDE - UNII:15FIX9V2JP)	TITANIUM DIOXIDE	3.125 g  in 50 mL

Inactive Ingredients
Ingredient Name	Strength
WATER (UNII: 059QF0KO0R)
DIMETHICONE (UNII: 92RU3N3Y1O)
BUTYLENE GLYCOL (UNII: 3XUS85K0RA)
PROPANEDIOL (UNII: 5965N8W85T)
GLYCERIN (UNII: PDC6A3C0OX)
DIETHYLHEXYL SUCCINATE (UNII: 69W9UMG3P8)
NYLON-12 (UNII: 446U8J075B)
FERRIC OXIDE RED (UNII: 1K09F3G675)
PEG-9 POLYDIMETHYLSILOXYETHYL DIMETHICONE (UNII: TYP81E471F)
PEG-10 DIMETHICONE (600 CST) (UNII: 8PR7V1SVM0)
ALUMINUM HYDROXIDE (UNII: 5QB0T2IUN0)
DIPHENYLSILOXY PHENYL TRIMETHICONE (UNII: I445L28B12)
SORBITAN SESQUIISOSTEARATE (UNII: VU97D01BF9)
DISTEARDIMONIUM HECTORITE (UNII: X687XDK09L)
STEARIC ACID (UNII: 4ELV7Z65AP)
DIMETHICONE/VINYL DIMETHICONE CROSSPOLYMER (SOFT PARTICLE) (UNII: 9E4CO0W6C5)
PHENOXYETHANOL (UNII: HIE492ZZ3T)
FERRIC OXIDE YELLOW (UNII: EX438O2MRT)
POLYMETHYLSILSESQUIOXANE (4.5 MICRONS) (UNII: 59Z907ZB69)
FERROSOFERRIC OXIDE (UNII: XM0M87F357)
EDETATE TRISODIUM (UNII: 420IP921MB)
TALC (UNII: 7SEV7J4R1U)
ASCORBYL GLUCOSIDE (UNII: 2V52R0NHXW)
.ALPHA.-TOCOPHEROL (UNII: H4N855PNZ1)
ALTEROMONAS MACLEODII POLYSACCHARIDES (UNII: AP6XG2GR8Z)
SEA SALT (UNII: 87GE52P74G)
HYDROGEN DIMETHICONE (13 CST) (UNII: 4QGR4P2YOI)
BUTYLATED HYDROXYTOLUENE (UNII: 1P9D0Z171K)
SODIUM METABISULFITE (UNII: 4VON5FNS3C)
TURMERIC (UNII: 856YO1Z64F)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 13734-169-60	1 in 1 CARTON	04/01/2021
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	04/01/2021

NARS PURE RADIANT TINTED MOISTURIZER GRANADA 
octinoxate and titanium dioxide cream

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 13734-170
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
OCTINOXATE (UNII: 4Y5P7MUD51) (OCTINOXATE - UNII:4Y5P7MUD51)	OCTINOXATE	3.745 g  in 50 mL
TITANIUM DIOXIDE (UNII: 15FIX9V2JP) (TITANIUM DIOXIDE - UNII:15FIX9V2JP)	TITANIUM DIOXIDE	3.125 g  in 50 mL

Inactive Ingredients
Ingredient Name	Strength
WATER (UNII: 059QF0KO0R)
DIMETHICONE (UNII: 92RU3N3Y1O)
BUTYLENE GLYCOL (UNII: 3XUS85K0RA)
PROPANEDIOL (UNII: 5965N8W85T)
GLYCERIN (UNII: PDC6A3C0OX)
DIETHYLHEXYL SUCCINATE (UNII: 69W9UMG3P8)
NYLON-12 (UNII: 446U8J075B)
FERRIC OXIDE RED (UNII: 1K09F3G675)
PEG-9 POLYDIMETHYLSILOXYETHYL DIMETHICONE (UNII: TYP81E471F)
PEG-10 DIMETHICONE (600 CST) (UNII: 8PR7V1SVM0)
ALUMINUM HYDROXIDE (UNII: 5QB0T2IUN0)
DIPHENYLSILOXY PHENYL TRIMETHICONE (UNII: I445L28B12)
SORBITAN SESQUIISOSTEARATE (UNII: VU97D01BF9)
DISTEARDIMONIUM HECTORITE (UNII: X687XDK09L)
STEARIC ACID (UNII: 4ELV7Z65AP)
DIMETHICONE/VINYL DIMETHICONE CROSSPOLYMER (SOFT PARTICLE) (UNII: 9E4CO0W6C5)
PHENOXYETHANOL (UNII: HIE492ZZ3T)
FERRIC OXIDE YELLOW (UNII: EX438O2MRT)
POLYMETHYLSILSESQUIOXANE (4.5 MICRONS) (UNII: 59Z907ZB69)
FERROSOFERRIC OXIDE (UNII: XM0M87F357)
EDETATE TRISODIUM (UNII: 420IP921MB)
TALC (UNII: 7SEV7J4R1U)
ASCORBYL GLUCOSIDE (UNII: 2V52R0NHXW)
.ALPHA.-TOCOPHEROL (UNII: H4N855PNZ1)
ALTEROMONAS MACLEODII POLYSACCHARIDES (UNII: AP6XG2GR8Z)
SEA SALT (UNII: 87GE52P74G)
HYDROGEN DIMETHICONE (13 CST) (UNII: 4QGR4P2YOI)
BUTYLATED HYDROXYTOLUENE (UNII: 1P9D0Z171K)
SODIUM METABISULFITE (UNII: 4VON5FNS3C)
TURMERIC (UNII: 856YO1Z64F)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 13734-170-60	1 in 1 CARTON	04/01/2021
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	04/01/2021

Labeler - NARS Cosmetics (837363571)

Establishment
Name	Address	ID/FEI	Business Operations
SHISEIDO AMERICA INC.		782677132	MANUFACTURE(13734-161, 13734-162, 13734-163, 13734-164, 13734-165, 13734-166, 13734-167, 13734-168, 13734-169, 13734-170, 13734-171, 13734-172, 13734-173, 13734-174, 13734-175, 13734-176) , ANALYSIS(13734-161, 13734-162, 13734-163, 13734-164, 13734-165, 13734-166, 13734-167, 13734-168, 13734-169, 13734-170, 13734-171, 13734-172, 13734-173, 13734-174, 13734-175, 13734-176)