DailyMed - 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

NDC Code(s): 13734-161-60, 13734-162-60, 13734-163-60, 13734-164-60, view more
13734-165-60, 13734-166-60, 13734-167-60, 13734-168-60, 13734-169-60, 13734-170-60, 13734-171-60, 13734-172-60, 13734-173-60, 13734-174-60, 13734-175-60, 13734-176-60
Packager: NARS Cosmetics

Category: HUMAN OTC DRUG LABEL

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.

Drug Label Information

Updated March 16, 2021

If you are a healthcare professional or from the pharmaceutical industry please visit this version.

Download DRUG LABEL INFO: PDF XML
Official Label (Printer Friendly)

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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

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

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

Ingredient Name	Basis of Strength	Strength
Active Ingredient/Active Moiety
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

Ingredient Name	Strength
Inactive Ingredients
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)

#	Item Code	Package Description	Marketing Start Date
Packaging
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 Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
Marketing Information
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

Ingredient Name	Basis of Strength	Strength
Active Ingredient/Active Moiety
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

Ingredient Name	Strength
Inactive Ingredients
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)

#	Item Code	Package Description	Marketing Start Date
Packaging
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 Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
Marketing Information
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

Ingredient Name	Basis of Strength	Strength
Active Ingredient/Active Moiety
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

Ingredient Name	Strength
Inactive Ingredients
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)

#	Item Code	Package Description	Marketing Start Date
Packaging
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 Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
Marketing Information
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

Ingredient Name	Basis of Strength	Strength
Active Ingredient/Active Moiety
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

Ingredient Name	Strength
Inactive Ingredients
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)

#	Item Code	Package Description	Marketing Start Date
Packaging
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 Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
Marketing Information
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

Ingredient Name	Basis of Strength	Strength
Active Ingredient/Active Moiety
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

Ingredient Name	Strength
Inactive Ingredients
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)

#	Item Code	Package Description	Marketing Start Date
Packaging
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 Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
Marketing Information
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

Ingredient Name	Basis of Strength	Strength
Active Ingredient/Active Moiety
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

Ingredient Name	Strength
Inactive Ingredients
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)

#	Item Code	Package Description	Marketing Start Date
Packaging
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 Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
Marketing Information
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

Ingredient Name	Basis of Strength	Strength
Active Ingredient/Active Moiety
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

Ingredient Name	Strength
Inactive Ingredients
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)

#	Item Code	Package Description	Marketing Start Date
Packaging
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 Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
Marketing Information
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

Ingredient Name	Basis of Strength	Strength
Active Ingredient/Active Moiety
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

Ingredient Name	Strength
Inactive Ingredients
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)

#	Item Code	Package Description	Marketing Start Date
Packaging
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 Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
Marketing Information
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

Ingredient Name	Basis of Strength	Strength
Active Ingredient/Active Moiety
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

Ingredient Name	Strength
Inactive Ingredients
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)

#	Item Code	Package Description	Marketing Start Date
Packaging
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 Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
Marketing Information
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

Ingredient Name	Basis of Strength	Strength
Active Ingredient/Active Moiety
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

Ingredient Name	Strength
Inactive Ingredients
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)

#	Item Code	Package Description	Marketing Start Date
Packaging
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 Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
Marketing Information
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

Ingredient Name	Basis of Strength	Strength
Active Ingredient/Active Moiety
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

Ingredient Name	Strength
Inactive Ingredients
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)

#	Item Code	Package Description	Marketing Start Date
Packaging
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 Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
Marketing Information
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

Ingredient Name	Basis of Strength	Strength
Active Ingredient/Active Moiety
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

Ingredient Name	Strength
Inactive Ingredients
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)

#	Item Code	Package Description	Marketing Start Date
Packaging
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 Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
Marketing Information
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

Ingredient Name	Basis of Strength	Strength
Active Ingredient/Active Moiety
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

Ingredient Name	Strength
Inactive Ingredients
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)

#	Item Code	Package Description	Marketing Start Date
Packaging
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 Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
Marketing Information
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

Ingredient Name	Basis of Strength	Strength
Active Ingredient/Active Moiety
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

Ingredient Name	Strength
Inactive Ingredients
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)

#	Item Code	Package Description	Marketing Start Date
Packaging
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 Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
Marketing Information
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

Ingredient Name	Basis of Strength	Strength
Active Ingredient/Active Moiety
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

Ingredient Name	Strength
Inactive Ingredients
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)

#	Item Code	Package Description	Marketing Start Date
Packaging
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 Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
Marketing Information
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

Ingredient Name	Basis of Strength	Strength
Active Ingredient/Active Moiety
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

Ingredient Name	Strength
Inactive Ingredients
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)

#	Item Code	Package Description	Marketing Start Date
Packaging
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 Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
Marketing Information
OTC MONOGRAPH NOT FINAL	part352	04/01/2021

Labeler - NARS Cosmetics (837363571)

Name	Address	ID/FEI	Business Operations
Establishment
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)

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	NDC
1	13734-161-60
2	13734-162-60
3	13734-163-60
4	13734-164-60
5	13734-165-60
6	13734-166-60
7	13734-167-60
8	13734-168-60
9	13734-169-60
10	13734-170-60
11	13734-171-60
12	13734-172-60
13	13734-173-60
14	13734-174-60
15	13734-175-60
16	13734-176-60

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