PURE SHEER Aurore

Dosage form: lipstick
Ingredients: Octinoxate 0.1258g in 1.7g, Titanium dioxide 0.0544g in 1.7g
Labeler: NARS COSMETICS
NDC Code: 13734-022

Disclaimer: Most OTC drugs are not reviewed and approved by FDA, however they may be marketed if they comply with applicable regulations and policies. FDA has not evaluated whether this product complies.

NARS PURE SHEER SPF LIP TREATMENT
SPF 15 SUNSCREEN

ACTIVE INGREDIENTS

OCTINOXATE 7.4%, TITANIUM DIOXIDE 3.2%,

INACTIVE INGREDIENTS

HEPTYLUNDECYL HYDROXYSTEARATE, POLYGLYCERYL-2 TRIISOSTEARATE, POLYETHYLENE, CYCLOPENTASILOXANE, POLYBUTENE, BEESWAX, MICROCRYSTALLINE WAX, DIISOSTEARYL MALATE, DIMETHICONE CROSSPOLYMER, C10-30 CHOLESTEROL/LANOSTEROL ESTERS, ALUMINUM HYDROXIDE, OCTYLDODECANOL, STEARIC ACID, HYDROGENATED COCO-GLYCERIDES, IRVINGIA GABONENSIS KERNEL BUTTER, SODIUM MAGNESIUM SILICATE, TOCOPHEROL, GLYCERIN, METHICONE, EUTERPE OLERACEA FRUIT OIL, LINSEED OIL/PALM OIL AMINOPROPANEDIOL ESTERS, BHT, TETRADECENE, RIBES NIGRUM (BLACK CURRANT) SEED OIL, DIMETHICONE, RUBUS IDAEUS (RASPBERRY) SEED OIL, SILICA, WATER, POLYSILICONE-2, TIN OXIDE, RUBUS CHAMAEMORUS SEED OIL, SODIUM HYALURONATE, [+/- (MAY CONTAIN): MICA, TITANIUM DIOXIDE, IRON OXIDES, RED 6 LAKE, RED 7 LAKE, YELLOW 5 LAKE, YELLOW 6 LAKE, BLUE 1 LAKE],

WARNING

IF RASH OR IRRITATION DEVELOPS AND PERSISTS, DISCONTINUE USE AND CONTACT A DOCTOR.

READ INSERTION

NARS™
NARS COSMETICS, NEW YORK, NY 10022 DIST. NEW YORK - SE PARIS - LONDON (UK) W2 5RH
MADE IN USA, MAKEUP YOUR MIND™ WWW.NARSCOSMETICS.COM, 1-888-788-NARS

PRINCIPAL DISPLAY PANEL - 0.06 Oz. Carton

NARS

PURE SHEER SPF LIP TREATMENT
SPF 15 SUNSCREEN

NET WT. 0.06 Oz. 1.7 g

PURE SHEER   AURORE
octinoxate and titanium dioxide lipstick
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:13734-022
Route of AdministrationTOPICALDEA Schedule    
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
Octinoxate (Octinoxate) Octinoxate0.1258 g  in 1.7 g
Titanium dioxide (Titanium dioxide) Titanium dioxide0.0544 g  in 1.7 g
Packaging
#Item CodePackage Description
1NDC:13734-022-401 CONTAINER (CONTAINER) in 1 CARTON
11.7 g in 1 CONTAINER
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC MONOGRAPH NOT FINALpart35205/01/2010
PURE SHEER   GRETA
octinoxate and titanium dioxide lipstick
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:13734-023
Route of AdministrationTOPICALDEA Schedule    
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
Octinoxate (Octinoxate) Octinoxate0.1258 g  in 1.7 g
Titanium dioxide (Titanium dioxide) Titanium dioxide0.0544 g  in 1.7 g
Packaging
#Item CodePackage Description
1NDC:13734-023-401 CONTAINER (CONTAINER) in 1 CARTON
11.7 g in 1 CONTAINER
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC MONOGRAPH NOT FINALpart35205/01/2010
PURE SHEER   PALOMA
octinoxate and titanium dioxide lipstick
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:13734-024
Route of AdministrationTOPICALDEA Schedule    
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
Octinoxate (Octinoxate) Octinoxate0.1258 g  in 1.7 g
Titanium dioxide (Titanium dioxide) Titanium dioxide0.0544 g  in 1.7 g
Packaging
#Item CodePackage Description
1NDC:13734-024-401 CONTAINER (CONTAINER) in 1 CARTON
11.7 g in 1 CONTAINER
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC MONOGRAPH NOT FINALpart35205/01/2010
PURE SHEER   LARA
octinoxate and titanium dioxide lipstick
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:13734-025
Route of AdministrationTOPICALDEA Schedule    
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
Octinoxate (Octinoxate) Octinoxate0.1258 g  in 1.7 g
Titanium dioxide (Titanium dioxide) Titanium dioxide0.0544 g  in 1.7 g
Packaging
#Item CodePackage Description
1NDC:13734-025-401 CONTAINER (CONTAINER) in 1 CARTON
11.7 g in 1 CONTAINER
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC MONOGRAPH NOT FINALpart35205/01/2010
PURE SHEER   ANGELIQUE
octinoxate and titanium dioxide lipstick
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:13734-026
Route of AdministrationTOPICALDEA Schedule    
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
Octinoxate (Octinoxate) Octinoxate0.1258 g  in 1.7 g
Titanium dioxide (Titanium dioxide) Titanium dioxide0.0544 g  in 1.7 g
Packaging
#Item CodePackage Description
1NDC:13734-026-401 CONTAINER (CONTAINER) in 1 CARTON
11.7 g in 1 CONTAINER
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC MONOGRAPH NOT FINALpart35205/01/2010
PURE SHEER   BIANCA
octinoxate and titanium dioxide lipstick
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:13734-027
Route of AdministrationTOPICALDEA Schedule    
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
Octinoxate (Octinoxate) Octinoxate0.1258 g  in 1.7 g
Titanium dioxide (Titanium dioxide) Titanium dioxide0.0544 g  in 1.7 g
Packaging
#Item CodePackage Description
1NDC:13734-027-401 CONTAINER (CONTAINER) in 1 CARTON
11.7 g in 1 CONTAINER
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC MONOGRAPH NOT FINALpart35205/01/2010
Labeler - NARS COSMETICS (837363571)
Establishment
NameAddressID/FEIOperations
SHISEIDO AMERICA INC.782677132ANALYSIS, MANUFACTURE
Establishment
NameAddressID/FEIOperations
Davlyn Industries Inc.624436254MANUFACTURE

Revised: 03/2010
 
NARS COSMETICS

Disclaimer: Every effort has been made to ensure that the information provided here is accurate, up-to-date and complete, but no guarantee is made to that effect. Drug information contained herein may be time sensitive. This information has been compiled for use by healthcare practitioners and consumers in the United States. The absence of a warning for a given drug or combination thereof in no way should be construed to indicate that the drug or combination is safe, effective or appropriate for any given patient. If you have questions about the substances you are taking, check with your doctor, nurse or pharmacist.

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