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Name:Nars Siberia
Manufacturer:Nars Cosmetics
Category:Over-the-counter (OTC) Marketed Drugs


NARS Powder Foundation Sunscreen SPF12 / PA++

NARS  SIBERIA - octinoxate and titanium dioxide powder 
NARS  PUNJAB - octinoxate and titanium dioxide powder 
NARS  STROMBOLI - octinoxate and titanium dioxide powder 
NARS  SYRACUSE - octinoxate and titanium dioxide powder 
NARS  TAHOE - octinoxate and titanium dioxide powder 
NARS  CADIZ - octinoxate and titanium dioxide powder 
NARS  NEW ORLEANS - octinoxate and titanium dioxide powder 
NARS  BENARES - octinoxate and titanium dioxide powder 
NARS  DEAUVILLE - octinoxate and titanium dioxide powder 
NARS COSMETICS

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

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NARS Powder Foundation Sunscreen
SPF12 / PA++

ACTIVE INGREDIENTS

OCTINOXATE 4.9%, TITANIUM DIOXIDE 6.6%

INACTIVE INGREDIENTS

NYLON-12, CALCIUM STEARATE, SILICA, DIMETHICONE, JOJOBA ALCOHOL, ISOPROPYL JOJOBATE, JOJOBA ESTERS, HYDROGENATED LECITHIN, TRIMETHYLSILOXYSILICATE, LAUROYL LYSINE, METHICONE, SORBITAN SESQUIOLEATE, TOCOPHEROL, BHT, METHYLPARABEN, PROPYLPARABEN, [+/- (MAY CONTAIN): MICA, TITANIUM DIOXIDE (CI 77891), IRON OXIDES (CI 77491 CI 77492 CI 77499)],

WARNINGS

FOR EXTERNAL USE ONLY. WHEN USING THIS PRODUCT, AVOID CONTACT WITH EYES. IF CONTACT OCCURS, RINSE EYES THOROUGHLY WITH WATER. IF RASH OR IRRITATION DEVELOPS AND PERSISTS, DISCONTINUE USE AND CONTACT A DOCTOR. KEEP OUT OF REACH OF CHILDREN. IF SWALLOWED, GET MEDICAL HELP OR CONTACT A POISON CONTROL CENTER RIGHT AWAY.

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

DERMATOLOGIST TESTED.

PRINCIPAL DISPLAY PANEL - 0.42 Oz. Carton

NARS

POWDER FOUNDATION SUNSCREEN
SPF 12 / PA++

NET WT. 0.42 Oz. 12 g

PRINCIPAL DISPLAY PANEL - 0.42 Oz. Carton

NARS   SIBERIA
octinoxate and titanium dioxide powder
Product Information
Product Type HUMAN OTC DRUG Item Code (Source) NDC:13734-013
Route of Administration TOPICAL DEA Schedule     
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
Octinoxate (Octinoxate) Octinoxate 588 mg  in 12 g
Titanium dioxide (Titanium dioxide) Titanium dioxide 792 mg  in 12 g
Product Characteristics
Color      Score     
Shape Size
Flavor Imprint Code
Contains     
Packaging
# Item Code Package Description Multilevel Packaging
1 NDC:13734-013-30 1 TRAY ( TRAY) in 1 CARTON contains a TRAY
1 12 g in 1 TRAY This package is contained within the CARTON (13734-013-30)

Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
OTC MONOGRAPH NOT FINAL part352 09/01/2009

NARS   PUNJAB
octinoxate and titanium dioxide powder
Product Information
Product Type HUMAN OTC DRUG Item Code (Source) NDC:13734-014
Route of Administration TOPICAL DEA Schedule     
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
Octinoxate (Octinoxate) Octinoxate 588 mg  in 12 g
Titanium dioxide (Titanium dioxide) Titanium dioxide 792 mg  in 12 g
Product Characteristics
Color      Score     
Shape Size
Flavor Imprint Code
Contains     
Packaging
# Item Code Package Description Multilevel Packaging
1 NDC:13734-014-30 1 TRAY ( TRAY) in 1 CARTON contains a TRAY
1 12 g in 1 TRAY This package is contained within the CARTON (13734-014-30)

Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
OTC MONOGRAPH NOT FINAL part352 09/01/2009

NARS   STROMBOLI
octinoxate and titanium dioxide powder
Product Information
Product Type HUMAN OTC DRUG Item Code (Source) NDC:13734-015
Route of Administration TOPICAL DEA Schedule     
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
Octinoxate (Octinoxate) Octinoxate 588 mg  in 12 g
Titanium dioxide (Titanium dioxide) Titanium dioxide 792 mg  in 12 g
Product Characteristics
Color      Score     
Shape Size
Flavor Imprint Code
Contains     
Packaging
# Item Code Package Description Multilevel Packaging
1 NDC:13734-015-30 1 TRAY ( TRAY) in 1 CARTON contains a TRAY
1 12 g in 1 TRAY This package is contained within the CARTON (13734-015-30)

Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
OTC MONOGRAPH NOT FINAL part352 09/01/2009

NARS   SYRACUSE
octinoxate and titanium dioxide powder
Product Information
Product Type HUMAN OTC DRUG Item Code (Source) NDC:13734-016
Route of Administration TOPICAL DEA Schedule     
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
Octinoxate (Octinoxate) Octinoxate 588 mg  in 12 g
Titanium dioxide (Titanium dioxide) Titanium dioxide 792 mg  in 12 g
Product Characteristics
Color      Score     
Shape Size
Flavor Imprint Code
Contains     
Packaging
# Item Code Package Description Multilevel Packaging
1 NDC:13734-016-30 1 TRAY ( TRAY) in 1 CARTON contains a TRAY
1 12 g in 1 TRAY This package is contained within the CARTON (13734-016-30)

Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
OTC MONOGRAPH NOT FINAL part352 09/01/2009

NARS   TAHOE
octinoxate and titanium dioxide powder
Product Information
Product Type HUMAN OTC DRUG Item Code (Source) NDC:13734-017
Route of Administration TOPICAL DEA Schedule     
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
Octinoxate (Octinoxate) Octinoxate 588 mg  in 12 g
Titanium dioxide (Titanium dioxide) Titanium dioxide 792 mg  in 12 g
Product Characteristics
Color      Score     
Shape Size
Flavor Imprint Code
Contains     
Packaging
# Item Code Package Description Multilevel Packaging
1 NDC:13734-017-30 1 TRAY ( TRAY) in 1 CARTON contains a TRAY
1 12 g in 1 TRAY This package is contained within the CARTON (13734-017-30)

Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
OTC MONOGRAPH NOT FINAL part352 09/01/2009

NARS   CADIZ
octinoxate and titanium dioxide powder
Product Information
Product Type HUMAN OTC DRUG Item Code (Source) NDC:13734-018
Route of Administration TOPICAL DEA Schedule     
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
Octinoxate (Octinoxate) Octinoxate 588 mg  in 12 g
Titanium dioxide (Titanium dioxide) Titanium dioxide 792 mg  in 12 g
Product Characteristics
Color      Score     
Shape Size
Flavor Imprint Code
Contains     
Packaging
# Item Code Package Description Multilevel Packaging
1 NDC:13734-018-30 1 TRAY ( TRAY) in 1 CARTON contains a TRAY
1 12 g in 1 TRAY This package is contained within the CARTON (13734-018-30)

Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
OTC MONOGRAPH NOT FINAL part352 09/01/2009

NARS   NEW ORLEANS
octinoxate and titanium dioxide powder
Product Information
Product Type HUMAN OTC DRUG Item Code (Source) NDC:13734-019
Route of Administration TOPICAL DEA Schedule     
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
Octinoxate (Octinoxate) Octinoxate 588 mg  in 12 g
Titanium dioxide (Titanium dioxide) Titanium dioxide 792 mg  in 12 g
Product Characteristics
Color      Score     
Shape Size
Flavor Imprint Code
Contains     
Packaging
# Item Code Package Description Multilevel Packaging
1 NDC:13734-019-30 1 TRAY ( TRAY) in 1 CARTON contains a TRAY
1 12 g in 1 TRAY This package is contained within the CARTON (13734-019-30)

Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
OTC MONOGRAPH NOT FINAL part352 09/01/2009

NARS   BENARES
octinoxate and titanium dioxide powder
Product Information
Product Type HUMAN OTC DRUG Item Code (Source) NDC:13734-020
Route of Administration TOPICAL DEA Schedule     
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
Octinoxate (Octinoxate) Octinoxate 588 mg  in 12 g
Titanium dioxide (Titanium dioxide) Titanium dioxide 792 mg  in 12 g
Product Characteristics
Color      Score     
Shape Size
Flavor Imprint Code
Contains     
Packaging
# Item Code Package Description Multilevel Packaging
1 NDC:13734-020-30 1 TRAY ( TRAY) in 1 CARTON contains a TRAY
1 12 g in 1 TRAY This package is contained within the CARTON (13734-020-30)

Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
OTC MONOGRAPH NOT FINAL part352 09/01/2009

NARS   DEAUVILLE
octinoxate and titanium dioxide powder
Product Information
Product Type HUMAN OTC DRUG Item Code (Source) NDC:13734-021
Route of Administration TOPICAL DEA Schedule     
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
Octinoxate (Octinoxate) Octinoxate 137.2 mg  in 2.8 g
Titanium dioxide (Titanium dioxide) Titanium dioxide 184.8 mg  in 2.8 g
Product Characteristics
Color      Score     
Shape Size
Flavor Imprint Code
Contains     
Packaging
# Item Code Package Description Multilevel Packaging
1 NDC:13734-021-30 1 TRAY ( TRAY) in 1 CARTON contains a TRAY
1 2.8 g in 1 TRAY This package is contained within the CARTON (13734-021-30)

Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
OTC MONOGRAPH NOT FINAL part352 04/01/2010

Labeler - NARS COSMETICS (837363571)
Establishment
Name Address ID/FEI Operations
SHISEIDO AMERICA INC. 782677132 ANALYSIS, MANUFACTURE
Establishment
Name Address ID/FEI Operations
Davlyn Industries Inc. 624436254 MANUFACTURE

Revised: 03/2010 NARS COSMETICS



Source: http://dailymed.nlm.nih.gov
Reproduced with permission of U.S. National Library of Medicine


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