SUPREMACIE  NX JOUR- ensulizole, homosalate, octinoxate, and oxybenzone cream 
Ventura Corporation, LTDA

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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Suprémacie Nx Tour Replenishing Treatment Daytime Face Cream SPF 15 Normal to Dry Skin

ACTIVE INGREDIENTS: ENSULIZOLE 2.0%, HOMOSALATE 2.0%, OCTINOXATE 7.0%, OXYBENZONE 4.0%.

WARNINGS: For external use only. Keep out of reach of children. If swallowed, get medical help or contact a Poison Control Center right away. When using this product keep out of eyes. Rinse with water to remove. Stop use and ask a doctor if irritation develops and lasts.

USES: Sun Protection Factor 15. Helps prevent sunburn.

DIRECTIONS: Apply evenly before sun exposure and as needed.

PRINCIPAL DISPLAY PANEL - 50 g jar

L'BEL
PARIS

SUPREMACIE NX JOUR

traitement reconstituant crème
de jour pour le visage fps 15
tratamiento reconstituyente crema
facial de día fps 15
replenishing treatment daytime face
cream spf 15

peau normale à sèche / normal to dry
skin / cutis normal a seco

50 g e (1.7 oz.)

PRINCIPAL DISPLAY PANEL - 50 g jar
SUPREMACIE   NX JOUR
ensulizole, homosalate, octinoxate, and oxybenzone cream
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:13537-261
Route of AdministrationTOPICAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
Ensulizole (UNII: 9YQ9DI1W42) (Ensulizole - UNII:9YQ9DI1W42) Ensulizole0.001 g  in 5 g
Homosalate (UNII: V06SV4M95S) (Homosalate - UNII:V06SV4M95S) Homosalate0.001 g  in 5 g
Octinoxate (UNII: 4Y5P7MUD51) (Octinoxate - UNII:4Y5P7MUD51) Octinoxate0.00375 g  in 5 g
Oxybenzone (UNII: 95OOS7VE0Y) (Oxybenzone - UNII:95OOS7VE0Y) Oxybenzone0.002 g  in 5 g
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:13537-261-641 in 1 BOX
1NDC:13537-261-615 g in 1 TUBE
2NDC:13537-261-651 in 1 JAR
2NDC:13537-261-6250 g in 1 JAR
3NDC:13537-261-631 g in 1 PACKET
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC MONOGRAPH NOT FINALpart35202/19/2010
Labeler - Ventura Corporation, LTDA (602751344)

Revised: 2/2010
Document Id: c5dc0cbd-4b27-43dd-ab25-896c012a439a
Set id: fcd21129-4cb4-4cfb-9865-3cfde69eac0b
Version: 1
Effective Time: 20100207
 
Ventura Corporation, LTDA