SUPREMACIE- ensulizole, homosalate, octinoxate, and oxybenzone cream

Supremacie by

Drug Labeling and Warnings

Supremacie by is a Otc medication manufactured, distributed, or labeled by Ventura Corporation, LTDA. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

ACTIVE INGREDIENT

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

WARNINGS

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.

INDICATIONS & USAGE

USES: Sun Protection Factor 15. Helps prevent sunburn.

DOSAGE & ADMINISTRATION

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.)

INGREDIENTS AND APPEARANCE

SUPREMACIE   NX JOUR
ensulizole, homosalate, octinoxate, and oxybenzone cream

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 13537-261
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
Ensulizole (UNII: 9YQ9DI1W42) (Ensulizole - UNII:9YQ9DI1W42)	Ensulizole	0.001 g  in 5 g
Homosalate (UNII: V06SV4M95S) (Homosalate - UNII:V06SV4M95S)	Homosalate	0.001 g  in 5 g
Octinoxate (UNII: 4Y5P7MUD51) (Octinoxate - UNII:4Y5P7MUD51)	Octinoxate	0.00375 g  in 5 g
Oxybenzone (UNII: 95OOS7VE0Y) (Oxybenzone - UNII:95OOS7VE0Y)	Oxybenzone	0.002 g  in 5 g

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 13537-261-64	1 in 1 BOX
1	NDC: 13537-261-61	5 g in 1 TUBE
2	NDC: 13537-261-65	1 in 1 JAR
2	NDC: 13537-261-62	50 g in 1 JAR
3	NDC: 13537-261-63	1 g in 1 PACKET

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC MONOGRAPH NOT FINAL	part352	02/19/2010

Labeler - Ventura Corporation, LTDA (602751344)