SUPREMACIE- ensulizole, homosalate, octinoxate, and oxybenzone cream

Country: United States

Language: English

Source: NLM (National Library of Medicine)

Active ingredient:

Ensulizole (UNII: 9YQ9DI1W42) (Ensulizole - UNII:9YQ9DI1W42), Homosalate (UNII: V06SV4M95S) (Homosalate - UNII:V06SV4M95S), Octinoxate (UNII: 4Y5P7MUD51) (Octinoxate - UNII:4Y5P7MUD51), Oxybenzone (UNII: 95OOS7VE0Y) (Oxybenzone - UNII:95OOS7VE0Y)

Available from:

Ventura Corporation, LTDA

INN (International Name):

Ensulizole

Composition:

Ensulizole 0.001 g in 5 g

Administration route:

TOPICAL

Prescription type:

OTC DRUG

Therapeutic indications:

USES: Sun Protection Factor 15. Helps prevent sunburn.

Authorization status:

OTC monograph not final

Summary of Product characteristics

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._
----------
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.)
SUPREMACIE NX JOUR
Ventura Corporation, LTDA
ensulizole, homosalate, octinoxate, and oxybenzone cream
PRODUCT INFORMATION
PRODUCT T YPE
HUMAN OTC DRUG
ITE M CODE (SOURCE )
NDC:13537-26 1
ROUTE OF ADMINISTRATION
TOPICAL
ACTIVE INGREDIENT/ACTIVE MOIETY
INGREDIENT NAME
BASIS OF STRENGTH
STRE NG TH
ENSULIZO LE (UNII: 9 YQ9 DI1W42) (Ensulizo le - UNII:9 YQ9 DI1W42)
Ensuliz o le
0 .0 0 1 g in 5 g
HO MO SA LA TE (UNII: V0 6 SV4M9 5S) (Ho mo salate - UNII:V0 6 SV4M9
5S)
Ho mo sa la te
0 .0 0 1 g in 5 g
O CTINO XA TE (UNII: 4Y5P7MUD51) (Octino xate - UNII:4Y5P7MUD51)
O c tino xa te
0 .0 0 375 g in 5 g
O XYBENZO NE (UNII: 9 5OOS7VE0 Y) (Oxybenzo ne - UNII:9 5OOS7VE0 Y)
O xybe nz o ne
0 .0 0 2 g in 5 g
PACKAG ING
#
ITEM CODE
PACKAGE DESCRIPTION
MARKETING START DATE
MARKETING END DATE
1
NDC:13537-26 1-6 4
1 in 1 BOX
1
NDC:13537-26 1-6 1
5 g in