LBEL  SUPREMACIE MAINS- ensulizole, octinoxate, and oxybenzone cream 
VENTURA INTERNATIONAL LTD.,

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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L'BEL
SUPRÉMACIE
MAINS

Drug Facts

Active Ingredients

Ensulizole (3 %), Octinoxate (7.5%), Oxybenzone (2 %)

Purpose

Sunscreen

Uses

Warnings

When using this product

  • keep out of eyes. Rinse with water to remove.

Stop use and ask a doctor if

  • rash and irritation develops and lasts.

  • Keep out of reach of children. If swallowed, get medical help or contact a Poison Control Center right away.

Directions

Other information

Inactive ingredients

Aqua (water), c12-15 alkyl benzoate, cyclopentasiloxane, saccharomyces/xylinum/black tea ferment, triethanolamine, glycerin, cyclohexasiloxane, cetyl alcohol, glyceryl stearate, cetearyl alcohol, talc, propyleneglycol, peg-100 stearate, parfum (fragance), diazolidinyl urea, phenyl trimethicone, sodium lactate, acrylates/c10-30 alkylacrilate crosspolymer, ceteareth-20, hydroxyethylcellulose, methylparaben, propylparaben, butylene glycol, hydrolyzed keratin, arctostaphylos uva ursi/leaf extract, panthenol, citrus unshiu peel extract, dimethicone crosspolymer, dimethicone/vinyl dimethicone crosspolymer, ci 77891 (titanium dioxide), tetrasodium edta, dimethiconol, phenoxyethanol, nymphaea coerulea flower extract, ci 19140 (yellow 5), ci 14700 (red 4), butylparaben, ethylparaben, isobutylparaben.

US: Dist. by Ventura International, Ltd. San Francisco, CA 94111

PRINCIPAL DISPLAY PANEL - 100 ml Carton

L'BEL

SUPRÉMACIE
MAINS

replenishing treatment
hand cream spf 15

100 ml e (3.3 fl.oz.)

Principal Display Panel - 100 ml Carton
LBEL   SUPREMACIE MAINS
ensulizole, octinoxate, and oxybenzone cream
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:14783-072
Route of AdministrationTOPICAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
Ensulizole (UNII: 9YQ9DI1W42) (Ensulizole - UNII:9YQ9DI1W42) Ensulizole3 g  in 100 mL
Octinoxate (UNII: 4Y5P7MUD51) (Octinoxate - UNII:4Y5P7MUD51) Octinoxate7.5 g  in 100 mL
Oxybenzone (UNII: 95OOS7VE0Y) (Oxybenzone - UNII:95OOS7VE0Y) Oxybenzone6.2 g  in 100 mL
Inactive Ingredients
Ingredient NameStrength
water (UNII: 059QF0KO0R)  
c12-15 alkyl benzoate (UNII: A9EJ3J61HQ)  
cyclomethicone 5 (UNII: 0THT5PCI0R)  
tea leaf (UNII: GH42T47V24)  
trolamine (UNII: 9O3K93S3TK)  
glycerin (UNII: PDC6A3C0OX)  
cyclomethicone 6 (UNII: XHK3U310BA)  
cetyl alcohol (UNII: 936JST6JCN)  
glyceryl monostearate (UNII: 230OU9XXE4)  
cetostearyl alcohol (UNII: 2DMT128M1S)  
talc (UNII: 7SEV7J4R1U)  
propylene glycol (UNII: 6DC9Q167V3)  
polyoxyl 100 stearate (UNII: YD01N1999R)  
diazolidinyl urea (UNII: H5RIZ3MPW4)  
phenyl trimethicone (UNII: DR0K5NOJ4R)  
sodium lactate (UNII: TU7HW0W0QT)  
polyoxyl 20 cetostearyl ether (UNII: YRC528SWUY)  
methylparaben (UNII: A2I8C7HI9T)  
propylparaben (UNII: Z8IX2SC1OH)  
butylene glycol (UNII: 3XUS85K0RA)  
arctostaphylos uva-ursi leaf (UNII: 3M5V3D1X36)  
panthenol (UNII: WV9CM0O67Z)  
tangerine (UNII: KH3E3096OO)  
dimethicone (UNII: 92RU3N3Y1O)  
titanium dioxide (UNII: 15FIX9V2JP)  
edetate sodium (UNII: MP1J8420LU)  
phenoxyethanol (UNII: HIE492ZZ3T)  
FD&C YELLOW NO. 5 (UNII: I753WB2F1M)  
FD&C RED NO. 4 (UNII: X3W0AM1JLX)  
butylparaben (UNII: 3QPI1U3FV8)  
ethylparaben (UNII: 14255EXE39)  
isobutylparaben (UNII: 0QQJ25X58G)  
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:14783-072-611 in 1 BOX
1NDC:14783-072-62100 mL in 1 JAR
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC MONOGRAPH FINALpart35208/15/2010
LBEL   SUPREMACIE MAINS
ensulizole, octinoxate, and oxybenzone cream
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:14783-062
Route of AdministrationTOPICAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
Ensulizole (UNII: 9YQ9DI1W42) (Ensulizole - UNII:9YQ9DI1W42) Ensulizole0.15 g  in 5 mL
Octinoxate (UNII: 4Y5P7MUD51) (Octinoxate - UNII:4Y5P7MUD51) Octinoxate0.38 g  in 5 mL
Oxybenzone (UNII: 95OOS7VE0Y) (Oxybenzone - UNII:95OOS7VE0Y) Oxybenzone0.31 g  in 5 mL
Inactive Ingredients
Ingredient NameStrength
water (UNII: 059QF0KO0R)  
c12-15 alkyl benzoate (UNII: A9EJ3J61HQ)  
cyclomethicone 5 (UNII: 0THT5PCI0R)  
tea leaf (UNII: GH42T47V24)  
trolamine (UNII: 9O3K93S3TK)  
glycerin (UNII: PDC6A3C0OX)  
cyclomethicone 6 (UNII: XHK3U310BA)  
cetyl alcohol (UNII: 936JST6JCN)  
glyceryl monostearate (UNII: 230OU9XXE4)  
cetostearyl alcohol (UNII: 2DMT128M1S)  
talc (UNII: 7SEV7J4R1U)  
propylene glycol (UNII: 6DC9Q167V3)  
polyoxyl 100 stearate (UNII: YD01N1999R)  
diazolidinyl urea (UNII: H5RIZ3MPW4)  
phenyl trimethicone (UNII: DR0K5NOJ4R)  
sodium lactate (UNII: TU7HW0W0QT)  
polyoxyl 20 cetostearyl ether (UNII: YRC528SWUY)  
methylparaben (UNII: A2I8C7HI9T)  
propylparaben (UNII: Z8IX2SC1OH)  
butylene glycol (UNII: 3XUS85K0RA)  
arctostaphylos uva-ursi leaf (UNII: 3M5V3D1X36)  
panthenol (UNII: WV9CM0O67Z)  
tangerine (UNII: KH3E3096OO)  
dimethicone (UNII: 92RU3N3Y1O)  
titanium dioxide (UNII: 15FIX9V2JP)  
edetate sodium (UNII: MP1J8420LU)  
phenoxyethanol (UNII: HIE492ZZ3T)  
FD&C YELLOW NO. 5 (UNII: I753WB2F1M)  
FD&C RED NO. 4 (UNII: X3W0AM1JLX)  
butylparaben (UNII: 3QPI1U3FV8)  
ethylparaben (UNII: 14255EXE39)  
isobutylparaben (UNII: 0QQJ25X58G)  
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:14783-062-511 in 1 BOX
1NDC:14783-062-525 mL in 1 JAR
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC MONOGRAPH FINALpart35208/15/2010
Labeler - VENTURA INTERNATIONAL LTD., (603192787)

Revised: 8/2010
Document Id: f9c27f44-9167-439a-a8bf-0280eabe477e
Set id: 2062a8d1-de1e-468c-9105-20aa01e1150f
Version: 1
Effective Time: 20100810
 
VENTURA INTERNATIONAL LTD.,