LBel Supremacie Mains

Dosage form: cream
Ingredients: Ensulizole 3g in 100mL, Octinoxate 7.5g in 100mL, Oxybenzone 6.2g in 100mL
Labeler: VENTURA INTERNATIONAL LTD.,
NDC Code: 14783-072

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.

L'BEL
SUPRÉMACIE
MAINS

Drug Facts

Active Ingredients

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

Purpose

Sunscreen

Uses
  • helps prevent sunburn
  • higher SPF gives more sunburn protection
  • provides moderate protection against sunburn

Warnings
  • For external use only.

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
  • moderate sun protection product.
  • apply smoothly every morning before sun exposure and as needed.
  • apply a small amount of the product to the back of clean, dry hands. Massage softly until completely absorbed.
  • children under 6 months of age: ask a doctor.

Other information
  • Sun alert: Limiting sun exposure, wearing protective clothing, and using sunscreens may reduce the risk of skin cancer, and other harmful effects of the sun.

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.)

LBEL   SUPREMACIE MAINS
ensulizole, octinoxate, and oxybenzone cream
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:14783-072
Route of AdministrationTOPICALDEA Schedule    
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
Ensulizole (Ensulizole) Ensulizole3 g  in 100 mL
Octinoxate (Octinoxate) Octinoxate7.5 g  in 100 mL
Oxybenzone (Oxybenzone) Oxybenzone6.2 g  in 100 mL
Inactive Ingredients
Ingredient NameStrength
water 
c12-15 alkyl benzoate 
cyclomethicone 5 
tea leaf 
trolamine 
glycerin 
cyclomethicone 6 
cetyl alcohol 
glyceryl monostearate 
cetostearyl alcohol 
talc 
propylene glycol 
polyoxyl 100 stearate 
diazolidinyl urea 
phenyl trimethicone 
sodium lactate 
polyoxyl 20 cetostearyl ether 
methylparaben 
propylparaben 
butylene glycol 
arctostaphylos uva-ursi leaf 
panthenol 
tangerine 
dimethicone 
titanium dioxide 
edetate sodium 
phenoxyethanol 
FD&C YELLOW NO. 5 
FD&C RED NO. 4 
butylparaben 
ethylparaben 
isobutylparaben 
Packaging
#Item CodePackage Description
1NDC:14783-072-611 JAR (JAR) 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 AdministrationTOPICALDEA Schedule    
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
Ensulizole (Ensulizole) Ensulizole0.15 g  in 5 mL
Octinoxate (Octinoxate) Octinoxate0.38 g  in 5 mL
Oxybenzone (Oxybenzone) Oxybenzone0.31 g  in 5 mL
Inactive Ingredients
Ingredient NameStrength
water 
c12-15 alkyl benzoate 
cyclomethicone 5 
tea leaf 
trolamine 
glycerin 
cyclomethicone 6 
cetyl alcohol 
glyceryl monostearate 
cetostearyl alcohol 
talc 
propylene glycol 
polyoxyl 100 stearate 
diazolidinyl urea 
phenyl trimethicone 
sodium lactate 
polyoxyl 20 cetostearyl ether 
methylparaben 
propylparaben 
butylene glycol 
arctostaphylos uva-ursi leaf 
panthenol 
tangerine 
dimethicone 
titanium dioxide 
edetate sodium 
phenoxyethanol 
FD&C YELLOW NO. 5 
FD&C RED NO. 4 
butylparaben 
ethylparaben 
isobutylparaben 
Packaging
#Item CodePackage Description
1NDC:14783-062-511 JAR (JAR) 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: 08/2010
 
VENTURA INTERNATIONAL LTD.,

Disclaimer: Every effort has been made to ensure that the information provided here is accurate, up-to-date and complete, but no guarantee is made to that effect. Drug information contained herein may be time sensitive. This information has been compiled for use by healthcare practitioners and consumers in the United States. The absence of a warning for a given drug or combination thereof in no way should be construed to indicate that the drug or combination is safe, effective or appropriate for any given patient. If you have questions about the substances you are taking, check with your doctor, nurse or pharmacist.

Hide
(web1)