LBel Supremacie Teint

Dosage form: cream
Ingredients: Octinoxate 1.35g in 30g
Labeler: VENTURA INTERNATIONAL LTD.,
NDC Code: 14783-085

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 TEINT

Drug Facts

Active Ingredients

Octinoxate (4.5 %)

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 smootly every morning before sun exposure and as needed.
  • 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), cyclopentasiloxane, butylene glycol, cyclohexasiloxane, phenyl trimethicone, polyglyceryl-4 isostearate, cetyl peg/ppg-10/1 dimethicone, polydodecanamideaminium triazadiphenylethenesulfonate, hexyl laurate, mannitol, glycerin, peg/ppg-18/18 dimethicone, glycine soja (soybean) protein, ethylene/acrylic acid copolymer, sodium chloride, disteardimonium hectorite, dimethicone, propylene glycol, dimethicone crosspolymer, dimethicone/vinyl dimethicone crosspolymer, diazolidinyl urea, hydrolyzed keratin, dimethiconol, sucrose, methylparaben, serine, parfum (fragance), methicone, arginine, cyclodextrin, polyvinylalcohol crosspolymer, pca, bht, macrocystis pyrifera extract, faex extract (yeast extract), alanine, propylparaben, hydrolyzed wheat protein, pvp, carbomer, polysorbate 20, disodium succinate, palmitoyl pentapeptide-4, threonine, mourera fluviatilis extract. May contain: ci 77891(titanium dioxide), ci 77491, ci 77492, ci 77499 (iron oxides).

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

PRINCIPAL DISPLAY PANEL - 30 g Carton

L'BEL

SUPRÉMACIE TEINT

replenhising foundation spf 14

30 g e (1 oz.)

LBEL   SUPREMACIE TEINT
octinoxate cream
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:14783-085
Route of AdministrationTOPICALDEA Schedule    
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
Octinoxate (Octinoxate) Octinoxate1.35 g  in 30 g
Inactive Ingredients
Ingredient NameStrength
water 
cyclomethicone 5 
butylene glycol 
cyclomethicone 6 
phenyl trimethicone 
polyglyceryl-4 isostearate 
dimethicone 
hexyl laurate 
mannitol 
glycerin 
glycine 
sodium chloride 
hectorite 
propylene glycol 
diazolidinyl urea 
sucrose 
methylparaben 
serine 
arginine 
butylated hydroxytoluene 
yeast 
alanine 
propylparaben 
wheat 
polysorbate 20 
sodium succinate anhydrous 
threonine 
titanium dioxide 
ferric oxide red 
ferric oxide yellow 
ferrosoferric oxide 
Packaging
#Item CodePackage Description
1NDC:14783-085-631 JAR (JAR) in 1 BOX
1NDC:14783-085-6430 g 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.

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