LBel Clarifique Dermo Radiance Mains SPF 15

Dosage form: cream
Ingredients: Octinoxate 7.5g in 100g, Octisalate 5g in 100g, Oxybenzone 6g in 100g
Labeler: VENTURA INTERNATIONAL LTD.,
NDC Code: 14783-077

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
CLARIFIQUE
DERMO RADIANCE
MAINS SPF 15

Drug Facts

Active Ingredients

Octinoxate (7.5 %), Octisalate (5 %), Oxybenzone (6 %)

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
  • Apply smoothly twice a day before sun exposure and as needed.
  • Reapply as needed or after towel drying, swimming or sweating.
  • Moderate sun protection product.
  • 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), cyclohexasiloxane, c12-15 alkyl benzoate, cetearyl alcohol, ethylhexyl stearate, cyclopentasiloxane, citrus unshui peel extract, propylene glycol, triethanolamine, glycerin, dicetyl phosphate, ceteth-10 phosphate, sodium lactate, tocopheryl acetate, phenoxyethanol, diazolidinyl urea, parfum (fragance), glycolic acid, methylparaben, sucrose, urea, sodium citrate, propylparaben, malic acid, tartaric acid, camellia sinensis leaf extract.

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

PRINCIPAL DISPLAY PANEL - 100 g Tube Carton

L'BEL

CLARIFIQUE
DERMO RADIANCE
MAINS SPF 15

clarifying and illuminating
treatment hand cream spf 15

100 g e (3.5 oz.)

LBEL   CLARIFIQUE DERMO RADIANCE MAINS SPF 15
octinoxate, octisalate, and oxybenzone cream
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:14783-077
Route of AdministrationTOPICALDEA Schedule    
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
Octinoxate (Octinoxate) Octinoxate7.5 g  in 100 g
Octisalate (Octisalate) Octisalate5 g  in 100 g
Oxybenzone (Oxybenzone) Oxybenzone6 g  in 100 g
Inactive Ingredients
Ingredient NameStrength
water 
cyclomethicone 6 
c12-15 alkyl benzoate 
cetostearyl alcohol 
cyclomethicone 5 
tangerine 
propylene glycol 
trolamine 
glycerin 
dihexadecyl phosphate 
phosphate ion 
sodium lactate 
phenoxyethanol 
diazolidinyl urea 
glycolic acid 
methylparaben 
sucrose 
urea 
sodium citrate 
propylparaben 
malic acid 
tartaric acid 
green tea leaf 
Packaging
#Item CodePackage Description
1NDC:14783-077-611 TUBE (TUBE) in 1 BOX
1NDC:14783-077-62100 g in 1 TUBE
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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