LBEL Dermo Clarite Clarifying and Moisturizing with SPF 30

Dosage form: lotion
Ingredients: Avobenzone 0.03g in 1mL, Ensulizole 0.03g in 1mL, Octisalate 0.05g in 1mL, Octocrylene 0.05g in 1mL, Oxybenzone 0.06g in 1mL
Labeler: Ventura Corporation Ltd.
NDC Code: 13537-404

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
clarifying and moisturizing
facial lotion with SPF 30

Drug Facts

Active Ingredients

Butyl methoxydibenzoylmethane 3.0%,
Ensulizole 3.0%,
Octisalate 5.0%,
Octocrylene 5.0%,
Oxybenzone 6.0%

Purpose

Sunscreen

Uses
  • Helps prevent sunburn

Warnings

Skin Cancer / Skin Aging Alert
  • Spending time in the sun increases your risk of skin cancer and early skin aging. This product has been shown only to help prevent sunburn, not skin cancer or early skin aging.

  • For external use only.

  • Do not use on damage or broken skin.

  • When using this product keep out of eyes. Rinse with water to remove.

  • Stop use and ask a doctor if rash occurs.

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

Directions
  • Apply liberally and evenly 15 minutes before sun exposure.
  • Children under 6 months of age: Ask a doctor
  • Reapply at least every 2 hours
  • Use a water resistant sunscreen if swimming or sweating.

Other information
  • Protect the product in this container from excessive heat and direct sun.

Inactive ingredients

water, dicaprylyl carbonate, cetearyl alcohol, phenethyl benzoate, triethanolamine, cyclopentasiloxane, propylene glycol, methyl methacrylate crosspolymer, sorbitan stearate, triethylhexanoin, potassium cetyl phosphate, phenoxyethanol, dimethicone, stearyl dimethicone, ceteareth-20, xanthan gum, chlorphenesin, fragrance, vigna aconitifolia seed extract, cetyl alcohol, dimethylmethoxy chromanyl palmitate, glyceryl stearate, methylparaben, sodium cocoyl glutamate, tetrasodium edta, peg-75 stearate, butylparaben, sorbic acid, ceteth-20, steareth-20.

P.R.: Distributed by Ventura Corporation, Ltd.
San Juan, Puerto Rico 00926.

PRINCIPAL DISPLAY PANEL - 30 ml Bottle Carton

L'BEL

clarifying and moisturizing
facial lotion with SPF 30

30 ml e (1 fl.oz.)

LBEL   DERMO CLARITE CLARIFYING AND MOISTURIZING WITH SPF 30
avobenzone, ensulizole, octisalate, octocrylene, and oxybenzone lotion
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:13537-404
Route of AdministrationTOPICALDEA Schedule    
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
Avobenzone (Avobenzone) Avobenzone0.03 g  in 1 mL
Ensulizole (Ensulizole) Ensulizole0.03 g  in 1 mL
Octisalate (Octisalate) Octisalate0.05 g  in 1 mL
Octocrylene (Octocrylene) Octocrylene0.05 g  in 1 mL
Oxybenzone (Oxybenzone) Oxybenzone0.06 g  in 1 mL
Inactive Ingredients
Ingredient NameStrength
water 
dicaprylyl carbonate 
alcohol 
phenethyl benzoate 
trolamine 
cyclomethicone 5 
propylene glycol 
sorbitan monostearate 
triethylhexanoin 
potassium cetyl phosphate 
phenoxyethanol 
dimethicone 
polyoxyl 20 cetostearyl ether 
xanthan gum 
chlorphenesin 
moth bean 
cetyl alcohol 
glyceryl monostearate 
methylparaben 
edetate sodium 
peg-75 stearate 
butylparaben 
sorbic acid 
ceteth-20 
steareth-20 
Packaging
#Item CodePackage Description
1NDC:13537-404-011 BOTTLE (BOTTLE) in 1 BOX
1NDC:13537-404-0230 mL in 1 BOTTLE
2NDC:13537-404-031 BOTTLE (BOTTLE) in 1 BOX
2NDC:13537-404-043 mL in 1 BOTTLE
3NDC:13537-404-051 mL in 1 PACKET
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC MONOGRAPH NOT FINALpart35212/13/2011
Labeler - Ventura Corporation Ltd. (602751344)
Establishment
NameAddressID/FEIOperations
Bel Star, S. A.(Colombia)880160197MANUFACTURE(13537-404)
Establishment
NameAddressID/FEIOperations
Yobel Supply Chain Management (Peru)934116930MANUFACTURE(13537-404)

Revised: 11/2011
 
Ventura Corporation 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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