LBel Paris Renovance Jour

Dosage form: cream
Ingredients: Octinoxate 3.75g in 50g, Octocrylene 2.5g in 50g, Oxybenzone 1.5g in 50g
Labeler: Ventura International LTD
NDC Code: 14783-038

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
RENOVÂNCE JOUR

Drug Facts

Active Ingredients

Octinoxate (7.5 %), Octocrylene (5 %), Oxybenzone (3 %)

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 every morning before sun exposure and as needed.
  • Children under 6 months of age: ask a doctor.

Other information
  • Moderate sun protection product.
  • 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, soy protein phthalate, glycerin, pisum sativum (pea) extract, c12-15 alkyl benzoate, caprylic / capric triglyceride, cyclopentasiloxane, cetyl alcohol, cetearyl alcohol, isopropyl myristate, isononyl isononanoate, sorbitan stearate, mannitol, glyceryl stearate, potassium cetyl phosphate, dimethicone / vinyl dimethicone crosspolymer, dimethicone crosspolymer, triethanolamine, acrylates / c10-30 alkyl acrylate crosspolymer, ceteareth-20, propylparaben, panthenol, sodium pca, steareth-20, ceteth-20, parfum (fragance), ci 77891 (titanium dioxide), chlorphenesin, dimethiconol, teprenone, ppg-26-buteth-26, polysorbate 80, peg-40 hydrogenated castor oil, tetrasodium edta, cyclodextrin, butylene glycol, hydrolyzed algin, hedera helix (ivy) leaf / stem extract, faex extract (yeast extract), magnesium pca, chlorella vulgaris extract, maris aqua (sea water), algin, tocopheryl acetate, zinc pca, retinyl palmitate, saccharomyces / magnesium ferment, ascorbyl palmitate, serine, urea, acacia, senegal gum, bioflavonoids, allantoin, disodium succinate, saccharomyces /iron ferment, manganese pca, saccharomyces /copper ferment, saccharomyces /calcium ferment, saccharomyces /silicon ferment, saccharomyces /zinc ferment.

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

PRINCIPAL DISPLAY PANEL - 50 g Jar Carton

L'BEL

RENOVÂNCE JOUR

intensive refining, fortifying and renewing treatment
spf 15 daytime face and neck cream

50 g e (1.7 oz.)

LBEL PARIS   RENOVANCE JOUR
octinoxate, octocrylene, and oxybenzone cream
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:14783-038
Route of AdministrationTOPICALDEA Schedule    
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
Octinoxate (Octinoxate) Octinoxate3.75 g  in 50 g
Octocrylene (Octocrylene) Octocrylene2.5 g  in 50 g
Oxybenzone (Oxybenzone) Oxybenzone1.5 g  in 50 g
Inactive Ingredients
Ingredient NameStrength
water 
cyclomethicone 6 
glycerin 
snow pea 
c12-15 alkyl benzoate 
medium-chain triglycerides 
cyclomethicone 5 
cetyl alcohol 
cetostearyl alcohol 
isopropyl myristate 
isononyl isononanoate 
sorbitan monostearate 
mannitol 
glyceryl monostearate 
potassium cetyl phosphate 
trolamine 
polyoxyl 20 cetostearyl ether 
propylparaben 
panthenol 
sodium pyrrolidone carboxylate 
steareth-20 
ceteth-20 
chlorphenesin 
titanium dioxide 
teprenone 
polysorbate 80 
polyoxyl 40 hydrogenated castor oil 
edetate sodium 
butylene glycol 
kalmia latifolia leaf 
yeast 
vitamin a palmitate 
ascorbyl palmitate 
serine 
urea 
acacia 
allantoin 
sodium succinate anhydrous 
Packaging
#Item CodePackage Description
1NDC:14783-038-611 JAR (JAR) in 1 BOX
1NDC:14783-038-6250 g in 1 JAR
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC MONOGRAPH FINALpart35208/15/2010
LBEL PARIS   RENOVANCE JOUR
octinoxate, octocrylene, and oxybenzone cream
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:14783-028
Route of AdministrationTOPICALDEA Schedule    
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
Octinoxate (Octinoxate) Octinoxate0.375 g  in 5 g
Octocrylene (Octocrylene) Octocrylene0.25 g  in 5 g
Oxybenzone (Oxybenzone) Oxybenzone0.15 g  in 5 g
Inactive Ingredients
Ingredient NameStrength
water 
cyclomethicone 6 
glycerin 
snow pea 
c12-15 alkyl benzoate 
medium-chain triglycerides 
cyclomethicone 5 
cetyl alcohol 
cetostearyl alcohol 
isopropyl myristate 
isononyl isononanoate 
sorbitan monostearate 
mannitol 
glyceryl monostearate 
potassium cetyl phosphate 
trolamine 
polyoxyl 20 cetostearyl ether 
propylparaben 
panthenol 
sodium pyrrolidone carboxylate 
steareth-20 
ceteth-20 
chlorphenesin 
titanium dioxide 
teprenone 
polysorbate 80 
polyoxyl 40 hydrogenated castor oil 
edetate sodium 
butylene glycol 
kalmia latifolia leaf 
yeast 
vitamin a palmitate 
ascorbyl palmitate 
serine 
urea 
acacia 
allantoin 
sodium succinate anhydrous 
Packaging
#Item CodePackage Description
1NDC:14783-028-511 JAR (JAR) in 1 BOX
1NDC:14783-028-525 g in 1 JAR
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC MONOGRAPH FINALpart35208/15/2010
LBEL PARIS   RENOVANCE JOUR
octinoxate, octocrylene, and oxybenzone cream
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:14783-018
Route of AdministrationTOPICALDEA Schedule    
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
Octinoxate (Octinoxate) Octinoxate0.075 g  in 1 g
Octocrylene (Octocrylene) Octocrylene0.05 g  in 1 g
Oxybenzone (Oxybenzone) Oxybenzone0.03 g  in 1 g
Inactive Ingredients
Ingredient NameStrength
water 
cyclomethicone 6 
glycerin 
snow pea 
c12-15 alkyl benzoate 
medium-chain triglycerides 
cyclomethicone 5 
cetyl alcohol 
cetostearyl alcohol 
isopropyl myristate 
isononyl isononanoate 
sorbitan monostearate 
mannitol 
glyceryl monostearate 
potassium cetyl phosphate 
trolamine 
polyoxyl 20 cetostearyl ether 
propylparaben 
panthenol 
sodium pyrrolidone carboxylate 
steareth-20 
ceteth-20 
chlorphenesin 
titanium dioxide 
teprenone 
polysorbate 80 
polyoxyl 40 hydrogenated castor oil 
edetate sodium 
butylene glycol 
kalmia latifolia leaf 
yeast 
vitamin a palmitate 
ascorbyl palmitate 
serine 
urea 
acacia 
allantoin 
sodium succinate anhydrous 
Packaging
#Item CodePackage Description
1NDC:14783-018-411 JAR (JAR) in 1 BOX
1NDC:14783-018-421 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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