LBEL PARIS  RENOVANCE JOUR- octinoxate, octocrylene, and oxybenzone cream 
Ventura International LTD

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.

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L'BEL
RENOVÂNCE JOUR

Drug Facts

Active Ingredients

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

Purpose

Sunscreen

Uses

Warnings

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

Other information

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.)

Principal Display Panel
LBEL PARIS   RENOVANCE JOUR
octinoxate, octocrylene, and oxybenzone cream
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:14783-038
Route of AdministrationTOPICAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
Octinoxate (UNII: 4Y5P7MUD51) (Octinoxate - UNII:4Y5P7MUD51) Octinoxate3.75 g  in 50 g
Octocrylene (UNII: 5A68WGF6WM) (Octocrylene - UNII:5A68WGF6WM) Octocrylene2.5 g  in 50 g
Oxybenzone (UNII: 95OOS7VE0Y) (Oxybenzone - UNII:95OOS7VE0Y) Oxybenzone1.5 g  in 50 g
Inactive Ingredients
Ingredient NameStrength
water (UNII: 059QF0KO0R)  
cyclomethicone 6 (UNII: XHK3U310BA)  
glycerin (UNII: PDC6A3C0OX)  
snow pea (UNII: 84SKC33B1I)  
c12-15 alkyl benzoate (UNII: A9EJ3J61HQ)  
medium-chain triglycerides (UNII: C9H2L21V7U)  
cyclomethicone 5 (UNII: 0THT5PCI0R)  
cetyl alcohol (UNII: 936JST6JCN)  
cetostearyl alcohol (UNII: 2DMT128M1S)  
isopropyl myristate (UNII: 0RE8K4LNJS)  
isononyl isononanoate (UNII: S4V5BS6GCX)  
sorbitan monostearate (UNII: NVZ4I0H58X)  
mannitol (UNII: 3OWL53L36A)  
glyceryl monostearate (UNII: 230OU9XXE4)  
potassium cetyl phosphate (UNII: 03KCY6P7UT)  
trolamine (UNII: 9O3K93S3TK)  
polyoxyl 20 cetostearyl ether (UNII: YRC528SWUY)  
propylparaben (UNII: Z8IX2SC1OH)  
panthenol (UNII: WV9CM0O67Z)  
sodium pyrrolidone carboxylate (UNII: 469OTG57A2)  
steareth-20 (UNII: L0Q8IK9E08)  
ceteth-20 (UNII: I835H2IHHX)  
chlorphenesin (UNII: I670DAL4SZ)  
titanium dioxide (UNII: 15FIX9V2JP)  
teprenone (UNII: S8S8451A4O)  
polysorbate 80 (UNII: 6OZP39ZG8H)  
polyoxyl 40 hydrogenated castor oil (UNII: 7YC686GQ8F)  
edetate sodium (UNII: MP1J8420LU)  
butylene glycol (UNII: 3XUS85K0RA)  
kalmia latifolia leaf (UNII: 79N6542N18)  
yeast (UNII: 3NY3SM6B8U)  
vitamin a palmitate (UNII: 1D1K0N0VVC)  
ascorbyl palmitate (UNII: QN83US2B0N)  
serine (UNII: 452VLY9402)  
urea (UNII: 8W8T17847W)  
acacia (UNII: 5C5403N26O)  
allantoin (UNII: 344S277G0Z)  
sodium succinate anhydrous (UNII: V8ZGC8ISR3)  
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:14783-038-611 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 AdministrationTOPICAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
Octinoxate (UNII: 4Y5P7MUD51) (Octinoxate - UNII:4Y5P7MUD51) Octinoxate0.375 g  in 5 g
Octocrylene (UNII: 5A68WGF6WM) (Octocrylene - UNII:5A68WGF6WM) Octocrylene0.25 g  in 5 g
Oxybenzone (UNII: 95OOS7VE0Y) (Oxybenzone - UNII:95OOS7VE0Y) Oxybenzone0.15 g  in 5 g
Inactive Ingredients
Ingredient NameStrength
water (UNII: 059QF0KO0R)  
cyclomethicone 6 (UNII: XHK3U310BA)  
glycerin (UNII: PDC6A3C0OX)  
snow pea (UNII: 84SKC33B1I)  
c12-15 alkyl benzoate (UNII: A9EJ3J61HQ)  
medium-chain triglycerides (UNII: C9H2L21V7U)  
cyclomethicone 5 (UNII: 0THT5PCI0R)  
cetyl alcohol (UNII: 936JST6JCN)  
cetostearyl alcohol (UNII: 2DMT128M1S)  
isopropyl myristate (UNII: 0RE8K4LNJS)  
isononyl isononanoate (UNII: S4V5BS6GCX)  
sorbitan monostearate (UNII: NVZ4I0H58X)  
mannitol (UNII: 3OWL53L36A)  
glyceryl monostearate (UNII: 230OU9XXE4)  
potassium cetyl phosphate (UNII: 03KCY6P7UT)  
trolamine (UNII: 9O3K93S3TK)  
polyoxyl 20 cetostearyl ether (UNII: YRC528SWUY)  
propylparaben (UNII: Z8IX2SC1OH)  
panthenol (UNII: WV9CM0O67Z)  
sodium pyrrolidone carboxylate (UNII: 469OTG57A2)  
steareth-20 (UNII: L0Q8IK9E08)  
ceteth-20 (UNII: I835H2IHHX)  
chlorphenesin (UNII: I670DAL4SZ)  
titanium dioxide (UNII: 15FIX9V2JP)  
teprenone (UNII: S8S8451A4O)  
polysorbate 80 (UNII: 6OZP39ZG8H)  
polyoxyl 40 hydrogenated castor oil (UNII: 7YC686GQ8F)  
edetate sodium (UNII: MP1J8420LU)  
butylene glycol (UNII: 3XUS85K0RA)  
kalmia latifolia leaf (UNII: 79N6542N18)  
yeast (UNII: 3NY3SM6B8U)  
vitamin a palmitate (UNII: 1D1K0N0VVC)  
ascorbyl palmitate (UNII: QN83US2B0N)  
serine (UNII: 452VLY9402)  
urea (UNII: 8W8T17847W)  
acacia (UNII: 5C5403N26O)  
allantoin (UNII: 344S277G0Z)  
sodium succinate anhydrous (UNII: V8ZGC8ISR3)  
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:14783-028-511 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 AdministrationTOPICAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
Octinoxate (UNII: 4Y5P7MUD51) (Octinoxate - UNII:4Y5P7MUD51) Octinoxate0.075 g  in 1 g
Octocrylene (UNII: 5A68WGF6WM) (Octocrylene - UNII:5A68WGF6WM) Octocrylene0.05 g  in 1 g
Oxybenzone (UNII: 95OOS7VE0Y) (Oxybenzone - UNII:95OOS7VE0Y) Oxybenzone0.03 g  in 1 g
Inactive Ingredients
Ingredient NameStrength
water (UNII: 059QF0KO0R)  
cyclomethicone 6 (UNII: XHK3U310BA)  
glycerin (UNII: PDC6A3C0OX)  
snow pea (UNII: 84SKC33B1I)  
c12-15 alkyl benzoate (UNII: A9EJ3J61HQ)  
medium-chain triglycerides (UNII: C9H2L21V7U)  
cyclomethicone 5 (UNII: 0THT5PCI0R)  
cetyl alcohol (UNII: 936JST6JCN)  
cetostearyl alcohol (UNII: 2DMT128M1S)  
isopropyl myristate (UNII: 0RE8K4LNJS)  
isononyl isononanoate (UNII: S4V5BS6GCX)  
sorbitan monostearate (UNII: NVZ4I0H58X)  
mannitol (UNII: 3OWL53L36A)  
glyceryl monostearate (UNII: 230OU9XXE4)  
potassium cetyl phosphate (UNII: 03KCY6P7UT)  
trolamine (UNII: 9O3K93S3TK)  
polyoxyl 20 cetostearyl ether (UNII: YRC528SWUY)  
propylparaben (UNII: Z8IX2SC1OH)  
panthenol (UNII: WV9CM0O67Z)  
sodium pyrrolidone carboxylate (UNII: 469OTG57A2)  
steareth-20 (UNII: L0Q8IK9E08)  
ceteth-20 (UNII: I835H2IHHX)  
chlorphenesin (UNII: I670DAL4SZ)  
titanium dioxide (UNII: 15FIX9V2JP)  
teprenone (UNII: S8S8451A4O)  
polysorbate 80 (UNII: 6OZP39ZG8H)  
polyoxyl 40 hydrogenated castor oil (UNII: 7YC686GQ8F)  
edetate sodium (UNII: MP1J8420LU)  
butylene glycol (UNII: 3XUS85K0RA)  
kalmia latifolia leaf (UNII: 79N6542N18)  
yeast (UNII: 3NY3SM6B8U)  
vitamin a palmitate (UNII: 1D1K0N0VVC)  
ascorbyl palmitate (UNII: QN83US2B0N)  
serine (UNII: 452VLY9402)  
urea (UNII: 8W8T17847W)  
acacia (UNII: 5C5403N26O)  
allantoin (UNII: 344S277G0Z)  
sodium succinate anhydrous (UNII: V8ZGC8ISR3)  
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:14783-018-411 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: 8/2010
Document Id: 0c3c71b9-8f8d-4de9-8fe4-04a2cb405093
Set id: c79594c9-3534-45ff-a992-9b08b6934241
Version: 1
Effective Time: 20100810
 
Ventura International LTD