LBEL PARIS  REGRESSION JOUR- octinoxate, octisalate, 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
PARIS
REGRESSION
JOUR

Drug Facts

Active Ingredients

Octinoxate (7.5 %), Octisalate (4 %), Oxybenzone (4 %)

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), glycine soja (soybean) protein, c12-15 alkyl benzoate, pisum sativum (pea) extract, cyclohexasiloxane, dimethicone, mannitol, cetearyl alcohol, glyceryl stearate, hdi/ trimethylol hexyllactone crosspolymer, phenoxyethanol, sodium acrylate/ acryloyldimethyltaurate/ dimethylacrylamide crosspolymer, c20-22 alkyl phosphate, hydroxyethyl acrylate/ sodium acryloyldymethyl taurate copolymer, c20-22 alcohols, triethanolamine, isohexadecane, methylparaben, c14-22 alcohols, cetearyl glucoside, hydrolyzed adansonia digitata extract, butylparaben, cyclopentasiloxane, chlorphenesin, propylparaben, xanthan gum, disodium edta, acrylates/c10-30 alkyl acrylate crosspolymer, parfum (fragance), sorbic acid, polysorbate 60, cyclodextrin, c12-20 alkyl glucoside, faex extract (yeast extract), hydrolyzed algin, ethylparaben, chlorella vulgaris extract, maris aqua (sea water), isobutylparaben, silica, disodium succinate, ci42090 (blue 1).

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

PRINCIPAL DISPLAY PANEL - 50 ml Carton

L'BEL
PARIS

REGRESSION
JOUR

protective complex against
the first signs of age
with spf 15 facial day lotion
normal to combination skin

50 ml e (1.6 fl.oz.)

Principal Display Panel - 50 ml Carton
LBEL PARIS   REGRESSION JOUR
octinoxate, octisalate, and oxybenzone cream
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:14783-055
Route of AdministrationTOPICAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
Octinoxate (UNII: 4Y5P7MUD51) (Octinoxate - UNII:4Y5P7MUD51) Octinoxate3.75 g  in 50 g
Octisalate (UNII: 4X49Y0596W) (Octisalate - UNII:4X49Y0596W) Octisalate2 g  in 50 g
Oxybenzone (UNII: 95OOS7VE0Y) (Oxybenzone - UNII:95OOS7VE0Y) Oxybenzone2 g  in 50 g
Inactive Ingredients
Ingredient NameStrength
water (UNII: 059QF0KO0R)  
soybean (UNII: L7HT8F1ZOD)  
c12-15 alkyl benzoate (UNII: A9EJ3J61HQ)  
snow pea (UNII: 84SKC33B1I)  
cyclomethicone 6 (UNII: XHK3U310BA)  
dimethicone (UNII: 92RU3N3Y1O)  
mannitol (UNII: 3OWL53L36A)  
cetostearyl alcohol (UNII: 2DMT128M1S)  
glyceryl monostearate (UNII: 230OU9XXE4)  
phenoxyethanol (UNII: HIE492ZZ3T)  
trolamine (UNII: 9O3K93S3TK)  
isohexadecane (UNII: 918X1OUF1E)  
methylparaben (UNII: A2I8C7HI9T)  
butylparaben (UNII: 3QPI1U3FV8)  
cyclomethicone 5 (UNII: 0THT5PCI0R)  
chlorphenesin (UNII: I670DAL4SZ)  
propylparaben (UNII: Z8IX2SC1OH)  
xanthan gum (UNII: TTV12P4NEE)  
edetate disodium (UNII: 7FLD91C86K)  
sorbic acid (UNII: X045WJ989B)  
polysorbate 60 (UNII: CAL22UVI4M)  
yeast (UNII: 3NY3SM6B8U)  
ethylparaben (UNII: 14255EXE39)  
isobutylparaben (UNII: 0QQJ25X58G)  
silicon dioxide (UNII: ETJ7Z6XBU4)  
sodium succinate anhydrous (UNII: V8ZGC8ISR3)  
FD&C blue no. 1 (UNII: H3R47K3TBD)  
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:14783-055-611 in 1 BOX
1NDC:14783-055-6650 g in 1 JAR
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC MONOGRAPH FINALpart35208/15/2010
LBEL PARIS   REGRESSION JOUR
octinoxate, octisalate, and oxybenzone cream
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:14783-045
Route of AdministrationTOPICAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
Octinoxate (UNII: 4Y5P7MUD51) (Octinoxate - UNII:4Y5P7MUD51) Octinoxate0.375 g  in 5 g
Octisalate (UNII: 4X49Y0596W) (Octisalate - UNII:4X49Y0596W) Octisalate0.2 g  in 5 g
Oxybenzone (UNII: 95OOS7VE0Y) (Oxybenzone - UNII:95OOS7VE0Y) Oxybenzone0.2 g  in 5 g
Inactive Ingredients
Ingredient NameStrength
water (UNII: 059QF0KO0R)  
soybean (UNII: L7HT8F1ZOD)  
c12-15 alkyl benzoate (UNII: A9EJ3J61HQ)  
snow pea (UNII: 84SKC33B1I)  
cyclomethicone 6 (UNII: XHK3U310BA)  
dimethicone (UNII: 92RU3N3Y1O)  
mannitol (UNII: 3OWL53L36A)  
cetostearyl alcohol (UNII: 2DMT128M1S)  
glyceryl monostearate (UNII: 230OU9XXE4)  
phenoxyethanol (UNII: HIE492ZZ3T)  
trolamine (UNII: 9O3K93S3TK)  
isohexadecane (UNII: 918X1OUF1E)  
methylparaben (UNII: A2I8C7HI9T)  
butylparaben (UNII: 3QPI1U3FV8)  
cyclomethicone 5 (UNII: 0THT5PCI0R)  
chlorphenesin (UNII: I670DAL4SZ)  
propylparaben (UNII: Z8IX2SC1OH)  
xanthan gum (UNII: TTV12P4NEE)  
edetate disodium (UNII: 7FLD91C86K)  
sorbic acid (UNII: X045WJ989B)  
polysorbate 60 (UNII: CAL22UVI4M)  
yeast (UNII: 3NY3SM6B8U)  
ethylparaben (UNII: 14255EXE39)  
isobutylparaben (UNII: 0QQJ25X58G)  
silicon dioxide (UNII: ETJ7Z6XBU4)  
sodium succinate anhydrous (UNII: V8ZGC8ISR3)  
FD&C blue no. 1 (UNII: H3R47K3TBD)  
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:14783-045-511 in 1 BOX
1NDC:14783-045-525 g in 1 JAR
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC MONOGRAPH FINALpart35208/15/2010
LBEL PARIS   REGRESSION JOUR
octinoxate, octisalate, and oxybenzone cream
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:14783-035
Route of AdministrationTOPICAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
Octinoxate (UNII: 4Y5P7MUD51) (Octinoxate - UNII:4Y5P7MUD51) Octinoxate0.75 g  in 1 g
Octisalate (UNII: 4X49Y0596W) (Octisalate - UNII:4X49Y0596W) Octisalate0.04 g  in 1 g
Oxybenzone (UNII: 95OOS7VE0Y) (Oxybenzone - UNII:95OOS7VE0Y) Oxybenzone2 g  in 1 g
Inactive Ingredients
Ingredient NameStrength
water (UNII: 059QF0KO0R)  
soybean (UNII: L7HT8F1ZOD)  
c12-15 alkyl benzoate (UNII: A9EJ3J61HQ)  
snow pea (UNII: 84SKC33B1I)  
cyclomethicone 6 (UNII: XHK3U310BA)  
dimethicone (UNII: 92RU3N3Y1O)  
mannitol (UNII: 3OWL53L36A)  
cetostearyl alcohol (UNII: 2DMT128M1S)  
glyceryl monostearate (UNII: 230OU9XXE4)  
phenoxyethanol (UNII: HIE492ZZ3T)  
trolamine (UNII: 9O3K93S3TK)  
isohexadecane (UNII: 918X1OUF1E)  
methylparaben (UNII: A2I8C7HI9T)  
butylparaben (UNII: 3QPI1U3FV8)  
cyclomethicone 5 (UNII: 0THT5PCI0R)  
chlorphenesin (UNII: I670DAL4SZ)  
propylparaben (UNII: Z8IX2SC1OH)  
xanthan gum (UNII: TTV12P4NEE)  
edetate disodium (UNII: 7FLD91C86K)  
sorbic acid (UNII: X045WJ989B)  
polysorbate 60 (UNII: CAL22UVI4M)  
yeast (UNII: 3NY3SM6B8U)  
ethylparaben (UNII: 14255EXE39)  
isobutylparaben (UNII: 0QQJ25X58G)  
silicon dioxide (UNII: ETJ7Z6XBU4)  
sodium succinate anhydrous (UNII: V8ZGC8ISR3)  
FD&C blue no. 1 (UNII: H3R47K3TBD)  
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:14783-035-411 in 1 BOX
1NDC:14783-035-421 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: 4922ce2e-1697-4239-a440-41c84aa55b30
Set id: 132ef4d4-8554-4e37-89a9-c9b5db96cc13
Version: 1
Effective Time: 20100810
 
Ventura International LTD