LBEL PARIS  REGRESSION JOUR- avobenzone, ensulizole, octinoxate, 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

Avobenzone (2 %), Ensulizole (1 %), Octinoxate (7.5 %), Oxybenzone (2 %)

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, propylene glycol, cyclopentasiloxane, cetyl alcohol, c12-15 alkyl benzoate, pisum sativum (pea) extract, cyclohexasiloxane, triethanolamine, glyceryl stearate, mannitol, corn starch modified, polyacrylamide, phenoxyethanol, stearic acid, hydrolyzed adansonia digitata extract, peg-75 stearate, methylparaben, c13- 14 isoparaffin, propylparaben, xanthan gum, parfum (fragance), ceteth-20, steareth-20, pentaerythrityl tetra-di-t-butyl hydroxyhydrocinnamate, acrylates/c10-30 alkyl acrylate crosspolymer, disodium edta, laureth-7, cyclodextrin, dimethicone crosspolymer, faex extract (yeast extract), dimethicone, hydrolyzed algin, butylparaben, ethylparaben, chlorella vulgaris extract, maris aqua (sea water), isobutylparaben, laureth-23, laureth-4, disodium succinate, ci42090 (blue 1).

PRINCIPAL DISPLAY PANEL - 50 g Jar Carton

L'BEL
PARIS

REGRESSION JOUR

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

50 g e (1.7 oz.)

Principal Display Panel - 50 g Jar Carton

PRINCIPAL DISPLAY PANEL - 5 g Jar Carton

L'BEL
PARIS

REGRESSION JOUR

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

5 g e (.17 oz.)

Principal Display Panel - 5 g Jar Carton
LBEL PARIS   REGRESSION JOUR
avobenzone, ensulizole, octinoxate, and oxybenzone cream
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:14783-049
Route of AdministrationTOPICAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
Avobenzone (UNII: G63QQF2NOX) (Avobenzone - UNII:G63QQF2NOX) Avobenzone1 g  in 50 g
Ensulizole (UNII: 9YQ9DI1W42) (Ensulizole - UNII:9YQ9DI1W42) Ensulizole0.5 g  in 50 g
Octinoxate (UNII: 4Y5P7MUD51) (Octinoxate - UNII:4Y5P7MUD51) Octinoxate3.75 g  in 50 g
Oxybenzone (UNII: 95OOS7VE0Y) (Oxybenzone - UNII:95OOS7VE0Y) Oxybenzone1 g  in 50 g
Inactive Ingredients
Ingredient NameStrength
water (UNII: 059QF0KO0R)  
soybean (UNII: L7HT8F1ZOD)  
propylene glycol (UNII: 6DC9Q167V3)  
cyclomethicone 5 (UNII: 0THT5PCI0R)  
cetyl alcohol (UNII: 936JST6JCN)  
c12-15 alkyl benzoate (UNII: A9EJ3J61HQ)  
snow pea (UNII: 84SKC33B1I)  
cyclomethicone 6 (UNII: XHK3U310BA)  
trolamine (UNII: 9O3K93S3TK)  
glyceryl monostearate (UNII: 230OU9XXE4)  
mannitol (UNII: 3OWL53L36A)  
phenoxyethanol (UNII: HIE492ZZ3T)  
stearic acid (UNII: 4ELV7Z65AP)  
methylparaben (UNII: A2I8C7HI9T)  
c13-14 isoparaffin (UNII: E4F12ROE70)  
propylparaben (UNII: Z8IX2SC1OH)  
xanthan gum (UNII: TTV12P4NEE)  
ceteth-20 (UNII: I835H2IHHX)  
steareth-20 (UNII: L0Q8IK9E08)  
edetate disodium (UNII: 7FLD91C86K)  
laureth-7 (UNII: Z95S6G8201)  
yeast (UNII: 3NY3SM6B8U)  
dimethicone (UNII: 92RU3N3Y1O)  
butylparaben (UNII: 3QPI1U3FV8)  
ethylparaben (UNII: 14255EXE39)  
isobutylparaben (UNII: 0QQJ25X58G)  
laureth-23 (UNII: N72LMW566G)  
laureth-4 (UNII: 6HQ855798J)  
sodium succinate anhydrous (UNII: V8ZGC8ISR3)  
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:14783-049-611 in 1 BOX
1NDC:14783-049-6250 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
avobenzone, ensulizole, octinoxate, and oxybenzone cream
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:14783-039
Route of AdministrationTOPICAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
Avobenzone (UNII: G63QQF2NOX) (Avobenzone - UNII:G63QQF2NOX) Avobenzone0.1 g  in 5 g
Ensulizole (UNII: 9YQ9DI1W42) (Ensulizole - UNII:9YQ9DI1W42) Ensulizole0.05 g  in 5 g
Octinoxate (UNII: 4Y5P7MUD51) (Octinoxate - UNII:4Y5P7MUD51) Octinoxate0.375 g  in 5 g
Oxybenzone (UNII: 95OOS7VE0Y) (Oxybenzone - UNII:95OOS7VE0Y) Oxybenzone0.1 g  in 5 g
Inactive Ingredients
Ingredient NameStrength
water (UNII: 059QF0KO0R)  
soybean (UNII: L7HT8F1ZOD)  
propylene glycol (UNII: 6DC9Q167V3)  
cyclomethicone 5 (UNII: 0THT5PCI0R)  
cetyl alcohol (UNII: 936JST6JCN)  
c12-15 alkyl benzoate (UNII: A9EJ3J61HQ)  
snow pea (UNII: 84SKC33B1I)  
cyclomethicone 6 (UNII: XHK3U310BA)  
trolamine (UNII: 9O3K93S3TK)  
glyceryl monostearate (UNII: 230OU9XXE4)  
mannitol (UNII: 3OWL53L36A)  
phenoxyethanol (UNII: HIE492ZZ3T)  
stearic acid (UNII: 4ELV7Z65AP)  
methylparaben (UNII: A2I8C7HI9T)  
c13-14 isoparaffin (UNII: E4F12ROE70)  
propylparaben (UNII: Z8IX2SC1OH)  
xanthan gum (UNII: TTV12P4NEE)  
ceteth-20 (UNII: I835H2IHHX)  
steareth-20 (UNII: L0Q8IK9E08)  
edetate disodium (UNII: 7FLD91C86K)  
laureth-7 (UNII: Z95S6G8201)  
yeast (UNII: 3NY3SM6B8U)  
dimethicone (UNII: 92RU3N3Y1O)  
butylparaben (UNII: 3QPI1U3FV8)  
ethylparaben (UNII: 14255EXE39)  
isobutylparaben (UNII: 0QQJ25X58G)  
laureth-23 (UNII: N72LMW566G)  
laureth-4 (UNII: 6HQ855798J)  
sodium succinate anhydrous (UNII: V8ZGC8ISR3)  
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:14783-039-511 in 1 BOX
1NDC:14783-039-525 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: 35041b4f-d141-4cf0-91c9-829ff347fe90
Set id: 024de8f0-1d3a-4761-8674-5d1a8ac9133c
Version: 1
Effective Time: 20100810
 
Ventura International LTD