LBEL REGRESSION JOUR  PROTECTIVE COMPLEX WITH SPF 15 FACIAL DAY NORMAL TO DRY SKIN- 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 REGRESSION JOUR
Protective Complex with SPF 15 Facial day normal to dry skin

Drug Facts

Active IngredientsPurpose
Avobenzone (2 %)Sunscreen
Ensulizole (1 %)Sunscreen
Octinoxate (7.5 %)Sunscreen
Oxybenzone (2 %)Sunscreen

Uses

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 damaged 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

Other information

Inactive ingredients

Aqua (water), glycine soja protein (glycine soja (soybean) protein), propylene glycol, cyclopentasiloxane, cetyl alcohol, c12-15 alkyl benzoate, pisum sativum extract (pisum sativum (pea) extract), cyclohexasiloxane, triethanolamine, glyceryl stearate, mannitol, corn starch modified, phenoxyethanol, polyacrylamide, hydrolyzed adansonia digitata extract,stearic acid, peg-75 stearate, methylparaben, c13-14 isoparaffin, propylparaben, xanthan gum, parfum (fragrance), ceteth-20, pentaerythrityl tetra-di-t-butyl hydroxyhydrocinnamate, steareth-20, acrylates/c10-30 alkyl acrylate crosspolymer, disodium edta, laureth-7, cyclodextrin, dimethicone crosspolymer, dimethicone, faex extract (yeast extract), hydrolyzed algin, butylparaben, ethylparaben, chlorella vulgaris extract, isobutylparaben, maris aqua (sea water), laureth-23, laureth-4, disodium succinate, CI 42090 (blue 1)

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

PRINCIPAL DISPLAY PANEL - 5 g Jar Box

L'BEL

REGRESSION JOUR

protective complex with SPF 15
facial day cream
normal to dry skin

5 g e (.17 oz.)

Principal Display Panel - 5 g Jar Box
LBEL REGRESSION JOUR   PROTECTIVE COMPLEX WITH SPF 15 FACIAL DAY NORMAL TO DRY SKIN
avobenzone, ensulizole, octinoxate, and oxybenzone cream
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:14783-025
Route of AdministrationTOPICAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
Avobenzone (UNII: G63QQF2NOX) (Avobenzone - UNII:G63QQF2NOX) Avobenzone0.02 g  in 1 g
Ensulizole (UNII: 9YQ9DI1W42) (Ensulizole - UNII:9YQ9DI1W42) Ensulizole0.01 g  in 1 g
Octinoxate (UNII: 4Y5P7MUD51) (Octinoxate - UNII:4Y5P7MUD51) Octinoxate0.075 g  in 1 g
Oxybenzone (UNII: 95OOS7VE0Y) (Oxybenzone - UNII:95OOS7VE0Y) Oxybenzone0.02 g  in 1 g
Inactive Ingredients
Ingredient NameStrength
WATER (UNII: 059QF0KO0R)  
PROPYLENE GLYCOL (UNII: 6DC9Q167V3)  
CYCLOMETHICONE 5 (UNII: 0THT5PCI0R)  
CETYL ALCOHOL (UNII: 936JST6JCN)  
ALKYL (C12-15) BENZOATE (UNII: A9EJ3J61HQ)  
PEA (UNII: W4X7H8GYFM)  
CYCLOMETHICONE 6 (UNII: XHK3U310BA)  
TROLAMINE (UNII: 9O3K93S3TK)  
GLYCERYL MONOSTEARATE (UNII: 230OU9XXE4)  
MANNITOL (UNII: 3OWL53L36A)  
PHENOXYETHANOL (UNII: HIE492ZZ3T)  
STEARIC ACID (UNII: 4ELV7Z65AP)  
PEG-75 STEARATE (UNII: OT38R0N74H)  
METHYLPARABEN (UNII: A2I8C7HI9T)  
C13-14 ISOPARAFFIN (UNII: E4F12ROE70)  
PROPYLPARABEN (UNII: Z8IX2SC1OH)  
XANTHAN GUM (UNII: TTV12P4NEE)  
CETETH-20 (UNII: I835H2IHHX)  
PENTAERYTHRITOL TETRAKIS(3-(3,5-DI-TERT-BUTYL-4-HYDROXYPHENYL)PROPIONATE) (UNII: 255PIF62MS)  
STEARETH-20 (UNII: L0Q8IK9E08)  
EDETATE DISODIUM (UNII: 7FLD91C86K)  
LAURETH-7 (UNII: Z95S6G8201)  
DIMETHICONE (UNII: 92RU3N3Y1O)  
YEAST (UNII: 3NY3SM6B8U)  
BUTYLPARABEN (UNII: 3QPI1U3FV8)  
ETHYLPARABEN (UNII: 14255EXE39)  
CHLORELLA VULGARIS (UNII: RYQ4R60M02)  
ISOBUTYLPARABEN (UNII: 0QQJ25X58G)  
LAURETH-23 (UNII: N72LMW566G)  
LAURETH-4 (UNII: 6HQ855798J)  
SODIUM SUCCINATE ANHYDROUS (UNII: V8ZGC8ISR3)  
FD&C BLUE NO. 1 (UNII: H3R47K3TBD)  
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:14783-025-611 in 1 BOX
1NDC:14783-025-6650 g in 1 JAR
2NDC:14783-025-041 in 1 BOX
2NDC:14783-025-035 g in 1 JAR
3NDC:14783-025-011 g in 1 PACKET
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC MONOGRAPH NOT FINALpart35205/14/2012
Labeler - Ventura International Ltd. (603192787)
Establishment
NameAddressID/FEIBusiness Operations
MF Productions Saumur (France)266769145MANUFACTURE

Revised: 5/2012
Document Id: 8bb9e858-d994-4a1a-80d2-777a2dfba3e2
Set id: 1c6b71d2-3f5d-485f-b571-2e046cbcef91
Version: 1
Effective Time: 20120521
 
Ventura International Ltd.