Label: LBEL REGRESSION JOUR PROTECTIVE COMPLEX WITH SPF 15 FACIAL DAY NORMAL TO COMBINATION SKIN- octinoxate, octisalate, oxybenzone lotion

  • Category: HUMAN OTC DRUG LABEL
  • DEA Schedule: None
  • Marketing Status: OTC monograph final

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.

Drug Label Information

Updated March 28, 2012

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  • L'BEL REGRESSION JOUR Protective Complex With SPF 15 Facial Day Lotion Normal to Combination Skin


  • Active Ingredients

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

  • Uses

    • Helps prevent sunburn.
  • 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

    • Apply liberally and evenly 15 minutes before sun exposure.
    • Apply after cleansing and toning on face and neck
    • Reapply at least every 2 hours.
    • Use a water resistant sunscreen if swimming or sweating.
    • Children under 6 months of age: Ask a doctor.
  • Other information

    • Protect the product in this container from excessive heat and direct sun.
    • Apply in the morning at the end of your skin care routine.
    • Apply with the fingertips, spreading softly throughout the face until completely absorbed
  • Inactive Ingredients

    AQUA (WATER), GLYCINE SOJA PROTEIN (GLYCINE SOJA (SOYBEAN) PROTEIN), C12-15 ALKYL BENZOATE, PISUM SATIVUM EXTRACT (PISUM SATIVUM (PEA) EXTRACT), CYCLOHEXASILOXANE, DIMETHICONE, MANNITOL, CETEARYL ALCOHOL, HDI/TRIMETHYLOL HEXYLLACTONE CROSSPOLYMER, PHENOXYETHANOL, SODIUM ACRYLATE/ACRYLOYLDIMETHYLTAURATE/DIMETHYLACRYLAMIDE CROSSPOLYMER, C20-22 ALKYL PHOSPHATE, GLYCERYL STEARATE, HYDROXYETHYL ACRYLATE/SODIUM ACRYLOYLDYMETHYL TAURATE COPOLYMER, C20-22 ALCOHOLS, TRIETHANOLAMINE, ISOHEXADECANE, METHYLPARABEN, C14-22 ALCOHOLS,CETEARYL GLUCOSIDE, HYDROLYZED ADANSONIA DIGITATA EXTRACT, BUTYLPARABEN, CYCLOPENTASILOXANE, CHLORPHENESIN, XANTHAN GUM, PROPYLPARABEN, ACRYLATES/C10-30 ALKYL ACRYLATE CROSSPOLYMER, DISODIUM EDTA, PARFUM (FRAGRANCE), 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, CI 42090 (BLUE  1)

  • Purpose

    Sunscreen

  • Call us toll-free: In the United States at 1-800-992-LBEL (5235), in Puerto Rico, 1-866-366-3235 (Metro area). US: Dis. by Ventura International Ltd.

    US:  Dis. by Ventura International Ltd. DBA Belcorp USA, San Francisco, CA 94111   P.R.:  Dist. by Ventura Corporation Ltd., San Juan, Puerto Rico 00926.  MADE IN FRANCE

  • EXPERT ROUTINE L'BEL

    L'Bel presents Expert Routine, a skin care program with two steps that work together for enhanced results:

    1. Cleanse the skin according to its needs
    2. Noursih according to age
    PROGRESSION JOUR
    Protective complex with SPF 15

    The skin is an organ that acts as the body's first line of defense against environmental aggressions.  However, after the age of 30, the skin's natural self-defense properties diminish, making it more vulnerable to ultraviolet (UVA and UVB) rays, as well as to pollution, which can accelerate the aging process.

    The skin does not recover as quickly as it once did.  For that reason, it is essential to give your skin the protection it needs.

    Regression Jour with Sun Protection Factor (SPF) 15, in addition to moisturizing the skin, acts as a shield to protect its youthful appearance.

    Discover the effectiveness of its action
    • Protective Shield Complex:  Effective plant-derived complex that helps maintain the skin's natural defenses.
    • Hydra-Film Technology:  Seaweed extract that helps recover the skin's hydrolipid layer - responsible for hydration, absorption and water retention - to transport moisture to the skin cells that need it most.
    In two options according to your skin's needs:
    • Regression Jour protective complex with SPF 15 facial day cream normal to dry skin.
    • Regression Jour protective complex with SPF 15 facial day cream normal to combination skin.
    USES:  Helps prevent sunburn.

    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:
    • Apply liberally and evenly 15 minutes before sun exposure.
    • Apply after cleansing and toning on face and neck
    • Reapply at least every 2 hours
    • Use a water resistant sunscreen if swimming or sweating.
    • Children under 6 months of age:  Ask a doctor
    OTHER INFORMATION:
    • Protect the product in this container from excessive heat and direct sun.
    • Apply in the morning at the end of your skin care routine
    • Apply with fingertips, spreading softly throughout the face until completely absorbed
    • HYPOALLERGENIC
    • CLINICALLY AND DERMATOLOGICALLY TESTED
  • PRINCIPAL DISPLAY PANEL

    After the age of 30

    NEW REGRESSION JOUR Protective complex with SPF 15 facial day lotion normal to combination skin 50 ml e (1.6 fl. oz.)    L'BEL

  • L'BEL REGRESSION JOUR Protective Complex With SPF 15 Facial Day Lotion Normal to Combination Skin


    Reg Jour Nto C50ml A

    Reg Jour Nto C50ml BReg Jour Nto C50ml CReg JourNto C50ml D

  • INGREDIENTS AND APPEARANCE
    LBEL REGRESSION JOUR PROTECTIVE COMPLEX WITH SPF 15 FACIAL DAY NORMAL TO COMBINATION SKIN 
    octinoxate, octisalate, oxybenzone lotion
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:43455-0003
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    OCTINOXATE (UNII: 4Y5P7MUD51) (OCTINOXATE - UNII:4Y5P7MUD51) OCTINOXATE7.5 mL  in 100 mL
    OCTISALATE (UNII: 4X49Y0596W) (OCTISALATE - UNII:4X49Y0596W) OCTISALATE4 mL  in 100 mL
    OXYBENZONE (UNII: 95OOS7VE0Y) (OXYBENZONE - UNII:95OOS7VE0Y) OXYBENZONE4 mL  in 100 mL
    Inactive Ingredients
    Ingredient NameStrength
    WATER (UNII: 059QF0KO0R)  
    SOY PROTEIN (UNII: R44IWB3RN5)  
    ALKYL (C12-15) BENZOATE (UNII: A9EJ3J61HQ)  
    PEA (UNII: W4X7H8GYFM)  
    CYCLOMETHICONE 6 (UNII: XHK3U310BA)  
    DIMETHICONE (UNII: 92RU3N3Y1O)  
    MANNITOL (UNII: 3OWL53L36A)  
    CETOSTEARYL ALCOHOL (UNII: 2DMT128M1S)  
    PHENOXYETHANOL (UNII: HIE492ZZ3T)  
    SODIUM ACRYLATE/SODIUM ACRYLOYLDIMETHYLTAURATE COPOLYMER (4000000 MW) (UNII: 1DXE3F3OZX)  
    C20-22 ALKYL PHOSPHATE (UNII: L4VKP0Y7RP)  
    GLYCERYL MONOSTEARATE (UNII: 230OU9XXE4)  
    2-HYDROXYETHYL ACRYLATE (UNII: 25GT92NY0C)  
    C20-22 ALCOHOLS (UNII: O4M0347C6A)  
    TROLAMINE (UNII: 9O3K93S3TK)  
    ISOHEXADECANE (UNII: 918X1OUF1E)  
    METHYLPARABEN (UNII: A2I8C7HI9T)  
    C14-22 ALCOHOLS (UNII: B1K89384RJ)  
    CETEARYL GLUCOSIDE (UNII: 09FUA47KNA)  
    BUTYLPARABEN (UNII: 3QPI1U3FV8)  
    CYCLOMETHICONE 5 (UNII: 0THT5PCI0R)  
    CHLORPHENESIN (UNII: I670DAL4SZ)  
    XANTHAN GUM (UNII: TTV12P4NEE)  
    PROPYLPARABEN (UNII: Z8IX2SC1OH)  
    CARBOMER INTERPOLYMER TYPE A (55000 MPA.S) (UNII: 59TL3WG5CO)  
    EDETATE DISODIUM (UNII: 7FLD91C86K)  
    SORBIC ACID (UNII: X045WJ989B)  
    POLYSORBATE 60 (UNII: CAL22UVI4M)  
    C12-20 ALKYL GLUCOSIDE (UNII: K67N5Z1RUA)  
    YEAST (UNII: 3NY3SM6B8U)  
    ETHYLPARABEN (UNII: 14255EXE39)  
    CHLORELLA VULGARIS (UNII: RYQ4R60M02)  
    ISOBUTYLPARABEN (UNII: 0QQJ25X58G)  
    SILICON DIOXIDE (UNII: ETJ7Z6XBU4)  
    SODIUM SUCCINATE ANHYDROUS (UNII: V8ZGC8ISR3)  
    D&C BLUE NO. 4 (UNII: 0KSY80VYS3)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:43455-0003-01 mL in 1 POUCH
    2NDC:43455-0003-15 mL in 1 JAR
    3NDC:43455-0003-250 mL in 1 JAR
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph finalpart35203/28/2012
    Labeler - Ventura International, LTD (603192787)
    Establishment
    NameAddressID/FEIBusiness Operations
    MF Productions266769145manufacture