Label: LBEL SUPREMACIE NX JOUR REPLENISHING TREATMENT DAYTIME FACE SPF 15 NORMAL TO DRY SKIN- ensulizole, homosalate, octinoxate, oxybenzone cream

  • 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

If you are a consumer or patient please visit this version.

  • L'BEL SUPREMACIE NX JOUR Replenishing Treatment Daytime Face Cream SPF 15 Normal To Dry Skin


  • Active Ingredients

    ENSULIZOLE (2.0%)
    HOMOSALATE (2.0%)
    OCTINOXATE (7.5%)
    OXYBENZONE (4.0%)

  • 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.

    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.
    • Reapply at least every 2 years.
    • 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.
    • Use in the morning after cleanser and toner. Apply a small quantity with your fingertips, spreading it over your face with rising, circular movements. Message in gently to help facilitate absorption.
  • Inactive Ingredients

    Aqua (water), pisum sativum extract (pisum sativum (pea) extract), glycerin, cetyl alcohol, cyclopentasiloxane, triethanolamine, c12-15 alkyl benzoate, cyclohexasiloxane, glyceryl stearate, stearic acid, phenoxyethanol,polyacrylamide, erythritol,parfum (fragrance), peg-75 stearate, sodium polystyrene sulfonate,methylparaben, trifolium pratense flower extract(trifolium pratense (clover) flower extract), c13-14 isoparaffin,sorghum bicolor stalk juice, propylparaben, xanthan gum, ceteth-20,steareth-20, butylene glycol, laureth-7, acrylates/c10-30 alkyl acrylate crosspolymer, tetrasodium edta, dimethicone, butylparaben, hydrolyzed algin, ethylparaben, chlorella vulgaris extract, lecithin,  maris aqua (sea water), isobutylparaben, carbomer, laureth-23, laureth-4, homarine hcl, ci 19140 (yellow 5),ci 14700 (red 4), biotinoyl tripeptide-1, ci 42090 (blue 1).

  • Purpose

    Sunscreen

  • 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. Nourish according to the age.

    SUPREMACIE NX JOUR
    replenishing daytime face cream SPF 15

    L'Bel, fully specialized in cosmetic facial treatment, presents the latest worldwide exclusive:  the new Supremacie NX line of replenishing cosmetic treatments improved for women after age 40.

    Dazzling beauty for women

    The moisturizing formula of Supremacie NX Jour, Offers enhanced results:

    • Immediate, strong and long-lasting hydration in the areas where the face needs it most.
    • Visibly diminishes the appearance of wrinkles.
    • Uncovers skin that looks more firm.

    A sensation of well-being that pervades the senses

    Its rich and creamy texture, ideal for absorption has been specially created to provide a pleasant sensation of softness and comfort. Its exquisite fragrance rich in essences awakens the skin with new and pleasant emotions.

    In two options according to your skin's needs:

    •  SUPREMACIE NX JOUR - replenishing daytime face cream SPF 15 Normal to Dry Skin

    •  SUPREMACIE NX JOUR - replenishing daytime face cream SPF 15 Normal to Oily 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. 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. Use in the morning after cleanser and toner. Apply a small quantity with your fingertips, spreading it over your face with rising, circular movements. Message in gently to help facilitate absorption.

    • HYPOALLERGENIC
    • DERMATOLOGICALLY AND CLINICALLY TESTED

  • PRINCIPAL DISPLAY PANEL

    L'BEL
    SUPREMACIE NX JOUR

    replenishing daytime face cream SPF 15
    normal to dry skin

    50 g e (1.7 oz..)

    US: Dist. 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.

  • LBEL SUPREMACIE NX JOUR Replenishing Treatment Daytime Face Cream SPF 15 Normal To Dry Skin


    Supremacie NX Jour



    Supremacie NX Jour 50 gSupremacie NX Jour 50 g A

  • INGREDIENTS AND APPEARANCE
    LBEL SUPREMACIE NX JOUR REPLENISHING TREATMENT DAYTIME FACE SPF 15 NORMAL TO DRY SKIN 
    ensulizole, homosalate, octinoxate, oxybenzone cream
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:43596-0005
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    ENSULIZOLE (UNII: 9YQ9DI1W42) (ENSULIZOLE - UNII:9YQ9DI1W42) ENSULIZOLE2 g  in 100 g
    HOMOSALATE (UNII: V06SV4M95S) (HOMOSALATE - UNII:V06SV4M95S) HOMOSALATE2 g  in 100 g
    OCTINOXATE (UNII: 4Y5P7MUD51) (OCTINOXATE - UNII:4Y5P7MUD51) OCTINOXATE7.5 g  in 100 g
    OXYBENZONE (UNII: 95OOS7VE0Y) (OXYBENZONE - UNII:95OOS7VE0Y) OXYBENZONE4 g  in 100 g
    Inactive Ingredients
    Ingredient NameStrength
    WATER (UNII: 059QF0KO0R)  
    PEA (UNII: W4X7H8GYFM)  
    GLYCERIN (UNII: PDC6A3C0OX)  
    CETYL ALCOHOL (UNII: 936JST6JCN)  
    CYCLOMETHICONE 5 (UNII: 0THT5PCI0R)  
    TROLAMINE (UNII: 9O3K93S3TK)  
    ALKYL (C12-15) BENZOATE (UNII: A9EJ3J61HQ)  
    CYCLOMETHICONE 6 (UNII: XHK3U310BA)  
    GLYCERYL MONOSTEARATE (UNII: 230OU9XXE4)  
    STEARIC ACID (UNII: 4ELV7Z65AP)  
    PHENOXYETHANOL (UNII: HIE492ZZ3T)  
    ERYTHRITOL (UNII: RA96B954X6)  
    PEG-75 STEARATE (UNII: OT38R0N74H)  
    SODIUM POLYSTYRENE SULFONATE (UNII: 1699G8679Z)  
    METHYLPARABEN (UNII: A2I8C7HI9T)  
    TRIFOLIUM PRATENSE FLOWER (UNII: 4JS0838828)  
    C13-14 ISOPARAFFIN (UNII: E4F12ROE70)  
    SORGHUM BICOLOR STEM JUICE (UNII: SKN30A294R)  
    PROPYLPARABEN (UNII: Z8IX2SC1OH)  
    XANTHAN GUM (UNII: TTV12P4NEE)  
    CETETH-20 (UNII: I835H2IHHX)  
    STEARETH-20 (UNII: L0Q8IK9E08)  
    BUTYLENE GLYCOL (UNII: 3XUS85K0RA)  
    LAURETH-7 (UNII: Z95S6G8201)  
    CARBOMER INTERPOLYMER TYPE A (55000 MPA.S) (UNII: 59TL3WG5CO)  
    EDETATE SODIUM (UNII: MP1J8420LU)  
    DIMETHICONE (UNII: 92RU3N3Y1O)  
    BUTYLPARABEN (UNII: 3QPI1U3FV8)  
    METHYLPARABEN (UNII: A2I8C7HI9T)  
    CHLORELLA VULGARIS (UNII: RYQ4R60M02)  
    ISOBUTYLPARABEN (UNII: 0QQJ25X58G)  
    LAURETH-23 (UNII: N72LMW566G)  
    LAURETH-4 (UNII: 6HQ855798J)  
    FD&C YELLOW NO. 5 (UNII: I753WB2F1M)  
    FD&C RED NO. 4 (UNII: X3W0AM1JLX)  
    BIOTINOYL TRIPEPTIDE-1 (UNII: O6380721VA)  
    FD&C BLUE NO. 1 (UNII: H3R47K3TBD)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:43596-0005-01 g in 1 POUCH
    2NDC:43596-0005-15 g in 1 JAR
    3NDC:43596-0005-250 g in 1 JAR
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph finalpart35203/28/2012
    Labeler - Ventura Corporation, LTD (602751344)
    Establishment
    NameAddressID/FEIBusiness Operations
    MF Productions266769145manufacture