Label: LBEL REGRESSION JOUR PROTECTIVE COMPLEX WITH SPF 15 FACIAL DAY NORMAL TO DRY SKIN- avobenzone, ensulizole, octinoxate, and oxybenzone cream

  • Category: HUMAN OTC DRUG LABEL
  • DEA Schedule: None
  • Marketing Status: OTC monograph not 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 May 21, 2012

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  • SPL UNCLASSIFIED SECTION

    Drug Facts

  • ACTIVE INGREDIENT

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

  • SPL UNCLASSIFIED SECTION

    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
  • INGREDIENTS AND APPEARANCE
    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
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