Label: LBEL PARIS- avobenzone, ensulizole, octinoxate, and 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 August 10, 2010

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  • SPL UNCLASSIFIED SECTION

    Drug Facts

  • Active Ingredients

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

  • Purpose

    Sunscreen

  • Uses

    • helps prevent sunburn
    • higher SPF gives more sunburn protection
    • provides moderate protection against sunburn
  • Warnings

    • 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 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

    • apply smoothly every morning before sun exposure and as needed.
    • apply after cleansing and toning on face and neck.
    • children under 6 months of age: ask a doctor.
  • Other information

    • Moderate sun protection product.
    • Sun alert: Limiting sun exposure, wearing protective clothing, and using sunscreens may reduce the risk of skin cancer, and other harmful effects of the sun.
  • 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
  • INGREDIENTS AND APPEARANCE
    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)
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