Label: LBEL PARIS- octinoxate, octisalate, 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

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

View All Sections
  • SPL UNCLASSIFIED SECTION

    Drug Facts

  • Active Ingredients

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

  • 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, c12-15 alkyl benzoate, pisum sativum (pea) extract, cyclohexasiloxane, dimethicone, mannitol, cetearyl alcohol, glyceryl stearate, hdi/ trimethylol hexyllactone crosspolymer, phenoxyethanol, sodium acrylate/ acryloyldimethyltaurate/ dimethylacrylamide crosspolymer, c20-22 alkyl phosphate, hydroxyethyl acrylate/ sodium acryloyldymethyl taurate copolymer, c20-22 alcohols, triethanolamine, isohexadecane, methylparaben, c14-22 alcohols, cetearyl glucoside, hydrolyzed adansonia digitata extract, butylparaben, cyclopentasiloxane, chlorphenesin, propylparaben, xanthan gum, disodium edta, acrylates/c10-30 alkyl acrylate crosspolymer, parfum (fragance), 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, ci42090 (blue 1).

  • SPL UNCLASSIFIED SECTION

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

  • PRINCIPAL DISPLAY PANEL - 50 ml Carton

    L'BEL
    PARIS

    REGRESSION
    JOUR

    protective complex against
    the first signs of age
    with spf 15 facial day lotion
    normal to combination skin

    50 ml e (1.6 fl.oz.)

    Principal Display Panel - 50 ml Carton
  • INGREDIENTS AND APPEARANCE
    LBEL PARIS   REGRESSION JOUR
    octinoxate, octisalate, and oxybenzone cream
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:14783-055
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    Octinoxate (UNII: 4Y5P7MUD51) (Octinoxate - UNII:4Y5P7MUD51) Octinoxate3.75 g  in 50 g
    Octisalate (UNII: 4X49Y0596W) (Octisalate - UNII:4X49Y0596W) Octisalate2 g  in 50 g
    Oxybenzone (UNII: 95OOS7VE0Y) (Oxybenzone - UNII:95OOS7VE0Y) Oxybenzone2 g  in 50 g
    Inactive Ingredients
    Ingredient NameStrength
    water (UNII: 059QF0KO0R)  
    soybean (UNII: L7HT8F1ZOD)  
    c12-15 alkyl benzoate (UNII: A9EJ3J61HQ)  
    snow pea (UNII: 84SKC33B1I)  
    cyclomethicone 6 (UNII: XHK3U310BA)  
    dimethicone (UNII: 92RU3N3Y1O)  
    mannitol (UNII: 3OWL53L36A)  
    cetostearyl alcohol (UNII: 2DMT128M1S)  
    glyceryl monostearate (UNII: 230OU9XXE4)  
    phenoxyethanol (UNII: HIE492ZZ3T)  
    trolamine (UNII: 9O3K93S3TK)  
    isohexadecane (UNII: 918X1OUF1E)  
    methylparaben (UNII: A2I8C7HI9T)  
    butylparaben (UNII: 3QPI1U3FV8)  
    cyclomethicone 5 (UNII: 0THT5PCI0R)  
    chlorphenesin (UNII: I670DAL4SZ)  
    propylparaben (UNII: Z8IX2SC1OH)  
    xanthan gum (UNII: TTV12P4NEE)  
    edetate disodium (UNII: 7FLD91C86K)  
    sorbic acid (UNII: X045WJ989B)  
    polysorbate 60 (UNII: CAL22UVI4M)  
    yeast (UNII: 3NY3SM6B8U)  
    ethylparaben (UNII: 14255EXE39)  
    isobutylparaben (UNII: 0QQJ25X58G)  
    silicon dioxide (UNII: ETJ7Z6XBU4)  
    sodium succinate anhydrous (UNII: V8ZGC8ISR3)  
    FD&C blue no. 1 (UNII: H3R47K3TBD)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:14783-055-611 in 1 BOX
    1NDC:14783-055-6650 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
    octinoxate, octisalate, and oxybenzone cream
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:14783-045
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    Octinoxate (UNII: 4Y5P7MUD51) (Octinoxate - UNII:4Y5P7MUD51) Octinoxate0.375 g  in 5 g
    Octisalate (UNII: 4X49Y0596W) (Octisalate - UNII:4X49Y0596W) Octisalate0.2 g  in 5 g
    Oxybenzone (UNII: 95OOS7VE0Y) (Oxybenzone - UNII:95OOS7VE0Y) Oxybenzone0.2 g  in 5 g
    Inactive Ingredients
    Ingredient NameStrength
    water (UNII: 059QF0KO0R)  
    soybean (UNII: L7HT8F1ZOD)  
    c12-15 alkyl benzoate (UNII: A9EJ3J61HQ)  
    snow pea (UNII: 84SKC33B1I)  
    cyclomethicone 6 (UNII: XHK3U310BA)  
    dimethicone (UNII: 92RU3N3Y1O)  
    mannitol (UNII: 3OWL53L36A)  
    cetostearyl alcohol (UNII: 2DMT128M1S)  
    glyceryl monostearate (UNII: 230OU9XXE4)  
    phenoxyethanol (UNII: HIE492ZZ3T)  
    trolamine (UNII: 9O3K93S3TK)  
    isohexadecane (UNII: 918X1OUF1E)  
    methylparaben (UNII: A2I8C7HI9T)  
    butylparaben (UNII: 3QPI1U3FV8)  
    cyclomethicone 5 (UNII: 0THT5PCI0R)  
    chlorphenesin (UNII: I670DAL4SZ)  
    propylparaben (UNII: Z8IX2SC1OH)  
    xanthan gum (UNII: TTV12P4NEE)  
    edetate disodium (UNII: 7FLD91C86K)  
    sorbic acid (UNII: X045WJ989B)  
    polysorbate 60 (UNII: CAL22UVI4M)  
    yeast (UNII: 3NY3SM6B8U)  
    ethylparaben (UNII: 14255EXE39)  
    isobutylparaben (UNII: 0QQJ25X58G)  
    silicon dioxide (UNII: ETJ7Z6XBU4)  
    sodium succinate anhydrous (UNII: V8ZGC8ISR3)  
    FD&C blue no. 1 (UNII: H3R47K3TBD)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:14783-045-511 in 1 BOX
    1NDC:14783-045-525 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
    octinoxate, octisalate, and oxybenzone cream
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:14783-035
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    Octinoxate (UNII: 4Y5P7MUD51) (Octinoxate - UNII:4Y5P7MUD51) Octinoxate0.75 g  in 1 g
    Octisalate (UNII: 4X49Y0596W) (Octisalate - UNII:4X49Y0596W) Octisalate0.04 g  in 1 g
    Oxybenzone (UNII: 95OOS7VE0Y) (Oxybenzone - UNII:95OOS7VE0Y) Oxybenzone2 g  in 1 g
    Inactive Ingredients
    Ingredient NameStrength
    water (UNII: 059QF0KO0R)  
    soybean (UNII: L7HT8F1ZOD)  
    c12-15 alkyl benzoate (UNII: A9EJ3J61HQ)  
    snow pea (UNII: 84SKC33B1I)  
    cyclomethicone 6 (UNII: XHK3U310BA)  
    dimethicone (UNII: 92RU3N3Y1O)  
    mannitol (UNII: 3OWL53L36A)  
    cetostearyl alcohol (UNII: 2DMT128M1S)  
    glyceryl monostearate (UNII: 230OU9XXE4)  
    phenoxyethanol (UNII: HIE492ZZ3T)  
    trolamine (UNII: 9O3K93S3TK)  
    isohexadecane (UNII: 918X1OUF1E)  
    methylparaben (UNII: A2I8C7HI9T)  
    butylparaben (UNII: 3QPI1U3FV8)  
    cyclomethicone 5 (UNII: 0THT5PCI0R)  
    chlorphenesin (UNII: I670DAL4SZ)  
    propylparaben (UNII: Z8IX2SC1OH)  
    xanthan gum (UNII: TTV12P4NEE)  
    edetate disodium (UNII: 7FLD91C86K)  
    sorbic acid (UNII: X045WJ989B)  
    polysorbate 60 (UNII: CAL22UVI4M)  
    yeast (UNII: 3NY3SM6B8U)  
    ethylparaben (UNII: 14255EXE39)  
    isobutylparaben (UNII: 0QQJ25X58G)  
    silicon dioxide (UNII: ETJ7Z6XBU4)  
    sodium succinate anhydrous (UNII: V8ZGC8ISR3)  
    FD&C blue no. 1 (UNII: H3R47K3TBD)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:14783-035-411 in 1 BOX
    1NDC:14783-035-421 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)
View All Sections

Find additional resources

(also available in the left menu)

Safety

Report Adverse Events, FDA Safety Recalls, Presence in Breast Milk

Related Resources

Medline Plus, Clinical Trials, PubMed, Biochemical Data Summary

More Info on this Drug

View Labeling Archives, RxNorm, Get Label RSS Feed, View NDC Code(s)NEW!