Label: LBEL EFFET PARFAIT MINERAL NATURAL SKIN EFFECT MOUSE FOUNDATION- octinoxate, titanium dioxide, and zinc oxide powder

  • 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 November 10, 2010

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

View All Sections
  • SPL UNCLASSIFIED SECTION

    Drug Facts

  • ACTIVE INGREDIENT

    Active IngredientPurpose
    Octinoxate 6.5%,Sunscreen
    Titanium Dioxide 2.4%Sunscreen
    Zinc Oxide 1.6%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 or 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 generously and evently before sun exposure and as needed
  • Other information

    • Sun alert: Limiting sun exposure, waring protective clothing, and using sunscreen may reduce the risk of skin aging, skin cancer, and other harmful effects of the sun.
  • Inactive ingredients

    Cyclopentasiloxane, Mica, Dimethicone Crosspolymer, Dimethicone/Vinyl Dimethicone Crosspolymer, Trimethylsiloxysilicate, Cyclohexasiloxane , Bis-hydroxyethoxypropyl Dimethicone, Octyldodecanol, Phenoxyethanol, Boron nitride, Disteardimonium Hectorite, Alumina, Cetyl peg/ppg-10/1 Dimethicone, Polyglyceryl-4 isostearate, Cera Microcristallina (Microcrystalline Wax), Silica, Hexyl Laurate, Dimethiconol, Caprylyl glycol, Tocopheryl Acetate, Chlorphenesin, Lauroyl Lysine, Petrolatum, Propylene Carbonate, Methicone, Phospholipids,Rhodiola Rosea Root Extract, Cholesterol, BHA, BHT, Carnosine, Triethoxycaprylylsilane, Candelilla Cera (Euphorbia Cerifera (candelilla) wax), Cera alba (Beeswax), Cetearyl Alcohol, Cetearyl Glucoside, Copernicia Cerifera Cera (Copernicia Cerifera (carnauba) wax), Polyglyceryl-2 Dipolyhydroxystearate, Glycosphingolipids, Alanyl Glutamine. May Contain: CI 77891(Titanium Dioxide) , CI 77491, CI 77492, CI 77499 (Iron Oxides).

  • SPL UNCLASSIFIED SECTION

    USA: Dist. by Ventura International Ltd. San Francisco, CA 94111. Made in Colombia. PUERTO RICO: Dist. by Ventura Corporation, Ltd., San Juan, Puerto Rico 00926. Made in Colombia.

  • PRINCIPAL DISPLAY PANEL - 30 g Carton

    EFFET PARFAIT
    MINÉRAL

    natural skin effect
    mousse foundation
    SPF 16

    30 g e (1 oz.)

    L'BEL

    Principal Display Panel - 30 g Carton
  • INGREDIENTS AND APPEARANCE
    LBEL EFFET PARFAIT MINERAL NATURAL SKIN EFFECT MOUSE FOUNDATION 
    octinoxate, titanium dioxide, and zinc oxide powder
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:14783-770
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    OCTINOXATE (UNII: 4Y5P7MUD51) (OCTINOXATE - UNII:4Y5P7MUD51) OCTINOXATE0.065 g  in 1 g
    TITANIUM DIOXIDE (UNII: 15FIX9V2JP) (TITANIUM DIOXIDE - UNII:15FIX9V2JP) TITANIUM DIOXIDE0.024 g  in 1 g
    ZINC OXIDE (UNII: SOI2LOH54Z) (ZINC OXIDE - UNII:SOI2LOH54Z) ZINC OXIDE0.016 g  in 1 g
    Inactive Ingredients
    Ingredient NameStrength
    CYCLOMETHICONE 5 (UNII: 0THT5PCI0R)  
    MICA (UNII: V8A1AW0880)  
    CYCLOMETHICONE 6 (UNII: XHK3U310BA)  
    OCTYLDODECANOL (UNII: 461N1O614Y)  
    PHENOXYETHANOL (UNII: HIE492ZZ3T)  
    ALUMINUM OXIDE (UNII: LMI26O6933)  
    POLYGLYCERYL-4 ISOSTEARATE (UNII: 820DPX33S7)  
    MICROCRYSTALLINE WAX (UNII: XOF597Q3KY)  
    SILICON DIOXIDE (UNII: ETJ7Z6XBU4)  
    HEXYL LAURATE (UNII: 4CG9F9W01Q)  
    CAPRYLYL GLYCOL (UNII: 00YIU5438U)  
    CHLORPHENESIN (UNII: I670DAL4SZ)  
    LAUROYL LYSINE (UNII: 113171Q70B)  
    PETROLATUM (UNII: 4T6H12BN9U)  
    PROPYLENE CARBONATE (UNII: 8D08K3S51E)  
    CHOLESTEROL (UNII: 97C5T2UQ7J)  
    BUTYLATED HYDROXYANISOLE (UNII: REK4960K2U)  
    BUTYLATED HYDROXYTOLUENE (UNII: 1P9D0Z171K)  
    CARNOSINE (UNII: 8HO6PVN24W)  
    CANDELILLA WAX (UNII: WL0328HX19)  
    YELLOW WAX (UNII: 2ZA36H0S2V)  
    CETOSTEARYL ALCOHOL (UNII: 2DMT128M1S)  
    CETEARYL GLUCOSIDE (UNII: 09FUA47KNA)  
    CARNAUBA WAX (UNII: R12CBM0EIZ)  
    ALANYL-GLUTAMINE (UNII: U5JDO2770Z)  
    FERRIC OXIDE RED (UNII: 1K09F3G675)  
    FERRIC OXIDE YELLOW (UNII: EX438O2MRT)  
    FERROSOFERRIC OXIDE (UNII: XM0M87F357)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:14783-770-311 in 1 CARTON
    1NDC:14783-770-3030 g in 1 BOTTLE
    2NDC:14783-770-041 in 1 CARTON
    2NDC:14783-770-033 g in 1 BOTTLE
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC MONOGRAPH NOT FINALpart35211/26/2010
    Labeler - Ventura International, Limited (603192787)
    Establishment
    NameAddressID/FEIBusiness Operations
    BelStar, S.A.880160197MANUFACTURE
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!