Label: LBEL EFFET PARFAIT LOOSE EXTRA-FINE PORTABLE SPF 15 FM PORCELAINE- BEIGE- octinoxate, titanium dioxide, and oxybenzone powder
LBEL EFFET PARFAIT LOOSE EXTRA-FINE PORTABLE SPF 15 FM TRANSLUCIDE- BEIGE- octinoxate, titanium dioxide, and oxybenzone powder
LBEL EFFET PARFAIT LOOSE EXTRA-FINE PORTABLE SPF 15 FM SANTE- BEIGE- octinoxate, titanium dioxide, and oxybenzone powder

  • 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 November 26, 2018

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

View All Sections
  • SPL UNCLASSIFIED SECTION

    Drug Facts

  • ACTIVE INGREDIENT

    Active IngredientsPurpose
    TITANIUM DIOXIDE 3.54 %Sunscreen
    OCTINOXATE 3.00 %Sunscreen
    OXYBENZONE 3.00 %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 damage 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.
  • Inactive ingredients

    TALC, ZEA MAYS (CORN) STARCH, SILICA, CALCIUM CARBONATE, KAOLIN, ZINC STEARATE, OCTYLDODECANOL, ISOSTEARYL NEOPENTANOATE, GLYCERYL CAPRYLATE, METHYL METHACRYLATE CROSSPOLYMER, MAGNESIUM MYRISTATE, PHENOXYETHANOL, SODIUM POTASSIUM ALUMINUM SILICATE, HYDROGEN DIMETHICONE, TOCOPHERYL ACETATE, ALUMINA, CAPRYLYL GLYCOL, CHLORPHENESIN, MICROCRYSTALLINE WAX, PETROLATUM, PHOSPHOLIPIDS, CHOLESTEROL, EUPHORBIA CERIFERA (CANDELILLA) WAX, BEESWAX, CETEARYL ALCOHOL, CETEARYL GLUCOSIDE, COPERNICIA CERIFERA (CARNAUBA) WAX, POLYGLYCERYL-2 DIPOLYHYDROXYSTEARATE, GLYCOSPHINGOLIPIDS.

    MAY CONTAIN:

    IRON OXIDES, TITANIUM DIOXIDE

  • SPL UNCLASSIFIED SECTION

    Dist. by Ventura Int Ltd. DBA Belcorp USA, Miami, FL 33126

  • PRINCIPAL DISPLAY PANEL - 12 g Case Box - PORCELAINE - BEIGE

    L'BEL

    EFFET PARFAIT

    loose extra-fine portable
    powder SPF 15 FM

    Net Wt. 0.42 oz. e (12 g)

    PRINCIPAL DISPLAY PANEL - 12 g Case Box - PORCELAINE - BEIGE
  • PRINCIPAL DISPLAY PANEL - 12 g Case Box - TRANSLUCIDE- BEIGE

    L'BEL

    EFFET PARFAIT

    loose extra-fine portable
    powder SPF 15 FM

    Net Wt. 0.42 oz. e (12 g)

    PRINCIPAL DISPLAY PANEL - 12 g Case Box - TRANSLUCIDE- BEIGE
  • PRINCIPAL DISPLAY PANEL - 12 g Case Box - SANTE- BEIGE

    L'BEL

    EFFET PARFAIT

    loose extra-fine portable
    powder SPF 15 FM

    Net Wt. 0.42 oz. e (12 g)

    PRINCIPAL DISPLAY PANEL - 12 g Case Box - SANTE- BEIGE
  • INGREDIENTS AND APPEARANCE
    LBEL EFFET PARFAIT LOOSE EXTRA-FINE PORTABLE SPF 15 FM   PORCELAINE- BEIGE
    octinoxate, titanium dioxide, and oxybenzone powder
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:14783-721
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    Octinoxate (UNII: 4Y5P7MUD51) (Octinoxate - UNII:4Y5P7MUD51) Octinoxate0.03 g  in 1 g
    Titanium Dioxide (UNII: 15FIX9V2JP) (Titanium Dioxide - UNII:15FIX9V2JP) Titanium Dioxide0.0354 g  in 1 g
    Oxybenzone (UNII: 95OOS7VE0Y) (Oxybenzone - UNII:95OOS7VE0Y) Oxybenzone0.03 g  in 1 g
    Inactive Ingredients
    Ingredient NameStrength
    TALC (UNII: 7SEV7J4R1U)  
    STARCH, CORN (UNII: O8232NY3SJ)  
    SILICON DIOXIDE (UNII: ETJ7Z6XBU4)  
    CALCIUM CARBONATE (UNII: H0G9379FGK)  
    KAOLIN (UNII: 24H4NWX5CO)  
    ZINC STEARATE (UNII: H92E6QA4FV)  
    OCTYLDODECANOL (UNII: 461N1O614Y)  
    ISOSTEARYL NEOPENTANOATE (UNII: 411THY156Q)  
    GLYCERYL MONOCAPRYLATE (UNII: TM2TZD4G4A)  
    MAGNESIUM MYRISTATE (UNII: Z1917F0578)  
    PHENOXYETHANOL (UNII: HIE492ZZ3T)  
    .ALPHA.-TOCOPHEROL ACETATE (UNII: 9E8X80D2L0)  
    ALUMINUM OXIDE (UNII: LMI26O6933)  
    CAPRYLYL GLYCOL (UNII: 00YIU5438U)  
    CHLORPHENESIN (UNII: I670DAL4SZ)  
    MICROCRYSTALLINE WAX (UNII: XOF597Q3KY)  
    PETROLATUM (UNII: 4T6H12BN9U)  
    LECITHIN, SOYBEAN (UNII: 1DI56QDM62)  
    CHOLESTEROL (UNII: 97C5T2UQ7J)  
    CANDELILLA WAX (UNII: WL0328HX19)  
    YELLOW WAX (UNII: 2ZA36H0S2V)  
    CETOSTEARYL ALCOHOL (UNII: 2DMT128M1S)  
    CETEARYL GLUCOSIDE (UNII: 09FUA47KNA)  
    CARNAUBA WAX (UNII: R12CBM0EIZ)  
    POLYGLYCERYL-2 DIPOLYHYDROXYSTEARATE (UNII: 9229XJ4V12)  
    FERRIC OXIDE RED (UNII: 1K09F3G675)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:14783-721-021 in 1 BOX12/22/2015
    1NDC:14783-721-0112 g in 1 CASE; Type 0: Not a Combination Product
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC MONOGRAPH FINALpart35212/22/2015
    LBEL EFFET PARFAIT LOOSE EXTRA-FINE PORTABLE SPF 15 FM   TRANSLUCIDE- BEIGE
    octinoxate, titanium dioxide, and oxybenzone powder
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:14783-722
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    Octinoxate (UNII: 4Y5P7MUD51) (Octinoxate - UNII:4Y5P7MUD51) Octinoxate0.03 g  in 1 g
    Titanium Dioxide (UNII: 15FIX9V2JP) (Titanium Dioxide - UNII:15FIX9V2JP) Titanium Dioxide0.0354 g  in 1 g
    Oxybenzone (UNII: 95OOS7VE0Y) (Oxybenzone - UNII:95OOS7VE0Y) Oxybenzone0.03 g  in 1 g
    Inactive Ingredients
    Ingredient NameStrength
    TALC (UNII: 7SEV7J4R1U)  
    STARCH, CORN (UNII: O8232NY3SJ)  
    SILICON DIOXIDE (UNII: ETJ7Z6XBU4)  
    CALCIUM CARBONATE (UNII: H0G9379FGK)  
    KAOLIN (UNII: 24H4NWX5CO)  
    ZINC STEARATE (UNII: H92E6QA4FV)  
    OCTYLDODECANOL (UNII: 461N1O614Y)  
    ISOSTEARYL NEOPENTANOATE (UNII: 411THY156Q)  
    GLYCERYL MONOCAPRYLATE (UNII: TM2TZD4G4A)  
    MAGNESIUM MYRISTATE (UNII: Z1917F0578)  
    PHENOXYETHANOL (UNII: HIE492ZZ3T)  
    .ALPHA.-TOCOPHEROL ACETATE (UNII: 9E8X80D2L0)  
    ALUMINUM OXIDE (UNII: LMI26O6933)  
    CAPRYLYL GLYCOL (UNII: 00YIU5438U)  
    CHLORPHENESIN (UNII: I670DAL4SZ)  
    MICROCRYSTALLINE WAX (UNII: XOF597Q3KY)  
    PETROLATUM (UNII: 4T6H12BN9U)  
    LECITHIN, SOYBEAN (UNII: 1DI56QDM62)  
    CHOLESTEROL (UNII: 97C5T2UQ7J)  
    CANDELILLA WAX (UNII: WL0328HX19)  
    YELLOW WAX (UNII: 2ZA36H0S2V)  
    CETOSTEARYL ALCOHOL (UNII: 2DMT128M1S)  
    CETEARYL GLUCOSIDE (UNII: 09FUA47KNA)  
    CARNAUBA WAX (UNII: R12CBM0EIZ)  
    POLYGLYCERYL-2 DIPOLYHYDROXYSTEARATE (UNII: 9229XJ4V12)  
    FERRIC OXIDE RED (UNII: 1K09F3G675)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:14783-722-021 in 1 BOX12/22/2015
    1NDC:14783-722-0112 g in 1 CASE; Type 0: Not a Combination Product
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC MONOGRAPH FINALpart35212/22/2015
    LBEL EFFET PARFAIT LOOSE EXTRA-FINE PORTABLE SPF 15 FM   SANTE- BEIGE
    octinoxate, titanium dioxide, and oxybenzone powder
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:14783-723
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    Octinoxate (UNII: 4Y5P7MUD51) (Octinoxate - UNII:4Y5P7MUD51) Octinoxate0.03 g  in 1 g
    Titanium Dioxide (UNII: 15FIX9V2JP) (Titanium Dioxide - UNII:15FIX9V2JP) Titanium Dioxide0.0354 g  in 1 g
    Oxybenzone (UNII: 95OOS7VE0Y) (Oxybenzone - UNII:95OOS7VE0Y) Oxybenzone0.03 g  in 1 g
    Inactive Ingredients
    Ingredient NameStrength
    TALC (UNII: 7SEV7J4R1U)  
    STARCH, CORN (UNII: O8232NY3SJ)  
    SILICON DIOXIDE (UNII: ETJ7Z6XBU4)  
    CALCIUM CARBONATE (UNII: H0G9379FGK)  
    KAOLIN (UNII: 24H4NWX5CO)  
    ZINC STEARATE (UNII: H92E6QA4FV)  
    OCTYLDODECANOL (UNII: 461N1O614Y)  
    ISOSTEARYL NEOPENTANOATE (UNII: 411THY156Q)  
    GLYCERYL MONOCAPRYLATE (UNII: TM2TZD4G4A)  
    MAGNESIUM MYRISTATE (UNII: Z1917F0578)  
    PHENOXYETHANOL (UNII: HIE492ZZ3T)  
    .ALPHA.-TOCOPHEROL ACETATE (UNII: 9E8X80D2L0)  
    ALUMINUM OXIDE (UNII: LMI26O6933)  
    CAPRYLYL GLYCOL (UNII: 00YIU5438U)  
    CHLORPHENESIN (UNII: I670DAL4SZ)  
    MICROCRYSTALLINE WAX (UNII: XOF597Q3KY)  
    PETROLATUM (UNII: 4T6H12BN9U)  
    LECITHIN, SOYBEAN (UNII: 1DI56QDM62)  
    CHOLESTEROL (UNII: 97C5T2UQ7J)  
    CANDELILLA WAX (UNII: WL0328HX19)  
    YELLOW WAX (UNII: 2ZA36H0S2V)  
    CETOSTEARYL ALCOHOL (UNII: 2DMT128M1S)  
    CETEARYL GLUCOSIDE (UNII: 09FUA47KNA)  
    CARNAUBA WAX (UNII: R12CBM0EIZ)  
    POLYGLYCERYL-2 DIPOLYHYDROXYSTEARATE (UNII: 9229XJ4V12)  
    FERRIC OXIDE RED (UNII: 1K09F3G675)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:14783-723-021 in 1 BOX12/22/2015
    1NDC:14783-723-0112 g in 1 CASE; Type 0: Not a Combination Product
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC MONOGRAPH FINALpart35212/22/2015
    Labeler - Ventura International LTD (603192787)
    Establishment
    NameAddressID/FEIBusiness Operations
    Bel Star S.A. (Colombia)880160197MANUFACTURE(14783-721, 14783-722, 14783-723)
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!