Label: LBEL- octinoxate and oxybenzone 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 May 16, 2011

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  • SPL UNCLASSIFIED SECTION

    Drug Facts

  • ACTIVE INGREDIENT

    Active IngredientsPurpose
    Octinoxate 7.5 %sunscreen
    Oxybenzone 2.0%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 liberally before sun exposure and as needed
  • Other Information

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

    isostearyl neopentanoate, mica, c12-15 alkyl benzoate, ethylhexyl palmitate, polymethyl methacrylate, dimethicone/vinyl dimethicone crosspolymer, polyethylene, ozokerite, kaolin, copernicia cerifera cera (copernicia cerifera (carnauba) wax), zea mays starch (zea mays (corn) starch), kojic dipalmitate, phenoxyethanol, dimethicone, octyldodecanol, glyceryl isostearate, isostearyl alcohol, methylparaben, silica, butyrospermum parkii (butyrospermum parkii (shea butter)), cera microcristallina (microcrystalline wax), propylparaben, beta-sitosterol, parfum (fragrance), candelilla cera (euphorbia cerifera (candelilla) wax), trimethylsiloxysilicate, petrolatum, phospholipids, bht, glycyrrhiza glabra root extract (glycyrrhiza glabra (licorice) root extract), butylparaben, ethylparaben, cholesterol, isobutylparaben, cera alba (beeswax), cetearyl alcohol, cetearyl glucoside, polyglyceryl-2 dipolyhydroxystearate, chitosan, glycosphingolipids. May contain: ci 77891 (titanium dioxide), ci 77492 (iron oxides), ci 77491 (iron oxides), ci 77499 (iron oxides).

  • PRINCIPAL DISPLAY PANEL - 8 g Carton

    EFFET
    PARFAIT

    facial spots clarifying effect compact spf 18

    8 g e (.28 oz.)

    L'BEL

    Principal Display Panel - 8 g Carton
  • INGREDIENTS AND APPEARANCE
    LBEL   EFFET PARFAIT
    octinoxate and oxybenzone powder
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:13537-240
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    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
    MICA (UNII: V8A1AW0880)  
    ALKYL (C12-15) BENZOATE (UNII: A9EJ3J61HQ)  
    ETHYLHEXYL PALMITATE (UNII: 2865993309)  
    CERESIN (UNII: Q1LS2UJO3A)  
    KAOLIN (UNII: 24H4NWX5CO)  
    CARNAUBA WAX (UNII: R12CBM0EIZ)  
    STARCH, CORN (UNII: O8232NY3SJ)  
    KOJIC DIPALMITATE (UNII: 13N249RWTM)  
    PHENOXYETHANOL (UNII: HIE492ZZ3T)  
    DIMETHICONE (UNII: 92RU3N3Y1O)  
    OCTYLDODECANOL (UNII: 461N1O614Y)  
    GLYCERYL ISOSTEARATE (UNII: HYE7O27HAO)  
    ISOSTEARYL ALCOHOL (UNII: Q613OCQ44Y)  
    METHYLPARABEN (UNII: A2I8C7HI9T)  
    SILICON DIOXIDE (UNII: ETJ7Z6XBU4)  
    SHEA BUTTER (UNII: K49155WL9Y)  
    MICROCRYSTALLINE WAX (UNII: XOF597Q3KY)  
    PROPYLPARABEN (UNII: Z8IX2SC1OH)  
    .BETA.-SITOSTEROL (UNII: S347WMO6M4)  
    CANDELILLA WAX (UNII: WL0328HX19)  
    PETROLATUM (UNII: 4T6H12BN9U)  
    BUTYLATED HYDROXYTOLUENE (UNII: 1P9D0Z171K)  
    GLYCYRRHIZA GLABRA (UNII: 2788Z9758H)  
    BUTYLPARABEN (UNII: 3QPI1U3FV8)  
    ETHYLPARABEN (UNII: 14255EXE39)  
    CHOLESTEROL (UNII: 97C5T2UQ7J)  
    ISOBUTYLPARABEN (UNII: 0QQJ25X58G)  
    YELLOW WAX (UNII: 2ZA36H0S2V)  
    CETOSTEARYL ALCOHOL (UNII: 2DMT128M1S)  
    CETEARYL GLUCOSIDE (UNII: 09FUA47KNA)  
    TITANIUM DIOXIDE (UNII: 15FIX9V2JP)  
    FERRIC OXIDE YELLOW (UNII: EX438O2MRT)  
    FERRIC OXIDE RED (UNII: 1K09F3G675)  
    FERROSOFERRIC OXIDE (UNII: XM0M87F357)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:13537-240-021 in 1 BOX
    1NDC:13537-240-018 g in 1 CASE
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC MONOGRAPH NOT FINALpart35208/16/2010
    Labeler - Ventura Corporation (San Juan, P.R.) (602751344)
    Establishment
    NameAddressID/FEIBusiness Operations
    Bel Star S.A. (Colombia)880160197MANUFACTURE
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