Label: LBEL- titanium dioxide, oxybenzone, zinc oxide, and octinoxate 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

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  • SPL UNCLASSIFIED SECTION

    Drug Facts

  • ACTIVE INGREDIENT

    Active IngredientPurpose   
    Titanium Dioxide 6.0%Sunscreen
    Oxybenzone 5.0 %Sunscreen
    Zinc Oxide 4.9%,Sunscreen
    Octinoxate 3.5%,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, wearing protective clothing, and using sunscreen may reduce the risk of skin aging, skin cancer, and other harmful effects of the sun.
  • Inactive ingredients

    Mica, Boron Nitride, Zea Mays Starch( zea mays (corn) starch), Zinc Stearate, Silica, Isononyl Isononanoate, Magnesium Myristate, Simmondsia Chinensis seed oil(simmondsia chinensis (jojoba) seed oil), Glyceryl Caprylate, Phenoxyethanol, Caprylyl Glycol, Chlorphenesin, Tocopheryl Acetate, Triethoxycaprylylsilane, Rhodiola Rosea Root Extract, Carnosine, Alanyl Glutamine. May contain: Iron Oxides, Titanium Dioxide.

  • 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 - 10 g Container Carton

    EFFET PARFAIT
    MINÉRAL

    natural skin effect powder SPF 20

    10 g e (.35 oz.)

    L'BEL

    PRINCIPAL DISPLAY PANEL - 10 g Container Carton
  • INGREDIENTS AND APPEARANCE
    LBEL   EFFET PARFAIT MINERAL
    titanium dioxide, oxybenzone, zinc oxide, and octinoxate powder
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:14783-013
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    TITANIUM DIOXIDE (UNII: 15FIX9V2JP) (TITANIUM DIOXIDE - UNII:15FIX9V2JP) TITANIUM DIOXIDE0.06 g  in 1 g
    OXYBENZONE (UNII: 95OOS7VE0Y) (OXYBENZONE - UNII:95OOS7VE0Y) OXYBENZONE0.05 g  in 1 g
    ZINC OXIDE (UNII: SOI2LOH54Z) (ZINC OXIDE - UNII:SOI2LOH54Z) ZINC OXIDE0.049 g  in 1 g
    OCTINOXATE (UNII: 4Y5P7MUD51) (OCTINOXATE - UNII:4Y5P7MUD51) OCTINOXATE0.035 g  in 1 g
    Inactive Ingredients
    Ingredient NameStrength
    MICA (UNII: V8A1AW0880)  
    STARCH, CORN (UNII: O8232NY3SJ)  
    ZINC STEARATE (UNII: H92E6QA4FV)  
    SILICON DIOXIDE (UNII: ETJ7Z6XBU4)  
    ISONONYL ISONONANOATE (UNII: S4V5BS6GCX)  
    JOJOBA OIL (UNII: 724GKU717M)  
    GLYCERYL CAPRYLATE (UNII: TM2TZD4G4A)  
    PHENOXYETHANOL (UNII: HIE492ZZ3T)  
    CAPRYLYL GLYCOL (UNII: 00YIU5438U)  
    CHLORPHENESIN (UNII: I670DAL4SZ)  
    CARNOSINE (UNII: 8HO6PVN24W)  
    ALANYL-GLUTAMINE (UNII: U5JDO2770Z)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:14783-013-111 in 1 CARTON
    1NDC:14783-013-1010 g in 1 CONTAINER
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC MONOGRAPH NOT FINALpart35212/15/2010
    Labeler - Ventura International, Limited (603192787)
    Establishment
    NameAddressID/FEIBusiness Operations
    BelStar, S.A.880160197MANUFACTURE
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