Label: DESPIGMEN PROTECTIVE 25- octinoxate, titanium dioxide cream

  • 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 June 16, 2011

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  • DESCRIPTION

    Protector that provides the latest in scientific cosmetics to prevent dark spots, protecting the skin from sun damage and aging.

    Protection against UVA light is due to its state-of-the art "organo-mineral" solar filter.

    Protection against UVB light occurs by a highly efficient inorganic filter.

    Perfectly protected, the skin appear uniform, luminous, and free from shine.


  • INSTRUCTIONS FOR USE

    Directions:  Gently massage into the skin of the face, neck, decolletage, and hands 30 minutes before sun exposure.

  • WARNINGS

    Warnings:  For external use only.  Keep out of reach of children.  Avoid contact with eyes.  Discontinue use if signs of irritation or rash appear.

  • ACTIVE INGREDIENT

    ACTIVE INGREDIENTS:

    OCTINOXATE 6% - sunscreen

    TITANIUM DIOXIDE 1.75% - sunscreen


  • INACTIVE INGREDIENT

    OTHER INGREDIENTS:  AQUA, TRIBEHENIN PEG-20 ESTERS, OCTYLDODECYL MYRISTATE, HYDROGENATED POLYDECENE, SIMMONDSIA CHINENSIS OIL, METHYLENE BIS-BENZOTRIAZOLYL TETRAMETHYLBUTYLPHENOL, GLYCERIN, C12-15 ALKYLBENZOATE, CETEARYL ALCOHOL, DECYL GLUCOSIDE, TOPHENYL ACETATE, ALUMINUM STEARATE, POLYHYDROXYSTEARIC ACID, ALUMINIUM OXIDE, DISODIUM EDTA, PROPYLENE GLYCOL, XANTYAN GUM, PHENOXYETHANOL, METHYLPARABEN, BUTYLPARABEN, ETHYLPARABEN, PROPYLPARABEN.

  • PRINCIPAL DISPLAY PANEL

    Image of Carton

  • INGREDIENTS AND APPEARANCE
    DESPIGMEN PROTECTIVE 25 
    octinoxate, titanium dioxide cream
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:75870-003
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    OCTINOXATE (UNII: 4Y5P7MUD51) (OCTINOXATE - UNII:4Y5P7MUD51) OCTINOXATE3 mL  in 50 mL
    TITANIUM DIOXIDE (UNII: 15FIX9V2JP) (TITANIUM - UNII:D1JT611TNE) TITANIUM DIOXIDE0.88 mL  in 50 mL
    Inactive Ingredients
    Ingredient NameStrength
    WATER (UNII: 059QF0KO0R)  
    TRIBEHENIN PEG-20 ESTERS (UNII: 84K9EH29Y9)  
    ABETIMUS SODIUM (UNII: F5Y7739G6U)  
    JOJOBA OIL (UNII: 724GKU717M)  
    BISOCTRIZOLE (UNII: 8NT850T0YS)  
    GLYCERIN (UNII: PDC6A3C0OX)  
    DODECYL BENZOATE (UNII: N4F51K239A)  
    ALPHA-TOCOPHEROL (UNII: H4N855PNZ1)  
    ALUMINUM STEARATE (UNII: U6XF9NP8HM)  
    HYDROXYSTEARIC ACID (UNII: 933ANU3H2S)  
    ALUMINUM OXIDE (UNII: LMI26O6933)  
    EDETATE DISODIUM (UNII: 7FLD91C86K)  
    PROPYLENE GLYCOL (UNII: 6DC9Q167V3)  
    XANTHAN GUM (UNII: TTV12P4NEE)  
    PHENOXYETHANOL (UNII: HIE492ZZ3T)  
    METHYLPARABEN (UNII: A2I8C7HI9T)  
    BUTYLPARABEN (UNII: 3QPI1U3FV8)  
    ETHYLPARABEN (UNII: 14255EXE39)  
    PROPYLPARABEN (UNII: Z8IX2SC1OH)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:75870-003-021 in 1 CARTON
    1NDC:75870-003-0150 mL in 1 TUBE
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph not finalpart35207/01/2007
    Labeler - LABORATORIOS DE COSMETICA SCIENTIFICA AT (467582193)
    Establishment
    NameAddressID/FEIBusiness Operations
    LABORATORIOS DE COSMETICA SCIENTIFICA ATACHE SA467582193manufacture
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