Label: PROTECTOR R PLUS- octinoxate, titanium dioxide, oxybenzone 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 February 20, 2012

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  • Active Ingredient

    Octinoxate 7.5%

    Titanium Dioxide 25%

    Oxybenzone 6%

  • Description

    Made with plant squalene, marine collagen and hyaluronic acid, intensive cream with double moisturizing control provides an overall reduction of signs of ageing by progressively activating natural defence mechanisms. It strenghtens the moisture barrier and favours the skin regeneration process.  Suitable for use on very dry, dehydrated skin with wrinkles and lack of elasticity.

    200ml. 6.8 fl. Oz


  • Warning

    TOPICAL USE

    PROFESSIONAL USE

  • PRINCIPAL DISPLAY PANEL

    PROTECTOR200
  • INGREDIENTS AND APPEARANCE
    PROTECTOR  R PLUS
    octinoxate, titanium dioxide, oxybenzone cream
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:42248-124
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    OCTINOXATE (UNII: 4Y5P7MUD51) (OCTINOXATE - UNII:4Y5P7MUD51) OCTINOXATE15 mL  in 200 mL
    TITANIUM DIOXIDE (UNII: 15FIX9V2JP) (TITANIUM DIOXIDE - UNII:15FIX9V2JP) TITANIUM DIOXIDE50 mL  in 200 mL
    OXYBENZONE (UNII: 95OOS7VE0Y) (OXYBENZONE - UNII:95OOS7VE0Y) OXYBENZONE12 mL  in 200 mL
    Inactive Ingredients
    Ingredient NameStrength
    ALUMINUM OXIDE (UNII: LMI26O6933)  
    PROPYLPARABEN (UNII: Z8IX2SC1OH)  
    ALPHA-TOCOPHEROL ACETATE (UNII: 9E8X80D2L0)  
    SODIUM COCOYL ISETHIONATE (UNII: 518XTE8493)  
    SODIUM POLYACRYLATE (8000 MW) (UNII: 285CYO341L)  
    METHYLPARABEN SODIUM (UNII: CR6K9C2NHK)  
    WATER (UNII: 059QF0KO0R)  
    GLYCERYL MONOSTEARATE (UNII: 230OU9XXE4)  
    PEG-100 STEARATE (UNII: YD01N1999R)  
    WHITE WAX (UNII: 7G1J5DA97F)  
    HYDROGENATED SOYBEAN LECITHIN (UNII: H1109Z9J4N)  
    GLYCERIN (UNII: PDC6A3C0OX)  
    TROLAMINE (UNII: 9O3K93S3TK)  
    ISOBUTYLPARABEN (UNII: 0QQJ25X58G)  
    HYDROLYZED ELASTIN, BOVINE, ALKALINE (1000 MW) (UNII: ZR28QKN0WT)  
    CARBOMER 934 (UNII: Z135WT9208)  
    IMIDUREA (UNII: M629807ATL)  
    EDETATE DISODIUM (UNII: 7FLD91C86K)  
    METHYLPARABEN (UNII: A2I8C7HI9T)  
    COLLAGEN, SOLUBLE, FISH SKIN (UNII: 8JC99XGU4W)  
    PHENOXYETHANOL (UNII: HIE492ZZ3T)  
    BUTYLPARABEN (UNII: 3QPI1U3FV8)  
    ETHYLPARABEN (UNII: 14255EXE39)  
    (2-CARBETHOXYETHYL)DIETHOXY(METHYL)SILANE (UNII: N28HAC3H5P)  
    HYDROXYPROLINE (UNII: RMB44WO89X)  
    ASPARTIC ACID (UNII: 30KYC7MIAI)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:42248-124-01200 mL in 1 TUBE
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph not finalpart35212/01/2011
    Labeler - Zenith Medicosm SL (464239694)
    Registrant - Zenith Medicosm SL (464239694)
    Establishment
    NameAddressID/FEIBusiness Operations
    Zenith Medicosm SL464239694manufacture
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