Label: PRO LASER BODY- 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 May 23, 2012

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  • Active Ingredient

    Octinoxate 7.5%

    Titanium Dioxide 25%

    Oxybenzone 6%

  • Description

    PRO LASER BODY EMULSION

    SPF 35

    Protective body cream formulated with the perfect combination of sunscreens capable of covering a larger area of the solar radiation spectrum.  Indicated for use after laser body treatments and surgery, and for skin that has been subjected to aggressive treatments and that needs extreme protection and rapid regeneration

    Apply by rubbing into the skin until completely absorbed. Repeat 2 to 3 times a day. Not water resistant.

    150ml. 5.1 fl. Oz


  • Warning

    TOPICAL USE

  • PRINCIPAL DISPLAY PANEL

    PROLAS
  • INGREDIENTS AND APPEARANCE
    PRO LASER  BODY
    octinoxate, titanium dioxide, oxybenzone cream
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:42248-130
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    OCTINOXATE (UNII: 4Y5P7MUD51) (OCTINOXATE - UNII:4Y5P7MUD51) OCTINOXATE11.25 mL  in 150 mL
    TITANIUM DIOXIDE (UNII: 15FIX9V2JP) (TITANIUM DIOXIDE - UNII:15FIX9V2JP) TITANIUM DIOXIDE37.5 mL  in 150 mL
    OXYBENZONE (UNII: 95OOS7VE0Y) (OXYBENZONE - UNII:95OOS7VE0Y) OXYBENZONE9 mL  in 150 mL
    Inactive Ingredients
    Ingredient NameStrength
    ALUMINUM OXIDE (UNII: LMI26O6933)  
    PROPYLPARABEN (UNII: Z8IX2SC1OH)  
    ALPHA-TOCOPHEROL ACETATE (UNII: 9E8X80D2L0)  
    COCONUT ACID (UNII: 40U37V505D)  
    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:42248-130-01150 mL in 1 BOTTLE
    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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