Label: ULTIMATE SHEER SUNSCREEN SPF 70 DAYLOGIC- avobenzone 3% homosalate 15% octisalate 5% octocrylene 10% oxybenzone 3% stick

  • 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 19, 2018

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  • PRINCIPAL DISPLAY PANEL

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  • INGREDIENTS AND APPEARANCE
    ULTIMATE SHEER SUNSCREEN SPF 70  DAYLOGIC
    avobenzone 3% homosalate 15% octisalate 5% octocrylene 10% oxybenzone 3% stick
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:64048-1235
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    Avobenzone (UNII: G63QQF2NOX) (AVOBENZONE - UNII:G63QQF2NOX) Avobenzone3 g  in 100 g
    Homosalate (UNII: V06SV4M95S) (HOMOSALATE - UNII:V06SV4M95S) Homosalate15 g  in 100 g
    Octisalate (UNII: 4X49Y0596W) (OCTISALATE - UNII:4X49Y0596W) Octisalate5 g  in 100 g
    Octocrylene (UNII: 5A68WGF6WM) (OCTOCRYLENE - UNII:5A68WGF6WM) Octocrylene10 g  in 100 g
    Oxybenzone (UNII: 95OOS7VE0Y) (OXYBENZONE - UNII:95OOS7VE0Y) Oxybenzone3 g  in 100 g
    Inactive Ingredients
    Ingredient NameStrength
    YELLOW WAX (UNII: 2ZA36H0S2V)  
    BUTYLATED HYDROXYTOLUENE (UNII: 1P9D0Z171K)  
    ALKYL (C12-15) BENZOATE (UNII: A9EJ3J61HQ)  
    Caprylyl Glycol (UNII: 00YIU5438U)  
    NEOPENTYL GLYCOL DIETHYLHEXANOATE (UNII: U68ZV6W62C)  
    Neopentyl Glycol Diisostearate (UNII: 4M6OQ34JWW)  
    Octyldodecyl Neopentanoate (UNII: X8725R883T)  
    CERESIN (UNII: Q1LS2UJO3A)  
    Paraffin (UNII: I9O0E3H2ZE)  
    Petrolatum (UNII: 4T6H12BN9U)  
    POLYESTER-8 (1400 MW, CYANODIPHENYLPROPENOYL CAPPED) (UNII: T9296U138P)  
    HIGH DENSITY POLYETHYLENE (UNII: UG00KM4WR7)  
    SILICON DIOXIDE (UNII: ETJ7Z6XBU4)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:64048-1235-243 g in 1 PACKAGE; Type 0: Not a Combination Product12/22/2016
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph not finalpart35212/22/2016
    Labeler - Product Quiest Mfg (927768135)
    Registrant - Product Quiest Mfg (927768135)
    Establishment
    NameAddressID/FEIBusiness Operations
    Product Quiest Mfg927768135manufacture(64048-1235)