Label: WATERBLOCK SOLAR SPF 30- homosalate, octinoxate, octisalate, octocrylene, and oxybenzone liquid

  • 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 October 26, 2011

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  • active ingredients

    Homosalate (10.0%), Octinoxate (7.5%), Octisalate (5.0%), Octocrylene (10.0%), Oxybenzone (5.0%).

  • other ingredients

    Isododecane, Dicaprylyl Ether, Cyclopentasiloxane, Cocoglycerides, Butyloctyl Salicylate, Brassica Campestris/Aleurites Fordi Oil Copolymer, Diisopropyl Adipate, Melissa Officinalis Leaf Extract, Citrus Grandis (Grapefruit) Peel Oil, Retinyl Palmitate, Ascorbyl Palmitate, Limonene, Tocopheryl Acetate, Caprylyl Glycol.

  • warnings

    For external use only, not to be swallowed. Avoid contact with eyes. If contact occurs, flush thoroughly with water.

    If irritation develops, discontinue use.

    Do not use on infants under 6 months old.

  • SPL UNCLASSIFIED SECTION

    Dermalogica, Dist.
    Los Angeles, CA 90009 USA

  • PRINCIPAL DISPLAY PANEL - 125 ml Bottle Carton

    waterblock
    solar spray

    spf 30

    4.2 FL OZ / 125 ml e

    dermalogica®

    Principal Display Panel - 125 ml Bottle Carton
  • INGREDIENTS AND APPEARANCE
    WATERBLOCK SOLAR   SPF 30
    homosalate, octinoxate, octisalate, octocrylene, and oxybenzone liquid
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:21839-091
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    Homosalate (UNII: V06SV4M95S) (Homosalate - UNII:V06SV4M95S) Homosalate12.5 mL  in 125 mL
    Octinoxate (UNII: 4Y5P7MUD51) (Octinoxate - UNII:4Y5P7MUD51) Octinoxate9.4 mL  in 125 mL
    Octisalate (UNII: 4X49Y0596W) (Octisalate - UNII:4X49Y0596W) Octisalate6.25 mL  in 125 mL
    Octocrylene (UNII: 5A68WGF6WM) (Octocrylene - UNII:5A68WGF6WM) Octocrylene12.5 mL  in 125 mL
    Oxybenzone (UNII: 95OOS7VE0Y) (Oxybenzone - UNII:95OOS7VE0Y) Oxybenzone6.25 mL  in 125 mL
    Inactive Ingredients
    Ingredient NameStrength
    Isododecane (UNII: A8289P68Y2)  
    Dicaprylyl Ether (UNII: 77JZM5516Z)  
    Cyclomethicone 5 (UNII: 0THT5PCI0R)  
    Coco-glycerides (UNII: ISE9I7DNUG)  
    Butyloctyl Salicylate (UNII: 2EH13UN8D3)  
    Diisopropyl Adipate (UNII: P7E6YFV72X)  
    Melissa Officinalis Leaf (UNII: 50D2ZE9219)  
    Citrus Maxima Fruit Rind Oil (UNII: 8U3877WD44)  
    Vitamin A Palmitate (UNII: 1D1K0N0VVC)  
    Ascorbyl Palmitate (UNII: QN83US2B0N)  
    Alpha-Tocopherol Acetate (UNII: 9E8X80D2L0)  
    Caprylyl Glycol (UNII: 00YIU5438U)  
    Product Characteristics
    ColorYELLOW (Clear) Score    
    ShapeSize
    FlavorImprint Code
    Contains    
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:21839-091-251 in 1 BOX
    1125 mL in 1 BOTTLE, PLASTIC
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC MONOGRAPH NOT FINALpart35211/01/2005
    Labeler - Gordon Laboratories, Inc (008328619)
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