Label: BLUE LIZARD REGULAR  - octinoxate, octocrylene, oxybenzone and zinc oxide lotion 

  • Label RSS
  • NDC Code(s): 0316-2010-10, 0316-2010-15, 0316-2010-20, 0316-2010-30, view more
    0316-2010-40, 0316-2010-50, 0316-2010-60
  • Packager: Crown Laboratories
  • Category: HUMAN OTC DRUG LABEL
  • DEA Schedule: None
  • Marketing Status: OTC monograph final

NOTE: Most over the counter (OTC) are not reviewed and approved by the 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 12/12

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  • PRINCIPAL DISPLAY PANEL

    Blue Lizard Australian Sunscreen - Regular

    Broad Spectrum SPF 30+

    Zinc Oxide Formula

    Very Water Resistant (80 minutes)Blue Lizard Regular Label

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  • QUESTIONS

    Questions: Visit www.bluelizard.net or Call Toll Free 800.877.8869

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  • ACTIVE INGREDIENT

    Octinoxate - 7.5%

    Octocrylene - 2%

    Oxybenzone - 3%

    Zinc Oxide - 6%

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  • INGREDIENTS AND APPEARANCE
    BLUE LIZARD REGULAR  
    sunscreen lotion
    Product Information
    Product Type HUMAN OTC DRUG LABEL Item Code (Source) NDC:0316-2010
    Route of Administration TOPICAL DEA Schedule     
    Active Ingredient/Active Moiety
    Ingredient Name Basis of Strength Strength
    OCTINOXATE (OCTINOXATE) OCTINOXATE 76.5 mg  in 1 mL
    OCTOCRYLENE (OCTOCRYLENE) OCTOCRYLENE 20.4 mg  in 1 mL
    OXYBENZONE (OXYBENZONE) OXYBENZONE 30.6 mg  in 1 mL
    ZINC OXIDE (ZINC OXIDE) ZINC OXIDE 61.2 mg  in 1 mL
    Inactive Ingredients
    Ingredient Name Strength
    YELLOW WAX  
    CETYL PEG/PPG-10/1 DIMETHICONE (HLB 5)  
    DIAZOLIDINYL UREA  
    EDETATE DISODIUM  
    ETHYLHEXYL PALMITATE  
    ETHYLHEXYL STEARATE  
    ETHYLPARABEN  
    HEXYL LAURATE  
    HYDROGENATED CASTOR OIL  
    METHYL GLUCOSE DIOLEATE  
    METHYLPARABEN  
    OCTYLDODECYL NEOPENTANOATE  
    PEG-7 HYDROGENATED CASTOR OIL  
    POLYGLYCERYL-4 ISOSTEARATE  
    PROPYLENE GLYCOL  
    PROPYLPARABEN  
    WATER  
    SORBITAN MONOOLEATE  
    STEARIC ACID  
    .ALPHA.-TOCOPHEROL ACETATE  
    HEXADECYL POVIDONE (4 HEXADECYL BRANCHES/REPEAT)  
    DIMETHICONE  
    TRIMETHYLSILOXYSILICATE (M/Q 0.8-1.0)  
    Packaging
    # Item Code Package Description Marketing Start Date Marketing End Date
    1 NDC:0316-2010-10 5 mL in 1 PACKET
    2 NDC:0316-2010-15 7.5 mL in 1 PACKET
    3 NDC:0316-2010-20 37 mL in 1 BOTTLE, PLASTIC
    4 NDC:0316-2010-30 89 mL in 1 TUBE
    5 NDC:0316-2010-40 148 mL in 1 BOTTLE, PLASTIC
    6 NDC:0316-2010-50 259 mL in 1 BOTTLE, PLASTIC
    7 NDC:0316-2010-60 3785 mL in 1 JUG
    Marketing Information
    Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
    OTC monograph final part352 04/15/2001
    Labeler - Crown Laboratories (079035945)
    Registrant - Crown Laboratories (079035945)
    Establishment
    Name Address ID/FEI Business Operations
    Crown Laboratories 079035945 manufacture(0316-2010)
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