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

  • 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 12/14

If you are a consumer or patient please visit this version.

  • Active Ingredients

    Octinoxate - 7.5%

    Octocrylene - 2%

    Oxybenzone - 3%

    Zinc Oxide - 6%

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  • Uses

    • Helps prevent sunburn and photodamage caused by UVA/UVB exposure
    • Higher SPF gives more sunburn protection
    • If used as directed with other sun protection measures (see Directions), decreases the risk of skin cancer and early skin aging caused by the sun
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  • Warnings

    • When using this product
    • Keep out of eyes. Rinse with water to remove
    • Stop use and ask a doctor if
    • Rash or irritation occurs
    • Do not use
    • On damaged or broken skin
    • If allergic to any ingredient
    • If swallowed, get medical help or contact a Poison Control Center
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  • Directions

    • Shake well prior to use
    • Apply liberally to dry skin 15 minutes before sun exposure
    • For topical use only
    • Keep out of reach of children
    • Children under 6 months: ask a doctor
    • Sun Protection Measures:Spending time in the sun increases your risk of skin cancer and early skin aging. To decrease this risk, regularly use a sunscreen with a Broad Spectrum SPF value of 15 or higher and other sun protection measures including:
    • Limit time in the sun, especially from 10 a.m. - 2 p.m.
    • Wear long-sleeved shirts, pants, hats, and sunglasses
    • Reapply to dry skin:
    • after 80 minutes of swimming or sweating
    • immediately after towel drying
    • at least every 2 hours
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  • Other Information

    • Protect the product in this container from excessive heat and direct sun
    • May stain some fabrics
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  • Inactive Ingredients

    Beeswax, C12-15 Alkyl Benzoate, Cetyl Dimethicone, Cetyl Dimethicone Copolyol, Diazolidinyl Urea, Disodium EDTA, Ethylhexyl Palmitate, Ethylhexyl Stearate, Ethylparaben, Fragrance, Hexyl Laurate, Hydrogenated Castor Oil, Methyl Glucose Dioleate, Methylparaben, Octododecyl Neopentanoate, PEG-7 Hydrogenated Castor Oil, Polyglyceryl-4 Isostearate, Propylene Glycol, Propylparaben, Purified Water, Sorbitan Oleate, Stearic Acid, Tocopheryl Acetate (Vitamin E), Trimethylated Silica/Dimethicone, VP Hexadecene Copolymer

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  • Questions ?

    Visit www.bluelizard.net or call 800.877.8869

    Crown Laboratories, Inc., Johnson City, TN 37604

    Patents US#6698590 & 6405867; AU#1998083259

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  • Blue Lizard Regular Label

    Blue Lizard

    Australian Sunscreen

    Regular

    Broad Spectrum SPF 30+

    UVA/UVB Protection

    Bottle Turns Blue in UV Light

    Zinc Oxide Formula

    Water Resistant (80 minutes)

    Dermatologist Recommended

    BL Reg 5oz Label

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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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