Label: BLUE LIZARD REGULAR- sunscreen lotion

  • NDC Code(s): 0316-2010-10, 0316-2010-30, 0316-2010-40, 0316-2010-50, view more
    0316-2010-60
  • Packager: Crown Laboratories
  • Category: HUMAN OTC DRUG LABEL

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 12, 2021

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  • Active Ingredients

    Octinoxate - 7.5%

    Octocrylene - 2%

    Oxybenzone - 3%

    Zinc Oxide - 6%

  • 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
  • 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
  • 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
  • Other Information

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

    Beeswax, BHT, Cetyl Dimethicone, Cetyl PEG/PPG 10/1 Dimethicone, Diazolidinyl Urea, Dimethicone, Disodium EDTA, Ethylhexyl Palmitate, Ethylhexyl Stearate, Ethylparaben, Fragrance, Hexyl Laurate, Hydrogenated Castor Oil, Methyl Glucose Dioleate, Methylparaben, Octyldodecyl Neopentanoate, PEG-7 Hydrogenated Castor Oil, Polyglyceryl-4 Isostearate, Propylene Glycol, Propylparaben, Purified Water, Sorbitan Oleate, Stearic Acid, Tocopheryl Acetate (Vitamin E), Triethoxycaprylylsilane, Trimethylsiloxysilicate, VP Hexadecene Copolymer

  • Questions ?

    Visit www.bluelizard.net or call 800.877.8869

    Crown Laboratories, Inc., Johnson City, TN 37604

    Patent: US#6698590

  • Blue Lizard Regular Label

    Blue Lizard

    Australian Sunscreen

    UVA/UVB Protection

    Broad Spectrum SPF 30+

    Trusted by Dermatologist for over 20 years

    REGULAR

    mineral-based sunscreen

    combining mineral and chemical UV protectors

    Smart Bottle Technology

    Bottle Turns Blue in UV Light

    Water Resistant (80 minutes)

    blreg5oz

  • INGREDIENTS AND APPEARANCE
    BLUE LIZARD REGULAR 
    sunscreen lotion
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:0316-2010
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    OCTINOXATE (UNII: 4Y5P7MUD51) (OCTINOXATE - UNII:4Y5P7MUD51) OCTINOXATE76.5 mg  in 1 mL
    OCTOCRYLENE (UNII: 5A68WGF6WM) (OCTOCRYLENE - UNII:5A68WGF6WM) OCTOCRYLENE20.4 mg  in 1 mL
    OXYBENZONE (UNII: 95OOS7VE0Y) (OXYBENZONE - UNII:95OOS7VE0Y) OXYBENZONE30.6 mg  in 1 mL
    ZINC OXIDE (UNII: SOI2LOH54Z) (ZINC OXIDE - UNII:SOI2LOH54Z) ZINC OXIDE61.2 mg  in 1 mL
    Inactive Ingredients
    Ingredient NameStrength
    YELLOW WAX (UNII: 2ZA36H0S2V)  
    CETYL PEG/PPG-10/1 DIMETHICONE (HLB 5) (UNII: 035JKJ76MT)  
    DIAZOLIDINYL UREA (UNII: H5RIZ3MPW4)  
    EDETATE DISODIUM (UNII: 7FLD91C86K)  
    ETHYLHEXYL PALMITATE (UNII: 2865993309)  
    ETHYLHEXYL STEARATE (UNII: EG3PA2K3K5)  
    ETHYLPARABEN (UNII: 14255EXE39)  
    HEXYL LAURATE (UNII: 4CG9F9W01Q)  
    HYDROGENATED CASTOR OIL (UNII: ZF94AP8MEY)  
    METHYL GLUCOSE DIOLEATE (UNII: FA9KFJ4Z6P)  
    METHYLPARABEN (UNII: A2I8C7HI9T)  
    OCTYLDODECYL NEOPENTANOATE (UNII: X8725R883T)  
    PEG-7 HYDROGENATED CASTOR OIL (UNII: WE09129TH5)  
    POLYGLYCERYL-4 ISOSTEARATE (UNII: 820DPX33S7)  
    PROPYLENE GLYCOL (UNII: 6DC9Q167V3)  
    PROPYLPARABEN (UNII: Z8IX2SC1OH)  
    WATER (UNII: 059QF0KO0R)  
    SORBITAN MONOOLEATE (UNII: 06XEA2VD56)  
    STEARIC ACID (UNII: 4ELV7Z65AP)  
    .ALPHA.-TOCOPHEROL ACETATE (UNII: 9E8X80D2L0)  
    HEXADECYL POVIDONE (4 HEXADECYL BRANCHES/REPEAT) (UNII: AG75W62QYU)  
    DIMETHICONE (UNII: 92RU3N3Y1O)  
    TRIMETHYLSILOXYSILICATE (M/Q 0.8-1.0) (UNII: 25LXE464L2)  
    TRIETHOXYCAPRYLYLSILANE (UNII: LDC331P08E)  
    BUTYLATED HYDROXYTOLUENE (UNII: 1P9D0Z171K)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:0316-2010-105 mL in 1 PACKET; Type 0: Not a Combination Product10/01/200209/30/2010
    2NDC:0316-2010-3089 mL in 1 TUBE; Type 0: Not a Combination Product01/03/200605/31/2014
    3NDC:0316-2010-40148 mL in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product04/15/200106/30/2022
    4NDC:0316-2010-50259 mL in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product04/15/200104/30/2022
    5NDC:0316-2010-603785 mL in 1 JUG; Type 0: Not a Combination Product02/02/200404/30/2022
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph finalpart35204/15/200106/30/2022
    Labeler - Crown Laboratories (079035945)
    Registrant - Crown Laboratories (079035945)
    Establishment
    NameAddressID/FEIBusiness Operations
    Crown Laboratories079035945manufacture(0316-2010)
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