Label: BLUE LIZARD FACE- sunscreen gel

  • NDC Code(s): 0316-2055-10, 0316-2055-30, 0316-2055-40
  • Packager: Crown Laboratories
  • 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 December 14, 2021

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

  • Active Ingredients

    Octinoxate 5.5%

    Zinc Oxide 8.0%

  • 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
    • At least every 2 hours 
    • Use a water resistant sunscreen if swimming or sweating
  • Other Information

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

    Beeswax, BHT, C12-15 Alkyl Benzoate, C13-14 Isoparaffin, Caffeine, Camellia sinesis Leaf (Green Tea) Extract, Caprylyl Glycol, Chlorphenesin, Cyclomethicone, Dimethoxydiphenylsilane, Isotearyl Alcohol, Laureth-7, Lauryl PEG/PPG 18/18 Methicone, Phenoxyethanol, Polyacrylamide, Purified Water, Sodium Hyaluronate, Tocopheryl Acetate (Vitamin E), Triethoxycaprylylsilane

  • Questions?

    Visit www.bluelizard.net or call 800.877.8869

    Crown Laboratories, Inc., Johnson City, TN 37604

  • Blue Lizard Face Label

    BLUE LIZARD

    AUSTRALIAN SUNSCREEN

    30+

    UVA/UVB PROTECTION

    BROAD SPECTRUM

    SPF 30+

    TRUSTED BY DERMATOLOGISTS FOR OVER 20 YEARS

    FACE

    mineral-based sunscreen

    combining mineral and chemical UV protectors

    Smart Cap TECHNOLOGY

    CAP TURNS BLUE IN HARMFUL UV LIGHT

    LIGHTWEIGHT DAILY

    SUN PROTECTION

    P6138.11

    P613811

  • INGREDIENTS AND APPEARANCE
    BLUE LIZARD FACE 
    sunscreen gel
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:0316-2055
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    OCTINOXATE (UNII: 4Y5P7MUD51) (OCTINOXATE - UNII:4Y5P7MUD51) OCTINOXATE55 mg  in 1 g
    ZINC OXIDE (UNII: SOI2LOH54Z) (ZINC OXIDE - UNII:SOI2LOH54Z) ZINC OXIDE80 mg  in 1 g
    Inactive Ingredients
    Ingredient NameStrength
    DIMETHOXYDIPHENYLSILANE (UNII: 02QB6788GC)  
    ISOSTEARYL ALCOHOL (UNII: Q613OCQ44Y)  
    WATER (UNII: 059QF0KO0R)  
    ALKYL (C12-15) BENZOATE (UNII: A9EJ3J61HQ)  
    CYCLOMETHICONE (UNII: NMQ347994Z)  
    C13-14 ISOPARAFFIN (UNII: E4F12ROE70)  
    LAURETH-7 (UNII: Z95S6G8201)  
    ALPHA-TOCOPHEROL ACETATE (UNII: 9E8X80D2L0)  
    GREEN TEA LEAF (UNII: W2ZU1RY8B0)  
    YELLOW WAX (UNII: 2ZA36H0S2V)  
    CAFFEINE (UNII: 3G6A5W338E)  
    PHENOXYETHANOL (UNII: HIE492ZZ3T)  
    CAPRYLYL GLYCOL (UNII: 00YIU5438U)  
    CHLORPHENESIN (UNII: I670DAL4SZ)  
    LAURYL PEG/PPG-18/18 METHICONE (UNII: ZJ5S27D9NX)  
    BUTYLATED HYDROXYTOLUENE (UNII: 1P9D0Z171K)  
    POLYACRYLAMIDE (1500 MW) (UNII: 5D6TC4BRWV)  
    HYALURONATE SODIUM (UNII: YSE9PPT4TH)  
    TRIETHOXYCAPRYLYLSILANE (UNII: LDC331P08E)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:0316-2055-105 g in 1 POUCH; Type 0: Not a Combination Product04/06/201010/01/2021
    2NDC:0316-2055-3085 g in 1 TUBE; Type 0: Not a Combination Product04/06/201003/31/2024
    3NDC:0316-2055-40141.7 g in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product04/06/201008/31/2023
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph not finalpart35204/06/201003/31/2024
    Labeler - Crown Laboratories (079035945)
    Registrant - Crown Laboratories (079035945)
    Establishment
    NameAddressID/FEIBusiness Operations
    Crown Laboratories079035945manufacture(0316-2055)