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

Drug Label Information

Updated December 5, 2023

If you are a healthcare professional or from the pharmaceutical industry please visit this version.

  • Active Ingredients

    Octinoxate 5.5%

    Zinc Oxide 8.0%

  • Purpose

    Sunscreen

  • 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
    • 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

    Keep out of reach of children

  • 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 CHANGES COLOR IN HARMFUL UV LIGHT

    LIGHTWEIGHT DAILY

    SUN PROTECTION

    P6138.12

    BL Face P6138_12

  • 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 DrugM02004/06/201003/31/2024
    Labeler - Crown Laboratories (079035945)
    Registrant - Crown Laboratories (079035945)
    Establishment
    NameAddressID/FEIBusiness Operations
    Crown Laboratories079035945manufacture(0316-2055)