Label: BLUE LIZARD SENSITIVE FACE SUNSCREEN- titanium dioxide, zinc oxide gel

  • 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 October 13, 2021

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

  • Active Ingredients

    Titanium Dioxide 1.0%

    Zinc Oxide 7.8%

  • 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
    • 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


    Alumina, Aluminum Stearate, Beeswax, C12-15 Alkyl Benzoate, C13-14 Isoparaffin, Caffeine, Camellia Sinensis Leaf (Green Tea) Extract, Caprylyl Glycol, Chlorphenesin, Cyclomethicone, Dimethoxydiphenylsilane, Isostearyl Alcohol, Laureth-7, Lauryl PEG/PPG 18/18 Methicone, Phenoxyethanol, Polyacrylamide, Polyhydroxystearic Acid, Purified Water, Sodium Hyaluronate, Triethoxycaprylylsilane

  • Questions?

    Visit www.bluelizardsunscreen.com or call 800.877.8869

    Crown Laboratories, Inc., Johnson City, TN 37604

  • Blue Lizard Sensitive Face Tube

    BLUE LIZARD

    AUSTRALIAN SUNSCREEN

    30+

    UVA/UVB PROTECTION

    BROAD SPECTRUM

    SPF 30+

    TRUSTED BY DERMATOLOGISTS FOR OVER 20 YEARS

    SENSITIVE face

    mineral sunscreen

    Smart Cap TECHNOLOGY

    CAP TURNS BLUE IN HARMFUL UV LIGHT

    WITH HYDRATING HYALURONIC ACID

    P11467.02

    p1146702

  • Blue Lizard Sensitive Face Carton

    P11468.02

    p1146802

  • INGREDIENTS AND APPEARANCE
    BLUE LIZARD SENSITIVE FACE SUNSCREEN 
    titanium dioxide, zinc oxide gel
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:0316-2056
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    ZINC OXIDE (UNII: SOI2LOH54Z) (ZINC OXIDE - UNII:SOI2LOH54Z) ZINC OXIDE83.4 mg  in 1 g
    TITANIUM DIOXIDE (UNII: 15FIX9V2JP) (TITANIUM DIOXIDE - UNII:15FIX9V2JP) TITANIUM DIOXIDE10 mg  in 1 g
    Inactive Ingredients
    Ingredient NameStrength
    WATER (UNII: 059QF0KO0R)  
    ALKYL (C12-15) BENZOATE (UNII: A9EJ3J61HQ)  
    CYCLOMETHICONE (UNII: NMQ347994Z)  
    C13-14 ISOPARAFFIN (UNII: E4F12ROE70)  
    LAURETH-7 (UNII: Z95S6G8201)  
    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)  
    ALUMINUM OXIDE (UNII: LMI26O6933)  
    HYALURONATE SODIUM (UNII: YSE9PPT4TH)  
    TRIETHOXYCAPRYLYLSILANE (UNII: LDC331P08E)  
    ISOSTEARYL ALCOHOL (UNII: Q613OCQ44Y)  
    ALUMINUM STEARATE (UNII: U6XF9NP8HM)  
    POLYACRYLAMIDE (1500 MW) (UNII: 5D6TC4BRWV)  
    DIMETHOXYDIPHENYLSILANE (UNII: 02QB6788GC)  
    POLYHYDROXYSTEARIC ACID (2300 MW) (UNII: YXH47AOU0F)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:0316-2056-171 in 1 CARTON01/30/2019
    148 g in 1 TUBE; Type 0: Not a Combination Product
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph not finalpart35201/30/2019
    Labeler - Crown Laboratories (079035945)
    Establishment
    NameAddressID/FEIBusiness Operations
    Crown Laboratories079035945manufacture(0316-2056)