Label: BLUE LIZARD SHEER SPF 50 SUNSCREEN- titanium dioxide, zinc oxide lotion

  • Category: HUMAN OTC DRUG LABEL
  • DEA Schedule: None

Drug Label Information

Updated December 5, 2023

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

  • Active Ingredients

    Titanium Dioxide 9%

    Zinc Oxide 6%

  • 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:
    • after 80 minutes of swimming or sweating
    • immediately after towel drying
    • at least every 2 hours

    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

    Aloe Barbadensis Leaf Juice, Alumina, Aluminum Stearate, Butyrospermum Parkii (Shea) Butter, C12-15 Alkyl Benzoate, Caprylic/Capric Triglyceride, Carica Papaya (Papaya) Fruit Extract, Citric Acid, Citrus Aurantium Dulcis (Orange) Peel Extract, Crithmum Maritimum Extract, Cucumis Sativus (Cucumber) Fruit Extract, Diisopropyl Sebacate, Dimethoxydiphenylsilane/Triethoxycaprylylsilane Crosspolymer, Ethylhexylglycerin, Fucus Vesiculosus (Bladderwrack) Extract, Gamma-Nonalactone, Ginkgo Biloba (Ginkgo) Leaf Extract, Glycerin, Hamamelis Virginiana (Witch Hazel) Leaf Extract, Hydrogenated Vegetable Oil, Isostearyl Alcohol, Isostearyl Isostearate, Phenoxyethanol, Polyglyceryl-3 Polyricinoleate, Polyhydroxystearic Acid, Potassium Sorbate, Purified Water, Ricinus Communis (Castor) Seed Oil, Rosa Canina (Rosehip) Fruit Oil, Sclerocarya Birrea (Marula) Seed Oil, Sea Water, Sodium Benzoate, Sodium Chloride, Sorbitan Isostearate, Squalane, Tocopheryl Acetate (Vitamin E), Triethyl Citrate, and Xanthan Gum

  • Questions?

    Visit www.bluelizardsunscreen.com or call 800.877.8869

    Crown Laboratories, Inc., Johnson City, TN 37604

  • Blue Lizard Sheer Lotion - 3oz Tube Label

    BLUE LIZARD

    AUSTRALIAN SUNSCREEN

    50+

    Sheer Lotion

    mineral sunscreen

    UVA/UVB PROTECTION

    BROAD SPECTRUM

    SPF 50+

    WATER RESISTANT (80 MINUTES)

    P11899.00

    sheer-body-tube

  • Blue Lizard Sheer Lotion - 3oz Carton

    BLUE LIZARD

    AUSTRALIAN SUNSCREEN

    50+

    Sheer Lotion

    body

    mineral sunscreen

    UVA/UVB PROTECTION

    BROAD SPECTRUM

    SPF 50+

    WATER RESISTANT (80 MINUTES)

    P11902.01

    p1190201

  • INGREDIENTS AND APPEARANCE
    BLUE LIZARD SHEER SPF 50 SUNSCREEN 
    titanium dioxide, zinc oxide lotion
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:0316-2064
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    ZINC OXIDE (UNII: SOI2LOH54Z) (ZINC OXIDE - UNII:SOI2LOH54Z) ZINC OXIDE66.6 mg  in 1 mL
    TITANIUM DIOXIDE (UNII: 15FIX9V2JP) (TITANIUM DIOXIDE - UNII:15FIX9V2JP) TITANIUM DIOXIDE99.9 mg  in 1 mL
    Inactive Ingredients
    Ingredient NameStrength
    GLYCERIN (UNII: PDC6A3C0OX)  
    HAMAMELIS VIRGINIANA LEAF (UNII: T07U1161SV)  
    GINKGO (UNII: 19FUJ2C58T)  
    ALOE VERA LEAF (UNII: ZY81Z83H0X)  
    ALUMINUM OXIDE (UNII: LMI26O6933)  
    ALUMINUM STEARATE (UNII: U6XF9NP8HM)  
    SHEA BUTTER (UNII: K49155WL9Y)  
    ALKYL (C12-15) BENZOATE (UNII: A9EJ3J61HQ)  
    MEDIUM-CHAIN TRIGLYCERIDES (UNII: C9H2L21V7U)  
    PAPAYA (UNII: KU94FIY6JB)  
    CITRIC ACID MONOHYDRATE (UNII: 2968PHW8QP)  
    ORANGE PEEL (UNII: TI9T76XD44)  
    CRITHMUM MARITIMUM WHOLE (UNII: J7IHY79BKY)  
    CUCUMBER (UNII: YY7C30VXJT)  
    DIISOPROPYL SEBACATE (UNII: J8T3X564IH)  
    DIMETHOXYDIPHENYLSILANE (UNII: 02QB6788GC)  
    TRIETHOXYCAPRYLYLSILANE (UNII: LDC331P08E)  
    ETHYLHEXYLGLYCERIN (UNII: 147D247K3P)  
    FUCUS VESICULOSUS (UNII: 535G2ABX9M)  
    .GAMMA.-NONALACTONE (UNII: I1XGH66S8P)  
    HYDROGENATED PALM OIL (UNII: 257THB963H)  
    HYDROGENATED RAPESEED OIL (UNII: K168T6Y0YU)  
    ISOSTEARYL ISOSTEARATE (UNII: IV0Z586Z4Y)  
    POTASSIUM SORBATE (UNII: 1VPU26JZZ4)  
    WATER (UNII: 059QF0KO0R)  
    CASTOR OIL (UNII: D5340Y2I9G)  
    SCLEROCARYA BIRREA SEED OIL (UNII: WDO4TLS35F)  
    SODIUM CHLORIDE (UNII: 451W47IQ8X)  
    SORBITAN ISOSTEARATE (UNII: 01S2G2C1E4)  
    TRIETHYL CITRATE (UNII: 8Z96QXD6UM)  
    XANTHAN GUM (UNII: TTV12P4NEE)  
    SQUALANE (UNII: GW89575KF9)  
    POLYGLYCERYL-3 PENTARICINOLEATE (UNII: 7Q0OK5DOT4)  
    .ALPHA.-TOCOPHEROL ACETATE (UNII: 9E8X80D2L0)  
    ISOSTEARYL ALCOHOL (UNII: Q613OCQ44Y)  
    PHENOXYETHANOL (UNII: HIE492ZZ3T)  
    POLYHYDROXYSTEARIC ACID (2300 MW) (UNII: YXH47AOU0F)  
    ROSA CANINA FRUIT OIL (UNII: CR7307M3QZ)  
    SODIUM BENZOATE (UNII: OJ245FE5EU)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:0316-2064-301 in 1 CARTON05/06/2021
    189 mL in 1 TUBE; Type 0: Not a Combination Product
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC Monograph DrugM02005/06/2021
    Labeler - Crown Laboratories (079035945)
    Registrant - Crown Laboratories (079035945)
    Establishment
    NameAddressID/FEIBusiness Operations
    Crown Laboratories079035945manufacture(0316-2064)