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

  • 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 - 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 risks 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 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

    Alanine, Aloe Barbadensis Leaf Juice, Alumina, Aluminum Stearate, Arginine, Aspartic Acid, Butyrospermum Parkii (Shea) Butter, C12-15 Alkyl Benzoate, Caprylic/Capric Triglyceride, Carica Papaya (Papaya) Fruit Extract, Citric Acid, Crithmum Maritimum Extract, Cucumis Sativus (Cucumber) Fruit Extract, Diisopropyl Sebacate, Dimethoxydiphenylsilane/ Triethoxycaprylylsilane Crosspolymer, Ethylhexylglycerin, Fucus Vesiculosus (Bladderwrack) Extract, Ginkgo Biloba (Ginkgo) Leaf Extract, Glycerin, Glycine, Glycine Soja (Soybean) Oil, Hamamelis Virginiana (Witch Hazel) Leaf Extract, Histidine, Hydrogenated Vegetable Oil, Isoleucine, Isostearyl Alcohol, Isostearyl Isostearate, Oryza Sativa (Rice) Extract, Oryza Sativa (Rice) Germ Extract, PCA, Phenoxyethanol, Phenylalanine, Polyglyceryl-3 Diisostearate, Polyglyceryl-3 Polyricinoleate, Polyhydroxystearic Acid, Potassium Sorbate, Proline, Purified Water, Rosa Canina (Rosehip) Fruit Oil, Sclerocarya Birrea (Marula) Seed Oil, Serine, Sodium Benzoate, Sodium Chloride, Sodium Hyaluronate, Sodium Lactate, Sodium PCA, Sorbitan Isostearate, Squalane, Threonine, Tocopheryl Acetate (Vitamin E), Valine, and Xanthan Gum

  • Questions ?

    Visit www.bluelizardsunscreen.com or call 800.877.8869

    Crown Laboratories, Inc., Johnson City, TN 37604

  • Blue Lizard Sheer Lotion for Face - 1.7 fl oz Tube

    BLUE LIZARD

    AUSTRALIAN SUNSCREEN

    50+

    SHEER LOTION for face

    MINERAL SUNSCREEN

    UVA/UVB PROTECTION

    BROAD SPECTRUM

    SPF 50+

    WATER RESISTANT (80 MINUTES)

    sheer-face-tube

  • Blue Lizard Sheer Lotion for face - 1.7 fl oz carton

    BLUE LIZARD

    AUSTRALIAN SUNSCREEN

    50+

    SHEER LOTION for face

    MINERAL SUNSCREEN

    UVA/UVB PROTECTION

    BROAD SPECTRUM

    SPF 50+

    WATER RESISTANT (80 MINUTES)

    p1190201

  • INGREDIENTS AND APPEARANCE
    BLUE LIZARD SHEER FACE SPF 50 SUNSCREEN 
    titanium dioxide and zinc oxide lotion
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:0316-2057
    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
    SODIUM LACTATE (UNII: TU7HW0W0QT)  
    SODIUM PYRROLIDONE CARBOXYLATE (UNII: 469OTG57A2)  
    THREONINE (UNII: 2ZD004190S)  
    VALINE (UNII: HG18B9YRS7)  
    XANTHAN GUM (UNII: TTV12P4NEE)  
    SORBITAN ISOSTEARATE (UNII: 01S2G2C1E4)  
    .ALPHA.-TOCOPHEROL ACETATE (UNII: 9E8X80D2L0)  
    HYALURONATE SODIUM (UNII: YSE9PPT4TH)  
    WATER (UNII: 059QF0KO0R)  
    SERINE (UNII: 452VLY9402)  
    SODIUM BENZOATE (UNII: OJ245FE5EU)  
    ALUMINUM STEARATE (UNII: U6XF9NP8HM)  
    ALUMINUM OXIDE (UNII: LMI26O6933)  
    ISOSTEARYL ISOSTEARATE (UNII: IV0Z586Z4Y)  
    FUCUS VESICULOSUS (UNII: 535G2ABX9M)  
    GINKGO (UNII: 19FUJ2C58T)  
    GLYCERIN (UNII: PDC6A3C0OX)  
    GLYCINE (UNII: TE7660XO1C)  
    HISTIDINE (UNII: 4QD397987E)  
    POLYGLYCERYL-3 PENTARICINOLEATE (UNII: 7Q0OK5DOT4)  
    HYDROGENATED RAPESEED OIL (UNII: K168T6Y0YU)  
    SOYBEAN OIL (UNII: 241ATL177A)  
    RICE GERM (UNII: 7N2B70SFEZ)  
    PIDOLIC ACID (UNII: SZB83O1W42)  
    POLYGLYCERYL-3 DIISOSTEARATE (UNII: 46P231IQV8)  
    ASPARTIC ACID (UNII: 30KYC7MIAI)  
    ETHYLHEXYLGLYCERIN (UNII: 147D247K3P)  
    SHEA BUTTER (UNII: K49155WL9Y)  
    PAPAYA (UNII: KU94FIY6JB)  
    CRITHMUM MARITIMUM (UNII: J7IHY79BKY)  
    ALOE VERA LEAF (UNII: ZY81Z83H0X)  
    CUCUMBER (UNII: YY7C30VXJT)  
    PHENOXYETHANOL (UNII: HIE492ZZ3T)  
    PHENYLALANINE (UNII: 47E5O17Y3R)  
    ISOLEUCINE (UNII: 04Y7590D77)  
    ISOSTEARYL ALCOHOL (UNII: Q613OCQ44Y)  
    SQUALANE (UNII: GW89575KF9)  
    SCLEROCARYA BIRREA SEED OIL (UNII: WDO4TLS35F)  
    ROSA CANINA FRUIT OIL (UNII: CR7307M3QZ)  
    PROLINE (UNII: 9DLQ4CIU6V)  
    SODIUM CHLORIDE (UNII: 451W47IQ8X)  
    ALKYL (C12-15) BENZOATE (UNII: A9EJ3J61HQ)  
    CITRIC ACID MONOHYDRATE (UNII: 2968PHW8QP)  
    DIISOPROPYL SEBACATE (UNII: J8T3X564IH)  
    HAMAMELIS VIRGINIANA LEAF (UNII: T07U1161SV)  
    TRIETHOXYCAPRYLYLSILANE (UNII: LDC331P08E)  
    POTASSIUM SORBATE (UNII: 1VPU26JZZ4)  
    DIMETHOXYDIPHENYLSILANE (UNII: 02QB6788GC)  
    POLYHYDROXYSTEARIC ACID (2300 MW) (UNII: YXH47AOU0F)  
    HYDROGENATED PALM OIL (UNII: 257THB963H)  
    ALANINE (UNII: OF5P57N2ZX)  
    ARGININE (UNII: 94ZLA3W45F)  
    MEDIUM-CHAIN TRIGLYCERIDES (UNII: C9H2L21V7U)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:0316-2057-171 in 1 CARTON05/13/2021
    148 mL in 1 TUBE; Type 0: Not a Combination Product
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph not finalpart35205/13/2021
    Labeler - Crown Laboratories (079035945)
    Establishment
    NameAddressID/FEIBusiness Operations
    Crown Laboratories079035945manufacture(0316-2057)