Label: BLUE LIZARD KIDS SPF 50 SUNSCREEN- octisalate and titanium dioxide and zinc oxide lotion

  • NDC Code(s): 0316-2062-30, 0316-2062-40, 0316-2062-45, 0316-2062-50
  • 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

    Octisalate 5%

    Titanium Dioxide 5.36%

    Zinc Oxide 10%

  • 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

    • 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

    Alumina, Aluminum Stearate, Beeswax, Butyloctyl Salicylate, C12-15 Alkyl Benzoate, Capylic/Capric Triglyceride, Caprylyl Glycol, Cetyl Dimethicone, Cetyl PEG/PPG-10/1 Dimethicone, Diisopropyl Sebacate, Dimethicone, Disodium EDTA, Ethylhexylglycerin, Hexyl Laurate, Hydrogenated Castor Oil, Isostearyl Isostearate, L-Arginine, Methyl Glucose Dioleate, Methylpropanediol, Octyldodecyl Neopentanoate, PEG-7 Hydrogenated Castor Oil, Phenoxyethanol, Phenylpropanol, Polyglyceryl-4 Isostearate, Polyhydroxystearic Acid, Polyurethane-35, Propanediol, Purified Water, Sorbitan Oleate, Stearic Acid, Tocopheryl Acetate, Triethoxycaprylylsilane, Trimethylsiloxysilicate, VP Hexadecene Copolymer

  • Questions?

    Visit www.bluelizardsunscreen.com or call 800.877.8869

    Crown Laboratories, Inc., Johnson City, TN 37604

  • Blue Lizard Kids 5oz Tube

    BLUE LIZARD

    AUSTRALIAN SUNSCREEN

    50+

    UVA/UVB PROTECTION

    BROAD SPECTRUM SPF 50+

    No. 1 pediatrician recommended mineral-based sunscreen brand

    KIDS

    mineral-based sunscreen

    combining mineral and chemical UV protectors

    Smart Cap TECHNOLOGY

    CAP CHANGES COLOR IN HARMFUL UV LIGHT

    WATER RESISTANT (80 MINUTES)

    P11778.01

    p1177801

  • INGREDIENTS AND APPEARANCE
    BLUE LIZARD KIDS SPF 50 SUNSCREEN 
    octisalate and titanium dioxide and zinc oxide lotion
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:0316-2062
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    TITANIUM DIOXIDE (UNII: 15FIX9V2JP) (TITANIUM DIOXIDE - UNII:15FIX9V2JP) TITANIUM DIOXIDE59.5 mg  in 1 mL
    ZINC OXIDE (UNII: SOI2LOH54Z) (ZINC OXIDE - UNII:SOI2LOH54Z) ZINC OXIDE111 mg  in 1 mL
    OCTISALATE (UNII: 4X49Y0596W) (OCTISALATE - UNII:4X49Y0596W) OCTISALATE55.5 mg  in 1 mL
    Inactive Ingredients
    Ingredient NameStrength
    POLYGLYCERYL-4 ISOSTEARATE (UNII: 820DPX33S7)  
    PHENOXYETHANOL (UNII: HIE492ZZ3T)  
    PROPANEDIOL (UNII: 5965N8W85T)  
    WATER (UNII: 059QF0KO0R)  
    SORBITAN MONOOLEATE (UNII: 06XEA2VD56)  
    STEARIC ACID (UNII: 4ELV7Z65AP)  
    .ALPHA.-TOCOPHEROL ACETATE (UNII: 9E8X80D2L0)  
    DIMETHICONE (UNII: 92RU3N3Y1O)  
    TRIMETHYLSILOXYSILICATE (M/Q 0.8-1.0) (UNII: 25LXE464L2)  
    HEXADECYL POVIDONE (4 HEXADECYL BRANCHES/REPEAT) (UNII: AG75W62QYU)  
    POLYHYDROXYSTEARIC ACID (2300 MW) (UNII: YXH47AOU0F)  
    CETYL DIMETHICONE 25 (UNII: U4AS1BW4ZB)  
    ISOSTEARYL ISOSTEARATE (UNII: IV0Z586Z4Y)  
    ETHYLHEXYLGLYCERIN (UNII: 147D247K3P)  
    PHENYLPROPANOL (UNII: 0F897O3O4M)  
    DIISOPROPYL SEBACATE (UNII: J8T3X564IH)  
    POLYURETHANE-35 (NOT MORE THAN 500 MPA.S AT 40%) (UNII: Q2LKX89BE0)  
    BUTYLOCTYL SALICYLATE (UNII: 2EH13UN8D3)  
    MEDIUM-CHAIN TRIGLYCERIDES (UNII: C9H2L21V7U)  
    YELLOW WAX (UNII: 2ZA36H0S2V)  
    ALUMINUM OXIDE (UNII: LMI26O6933)  
    ALUMINUM STEARATE (UNII: U6XF9NP8HM)  
    TRIETHOXYCAPRYLYLSILANE (UNII: LDC331P08E)  
    CAPRYLYL GLYCOL (UNII: 00YIU5438U)  
    ARGININE (UNII: 94ZLA3W45F)  
    METHYLPROPANEDIOL (UNII: N8F53B3R4R)  
    CETYL PEG/PPG-10/1 DIMETHICONE (HLB 5) (UNII: 035JKJ76MT)  
    ALKYL (C12-15) BENZOATE (UNII: A9EJ3J61HQ)  
    EDETATE DISODIUM (UNII: 7FLD91C86K)  
    HEXYL LAURATE (UNII: 4CG9F9W01Q)  
    HYDROGENATED CASTOR OIL (UNII: ZF94AP8MEY)  
    METHYL GLUCOSE DIOLEATE (UNII: FA9KFJ4Z6P)  
    OCTYLDODECYL NEOPENTANOATE (UNII: X8725R883T)  
    PEG-7 HYDROGENATED CASTOR OIL (UNII: WE09129TH5)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:0316-2062-3089 mL in 1 TUBE; Type 0: Not a Combination Product05/01/2021
    2NDC:0316-2062-401 in 1 CARTON05/01/2021
    2148 mL in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product
    3NDC:0316-2062-50259 mL in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product05/01/2021
    4NDC:0316-2062-45148 mL in 1 TUBE; Type 0: Not a Combination Product02/09/2021
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC Monograph DrugM02002/09/2021
    Labeler - Crown Laboratories (079035945)
    Establishment
    NameAddressID/FEIBusiness Operations
    Crown Laboratories079035945manufacture(0316-2062)