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

  • NDC Code(s): 0316-2072-30, 0316-2072-40, 0316-2072-45, 0316-2072-50
  • Packager: Crown Laboratories
  • 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 14, 2021

If you are a consumer or patient 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

    • 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

    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 Active 5oz Tube

    BLUE LIZARD

    AUSTRALIAN SUNSCREEN

    50+

    UVA/UVB PROTECTION

    BROAD SPECTRUM

    SPF 50+

    ACTIVE

    mineral-based sunscreen

    combining mineral and chemical UV protectors

    Smart Cap TECHNOLOGY

    CAP CHANGES COLOR IN HARMFUL UV LIGHT

    WATER RESISTANT (80 MINUTES)

    P11863.00

    5oz-tube

  • INGREDIENTS AND APPEARANCE
    BLUE LIZARD ACTIVE SPF 50 SUNSCREEN 
    octisalate and titanium dioxide and zinc oxide lotion
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:0316-2072
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    OCTISALATE (UNII: 4X49Y0596W) (OCTISALATE - UNII:4X49Y0596W) OCTISALATE55.5 mg  in 1 mL
    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
    Inactive Ingredients
    Ingredient NameStrength
    MEDIUM-CHAIN TRIGLYCERIDES (UNII: C9H2L21V7U)  
    ALUMINUM OXIDE (UNII: LMI26O6933)  
    ALUMINUM STEARATE (UNII: U6XF9NP8HM)  
    TRIETHOXYCAPRYLYLSILANE (UNII: LDC331P08E)  
    YELLOW WAX (UNII: 2ZA36H0S2V)  
    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)  
    CAPRYLYL GLYCOL (UNII: 00YIU5438U)  
    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)  
    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)  
    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)  
    ISOSTEARYL ISOSTEARATE (UNII: IV0Z586Z4Y)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:0316-2072-3089 mL in 1 TUBE; Type 0: Not a Combination Product05/01/2021
    2NDC:0316-2072-50259 mL in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product05/01/2021
    3NDC:0316-2072-45148 mL in 1 TUBE; Type 0: Not a Combination Product02/09/2021
    4NDC:0316-2072-401 in 1 CARTON02/24/2021
    4148 mL in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph not finalpart35202/09/2021
    Labeler - Crown Laboratories (079035945)
    Establishment
    NameAddressID/FEIBusiness Operations
    Crown Laboratories079035945manufacture(0316-2072)