Label: BLUE LIZARD SPORT SUNSCREEN- octocrylene and zinc oxide lotion

  • NDC Code(s): 0316-2021-10, 0316-2021-30, 0316-2021-40, 0316-2021-45, view more
    0316-2021-50, 0316-2021-60
  • 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 February 13, 2023

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  • Active Ingredients

    Octocrylene - 4%

    Zinc Oxide - 9.7%

  • 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
  • Other Information

    • Protect the product in this container from excessive heat and direct sun
    • May stain some fabrics
  • Inactive Ingredients:

    Beeswax, Caprylyl Glycol, Cetyl Dimethicone, Cetyl PEG/PPG-10/1 Dimethicone, Chlorphenesin, Dimethicone, Disodium EDTA, Ethylhexyl Palmitate, Ethylhexyl Stearate, Hexyl Laurate, Hydrogenated Castor Oil, Methyl Glucose Dioleate, Octyldodecyl Neopentanoate, PEG-7 Hydrogenated Castor Oil, Phenoxyethanol, Polyglyceryl-4 Isostearate, Propanediol, Purified Water, Sorbitan Oleate, Stearic Acid, Tocopheryl Acetate (Vitamin E), Triethoxycaprylylsilane, Trimethylsiloxysilicate, VP Hexadecene Copolymer

  • Questions?

    Visit www.bluelizardsunscreen.com or call 800.877.8869

    Crown Laboratories, Inc., Johnson City, TN 37604

  • Blue Lizard Sport 3oz Label

    BLUE LIZARD

    AUSTRALIAN SUNSCREEN

    30+

    UVA/UVB PROTECTION

    BROAD SPECTRUM

    SPF 30+

    TRUSTED BY DERMATOLOGISTS FOR OVER 20 YEARS

    SPORT

    mineral-based sunscreen

    combining mineral and chemical UV protectors for water-resistance performance you can trust.

    Smart Cap TECHNOLOGY

    CAP CHANGES COLOR IN HARMFUL UV LIGHT

    WATER RESISTANT (80 MINUTES)

    P11449.02

    p1144902

  • INGREDIENTS AND APPEARANCE
    BLUE LIZARD SPORT SUNSCREEN 
    octocrylene and zinc oxide lotion
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:0316-2021
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    OCTOCRYLENE (UNII: 5A68WGF6WM) (OCTOCRYLENE - UNII:5A68WGF6WM) OCTOCRYLENE41.8 mg  in 1 mL
    ZINC OXIDE (UNII: SOI2LOH54Z) (ZINC OXIDE - UNII:SOI2LOH54Z) ZINC OXIDE104.5 mg  in 1 mL
    Inactive Ingredients
    Ingredient NameStrength
    CHLORPHENESIN (UNII: I670DAL4SZ)  
    ETHYLHEXYL PALMITATE (UNII: 2865993309)  
    HYDROGENATED CASTOR OIL (UNII: ZF94AP8MEY)  
    YELLOW WAX (UNII: 2ZA36H0S2V)  
    CETYL PEG/PPG-10/1 DIMETHICONE (HLB 5) (UNII: 035JKJ76MT)  
    ETHYLHEXYL STEARATE (UNII: EG3PA2K3K5)  
    DIMETHICONE (UNII: 92RU3N3Y1O)  
    CAPRYLYL GLYCOL (UNII: 00YIU5438U)  
    HEXADECYL POVIDONE (4 HEXADECYL BRANCHES/REPEAT) (UNII: AG75W62QYU)  
    WATER (UNII: 059QF0KO0R)  
    .ALPHA.-TOCOPHEROL ACETATE (UNII: 9E8X80D2L0)  
    SORBITAN MONOOLEATE (UNII: 06XEA2VD56)  
    STEARIC ACID (UNII: 4ELV7Z65AP)  
    TRIMETHYLSILOXYSILICATE (M/Q 0.8-1.0) (UNII: 25LXE464L2)  
    HEXYL LAURATE (UNII: 4CG9F9W01Q)  
    METHYL GLUCOSE DIOLEATE (UNII: FA9KFJ4Z6P)  
    PEG-7 HYDROGENATED CASTOR OIL (UNII: WE09129TH5)  
    EDETATE DISODIUM (UNII: 7FLD91C86K)  
    OCTYLDODECYL NEOPENTANOATE (UNII: X8725R883T)  
    PHENOXYETHANOL (UNII: HIE492ZZ3T)  
    POLYGLYCERYL-4 ISOSTEARATE (UNII: 820DPX33S7)  
    PROPANEDIOL (UNII: 5965N8W85T)  
    TRIETHOXYCAPRYLYLSILANE (UNII: LDC331P08E)  
    CETYL DIMETHICONE 25 (UNII: U4AS1BW4ZB)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:0316-2021-105 mL in 1 PACKET; Type 0: Not a Combination Product01/02/2019
    2NDC:0316-2021-3089 mL in 1 TUBE; Type 0: Not a Combination Product01/02/2019
    3NDC:0316-2021-401 in 1 CARTON01/02/2019
    3148 mL in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product
    4NDC:0316-2021-50259 mL in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product01/02/2019
    5NDC:0316-2021-603785 mL in 1 JUG; Type 0: Not a Combination Product01/02/201901/31/2022
    6NDC:0316-2021-45148 mL in 1 TUBE; Type 0: Not a Combination Product01/02/201911/30/2022
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph not finalpart35201/02/2019
    Labeler - Crown Laboratories (079035945)
    Establishment
    NameAddressID/FEIBusiness Operations
    Crown Laboratories079035945manufacture(0316-2021)
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