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

Drug Label Information

Updated December 5, 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
    • 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:

    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)

    Mineral-Based Sunscreen

    Combining mineral and chemical UV protectors for water-resistant performance you can trust.

    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 DrugM02001/02/2019
    Labeler - Crown Laboratories (079035945)
    Establishment
    NameAddressID/FEIBusiness Operations
    Crown Laboratories079035945manufacture(0316-2021)
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