Label: BLUE LIZARD SENSITIVE SUNSCREEN- titanium dioxide and zinc oxide lotion

  • NDC Code(s): 0316-2045-10, 0316-2045-30, 0316-2045-40, 0316-2045-45, view more
    0316-2045-50, 0316-2045-60
  • 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 October 11, 2021

If you are a consumer or patient please visit this version.

  • Active Ingredients

    Titanium Dioxide - 5%

    Zinc Oxide - 10%

  • 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 of age: 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 40 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, C12-15 Alkyl Benzoate, 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, Polyhydroxystearic Acid, Propanediol, Purified Water, Sorbitan Oleate, Stearic Acid, Tocopheryl Acetate (Vitamin E), Triethoxycaprylylsilane, Trimethylsiloxysilicate, VP Hexadecene Copolymer

  • Questions ?

    Visit www.bluelizard.net or call 800.877.8869

    Crown Laboratories, Inc., Johnson City, TN 37604

  • Blue Lizard Sensitive 5oz Label

    BLUE LIZARD

    AUSTRALIAN SUNSCREEN

    30+

    UVA/UVB PROTECTION

    BROAD SPECTRUM

    SPF 30+

    TRUSTED BY DERMATOLOGISTS FOR OVER 20 YEARS

    SENSITIVE

    Mineral Sunscreen

    Protects your skin by acting like thousands of tiny shields that reflect UV rays.

    Smart Cap TECHNOLOGY

    CAP TURNS BLUE IN HARMFUL UV LIGHT

    WATER RESISTANT (40 MINUTES)

    P6047.13

    P604713

  • INGREDIENTS AND APPEARANCE
    BLUE LIZARD SENSITIVE SUNSCREEN 
    titanium dioxide and zinc oxide lotion
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:0316-2045
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    TITANIUM DIOXIDE (UNII: 15FIX9V2JP) (TITANIUM DIOXIDE - UNII:15FIX9V2JP) TITANIUM DIOXIDE54 mg  in 1 mL
    ZINC OXIDE (UNII: SOI2LOH54Z) (ZINC OXIDE - UNII:SOI2LOH54Z) ZINC OXIDE108 mg  in 1 mL
    Inactive Ingredients
    Ingredient NameStrength
    ETHYLHEXYL PALMITATE (UNII: 2865993309)  
    ETHYLHEXYL STEARATE (UNII: EG3PA2K3K5)  
    CAPRYLYL GLYCOL (UNII: 00YIU5438U)  
    HEXYL LAURATE (UNII: 4CG9F9W01Q)  
    HYDROGENATED CASTOR OIL (UNII: ZF94AP8MEY)  
    METHYL GLUCOSE DIOLEATE (UNII: FA9KFJ4Z6P)  
    CHLORPHENESIN (UNII: I670DAL4SZ)  
    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)  
    HEXADECYL POVIDONE (4 HEXADECYL BRANCHES/REPEAT) (UNII: AG75W62QYU)  
    DIMETHICONE (UNII: 92RU3N3Y1O)  
    TRIMETHYLSILOXYSILICATE (M/Q 0.8-1.0) (UNII: 25LXE464L2)  
    CETYL DIMETHICONE 25 (UNII: U4AS1BW4ZB)  
    POLYHYDROXYSTEARIC ACID (2300 MW) (UNII: YXH47AOU0F)  
    ALUMINUM STEARATE (UNII: U6XF9NP8HM)  
    TRIETHOXYCAPRYLYLSILANE (UNII: LDC331P08E)  
    ALUMINUM OXIDE (UNII: LMI26O6933)  
    YELLOW WAX (UNII: 2ZA36H0S2V)  
    ALKYL (C12-15) BENZOATE (UNII: A9EJ3J61HQ)  
    CETYL PEG/PPG-10/1 DIMETHICONE (HLB 5) (UNII: 035JKJ76MT)  
    EDETATE DISODIUM (UNII: 7FLD91C86K)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:0316-2045-105 mL in 1 PACKET; Type 0: Not a Combination Product04/01/2004
    2NDC:0316-2045-3089 mL in 1 TUBE; Type 0: Not a Combination Product01/03/2006
    3NDC:0316-2045-40148 mL in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product12/08/2003
    4NDC:0316-2045-50259 mL in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product01/03/2005
    5NDC:0316-2045-603785 mL in 1 JUG; Type 0: Not a Combination Product02/02/200405/31/2022
    6NDC:0316-2045-45148 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 finalpart35212/08/2003
    Labeler - Crown Laboratories (079035945)
    Registrant - Crown Laboratories (079035945)
    Establishment
    NameAddressID/FEIBusiness Operations
    Crown Laboratories079035945manufacture(0316-2045)