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

  • NDC Code(s): 0316-2046-10, 0316-2046-30, 0316-2046-40, 0316-2046-45, view more
    0316-2046-50
  • Packager: Crown Laboratories
  • Category: HUMAN OTC DRUG LABEL
  • DEA Schedule: None

Drug Label Information

Updated December 5, 2023

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

View All Sections
  • Active ingredients

    Titanium Dioxide 8%

    Zinc Oxide 10%

  • Purpose

    Sunscreen

  • Uses

    • helps prevent sunburn
  • Warnings

    For external use only

    Do not use

    • on damaged or broken skin

    When using this product

    • keep out of eyes. Rinse with water to remove

    Stop use and ask a doctor if

    • rash occurs

    Keep out of reach of children.

    If swallowed, get medical help or contact a Poison Control Center right away

  • Directions

    • shake well prior to use

    • Apply liberally 15 minutes before sun exposure

    • 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: l

    • limit time in the sun, especially from 10 a.m. - 2 p.m.
    • wear long-sleeved shirts, pants, hats, and sunglasses.

    • reapply:

    • 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, 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?

    Call 800.877.8869 or visit www.bluelizardsunscreen.com

    Crown Laboratories, Inc., Johnson City, TN 37604

  • Blue Lizard Sensitive 3oz Tube

    BLUE LIZARD

    AUSTRALIAN SUNSCREEN

    50+

    UVA/UVB PROTECTION

    BROAD SPECTRUM SPF 50+

    TRUSTED BY DERMATOLOGISTS FOR OVER 20 YEARS

    SENSITIVE

    mineral sunscreen

    Smart Cap TECHNOLOGY

    CAP CHANGES COLOR IN HARMFUL UV LIGHT

    WATER RESISTANT (80 MINUTES)

    3fl oz (89ml)

    P11661.03

    BL Sensitive SPF 50 P11661_03

  • INGREDIENTS AND APPEARANCE
    BLUE LIZARD SENSITIVE SPF 50 SUNSCREEN 
    titanium dioxide and zinc oxide lotion
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:0316-2046
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    TITANIUM DIOXIDE (UNII: 15FIX9V2JP) (TITANIUM DIOXIDE - UNII:15FIX9V2JP) TITANIUM DIOXIDE89.6 mg  in 1 mL
    ZINC OXIDE (UNII: SOI2LOH54Z) (ZINC OXIDE - UNII:SOI2LOH54Z) ZINC OXIDE112 mg  in 1 mL
    Inactive Ingredients
    Ingredient NameStrength
    PEG-7 HYDROGENATED CASTOR OIL (UNII: WE09129TH5)  
    POLYGLYCERYL-4 ISOSTEARATE (UNII: 820DPX33S7)  
    PHENOXYETHANOL (UNII: HIE492ZZ3T)  
    STEARIC ACID (UNII: 4ELV7Z65AP)  
    PROPANEDIOL (UNII: 5965N8W85T)  
    WATER (UNII: 059QF0KO0R)  
    SORBITAN MONOOLEATE (UNII: 06XEA2VD56)  
    .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)  
    POLYHYDROXYSTEARIC ACID (2300 MW) (UNII: YXH47AOU0F)  
    CETYL DIMETHICONE 25 (UNII: U4AS1BW4ZB)  
    ALUMINUM STEARATE (UNII: U6XF9NP8HM)  
    TRIETHOXYCAPRYLYLSILANE (UNII: LDC331P08E)  
    ETHYLHEXYL PALMITATE (UNII: 2865993309)  
    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)  
    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)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:0316-2046-105 mL in 1 PACKET; Type 0: Not a Combination Product03/02/2020
    2NDC:0316-2046-3089 mL in 1 TUBE; Type 0: Not a Combination Product02/17/2020
    3NDC:0316-2046-40148 mL in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product01/29/2020
    4NDC:0316-2046-50259 mL in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product02/24/2020
    5NDC:0316-2046-45148 mL in 1 TUBE; Type 0: Not a Combination Product02/17/2020
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC Monograph DrugM02001/29/2020
    Labeler - Crown Laboratories (079035945)
    Establishment
    NameAddressID/FEIBusiness Operations
    Crown Laboratories079035945manufacture(0316-2046)
View All Sections

Find additional resources

(also available in the left menu)

Safety

Report Adverse Events, FDA Safety Recalls, Presence in Breast Milk

Related Resources

Medline Plus, Clinical Trials, PubMed, Biochemical Data Summary

More Info on this Drug

View Labeling Archives, RxNorm, Get Label RSS Feed, View NDC Code(s)NEW!