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

  • NDC Code(s): 0316-2036-10, 0316-2036-30, 0316-2036-40, 0316-2036-45, view more
    0316-2036-46, 0316-2036-50
  • Packager: Crown Laboratories
  • Category: HUMAN OTC DRUG LABEL
  • DEA Schedule: None

Drug Label Information

Updated November 25, 2024

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

  • Active Ingredients

    Titanium Dioxide 8%

    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

    • 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

    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.bluelizardsunscreen.com or call 800.877.8869

    Crown Laboratories, Inc., Johnson City, TN 37604

  • Blue Lizard Baby 3oz Tube

    BLUE LIZARD

    AUSTRALIAN SUNSCREEN

    50+

    UVA/UVB PROTECTION

    BROAD SPECTRUM SPF 50+

    No. 1 PEDIATRICIAN RECOMMENDED

    mineral-based sunscreen brand

    BABY

    mineral sunscreen

    Smart Cap TECHNOLOGY

    CAP CHANGES COLOR IN HARMFUL UV LIGHT

    WATER RESISTANT (80 MINUTES)

    3fl oz (89ml)

    Mineral Sunscreen

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

    P11642.01

    p116472

  • INGREDIENTS AND APPEARANCE
    BLUE LIZARD BABY SPF 50 SUNSCREEN 
    titanium dioxide and zinc oxide lotion
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:0316-2036
    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
    ALUMINUM OXIDE (UNII: LMI26O6933)  
    ALUMINUM STEARATE (UNII: U6XF9NP8HM)  
    TRIETHOXYCAPRYLYLSILANE (UNII: LDC331P08E)  
    YELLOW WAX (UNII: 2ZA36H0S2V)  
    CETYL PEG/PPG-10/1 DIMETHICONE (HLB 5) (UNII: 035JKJ76MT)  
    ALKYL (C12-15) BENZOATE (UNII: A9EJ3J61HQ)  
    EDETATE DISODIUM (UNII: 7FLD91C86K)  
    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)  
    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)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:0316-2036-3089 mL in 1 TUBE; Type 0: Not a Combination Product02/17/2020
    2NDC:0316-2036-40148 mL in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product01/29/2020
    3NDC:0316-2036-50259 mL in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product02/24/202004/30/2024
    4NDC:0316-2036-105 mL in 1 PACKET; Type 0: Not a Combination Product03/02/2020
    5NDC:0316-2036-45148 mL in 1 TUBE; Type 0: Not a Combination Product02/17/202002/17/2020
    6NDC:0316-2036-46148 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(0316-2036)