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

  • Label RSS
  • NDC Code(s): 0316-2035-10, 0316-2035-20, 0316-2035-30, 0316-2035-40, view more
    0316-2035-50, 0316-2035-60
  • Packager: Crown Laboratories
  • Category: HUMAN OTC DRUG LABEL
  • DEA Schedule: None
  • Marketing Status: OTC monograph final

NOTE: Most over the counter (OTC) are not reviewed and approved by the 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 01/13

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

  • Active Ingredients

    Titanium Dioxide - 5%

    Zinc Oxide - 10%

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  • Questions

    Questions: Visit www.bluelizard.net or Call Toll Free 800.877.8869

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  • Drug Facts - Uses

    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
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  • Drug Facts - Warnings, Directions, and Other Information

    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 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 the 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:
    • At least every two hours
    • Use a water resistant sunscreen if swimming or sweating

    Other Information:

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

    Inactive Ingredients:

    Beeswax, C12-15 Alkyl Benzoate, Caprylyl Glycol, Cetyl Dimethicone, Cetyl Dimethicone Copolyol, Chlorphenesin, Disodium EDTA, Ethylhexyl Palmititate, Ethylhexyl Stearate, Hexyl Laurate, Hydrogenated Castor Oil, Methyl Glucose Dioleate, Octododecyl Neopentanoate, PEG-7 Hydrogenated Castor Oil, Phenoxyethanol, Polyglyeryl-4 Isostearate, Propanediol, Purified Water, Sorbitan Oleate, Stearic Acid, Tocopheryl Acetate (Vitamin E), Trimethylated Silica/Dimethicone, VP Hexadecene Copolymer

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  • Blue Lizard Baby 5oz Label

    Blue Lizard Australian Sunscreen - Baby

    Broad Spectrum SPF 30+

    Zinc Oxide and Titanium Dioxide Formula

    Paraben Free Chemical Free Fragrance Free

    BLBABY5oz.jpgBlue Lizard Baby 5oz Label

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  • INGREDIENTS AND APPEARANCE
    BLUE LIZARD BABY 
    titanium dioxide and zinc oxide lotion
    Product Information
    Product Type HUMAN OTC DRUG LABEL Item Code (Source) NDC:0316-2035
    Route of Administration TOPICAL DEA Schedule     
    Active Ingredient/Active Moiety
    Ingredient Name Basis of Strength Strength
    TITANIUM DIOXIDE (TITANIUM DIOXIDE) TITANIUM DIOXIDE 54 mg  in 1 mL
    ZINC OXIDE (ZINC OXIDE) ZINC OXIDE 108 mg  in 1 mL
    Inactive Ingredients
    Ingredient Name Strength
    YELLOW WAX  
    CETYL PEG/PPG-10/1 DIMETHICONE (HLB 5)  
    ALKYL (C12-15) BENZOATE  
    EDETATE DISODIUM  
    ETHYLHEXYL PALMITATE  
    ETHYLHEXYL STEARATE  
    CAPRYLYL GLYCOL  
    HEXYL LAURATE  
    HYDROGENATED CASTOR OIL  
    METHYL GLUCOSE DIOLEATE  
    CHLORPHENESIN  
    OCTYLDODECYL NEOPENTANOATE  
    PEG-7 HYDROGENATED CASTOR OIL  
    POLYGLYCERYL-4 ISOSTEARATE  
    PHENOXYETHANOL  
    PROPANEDIOL  
    WATER  
    SORBITAN MONOOLEATE  
    STEARIC ACID  
    .ALPHA.-TOCOPHEROL ACETATE  
    DIMETHICONE  
    TRIMETHYLSILOXYSILICATE (M/Q 0.8-1.0)  
    HEXADECYL POVIDONE (4 HEXADECYL BRANCHES/REPEAT)  
    Packaging
    # Item Code Package Description Marketing Start Date Marketing End Date
    1 NDC:0316-2035-20 37 mL in 1 BOTTLE, PLASTIC
    2 NDC:0316-2035-30 89 mL in 1 TUBE
    3 NDC:0316-2035-40 148 mL in 1 BOTTLE, PLASTIC
    4 NDC:0316-2035-50 259 mL in 1 BOTTLE, PLASTIC
    5 NDC:0316-2035-60 3785 mL in 1 JUG
    6 NDC:0316-2035-10 5 mL in 1 PACKET
    Marketing Information
    Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
    OTC monograph final part352 12/08/2003
    Labeler - Crown Laboratories (079035945)
    Registrant - Crown Laboratories (079035945)
    Establishment
    Name Address ID/FEI Business Operations
    Crown Laboratories 079035945 manufacture(0316-2035)
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