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Blue Lizard Face

Dosage form: gel
Ingredients: OCTINOXATE 55mg in 1g, ZINC OXIDE 80mg in 1g
Labeler: Crown Laboratories
NDC Code: 0316-2055

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.

Blue Lizard Face

Active Ingredients

Octinoxate 5.5%

Zinc Oxide 8.0%

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 
  • Keep out of reach of children
  • 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
  • At least every 2 hours 
  • Use a water resistant sunscreen if swimming or sweating

Other Information
  • Protect the product in this container from excessive heat and direct sun 
  • May stain some fabrics

Inactive Ingredients

Beeswax, C12-15 Alkyl Benzoate, C13-14 Isoparaffin, Caffeine, Camellia sinesis Leaf (Green Tea) Extract, Caprylyl Glycol, Chlorphenesin, Cyclomethicone, Hyaluronic Acid, Laureth-7, Lauryl PEG/PPG 18/18 Methicone, Phenoxyethanol, Polyacrylamide, Purified Water, and Tocopheryl Acetate (Vitamin E)

Questions?

Visit www.bluelizard.net or call 800.877.8869

Crown Laboratories, Inc., Johnson City, TN 37604

Patents: US#6698590 & 6405867; AU#1998083259

Blue Lizard Face Label

Blue Lizard

Australian Sunscreen

Face

Broad Spectrum SPF 30+

UVA/UVB Protection

Bottle turns blue in UV light

Zinc Oxide Formulation

Antioxidant Enriched

No Parabens

No Fragrances

Dermatologist Recommended

BLUE LIZARD FACE 
sunscreen gel
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:0316-2055
Route of AdministrationTOPICALDEA Schedule    
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
OCTINOXATE (OCTINOXATE) OCTINOXATE55 mg  in 1 g
ZINC OXIDE (ZINC OXIDE) ZINC OXIDE80 mg  in 1 g
Inactive Ingredients
Ingredient NameStrength
WATER 
ALKYL (C12-15) BENZOATE 
CYCLOMETHICONE 
C13-14 ISOPARAFFIN 
LAURETH-7 
ALPHA-TOCOPHEROL ACETATE 
HYALURONIC ACID 
GREEN TEA LEAF 
YELLOW WAX 
CAFFEINE  
PHENOXYETHANOL 
CAPRYLYL GLYCOL 
CHLORPHENESIN 
LAURYL PEG/PPG-18/18 METHICONE 
Packaging
#Item CodePackage Description
1NDC:0316-2055-2035.4 g in 1 BOTTLE, PLASTIC
2NDC:0316-2055-105 g in 1 POUCH
3NDC:0316-2055-3085 g in 1 TUBE
4NDC:0316-2055-40141.7 g in 1 BOTTLE, PLASTIC
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph not finalpart35204/06/2010
Labeler - Crown Laboratories (079035945)
Registrant - Crown Laboratories (079035945)
Establishment
NameAddressID/FEIOperations
Crown Laboratories079035945manufacture(0316-2055)

Revised: 12/2014
 
Crown Laboratories

Disclaimer: Every effort has been made to ensure that the information provided here is accurate, up-to-date and complete, but no guarantee is made to that effect. Drug information contained herein may be time sensitive. This information has been compiled for use by healthcare practitioners and consumers in the United States. The absence of a warning for a given drug or combination thereof in no way should be construed to indicate that the drug or combination is safe, effective or appropriate for any given patient. If you have questions about the substances you are taking, check with your doctor, nurse or pharmacist.

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