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%

Purpose and UseSunscreen

 - Provides high protection against sunburn
 - Helps prevent sunburn photodamage caused by UVA/UVB exposure
 - Higher SPF gives more sunburn protection

Warnings

- For topical use only

- When using this product keep out of eyes. Rinse with water to remove

- Stop use and ask a doctor if rash or irritation develops and lasts

- Keep out of the reach of children

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

- Do not use if allergic to any ingredient

Keep out of Reach of Children

 

Stop using and ask a doctor if rash develops and lasts

Pediatric Use

Children under 6 months of age; ask a doctor

Directions

- Shake well before each use

- Apply liberally to dry skin before sun exposure

- Reapply to dry skin as needed or after towel drying, swimming, or sweating

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

Made in the USA

Manufactured by:
Crown Laboratories, Inc.
Johnson City, TN 37604
800.334.4286

Distributed by:
Del-Ray Dermatologicals
Johnson City, TN 37604
United States

www.bluelizard.net

www.delrayderm.com

800.877.8869

Principal Display Panel

Blue Lizard

Australian Sunscreen

Face

Daily Moisturizer

SPF 30+

Bottle turns blue in UV light

Zinc Oxide Formulation

UVA/UVB Protection

Antioxidant Enriched

Oil Free/Non-greasy

Fragrance Free

Paraben Free

Dermatologist Recommended

5oz (141.7g)

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

Revised: 11/2011
 
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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