BLUE LIZARD REGULAR  - octinoxate, octocrylene, oxybenzone and zinc oxide lotion 
Crown Laboratories

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.

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Blue Lizard Australian Sunscreen - Regular

Broad Spectrum SPF 30+

Zinc Oxide Formula

Very Water Resistant (80 minutes)Blue Lizard Regular Label

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

Octinoxate - 7.5%

Octocrylene - 2%

Oxybenzone - 3%

Zinc Oxide - 6%

BLUE LIZARD REGULAR  
sunscreen lotion
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:0316-2010
Route of AdministrationTOPICALDEA Schedule    
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
OCTINOXATE (OCTINOXATE) OCTINOXATE76.5 mg  in 1 mL
OCTOCRYLENE (OCTOCRYLENE) OCTOCRYLENE20.4 mg  in 1 mL
OXYBENZONE (OXYBENZONE) OXYBENZONE30.6 mg  in 1 mL
ZINC OXIDE (ZINC OXIDE) ZINC OXIDE61.2 mg  in 1 mL
Inactive Ingredients
Ingredient NameStrength
YELLOW WAX 
CETYL PEG/PPG-10/1 DIMETHICONE (HLB 5) 
DIAZOLIDINYL UREA 
EDETATE DISODIUM 
ETHYLHEXYL PALMITATE 
ETHYLHEXYL STEARATE 
ETHYLPARABEN 
HEXYL LAURATE 
HYDROGENATED CASTOR OIL 
METHYL GLUCOSE DIOLEATE 
METHYLPARABEN 
OCTYLDODECYL NEOPENTANOATE 
PEG-7 HYDROGENATED CASTOR OIL 
POLYGLYCERYL-4 ISOSTEARATE 
PROPYLENE GLYCOL 
PROPYLPARABEN 
WATER 
SORBITAN MONOOLEATE 
STEARIC ACID 
.ALPHA.-TOCOPHEROL ACETATE 
HEXADECYL POVIDONE (4 HEXADECYL BRANCHES/REPEAT)  
DIMETHICONE 
TRIMETHYLSILOXYSILICATE (M/Q 0.8-1.0) 
Packaging
#Item CodePackage Description
1NDC:0316-2010-105 mL in 1 PACKET
2NDC:0316-2010-157.5 mL in 1 PACKET
3NDC:0316-2010-2037 mL in 1 BOTTLE, PLASTIC
4NDC:0316-2010-3089 mL in 1 TUBE
5NDC:0316-2010-40148 mL in 1 BOTTLE, PLASTIC
6NDC:0316-2010-50259 mL in 1 BOTTLE, PLASTIC
7NDC:0316-2010-603785 mL in 1 JUG
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph finalpart35204/15/2001
Labeler - Crown Laboratories (079035945)
Registrant - Crown Laboratories (079035945)
Establishment
NameAddressID/FEIBusiness Operations
Crown Laboratories079035945manufacture(0316-2010)

Revised: 12/2012
Document Id: b3be1c82-f291-4fc8-8586-26f67b74993e
Set id: b3be1c82-f291-4fc8-8586-26f67b74993e
Version: 1
Effective Time: 20121212
 
Crown Laboratories