BLUE LIZARD REGULAR- sunscreen 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 Regular

Active Ingredients

Octinoxate - 7.5%

Octocrylene - 2%

Oxybenzone - 3%

Zinc Oxide - 6%

Uses

Warnings

Directions

Other Information

Inactive Ingredients

Beeswax, BHT, Cetyl Dimethicone, Cetyl PEG/PPG 10/1 Dimethicone, Diazolidinyl Urea, Dimethicone, Disodium EDTA, Ethylhexyl Palmitate, Ethylhexyl Stearate, Ethylparaben, Fragrance, Hexyl Laurate, Hydrogenated Castor Oil, Methyl Glucose Dioleate, Methylparaben, Octyldodecyl Neopentanoate, PEG-7 Hydrogenated Castor Oil, Polyglyceryl-4 Isostearate, Propylene Glycol, Propylparaben, Purified Water, Sorbitan Oleate, Stearic Acid, Tocopheryl Acetate (Vitamin E), Triethoxycaprylylsilane, Trimethylsiloxysilicate, VP Hexadecene Copolymer

Questions ?

Visit www.bluelizard.net or call 800.877.8869

Crown Laboratories, Inc., Johnson City, TN 37604

Patent: US#6698590

Blue Lizard Regular Label

Blue Lizard

Australian Sunscreen

UVA/UVB Protection

Broad Spectrum SPF 30+

Trusted by Dermatologist for over 20 years

REGULAR

mineral-based sunscreen

combining mineral and chemical UV protectors

Smart Bottle Technology

Bottle Turns Blue in UV Light

Water Resistant (80 minutes)

blreg5oz

BLUE LIZARD REGULAR 
sunscreen lotion
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:0316-2010
Route of AdministrationTOPICAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
OCTINOXATE (UNII: 4Y5P7MUD51) (OCTINOXATE - UNII:4Y5P7MUD51) OCTINOXATE76.5 mg  in 1 mL
OCTOCRYLENE (UNII: 5A68WGF6WM) (OCTOCRYLENE - UNII:5A68WGF6WM) OCTOCRYLENE20.4 mg  in 1 mL
OXYBENZONE (UNII: 95OOS7VE0Y) (OXYBENZONE - UNII:95OOS7VE0Y) OXYBENZONE30.6 mg  in 1 mL
ZINC OXIDE (UNII: SOI2LOH54Z) (ZINC OXIDE - UNII:SOI2LOH54Z) ZINC OXIDE61.2 mg  in 1 mL
Inactive Ingredients
Ingredient NameStrength
YELLOW WAX (UNII: 2ZA36H0S2V)  
CETYL PEG/PPG-10/1 DIMETHICONE (HLB 5) (UNII: 035JKJ76MT)  
DIAZOLIDINYL UREA (UNII: H5RIZ3MPW4)  
EDETATE DISODIUM (UNII: 7FLD91C86K)  
ETHYLHEXYL PALMITATE (UNII: 2865993309)  
ETHYLHEXYL STEARATE (UNII: EG3PA2K3K5)  
ETHYLPARABEN (UNII: 14255EXE39)  
HEXYL LAURATE (UNII: 4CG9F9W01Q)  
HYDROGENATED CASTOR OIL (UNII: ZF94AP8MEY)  
METHYL GLUCOSE DIOLEATE (UNII: FA9KFJ4Z6P)  
METHYLPARABEN (UNII: A2I8C7HI9T)  
OCTYLDODECYL NEOPENTANOATE (UNII: X8725R883T)  
PEG-7 HYDROGENATED CASTOR OIL (UNII: WE09129TH5)  
POLYGLYCERYL-4 ISOSTEARATE (UNII: 820DPX33S7)  
PROPYLENE GLYCOL (UNII: 6DC9Q167V3)  
PROPYLPARABEN (UNII: Z8IX2SC1OH)  
WATER (UNII: 059QF0KO0R)  
SORBITAN MONOOLEATE (UNII: 06XEA2VD56)  
STEARIC ACID (UNII: 4ELV7Z65AP)  
.ALPHA.-TOCOPHEROL ACETATE (UNII: 9E8X80D2L0)  
HEXADECYL POVIDONE (4 HEXADECYL BRANCHES/REPEAT) (UNII: AG75W62QYU)  
DIMETHICONE (UNII: 92RU3N3Y1O)  
TRIMETHYLSILOXYSILICATE (M/Q 0.8-1.0) (UNII: 25LXE464L2)  
TRIETHOXYCAPRYLYLSILANE (UNII: LDC331P08E)  
BUTYLATED HYDROXYTOLUENE (UNII: 1P9D0Z171K)  
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:0316-2010-105 mL in 1 PACKET; Type 0: Not a Combination Product10/01/200209/30/2010
2NDC:0316-2010-3089 mL in 1 TUBE; Type 0: Not a Combination Product01/03/200605/31/2014
3NDC:0316-2010-40148 mL in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product04/15/200106/30/2022
4NDC:0316-2010-50259 mL in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product04/15/200104/30/2022
5NDC:0316-2010-603785 mL in 1 JUG; Type 0: Not a Combination Product02/02/200404/30/2022
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph finalpart35204/15/200106/30/2022
Labeler - Crown Laboratories (079035945)
Registrant - Crown Laboratories (079035945)
Establishment
NameAddressID/FEIBusiness Operations
Crown Laboratories079035945manufacture(0316-2010)

Revised: 10/2021
Document Id: ce2d96e5-f5ef-a4cc-e053-2a95a90ac512
Set id: b3be1c82-f291-4fc8-8586-26f67b74993e
Version: 6
Effective Time: 20211012
 
Crown Laboratories