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

  • 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:
  • after 80 minutes of swimming or sweating
  • immediately after towel drying
  • at least every 2 hours

Other Information

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

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
TRIETHOXYCAPRYLYLSILANE (UNII: LDC331P08E)  
BUTYLATED HYDROXYTOLUENE (UNII: 1P9D0Z171K)  
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)  
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:0316-2010-105 mL in 1 PACKET; Type 0: Not a Combination Product10/01/2002
2NDC:0316-2010-3089 mL in 1 TUBE; Type 0: Not a Combination Product01/03/2006
3NDC:0316-2010-40148 mL in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product04/15/2001
4NDC:0316-2010-50259 mL in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product04/15/2001
5NDC:0316-2010-603785 mL in 1 JUG; Type 0: Not a Combination Product02/02/2004
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: 9/2019
Document Id: 923435ed-eac4-326f-e053-2a95a90abf81
Set id: b3be1c82-f291-4fc8-8586-26f67b74993e
Version: 5
Effective Time: 20190911
 
Crown Laboratories