Blue Lizard Sport Original Sunscreen

Blue Lizard Sport Original Sunscreen

Drug Labeling and Warnings

Drug Details

k">

BLUE LIZARD SPORT ORIGINAL SUNSCREEN- 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.

----------

Blue Lizard Sport Original Sunscreen

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 risks 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 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 the reach of children
  • Children under 6 months of age: 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, 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, Octododecyl Neopentanoate, PEG-7 Hydrogenated Castor Oil, Polyglyceryl-4 Isostearate, Propylene Glycol, Propylparaben, Purified Water, Sorbitan Oleate, Stearic Acid, Tocopheryl Acetate (Vitamin E), Trimethylsiloxysilicate, VP Hexadecene Copolymer

Questions ?

Visit www.bluelizard.net or call 800.877.8869

Crown Laboratories, Inc., Johnson City, TN 37604

Blue Lizard Sport Original 3oz Label

BLUE LIZARD

AUSTRALIAN SUNSCREEN

30+

UVA/UVB PROTECTION

BROAD SPECTRUM

SPF 30+

TRUSTED BY DERMATOLOGISTS FOR OVER 20 YEARS

SPORT original

mineral-based sunscreen

combining mineral and chemical UV protectors for water-resistance performance you can trust.

Cap Turns Blue in UV Light

Water Resistant (80 Minutes)

P6048.08

p604808

BLUE LIZARD SPORT ORIGINAL SUNSCREEN 
octinoxate, octocrylene, oxybenzone, and zinc oxide lotion
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC: 0316-2019
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)  
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC: 0316-2019-3089 mL in 1 TUBE; Type 0: Not a Combination Product01/03/2006
2NDC: 0316-2019-401 in 1 CARTON04/15/2001
2148 mL in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product
3NDC: 0316-2019-50259 mL in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product05/01/2009
4NDC: 0316-2019-603787 mL in 1 JUG; Type 0: Not a Combination Product05/01/2009
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph not finalpart35204/15/2001
Labeler - Crown Laboratories (079035945)
Registrant - Crown Laboratories (079035945)
Establishment
NameAddressID/FEIBusiness Operations
Crown Laboratories079035945manufacture(0316-2019)

Revised: 1/2019
 
Crown Laboratories


© 2019 FDA.report
This site is not affiliated with or endorsed by the FDA.