Your browser does not support JavaScript! BLUE LIZARD SPORT (OCTINOXATE, OCTOCRYLENE, OXYBENZONE, AND ZINC OXIDE) LOTION [CROWN LABORATORIES]
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BLUE LIZARD SPORT (octinoxate, octocrylene, oxybenzone, and zinc oxide) lotion
[Crown Laboratories]


Category DEA Schedule Marketing Status
HUMAN OTC DRUG LABEL OTC monograph final
NOTE: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.
Drug Label Sections

Active Ingredients

Octinoxate - 7.5%

Octocrylene - 2%

Oxybenzone - 3%

Zinc Oxide - 6%

Questions

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

Drug Facts - Uses

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

Drug Facts - Warnings, Directions, and Other Information

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 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 two hours

Other Information:

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

Inactive Ingredients

Beeswax, C12-15 Alkyl Benzoate, Cetyl Dimethicone, Cetyl Dimethicone Copolyol, Diazolidinyl Urea, Disodium EDTA, Ethylhexyl Palmititate, Ethylhexyl Stearate, Ethylparaben, Fragrance, Hexyl Laurate, Hydrogenated Castor Oil, Methyl Glucose Dioleate, Methylparaben, Octododecyl Neopentanoate, PEG-7 Hydrogenated Castor Oil, Polyglyeryl-4 Isostearate, Propylene Glycol, Propylparaben, Purified Water, Sorbitan Oleate, Stearic Acid, Tocopheryl Acetate (Vitamin E), Trimethylated Silica/Dimethicone, VP Hexadecene Copolymer

Blue Lizard Sport 5oz Label

Blue Lizard Sport

Blue Lizard Australian Sunscreen - Sport

Broad Spectrum SPF 30+

Zinc Oxide Formula

Very Water Resistant (80 minutes)

BLSPORT5oz.jpgBlue Lizard Sport 5oz Label

BLUE LIZARD SPORT  
octinoxate, octocrylene, oxybenzone, and zinc oxide lotion
Product Information
Product TypeHUMAN OTC DRUG LABELItem Code (Source)NDC:0316-2020
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 DescriptionMarketing Start DateMarketing End Date
1NDC:0316-2020-2037 mL in 1 BOTTLE, PLASTIC
2NDC:0316-2020-3089 mL in 1 TUBE
3NDC:0316-2020-40148 mL in 1 BOTTLE, PLASTIC
4NDC:0316-2020-50259 mL in 1 BOTTLE, PLASTIC
5NDC:0316-2020-603787 mL in 1 JUG
6NDC:0316-2020-105 mL in 1 PACKET
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(0316-2020)

Revised: 1/2013
 
Crown Laboratories

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