BLUE LIZARD SPORT - 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 Sport

Active Ingredients

Octinoxate - 7.5%

Octocrylene - 2%

Oxybenzone - 3%

Zinc Oxide - 6%

Uses

Warnings

Directions

Other Information

Inactive Ingredients

Beeswax, C12-15 Alkyl Benzoate, Cetyl Dimethicone, Cetyl Dimethicone Copolyol, Diazolidinyl Urea, 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), Trimethylated Silica/Dimethicone, VP Hexadecene Copolymer

Questions ?

Visit www.bluelizard.net or call 800.877.8869

Crown Laboratories, Inc., Johnson City, TN 37604

Patents: US#6698590 & 6405867; AU#1998083259

Blue Lizard Sport Label

Blue Lizard

Australian Sunscreen

Sport

Broad Spectrum SPF 30+

UVA/UVB Protection

Bottle Turns Blue in UV Light

Zinc Oxide Formula

Water Resistant (80 minutes)

Dermatologist Recommended

Blue Lizard Sport 5oz Label

BLUE LIZARD SPORT  
octinoxate, octocrylene, oxybenzone, and zinc oxide lotion
Product Information
Product Type HUMAN OTC DRUG Item Code (Source) NDC:0316-2020
Route of Administration TOPICAL DEA Schedule     
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
OCTINOXATE (UNII: 4Y5P7MUD51) (OCTINOXATE - UNII:4Y5P7MUD51) OCTINOXATE 76.5 mg  in 1 mL
OCTOCRYLENE (UNII: 5A68WGF6WM) (OCTOCRYLENE - UNII:5A68WGF6WM) OCTOCRYLENE 20.4 mg  in 1 mL
OXYBENZONE (UNII: 95OOS7VE0Y) (OXYBENZONE - UNII:95OOS7VE0Y) OXYBENZONE 30.6 mg  in 1 mL
ZINC OXIDE (UNII: SOI2LOH54Z) (ZINC OXIDE - UNII:SOI2LOH54Z) ZINC OXIDE 61.2 mg  in 1 mL
Inactive Ingredients
Ingredient Name Strength
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 Code Package Description Marketing Start Date Marketing End Date
1 NDC:0316-2020-20 37 mL in 1 BOTTLE, PLASTIC
2 NDC:0316-2020-30 89 mL in 1 TUBE
3 NDC:0316-2020-40 148 mL in 1 BOTTLE, PLASTIC
4 NDC:0316-2020-50 259 mL in 1 BOTTLE, PLASTIC
5 NDC:0316-2020-60 3787 mL in 1 JUG
6 NDC:0316-2020-10 5 mL in 1 PACKET
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
OTC monograph final part352 04/15/2001
Labeler - Crown Laboratories (079035945)
Registrant - Crown Laboratories (079035945)
Establishment
Name Address ID/FEI Business Operations
Crown Laboratories 079035945 manufacture(0316-2020)

Revised: 12/2014
Document Id: e1003e28-743b-4098-99f3-7cdc7f7efee8
Set id: 35a1ec76-2ed0-4ef7-888e-98386652b7f0
Version: 8
Effective Time: 20141217
 
Crown Laboratories