BLUE LIZARD SENSITIVE SUNSCREEN- titanium dioxide 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 Sensitive

Active Ingredients

Titanium Dioxide - 5%

Zinc Oxide - 10%

Uses

Warnings

Directions

Other Information

Inactive Ingredients

Beeswax, C12-15 Alkyl Benzoate, Caprylyl Glycol, Cetyl Dimethicone, Cetyl Dimethicone Copolyol, Chlorphenesin, Disodium EDTA, Ethylhexyl Palmitate, Ethylhexyl Stearate, Hexyl Laurate, Hydrogenated Castor Oil, Methyl Glucose Dioleate, Octododecyl Neopentanoate, PEG-7 Hydrogenated Castor Oil, Phenoxyethanol, Polyglyceryl-4 Isostearate, Propanediol, 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 Sensitive 5oz Label

Blue Lizard

Australian Sunscreen

Sensitive

Broad Spectrum SPF 30+

UVA/UVB Protection

Titanium Dioxide and Zinc Oxide Formula

No Parabens

No Fragrances

Dermatologist Recommended

Blue Lizard Sensitive 5oz label

BLUE LIZARD SENSITIVE SUNSCREEN 
titanium dioxide and zinc oxide lotion
Product Information
Product Type HUMAN OTC DRUG Item Code (Source) NDC:0316-2045
Route of Administration TOPICAL DEA Schedule     
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
TITANIUM DIOXIDE (UNII: 15FIX9V2JP) (TITANIUM DIOXIDE - UNII:15FIX9V2JP) TITANIUM DIOXIDE 54 mg  in 1 mL
ZINC OXIDE (UNII: SOI2LOH54Z) (ZINC OXIDE - UNII:SOI2LOH54Z) ZINC OXIDE 108 mg  in 1 mL
Inactive Ingredients
Ingredient Name Strength
YELLOW WAX (UNII: 2ZA36H0S2V)  
CETYL PEG/PPG-10/1 DIMETHICONE (HLB 5) (UNII: 035JKJ76MT)  
ALKYL (C12-15) BENZOATE (UNII: A9EJ3J61HQ)  
EDETATE DISODIUM (UNII: 7FLD91C86K)  
ETHYLHEXYL PALMITATE (UNII: 2865993309)  
ETHYLHEXYL STEARATE (UNII: EG3PA2K3K5)  
CAPRYLYL GLYCOL (UNII: 00YIU5438U)  
HEXYL LAURATE (UNII: 4CG9F9W01Q)  
HYDROGENATED CASTOR OIL (UNII: ZF94AP8MEY)  
METHYL GLUCOSE DIOLEATE (UNII: FA9KFJ4Z6P)  
CHLORPHENESIN (UNII: I670DAL4SZ)  
OCTYLDODECYL NEOPENTANOATE (UNII: X8725R883T)  
PEG-7 HYDROGENATED CASTOR OIL (UNII: WE09129TH5)  
POLYGLYCERYL-4 ISOSTEARATE (UNII: 820DPX33S7)  
PHENOXYETHANOL (UNII: HIE492ZZ3T)  
PROPANEDIOL (UNII: 5965N8W85T)  
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:0316-2045-10 5 mL in 1 PACKET
2 NDC:0316-2045-20 37 mL in 1 BOTTLE, PLASTIC
3 NDC:0316-2045-30 89 mL in 1 TUBE
4 NDC:0316-2045-40 148 mL in 1 BOTTLE, PLASTIC
5 NDC:0316-2045-50 259 mL in 1 BOTTLE, PLASTIC
6 NDC:0316-2045-60 3785 mL in 1 JUG
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
OTC monograph final part352 12/08/2003
Labeler - Crown Laboratories (079035945)
Registrant - Crown Laboratories (079035945)
Establishment
Name Address ID/FEI Business Operations
Crown Laboratories 079035945 manufacture(0316-2045)

Revised: 12/2014
Document Id: f8406afd-500a-44c2-844e-ba3c44ef1cc1
Set id: 1e4d49f4-9e77-48b5-bce5-ff04ed885a0f
Version: 7
Effective Time: 20141217
 
Crown Laboratories