BLUE LIZARD FACE- sunscreen gel 
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 Face

Active Ingredients

Octinoxate 5.5%

Zinc Oxide 8.0%

Uses

Warnings

Directions

Other Information

Inactive Ingredients

Beeswax, BHT, C12-15 Alkyl Benzoate, C13-14 Isoparaffin, Caffeine, Camellia sinesis Leaf (Green Tea) Extract, Caprylyl Glycol, Chlorphenesin, Cyclomethicone, Dimethoxydiphenylsilane, Isotearyl Alcohol, Laureth-7, Lauryl PEG/PPG 18/18 Methicone, Phenoxyethanol, Polyacrylamide, Purified Water, Sodium Hyaluronate, Tocopheryl Acetate (Vitamin E), Triethoxycaprylylsilane

Questions?

Visit www.bluelizard.net or call 800.877.8869

Crown Laboratories, Inc., Johnson City, TN 37604

Blue Lizard Face Label

BLUE LIZARD

AUSTRALIAN SUNSCREEN

30+

UVA/UVB PROTECTION

BROAD SPECTRUM

SPF 30+

TRUSTED BY DERMATOLOGISTS FOR OVER 20 YEARS

FACE

mineral-based sunscreen

combining mineral and chemical UV protectors

Smart Cap TECHNOLOGY

CAP TURNS BLUE IN HARMFUL UV LIGHT

LIGHTWEIGHT DAILY

SUN PROTECTION

P6138.11

P613811

BLUE LIZARD FACE 
sunscreen gel
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:0316-2055
Route of AdministrationTOPICAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
OCTINOXATE (UNII: 4Y5P7MUD51) (OCTINOXATE - UNII:4Y5P7MUD51) OCTINOXATE55 mg  in 1 g
ZINC OXIDE (UNII: SOI2LOH54Z) (ZINC OXIDE - UNII:SOI2LOH54Z) ZINC OXIDE80 mg  in 1 g
Inactive Ingredients
Ingredient NameStrength
DIMETHOXYDIPHENYLSILANE (UNII: 02QB6788GC)  
ISOSTEARYL ALCOHOL (UNII: Q613OCQ44Y)  
WATER (UNII: 059QF0KO0R)  
ALKYL (C12-15) BENZOATE (UNII: A9EJ3J61HQ)  
CYCLOMETHICONE (UNII: NMQ347994Z)  
C13-14 ISOPARAFFIN (UNII: E4F12ROE70)  
LAURETH-7 (UNII: Z95S6G8201)  
ALPHA-TOCOPHEROL ACETATE (UNII: 9E8X80D2L0)  
GREEN TEA LEAF (UNII: W2ZU1RY8B0)  
YELLOW WAX (UNII: 2ZA36H0S2V)  
CAFFEINE (UNII: 3G6A5W338E)  
PHENOXYETHANOL (UNII: HIE492ZZ3T)  
CAPRYLYL GLYCOL (UNII: 00YIU5438U)  
CHLORPHENESIN (UNII: I670DAL4SZ)  
LAURYL PEG/PPG-18/18 METHICONE (UNII: ZJ5S27D9NX)  
BUTYLATED HYDROXYTOLUENE (UNII: 1P9D0Z171K)  
POLYACRYLAMIDE (1500 MW) (UNII: 5D6TC4BRWV)  
HYALURONATE SODIUM (UNII: YSE9PPT4TH)  
TRIETHOXYCAPRYLYLSILANE (UNII: LDC331P08E)  
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:0316-2055-105 g in 1 POUCH; Type 0: Not a Combination Product04/06/201010/01/2021
2NDC:0316-2055-3085 g in 1 TUBE; Type 0: Not a Combination Product04/06/201003/31/2024
3NDC:0316-2055-40141.7 g in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product04/06/201008/31/2023
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph not finalpart35204/06/201003/31/2024
Labeler - Crown Laboratories (079035945)
Registrant - Crown Laboratories (079035945)
Establishment
NameAddressID/FEIBusiness Operations
Crown Laboratories079035945manufacture(0316-2055)

Revised: 12/2021
Document Id: d32103a9-64f1-b583-e053-2995a90aa659
Set id: ab6ab076-eea1-4091-975e-0a0caeb00213
Version: 9
Effective Time: 20211214
 
Crown Laboratories