BLUE LIZARD ACTIVE SUNSCREEN- octocrylene 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 Active Sunscreen

Active Ingredients

Octocrylene - 4%

Zinc Oxide - 9.7%

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 risk 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 a 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 reach of children
  • Children under 6 months: 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, Caprylyl Glycol, Cetyl Dimethicone, Cetyl PEG/PPG-10/1 Dimethicone, Chlorphenesin, Dimethicone, Disodium EDTA, Ethylhexyl Palmitate, Ethylhexyl Stearate, Hexyl Laurate, Hydrogenated Castor Oil, Methyl Glucose Dioleate, Octyldodecyl Neopentanoate, PEG-7 Hydrogenated Castor Oil, Phenoxyethanol, Polyglyceryl-4 Isostearate, Propanediol, Purified Water, Sorbitan Oleate, Stearic Acid, Tocopheryl Acetate (Vitamin E), Triethoxycaprylylsilane, Trimethylsiloxysilicate, VP Hexadecene Copolymer

Questions?

Visit www.bluelizard.net or call 800.877.8869

Crown Laboratories, Inc., Johnson City, TN 37604

Blue Lizard Active 3oz Label

BLUE LIZARD

AUSTRALIAN SUNSCREEN

30+

UVA/UVB PROTECTION

BROAD SPECTRUM

SPF 30+

TRUSTED BY DERMATOLOGISTS FOR OVER 20 YEARS

ACTIVE

mineral-based sunscreen

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

Smart Cap TECHNOLOGY

CAP TURNS BLUE IN HARMFUL UV LIGHT

WATER RESISTANT (80 MINUTES)

P11486.01

P1148601

BLUE LIZARD ACTIVE SUNSCREEN 
octocrylene and zinc oxide lotion
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:0316-2071
Route of AdministrationTOPICAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
OCTOCRYLENE (UNII: 5A68WGF6WM) (OCTOCRYLENE - UNII:5A68WGF6WM) OCTOCRYLENE41.8 mg  in 1 mL
ZINC OXIDE (UNII: SOI2LOH54Z) (ZINC OXIDE - UNII:SOI2LOH54Z) ZINC OXIDE104.5 mg  in 1 mL
Inactive Ingredients
Ingredient NameStrength
CETYL DIMETHICONE 25 (UNII: U4AS1BW4ZB)  
TRIETHOXYCAPRYLYLSILANE (UNII: LDC331P08E)  
CHLORPHENESIN (UNII: I670DAL4SZ)  
ETHYLHEXYL PALMITATE (UNII: 2865993309)  
HYDROGENATED CASTOR OIL (UNII: ZF94AP8MEY)  
YELLOW WAX (UNII: 2ZA36H0S2V)  
CETYL PEG/PPG-10/1 DIMETHICONE (HLB 5) (UNII: 035JKJ76MT)  
ETHYLHEXYL STEARATE (UNII: EG3PA2K3K5)  
DIMETHICONE (UNII: 92RU3N3Y1O)  
CAPRYLYL GLYCOL (UNII: 00YIU5438U)  
HEXADECYL POVIDONE (4 HEXADECYL BRANCHES/REPEAT) (UNII: AG75W62QYU)  
WATER (UNII: 059QF0KO0R)  
.ALPHA.-TOCOPHEROL ACETATE (UNII: 9E8X80D2L0)  
SORBITAN MONOOLEATE (UNII: 06XEA2VD56)  
STEARIC ACID (UNII: 4ELV7Z65AP)  
TRIMETHYLSILOXYSILICATE (M/Q 0.8-1.0) (UNII: 25LXE464L2)  
HEXYL LAURATE (UNII: 4CG9F9W01Q)  
METHYL GLUCOSE DIOLEATE (UNII: FA9KFJ4Z6P)  
PEG-7 HYDROGENATED CASTOR OIL (UNII: WE09129TH5)  
EDETATE DISODIUM (UNII: 7FLD91C86K)  
OCTYLDODECYL NEOPENTANOATE (UNII: X8725R883T)  
PHENOXYETHANOL (UNII: HIE492ZZ3T)  
POLYGLYCERYL-4 ISOSTEARATE (UNII: 820DPX33S7)  
PROPANEDIOL (UNII: 5965N8W85T)  
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:0316-2071-105 mL in 1 PACKET; Type 0: Not a Combination Product01/02/2019
2NDC:0316-2071-3089 mL in 1 TUBE; Type 0: Not a Combination Product01/02/2019
3NDC:0316-2071-401 in 1 CARTON01/02/2019
3148 mL in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product
4NDC:0316-2071-50259 mL in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product01/02/2019
5NDC:0316-2071-603785 mL in 1 JUG; Type 0: Not a Combination Product01/02/2019
6NDC:0316-2071-45148 mL in 1 TUBE; Type 0: Not a Combination Product01/02/2019
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph not finalpart35201/02/2019
Labeler - Crown Laboratories (079035945)
Registrant - Crown Laboratories (079035945)
Establishment
NameAddressID/FEIBusiness Operations
Crown Laboratories079035945manufacture(0316-2071)

Revised: 10/2019
Document Id: 951f0e9e-ec02-0a12-e053-2a95a90a7f98
Set id: 87aadb10-2c32-31e5-e053-2a95a90abd66
Version: 4
Effective Time: 20191017
 
Crown Laboratories