BLUE LIZARD ACTIVE SPF 50 SUNSCREEN- octisalate and 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 Active SPF 50 Sunscreen

Active Ingredients

Octisalate - 5%

Titanium Dioxide - 5.36%

Zinc Oxide - 10%

Purpose

Sunscreen

Uses

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 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

Inactive Ingredients

Alumina, Aluminum Stearate, Beeswax, Butyloctyl Salicylate, C12-15 Alkyl Benzoate, Capylic/Capric Triglyceride, Caprylyl Glycol, Cetyl Dimethicone, Cetyl PEG/PPG-10/1 Dimethicone, Diisopropyl Sebacate, Dimethicone, Disodium EDTA, Ethylhexylglycerin, Hexyl Laurate, Hydrogenated Castor Oil, Isostearyl Isostearate, L-Arginine, Methyl Glucose Dioleate, Methylpropanediol, Octyldodecyl Neopentanoate, PEG-7 Hydrogenated Castor Oil, Phenoxyethanol, Phenylpropanol, Polyglyceryl-4 Isostearate, Polyhydroxystearic Acid, Polyurethane-35, Propanediol, Purified Water, Sorbitan Oleate, Stearic Acid, Tocopheryl Acetate, Triethoxycaprylylsilane, Trimethylsiloxysilicate, VP Hexadecene Copolymer

Questions ?

Visit www.bluelizardsunscreen.com or call 800.877.8869

Crown Laboratories, Inc., Johnson City, TN 37604

Blue Lizard Active 5oz Tube

BLUE LIZARD

AUSTRALIAN SUNSCREEN

50+

UVA/UVB PROTECTION

BROAD SPECTRUM

SPF 50+

ACTIVE

mineral-based sunscreen

combining mineral and chemical UV protectors

Smart Cap TECHNOLOGY

CAP CHANGES COLOR IN HARMFUL UV LIGHT

WATER RESISTANT (80 MINUTES)

P11863.00

5oz-tube

BLUE LIZARD ACTIVE SPF 50 SUNSCREEN 
octisalate and titanium dioxide and zinc oxide lotion
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:0316-2072
Route of AdministrationTOPICAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
OCTISALATE (UNII: 4X49Y0596W) (OCTISALATE - UNII:4X49Y0596W) OCTISALATE55.5 mg  in 1 mL
TITANIUM DIOXIDE (UNII: 15FIX9V2JP) (TITANIUM DIOXIDE - UNII:15FIX9V2JP) TITANIUM DIOXIDE59.5 mg  in 1 mL
ZINC OXIDE (UNII: SOI2LOH54Z) (ZINC OXIDE - UNII:SOI2LOH54Z) ZINC OXIDE111 mg  in 1 mL
Inactive Ingredients
Ingredient NameStrength
MEDIUM-CHAIN TRIGLYCERIDES (UNII: C9H2L21V7U)  
ALUMINUM OXIDE (UNII: LMI26O6933)  
ALUMINUM STEARATE (UNII: U6XF9NP8HM)  
TRIETHOXYCAPRYLYLSILANE (UNII: LDC331P08E)  
YELLOW WAX (UNII: 2ZA36H0S2V)  
ARGININE (UNII: 94ZLA3W45F)  
METHYLPROPANEDIOL (UNII: N8F53B3R4R)  
CETYL PEG/PPG-10/1 DIMETHICONE (HLB 5) (UNII: 035JKJ76MT)  
ALKYL (C12-15) BENZOATE (UNII: A9EJ3J61HQ)  
EDETATE DISODIUM (UNII: 7FLD91C86K)  
CAPRYLYL GLYCOL (UNII: 00YIU5438U)  
HEXYL LAURATE (UNII: 4CG9F9W01Q)  
HYDROGENATED CASTOR OIL (UNII: ZF94AP8MEY)  
METHYL GLUCOSE DIOLEATE (UNII: FA9KFJ4Z6P)  
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)  
DIMETHICONE (UNII: 92RU3N3Y1O)  
TRIMETHYLSILOXYSILICATE (M/Q 0.8-1.0) (UNII: 25LXE464L2)  
HEXADECYL POVIDONE (4 HEXADECYL BRANCHES/REPEAT) (UNII: AG75W62QYU)  
POLYHYDROXYSTEARIC ACID (2300 MW) (UNII: YXH47AOU0F)  
CETYL DIMETHICONE 25 (UNII: U4AS1BW4ZB)  
ETHYLHEXYLGLYCERIN (UNII: 147D247K3P)  
PHENYLPROPANOL (UNII: 0F897O3O4M)  
DIISOPROPYL SEBACATE (UNII: J8T3X564IH)  
POLYURETHANE-35 (NOT MORE THAN 500 MPA.S AT 40%) (UNII: Q2LKX89BE0)  
BUTYLOCTYL SALICYLATE (UNII: 2EH13UN8D3)  
ISOSTEARYL ISOSTEARATE (UNII: IV0Z586Z4Y)  
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:0316-2072-3089 mL in 1 TUBE; Type 0: Not a Combination Product05/01/2021
2NDC:0316-2072-50259 mL in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product05/01/2021
3NDC:0316-2072-45148 mL in 1 TUBE; Type 0: Not a Combination Product02/09/2021
4NDC:0316-2072-401 in 1 CARTON02/24/2021
4148 mL in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph not finalpart35202/09/2021
Labeler - Crown Laboratories (079035945)
Establishment
NameAddressID/FEIBusiness Operations
Crown Laboratories079035945manufacture(0316-2072)

Revised: 10/2021
Document Id: ce5337d4-bcfe-3886-e053-2a95a90af947
Set id: 6cd2936e-ded7-43a2-beea-9dfaf538176f
Version: 2
Effective Time: 20211014
 
Crown Laboratories