BLUE LIZARD KIDS SPF 50 SUNSCREEN- octisalate and titanium dioxide and zinc oxide lotion 
Crown Laboratories

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Blue Lizard Kids 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

• 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

Keep out of reach of children

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 Kids 5oz Tube

BLUE LIZARD

AUSTRALIAN SUNSCREEN

50+

UVA/UVB PROTECTION

BROAD SPECTRUM SPF 50+

No. 1 pediatrician recommended mineral-based sunscreen brand

KIDS

mineral-based sunscreen

combining mineral and chemical UV protectors

Smart Cap TECHNOLOGY

CAP CHANGES COLOR IN HARMFUL UV LIGHT

WATER RESISTANT (80 MINUTES)

P11778.01

p1177801

BLUE LIZARD KIDS SPF 50 SUNSCREEN 
octisalate and titanium dioxide and zinc oxide lotion
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:0316-2062
Route of AdministrationTOPICAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
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
OCTISALATE (UNII: 4X49Y0596W) (OCTISALATE - UNII:4X49Y0596W) OCTISALATE55.5 mg  in 1 mL
Inactive Ingredients
Ingredient NameStrength
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)  
ISOSTEARYL ISOSTEARATE (UNII: IV0Z586Z4Y)  
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)  
MEDIUM-CHAIN TRIGLYCERIDES (UNII: C9H2L21V7U)  
YELLOW WAX (UNII: 2ZA36H0S2V)  
ALUMINUM OXIDE (UNII: LMI26O6933)  
ALUMINUM STEARATE (UNII: U6XF9NP8HM)  
TRIETHOXYCAPRYLYLSILANE (UNII: LDC331P08E)  
CAPRYLYL GLYCOL (UNII: 00YIU5438U)  
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)  
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)  
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:0316-2062-3089 mL in 1 TUBE; Type 0: Not a Combination Product05/01/2021
2NDC:0316-2062-401 in 1 CARTON05/01/2021
2148 mL in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product
3NDC:0316-2062-50259 mL in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product05/01/2021
4NDC:0316-2062-45148 mL in 1 TUBE; Type 0: Not a Combination Product02/09/2021
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC Monograph DrugM02002/09/2021
Labeler - Crown Laboratories (079035945)
Establishment
NameAddressID/FEIBusiness Operations
Crown Laboratories079035945manufacture(0316-2062)

Revised: 12/2023
Document Id: 0bc8fdf2-a52f-d218-e063-6294a90a031d
Set id: ba4ae906-48c0-8384-e053-2995a90afb91
Version: 4
Effective Time: 20231205
 
Crown Laboratories