Active Ingredients

Octisalate 5%

Titanium Dioxide 5.36%

Zinc Oxide 10%

Purpose

Sunscreen

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 risks 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 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

Protect the product in this container from excessive heat and direct sun
May stain some fabrics

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 Type	HUMAN OTC DRUG	Item Code (Source)	NDC:0316-2062
Route of Administration	TOPICAL

Ingredient Name	Basis of Strength	Strength
Active Ingredient/Active Moiety
TITANIUM DIOXIDE (UNII: 15FIX9V2JP) (TITANIUM DIOXIDE - UNII:15FIX9V2JP)	TITANIUM DIOXIDE	59.5 mg in 1 mL
ZINC OXIDE (UNII: SOI2LOH54Z) (ZINC OXIDE - UNII:SOI2LOH54Z)	ZINC OXIDE	111 mg in 1 mL
OCTISALATE (UNII: 4X49Y0596W) (OCTISALATE - UNII:4X49Y0596W)	OCTISALATE	55.5 mg in 1 mL

Ingredient Name	Strength
Inactive Ingredients
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)

#	Item Code	Package Description	Marketing Start Date
Packaging
1	NDC:0316-2062-30	89 mL in 1 TUBE; Type 0: Not a Combination Product	05/01/2021
2	NDC:0316-2062-40	1 in 1 CARTON	05/01/2021
2		148 mL in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product
3	NDC:0316-2062-50	259 mL in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product	05/01/2021
4	NDC:0316-2062-45	148 mL in 1 TUBE; Type 0: Not a Combination Product	02/09/2021

Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
Marketing Information
OTC Monograph Drug	M020	02/09/2021

Labeler - Crown Laboratories (079035945)

Name	Address	ID/FEI	Business Operations
Establishment
Crown Laboratories		079035945	manufacture(0316-2062)

Blue Lizard Kids SPF 50 Sunscreen