BLUE LIZARD KIDS SUNSCREEN- octocrylene and zinc oxide lotion

Blue Lizard Kids Sunscreen by

Drug Labeling and Warnings

Blue Lizard Kids Sunscreen by is a Otc medication manufactured, distributed, or labeled by Crown Laboratories. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

Active Ingredients

Octocrylene - 4%

Zinc Oxide - 9.7%

Drug Facts - 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 Kids 3oz Label

BLUE LIZARD

AUSTRALIAN SUNSCREEN

30+

UVA/UVB PROTECTION

BROAD SPECTRUM

SPF 30+

No. 1 PEDIATRICIAN RECOMMENDED
mineral-based sunscreen brand

KIDS

mineral-based sunscreen

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

Smart Cap TECHNOLOGY

CAP TURNS BLUE INHARMFUL UV LIGHT

WATER RESISTANT (80 MINUTES)

P11469.02

INGREDIENTS AND APPEARANCE

BLUE LIZARD KIDS SUNSCREEN 
octocrylene and zinc oxide lotion

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 0316-2061
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
OCTOCRYLENE (UNII: 5A68WGF6WM) (OCTOCRYLENE - UNII:5A68WGF6WM)	OCTOCRYLENE	41.8 mg  in 1 mL
ZINC OXIDE (UNII: SOI2LOH54Z) (ZINC OXIDE - UNII:SOI2LOH54Z)	ZINC OXIDE	104.5 mg  in 1 mL

Inactive Ingredients
Ingredient Name	Strength
CETYL DIMETHICONE 25 (UNII: U4AS1BW4ZB)
YELLOW WAX (UNII: 2ZA36H0S2V)
CETYL PEG/PPG-10/1 DIMETHICONE (HLB 5) (UNII: 035JKJ76MT)
CHLORPHENESIN (UNII: I670DAL4SZ)
ETHYLHEXYL STEARATE (UNII: EG3PA2K3K5)
CAPRYLYL GLYCOL (UNII: 00YIU5438U)
ETHYLHEXYL PALMITATE (UNII: 2865993309)
HYDROGENATED CASTOR OIL (UNII: ZF94AP8MEY)
TRIMETHYLSILOXYSILICATE (M/Q 0.8-1.0) (UNII: 25LXE464L2)
HEXADECYL POVIDONE (4 HEXADECYL BRANCHES/REPEAT) (UNII: AG75W62QYU)
HEXYL LAURATE (UNII: 4CG9F9W01Q)
METHYL GLUCOSE DIOLEATE (UNII: FA9KFJ4Z6P)
PEG-7 HYDROGENATED CASTOR OIL (UNII: WE09129TH5)
DIMETHICONE (UNII: 92RU3N3Y1O)
EDETATE DISODIUM (UNII: 7FLD91C86K)
OCTYLDODECYL NEOPENTANOATE (UNII: X8725R883T)
PHENOXYETHANOL (UNII: HIE492ZZ3T)
POLYGLYCERYL-4 ISOSTEARATE (UNII: 820DPX33S7)
PROPANEDIOL (UNII: 5965N8W85T)
WATER (UNII: 059QF0KO0R)
SORBITAN MONOOLEATE (UNII: 06XEA2VD56)
STEARIC ACID (UNII: 4ELV7Z65AP)
.ALPHA.-TOCOPHEROL ACETATE (UNII: 9E8X80D2L0)
TRIETHOXYCAPRYLYLSILANE (UNII: LDC331P08E)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 0316-2061-10	5 mL in 1 PACKET; Type 0: Not a Combination Product	01/02/2019
2	NDC: 0316-2061-30	89 mL in 1 TUBE; Type 0: Not a Combination Product	01/02/2019
3	NDC: 0316-2061-40	1 in 1 CARTON	01/02/2019
3		148 mL in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product
4	NDC: 0316-2061-50	259 mL in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product	01/02/2019
5	NDC: 0316-2061-60	3785 mL in 1 JUG; Type 0: Not a Combination Product	01/02/2019
6	NDC: 0316-2061-45	148 mL in 1 TUBE; Type 0: Not a Combination Product	01/02/2019

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC monograph not final	part352	01/02/2019

Labeler - Crown Laboratories (079035945)

Registrant - Crown Laboratories (079035945)

Establishment
Name	Address	ID/FEI	Business Operations
Crown Laboratories		079035945	manufacture(0316-2061)