BLUE LIZARD KIDS SPF 50- zinc oxide spray

Blue Lizard Kids SPF 50 by

Drug Labeling and Warnings

Blue Lizard Kids SPF 50 by is a Otc medication manufactured, distributed, or labeled by Crown Laboratories. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

Active Ingredients

Zinc Oxide - 24%

Purpose

Sunscreen

Uses

• helps prevent sunburn

Warnings

For external use only

Contents under pressure. Do not puncture or incinerate. Do not store at temperature above 120 ˚F

Flammable: keep away from fire or flame

Do not use on damaged or broken skin

When using this product keep out of eyes. Rinse with water to remove

Stop use and ask doctor if rash occurs

Keep out of reach of children. If swallowed, get medical help or contact a Poison Control Center right away

Directions

shake well before and frequently during use

apply liberally 15 minutes before sun exposure

hold container 4 to 6 inches from the skin to apply

do not spray directly into face. Spray on hands then apply to face.

do not apply in windy conditions.

use in a well-ventilated area and avoid inhalation

children under 6 months of age: 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:

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

Aphanizomenon Flosaquae Extract, Butyloctyl Salicylate, C12-15 Alkyl Benzoate, Caprylyl Glycol, Cetyl Diglyceryl Tris(Trimethylsiloxy)silylethyl Dimethicone, Dimethicone, Ethylhexylglycerin, Glycerin, Hydrogen Dimethicone, Hydrogenated Polydecene, Isopropyl Myristate, Pentylene Glycol, Polyhydroxystearic Acid, Potassium Sorbate, Propanediol, Silica, Sodium Benzoate, Sodium Chloride, Sodium Phytate, Sorbitan Olivate, Synthetic Beeswax, Tetrafluoropropene, Water

Questions?

Call 800.877.8869 or visit www.bluelizardsunscreen.com

Blue Lizard Kids SPF 50+ Spray 5 oz Label

BLUE LIZARD

AUSTRALIAN SUNSCREEN

50+

UVA/UVB PROTECTION

BROAD SPECTRUM SPF 50+

Kids

mineral sunscreen spray

Water Resistant (80 Minutes)

100% Mineral Active Ingredient

Made with Earth Friendly Propellant

P11905.03

INGREDIENTS AND APPEARANCE

BLUE LIZARD KIDS SPF 50 
zinc oxide spray

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 0316-2081
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
ZINC OXIDE (UNII: SOI2LOH54Z) (ZINC OXIDE - UNII:SOI2LOH54Z)	ZINC OXIDE	24 mg  in 1 g

Inactive Ingredients
Ingredient Name	Strength
CAPRYLYL GLYCOL (UNII: 00YIU5438U)
BUTYLOCTYL SALICYLATE (UNII: 2EH13UN8D3)
POLYHYDROXYSTEARIC ACID (2300 MW) (UNII: YXH47AOU0F)
CETYL DIGLYCERYL TRIS(TRIMETHYLSILOXY)SILYLETHYL DIMETHICONE (3500 MM2/S) (UNII: KB7T6C99UP)
1,3,3,3-TETRAFLUOROPROPENE, (1E)- (UNII: 5I2481UOO8)
ISOPROPYL MYRISTATE (UNII: 0RE8K4LNJS)
SORBITAN OLIVATE (UNII: MDL271E3GR)
GLYCERIN (UNII: PDC6A3C0OX)
ETHYLHEXYLGLYCERIN (UNII: 147D247K3P)
ALKYL (C12-15) BENZOATE (UNII: A9EJ3J61HQ)
HYDROGEN DIMETHICONE (20 CST) (UNII: 12Z59IF64N)
HYDROGENATED POLY(C6-14 OLEFIN; 4 CST) (UNII: 7C6HV4SSLA)
PROPANEDIOL (UNII: 5965N8W85T)
PHYTATE SODIUM (UNII: 88496G1ERL)
SYNTHETIC BEESWAX (UNII: 08MNR5YE2R)
POTASSIUM SORBATE (UNII: 1VPU26JZZ4)
SILICON DIOXIDE (UNII: ETJ7Z6XBU4)
SODIUM BENZOATE (UNII: OJ245FE5EU)
SODIUM CHLORIDE (UNII: 451W47IQ8X)
DIMETHICONE (UNII: 92RU3N3Y1O)
PENTYLENE GLYCOL (UNII: 50C1307PZG)
APHANIZOMENON FLOSAQUAE (UNII: 49VG1X560X)
WATER (UNII: 059QF0KO0R)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 0316-2081-05	142 g in 1 BOTTLE, SPRAY; Type 0: Not a Combination Product	03/29/2021
2	NDC: 0316-2081-45	127.6 g in 1 BOTTLE, SPRAY; Type 0: Not a Combination Product	01/07/2022

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC monograph not final	part352	03/29/2021

Labeler - Crown Laboratories (079035945)

Registrant - Crown Laboratories (079035945)