BLUE LIZARD SPORT- octinoxate, octocrylene, oxybenzone, and zinc oxide lotion

Blue Lizard Sport by

Drug Labeling and Warnings

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

Drug Details [pdf]

Active Ingredients

Octinoxate - 7.5%

Octocrylene - 2%

Oxybenzone - 3%

Zinc Oxide - 6%

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
• Keep out of the reach of children
• 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 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, Cetyl Dimethicone, Cetyl Dimethicone Copolyol, Diazolidinyl Urea, Disodium EDTA, Ethylhexyl Palmitate, Ethylhexyl Stearate, Ethylparaben, Fragrance, Hexyl Laurate, Hydrogenated Castor Oil, Methyl Glucose Dioleate, Methylparaben, Octododecyl Neopentanoate, PEG-7 Hydrogenated Castor Oil, Polyglyceryl-4 Isostearate, Propylene Glycol, Propylparaben, Purified Water, Sorbitan Oleate, Stearic Acid, Tocopheryl Acetate (Vitamin E), Trimethylated Silica/Dimethicone, VP Hexadecene Copolymer

Questions ?

Visit www.bluelizard.net or call 800.877.8869

Crown Laboratories, Inc., Johnson City, TN 37604

Patents: US#6698590 & 6405867; AU#1998083259

Blue Lizard Sport Label

Blue Lizard

Australian Sunscreen

Sport

Broad Spectrum SPF 30+

UVA/UVB Protection

Bottle Turns Blue in UV Light

Zinc Oxide Formula

Water Resistant (80 minutes)

Dermatologist Recommended

P6669.05

INGREDIENTS AND APPEARANCE

BLUE LIZARD SPORT 
octinoxate, octocrylene, oxybenzone, and zinc oxide lotion

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 0316-2020
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
OCTINOXATE (UNII: 4Y5P7MUD51) (OCTINOXATE - UNII:4Y5P7MUD51)	OCTINOXATE	76.5 mg  in 1 mL
OCTOCRYLENE (UNII: 5A68WGF6WM) (OCTOCRYLENE - UNII:5A68WGF6WM)	OCTOCRYLENE	20.4 mg  in 1 mL
OXYBENZONE (UNII: 95OOS7VE0Y) (OXYBENZONE - UNII:95OOS7VE0Y)	OXYBENZONE	30.6 mg  in 1 mL
ZINC OXIDE (UNII: SOI2LOH54Z) (ZINC OXIDE - UNII:SOI2LOH54Z)	ZINC OXIDE	61.2 mg  in 1 mL

Inactive Ingredients
Ingredient Name	Strength
YELLOW WAX (UNII: 2ZA36H0S2V)
CETYL PEG/PPG-10/1 DIMETHICONE (HLB 5) (UNII: 035JKJ76MT)
DIAZOLIDINYL UREA (UNII: H5RIZ3MPW4)
EDETATE DISODIUM (UNII: 7FLD91C86K)
ETHYLHEXYL PALMITATE (UNII: 2865993309)
ETHYLHEXYL STEARATE (UNII: EG3PA2K3K5)
ETHYLPARABEN (UNII: 14255EXE39)
HEXYL LAURATE (UNII: 4CG9F9W01Q)
HYDROGENATED CASTOR OIL (UNII: ZF94AP8MEY)
METHYL GLUCOSE DIOLEATE (UNII: FA9KFJ4Z6P)
METHYLPARABEN (UNII: A2I8C7HI9T)
OCTYLDODECYL NEOPENTANOATE (UNII: X8725R883T)
PEG-7 HYDROGENATED CASTOR OIL (UNII: WE09129TH5)
POLYGLYCERYL-4 ISOSTEARATE (UNII: 820DPX33S7)
PROPYLENE GLYCOL (UNII: 6DC9Q167V3)
PROPYLPARABEN (UNII: Z8IX2SC1OH)
WATER (UNII: 059QF0KO0R)
SORBITAN MONOOLEATE (UNII: 06XEA2VD56)
STEARIC ACID (UNII: 4ELV7Z65AP)
.ALPHA.-TOCOPHEROL ACETATE (UNII: 9E8X80D2L0)
HEXADECYL POVIDONE (4 HEXADECYL BRANCHES/REPEAT) (UNII: AG75W62QYU)
DIMETHICONE (UNII: 92RU3N3Y1O)
TRIMETHYLSILOXYSILICATE (M/Q 0.8-1.0) (UNII: 25LXE464L2)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 0316-2020-20	37 mL in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product	04/15/2001	07/31/2021
2	NDC: 0316-2020-30	89 mL in 1 TUBE; Type 0: Not a Combination Product	01/03/2006	07/31/2021
3	NDC: 0316-2020-40	148 mL in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product	04/15/2001	07/31/2021
4	NDC: 0316-2020-50	259 mL in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product	05/01/2009	07/31/2021
5	NDC: 0316-2020-60	3787 mL in 1 JUG; Type 0: Not a Combination Product	05/01/2009	07/31/2021
6	NDC: 0316-2020-10	5 mL in 1 PACKET; Type 0: Not a Combination Product	10/01/2002	07/31/2021
7	NDC: 0316-2020-05	15 mL in 1 PACKET; Type 0: Not a Combination Product	01/18/2018	07/31/2021

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC monograph not final	part352	04/15/2001	07/31/2021

Labeler - Crown Laboratories (079035945)

Registrant - Crown Laboratories (079035945)

Establishment
Name	Address	ID/FEI	Business Operations
Crown Laboratories		079035945	manufacture(0316-2020)