BLUE LIZARD FACE- sunscreen gel

Blue Lizard Face by

Drug Labeling and Warnings

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

Drug Details [pdf]

Active Ingredients

Octinoxate 5.5%

Zinc Oxide 8.0%

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: 
• At least every 2 hours 
• Use a water resistant sunscreen if swimming or sweating

Other Information

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

Inactive Ingredients

Beeswax, BHT, C12-15 Alkyl Benzoate, C13-14 Isoparaffin, Caffeine, Camellia sinesis Leaf (Green Tea) Extract, Caprylyl Glycol, Chlorphenesin, Cyclomethicone, Dimethoxydiphenylsilane, Isotearyl Alcohol, Laureth-7, Lauryl PEG/PPG 18/18 Methicone, Phenoxyethanol, Polyacrylamide, Purified Water, Sodium Hyaluronate, Tocopheryl Acetate (Vitamin E), Triethoxycaprylylsilane

Questions?

Visit www.bluelizard.net or call 800.877.8869

Crown Laboratories, Inc., Johnson City, TN 37604

Blue Lizard Face Label

BLUE LIZARD

AUSTRALIAN SUNSCREEN

30+

UVA/UVB PROTECTION

BROAD SPECTRUM

SPF 30+

TRUSTED BY DERMATOLOGISTS FOR OVER 20 YEARS

FACE

mineral-based sunscreen

combining mineral and chemical UV protectors

Smart Cap TECHNOLOGY

CAP TURNS BLUE IN HARMFUL UV LIGHT

LIGHTWEIGHT DAILY

SUN PROTECTION

P6138.11

INGREDIENTS AND APPEARANCE

BLUE LIZARD FACE 
sunscreen gel

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 0316-2055
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
OCTINOXATE (UNII: 4Y5P7MUD51) (OCTINOXATE - UNII:4Y5P7MUD51)	OCTINOXATE	55 mg  in 1 g
ZINC OXIDE (UNII: SOI2LOH54Z) (ZINC OXIDE - UNII:SOI2LOH54Z)	ZINC OXIDE	80 mg  in 1 g

Inactive Ingredients
Ingredient Name	Strength
POLYACRYLAMIDE (1500 MW) (UNII: 5D6TC4BRWV)
HYALURONATE SODIUM (UNII: YSE9PPT4TH)
TRIETHOXYCAPRYLYLSILANE (UNII: LDC331P08E)
BUTYLATED HYDROXYTOLUENE (UNII: 1P9D0Z171K)
WATER (UNII: 059QF0KO0R)
ALKYL (C12-15) BENZOATE (UNII: A9EJ3J61HQ)
CYCLOMETHICONE (UNII: NMQ347994Z)
C13-14 ISOPARAFFIN (UNII: E4F12ROE70)
LAURETH-7 (UNII: Z95S6G8201)
ALPHA-TOCOPHEROL ACETATE (UNII: 9E8X80D2L0)
GREEN TEA LEAF (UNII: W2ZU1RY8B0)
YELLOW WAX (UNII: 2ZA36H0S2V)
CAFFEINE (UNII: 3G6A5W338E)
PHENOXYETHANOL (UNII: HIE492ZZ3T)
CAPRYLYL GLYCOL (UNII: 00YIU5438U)
CHLORPHENESIN (UNII: I670DAL4SZ)
LAURYL PEG/PPG-18/18 METHICONE (UNII: ZJ5S27D9NX)
ISOSTEARYL ALCOHOL (UNII: Q613OCQ44Y)
DIMETHOXYDIPHENYLSILANE (UNII: 02QB6788GC)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 0316-2055-10	5 g in 1 POUCH; Type 0: Not a Combination Product	04/06/2010
2	NDC: 0316-2055-30	85 g in 1 TUBE; Type 0: Not a Combination Product	04/06/2010
3	NDC: 0316-2055-40	141.7 g in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product	04/06/2010

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC monograph not final	part352	04/06/2010

Labeler - Crown Laboratories (079035945)

Registrant - Crown Laboratories (079035945)

Establishment
Name	Address	ID/FEI	Business Operations
Crown Laboratories		079035945	manufacture(0316-2055)