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

P613811

BLUE LIZARD FACE
sunscreen gel

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

Ingredient Name	Basis of Strength	Strength
Active Ingredient/Active Moiety
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

Ingredient Name	Strength
Inactive Ingredients
DIMETHOXYDIPHENYLSILANE (UNII: 02QB6788GC)
ISOSTEARYL ALCOHOL (UNII: Q613OCQ44Y)
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)
BUTYLATED HYDROXYTOLUENE (UNII: 1P9D0Z171K)
POLYACRYLAMIDE (1500 MW) (UNII: 5D6TC4BRWV)
HYALURONATE SODIUM (UNII: YSE9PPT4TH)
TRIETHOXYCAPRYLYLSILANE (UNII: LDC331P08E)

#	Item Code	Package Description	Marketing Start Date	Marketing End Date
Packaging
1	NDC:0316-2055-10	5 g in 1 POUCH; Type 0: Not a Combination Product	04/06/2010	10/01/2021
2	NDC:0316-2055-30	85 g in 1 TUBE; Type 0: Not a Combination Product	04/06/2010	03/31/2024
3	NDC:0316-2055-40	141.7 g in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product	04/06/2010	08/31/2023

Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
Marketing Information
OTC monograph not final	part352	04/06/2010	03/31/2024

Labeler - Crown Laboratories (079035945)

Registrant - Crown Laboratories (079035945)

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