BLUE LIZARD SENSITIVE SPF 50 SUNSCREEN- titanium dioxide and zinc oxide lotion

Blue Lizard Sensitive SPF 50 Sunscreen by

Drug Labeling and Warnings

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

Drug Details [pdf]

Active Ingredients

Titanium Dioxide - 8%

Zinc Oxide - 10%

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 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

Alumina, Aluminum Stearate, Beeswax, C12-15 Alkyl Benzoate, 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, Polyhydroxystearic Acid, 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 Sensitive 3oz Tube

BLUE LIZARD

AUSTRALIAN SUNSCREEN

50+

UVA/UVB PROTECTION

BROAD SPECTRUM

SPF 50+

TRUSTED BY DERMATOLOGISTS FOR OVER 20 YEARS

SENSITIVE

Mineral Sunscreen

Protects your skin by acting like thousands of tiny shields that reflect UV rays.

Smart Cap TECHNOLOGY

CAP TURNS BLUE IN HARMFUL UV LIGHT

WATER RESISTANT (80 MINUTES)

P11661.00

INGREDIENTS AND APPEARANCE

BLUE LIZARD SENSITIVE SPF 50 SUNSCREEN 
titanium dioxide and zinc oxide lotion

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 0316-2046
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
TITANIUM DIOXIDE (UNII: 15FIX9V2JP) (TITANIUM DIOXIDE - UNII:15FIX9V2JP)	TITANIUM DIOXIDE	89.6 mg  in 1 mL
ZINC OXIDE (UNII: SOI2LOH54Z) (ZINC OXIDE - UNII:SOI2LOH54Z)	ZINC OXIDE	112 mg  in 1 mL

Inactive Ingredients
Ingredient Name	Strength
ALUMINUM STEARATE (UNII: U6XF9NP8HM)
TRIETHOXYCAPRYLYLSILANE (UNII: LDC331P08E)
ETHYLHEXYL PALMITATE (UNII: 2865993309)
ALUMINUM OXIDE (UNII: LMI26O6933)
YELLOW WAX (UNII: 2ZA36H0S2V)
ALKYL (C12-15) BENZOATE (UNII: A9EJ3J61HQ)
CETYL PEG/PPG-10/1 DIMETHICONE (HLB 5) (UNII: 035JKJ76MT)
EDETATE DISODIUM (UNII: 7FLD91C86K)
ETHYLHEXYL STEARATE (UNII: EG3PA2K3K5)
CAPRYLYL GLYCOL (UNII: 00YIU5438U)
HEXYL LAURATE (UNII: 4CG9F9W01Q)
HYDROGENATED CASTOR OIL (UNII: ZF94AP8MEY)
METHYL GLUCOSE DIOLEATE (UNII: FA9KFJ4Z6P)
CHLORPHENESIN (UNII: I670DAL4SZ)
OCTYLDODECYL NEOPENTANOATE (UNII: X8725R883T)
PEG-7 HYDROGENATED CASTOR OIL (UNII: WE09129TH5)
POLYGLYCERYL-4 ISOSTEARATE (UNII: 820DPX33S7)
PHENOXYETHANOL (UNII: HIE492ZZ3T)
PROPANEDIOL (UNII: 5965N8W85T)
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)
POLYHYDROXYSTEARIC ACID (2300 MW) (UNII: YXH47AOU0F)
CETYL DIMETHICONE 25 (UNII: U4AS1BW4ZB)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 0316-2046-10	5 mL in 1 PACKET; Type 0: Not a Combination Product	03/02/2020
2	NDC: 0316-2046-30	89 mL in 1 TUBE; Type 0: Not a Combination Product	02/17/2020
3	NDC: 0316-2046-40	148 mL in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product	01/29/2020
4	NDC: 0316-2046-50	259 mL in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product	02/24/2020
5	NDC: 0316-2046-45	148 mL in 1 TUBE; Type 0: Not a Combination Product	02/17/2020

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC monograph not final	part352	01/29/2020

Labeler - Crown Laboratories (079035945)

Registrant - Crown Laboratories (079035945)

Establishment
Name	Address	ID/FEI	Business Operations
Crown Laboratories		079035945	manufacture(0316-2046)