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

Blue Lizard Sheer Face SPF 50 Sunscreen by

Drug Labeling and Warnings

Blue Lizard Sheer Face 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 9%

Zinc Oxide 6%

Purpose

Sunscreen

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

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

Keep out of reach of children

Other Information

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

Inactive Ingredients

Alanine, Aloe Barbadensis Leaf Juice, Alumina, Aluminum Stearate, Arginine, Aspartic Acid, Butyrospermum Parkii (Shea) Butter, C12-15 Alkyl Benzoate, Caprylic/Capric Triglyceride, Carica Papaya (Papaya) Fruit Extract, Citric Acid, Crithmum Maritimum Extract, Cucumis Sativus (Cucumber) Fruit Extract, Diisopropyl Sebacate, Dimethoxydiphenylsilane/ Triethoxycaprylylsilane Crosspolymer, Ethylhexylglycerin, Fucus Vesiculosus (Bladderwrack) Extract, Ginkgo Biloba (Ginkgo) Leaf Extract, Glycerin, Glycine, Glycine Soja (Soybean) Oil, Hamamelis Virginiana (Witch Hazel) Leaf Extract, Histidine, Hydrogenated Vegetable Oil, Isoleucine, Isostearyl Alcohol, Isostearyl Isostearate, Oryza Sativa (Rice) Extract, Oryza Sativa (Rice) Germ Extract, PCA, Phenoxyethanol, Phenylalanine, Polyglyceryl-3 Diisostearate, Polyglyceryl-3 Polyricinoleate, Polyhydroxystearic Acid, Potassium Sorbate, Proline, Purified Water, Rosa Canina (Rosehip) Fruit Oil, Sclerocarya Birrea (Marula) Seed Oil, Serine, Sodium Benzoate, Sodium Chloride, Sodium Hyaluronate, Sodium Lactate, Sodium PCA, Sorbitan Isostearate, Squalane, Threonine, Tocopheryl Acetate (Vitamin E), Valine, and Xanthan Gum

Questions?

Visit www.bluelizardsunscreen.com or call 800.877.8869

Crown Laboratories, Inc., Johnson City, TN 37604

Blue Lizard Sheer Lotion for Face - 1.7 fl oz Tube

BLUE LIZARD

AUSTRALIAN SUNSCREEN

50+

SHEER LOTION for face

MINERAL SUNSCREEN

UVA/UVB PROTECTION

BROAD SPECTRUM

SPF 50+

WATER RESISTANT (80 MINUTES)

P11901.00

Blue Lizard Sheer Lotion for face - 1.7 fl oz carton

BLUE LIZARD

AUSTRALIAN SUNSCREEN

50+

SHEER LOTION for face

MINERAL SUNSCREEN

BLUE LIGHT PROTECTION

UVA/UVB PROTECTION

BROAD SPECTRUM SPF 50+

WATER RESISTANT (80 MINUTES)

P11900.01

INGREDIENTS AND APPEARANCE

BLUE LIZARD SHEER FACE SPF 50 SUNSCREEN 
titanium dioxide and zinc oxide lotion

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 0316-2057
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
ZINC OXIDE (UNII: SOI2LOH54Z) (ZINC OXIDE - UNII:SOI2LOH54Z)	ZINC OXIDE	66.6 mg  in 1 mL
TITANIUM DIOXIDE (UNII: 15FIX9V2JP) (TITANIUM DIOXIDE - UNII:15FIX9V2JP)	TITANIUM DIOXIDE	99.9 mg  in 1 mL

Inactive Ingredients
Ingredient Name	Strength
SODIUM LACTATE (UNII: TU7HW0W0QT)
SODIUM PYRROLIDONE CARBOXYLATE (UNII: 469OTG57A2)
THREONINE (UNII: 2ZD004190S)
VALINE (UNII: HG18B9YRS7)
XANTHAN GUM (UNII: TTV12P4NEE)
SORBITAN ISOSTEARATE (UNII: 01S2G2C1E4)
.ALPHA.-TOCOPHEROL ACETATE (UNII: 9E8X80D2L0)
HYALURONATE SODIUM (UNII: YSE9PPT4TH)
WATER (UNII: 059QF0KO0R)
SERINE (UNII: 452VLY9402)
SODIUM BENZOATE (UNII: OJ245FE5EU)
ALUMINUM STEARATE (UNII: U6XF9NP8HM)
ALUMINUM OXIDE (UNII: LMI26O6933)
ISOSTEARYL ISOSTEARATE (UNII: IV0Z586Z4Y)
FUCUS VESICULOSUS (UNII: 535G2ABX9M)
GINKGO (UNII: 19FUJ2C58T)
GLYCERIN (UNII: PDC6A3C0OX)
GLYCINE (UNII: TE7660XO1C)
HISTIDINE (UNII: 4QD397987E)
POLYGLYCERYL-3 PENTARICINOLEATE (UNII: 7Q0OK5DOT4)
HYDROGENATED RAPESEED OIL (UNII: K168T6Y0YU)
SOYBEAN OIL (UNII: 241ATL177A)
RICE GERM (UNII: 7N2B70SFEZ)
PIDOLIC ACID (UNII: SZB83O1W42)
POLYGLYCERYL-3 DIISOSTEARATE (UNII: 46P231IQV8)
ASPARTIC ACID (UNII: 30KYC7MIAI)
ETHYLHEXYLGLYCERIN (UNII: 147D247K3P)
SHEA BUTTER (UNII: K49155WL9Y)
PAPAYA (UNII: KU94FIY6JB)
CRITHMUM MARITIMUM (UNII: J7IHY79BKY)
ALOE VERA LEAF (UNII: ZY81Z83H0X)
CUCUMBER (UNII: YY7C30VXJT)
PHENOXYETHANOL (UNII: HIE492ZZ3T)
PHENYLALANINE (UNII: 47E5O17Y3R)
ISOLEUCINE (UNII: 04Y7590D77)
ISOSTEARYL ALCOHOL (UNII: Q613OCQ44Y)
SQUALANE (UNII: GW89575KF9)
SCLEROCARYA BIRREA SEED OIL (UNII: WDO4TLS35F)
ROSA CANINA FRUIT OIL (UNII: CR7307M3QZ)
PROLINE (UNII: 9DLQ4CIU6V)
SODIUM CHLORIDE (UNII: 451W47IQ8X)
ALKYL (C12-15) BENZOATE (UNII: A9EJ3J61HQ)
CITRIC ACID MONOHYDRATE (UNII: 2968PHW8QP)
DIISOPROPYL SEBACATE (UNII: J8T3X564IH)
HAMAMELIS VIRGINIANA LEAF (UNII: T07U1161SV)
TRIETHOXYCAPRYLYLSILANE (UNII: LDC331P08E)
POTASSIUM SORBATE (UNII: 1VPU26JZZ4)
DIMETHOXYDIPHENYLSILANE (UNII: 02QB6788GC)
POLYHYDROXYSTEARIC ACID (2300 MW) (UNII: YXH47AOU0F)
HYDROGENATED PALM OIL (UNII: 257THB963H)
ALANINE (UNII: OF5P57N2ZX)
ARGININE (UNII: 94ZLA3W45F)
MEDIUM-CHAIN TRIGLYCERIDES (UNII: C9H2L21V7U)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 0316-2057-17	1 in 1 CARTON	05/13/2021
1		48 mL in 1 TUBE; Type 0: Not a Combination Product

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC Monograph Drug	M020	05/13/2021

Labeler - Crown Laboratories (079035945)

Establishment
Name	Address	ID/FEI	Business Operations
Crown Laboratories		079035945	manufacture(0316-2057)