FDA.reportPublic FDA data

Blue Lizard Sheer Lotion SPF 50 Sunscreen

Manufacturer
Crown Laboratories
Effective date
2026-01-12
Label type
HUMAN OTC DRUG LABEL
Version
7
Source
full-release
Hydrated at
2026-06-01 01:32:45

Label at a glance#

ProductBlue Lizard Sheer SPF 50 Sunscreen
Active ingredientZINC OXIDE, TITANIUM DIOXIDE
Label structure10 sections

Indications and 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

Dosage and administration

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 includi...

Label contents#

Full prescribing information#

Active Ingredients

OTC - ACTIVE INGREDIENT SECTION

Titanium Dioxide 9%

Zinc Oxide 6%

Purpose

OTC - PURPOSE SECTION

Sunscreen

Uses

INDICATIONS & USAGE SECTION

  • 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

WARNINGS SECTION

  • 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

DOSAGE & ADMINISTRATION SECTION

  • 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

Keep out of reach of children

OTC - KEEP OUT OF REACH OF CHILDREN SECTION

Other Information

OTHER SAFETY INFORMATION

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

Inactive Ingredients

INACTIVE INGREDIENT SECTION

Aloe Barbadensis Leaf Juice, Alumina, Aluminum Stearate, Butyrospermum Parkii (Shea) Butter, C12-15 Alkyl Benzoate, Caprylic/Capric Triglyceride, Carica Papaya (Papaya) Fruit Extract, Citric Acid, Citrus Aurantium Dulcis (Orange) Peel Extract, Crithmum Maritimum Extract, Cucumis Sativus (Cucumber) Fruit Extract, Diisopropyl Sebacate, Dimethoxydiphenylsilane/Triethoxycaprylylsilane Crosspolymer, Ethylhexylglycerin, Fucus Vesiculosus (Bladderwrack) Extract, Gamma-Nonalactone, Ginkgo Biloba (Ginkgo) Leaf Extract, Glycerin, Hamamelis Virginiana (Witch Hazel) Leaf Extract, Hydrogenated Vegetable Oil, Isostearyl Alcohol, Isostearyl Isostearate, Phenoxyethanol, Polyglyceryl-3 Polyricinoleate, Polyhydroxystearic Acid, Potassium Sorbate, Purified Water, Ricinus Communis (Castor) Seed Oil, Rosa Canina (Rosehip) Fruit Oil, Sclerocarya Birrea (Marula) Seed Oil, Sea Water, Sodium Benzoate, Sodium Chloride, Sorbitan Isostearate, Squalane, Tocopheryl Acetate (Vitamin E), Triethyl Citrate, and Xanthan Gum

Questions?

OTC - QUESTIONS SECTION

Visit www.bluelizardsunscreen.com or call 800.877.8869

Crown Laboratories, Inc., Johnson City, TN 37604

Blue Lizard Sheer Lotion - 3oz Tube Label

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

BLUE LIZARD

AUSTRALIAN SUNSCREEN

50+

Sheer Lotion

mineral sunscreen

UVA/UVB PROTECTION

BROAD SPECTRUM

SPF 50+

WATER RESISTANT (80 MINUTES)

P11899.00

sheer-body-tubesheer-body-tube

Blue Lizard Sheer Lotion - 3oz Carton

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

BLUE LIZARD

AUSTRALIAN SUNSCREEN

50+

Sheer Lotion

body

mineral sunscreen

UVA/UVB PROTECTION

BROAD SPECTRUM

SPF 50+

WATER RESISTANT (80 MINUTES)

P11902.01

p1190201p1190201

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
0316-2064-302023-02-13C16284748780-1f386c649-c61d-0266-e053-dadaa90a7c1aBlue Lizard Sheer Lotion SPF 50 Sunscreen
0316-2064-302023-02-13C16284748780-1f386c649-c61d-0266-e053-dadaa90a7c1aBlue Lizard Sheer Lotion SPF 50 Sunscreen
0316-2064-302023-02-13C16284748780-1f386c649-c61d-0266-e053-dadaa90a7c1aBlue Lizard Sheer Lotion SPF 50 Sunscreen
0316-2064-302023-01-30C16284748780-1f386c649-c61d-0266-e053-dadaa90a7c1aBlue Lizard Sheer Lotion SPF 50 Sunscreen
0316-2064-302023-01-30C16284748780-1f386c649-c61d-0266-e053-dadaa90a7c1aBlue Lizard Sheer Lotion SPF 50 Sunscreen
0316-2064-302023-01-30C16284748780-1f386c649-c61d-0266-e053-dadaa90a7c1aBlue Lizard Sheer Lotion SPF 50 Sunscreen

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
0316-2064-30Blue Lizard Sheer SPF 50 Sunscreen1 in 1 CARTONLOTION17
0316-2064-30Blue Lizard Sheer SPF 50 Sunscreen89 mL in 1 TUBELOTION897

Products#

Every source-derived product name is available through these pages.

DailyMed product names page 1 of 2 · 43 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
0316-20640316-2064-30

Ingredients#

Every source-derived ingredient row is available through these pages.

DailyMed ingredient rows page 1 of 2 · 41 matching rows.

Name, UNII, Kind table
NameUNIIKind
HAMAMELIS VIRGINIANA LEAFT07U1161SVIACT
GINKGO19FUJ2C58TIACT
GLYCERINPDC6A3C0OXIACT
ALOE VERA LEAFZY81Z83H0XIACT
ALUMINUM OXIDELMI26O6933IACT
ALUMINUM STEARATEU6XF9NP8HMIACT
SHEA BUTTERK49155WL9YIACT
ALKYL (C12-15) BENZOATEA9EJ3J61HQIACT
MEDIUM-CHAIN TRIGLYCERIDESC9H2L21V7UIACT
PAPAYAKU94FIY6JBIACT
CITRIC ACID MONOHYDRATE2968PHW8QPIACT
ORANGE PEELTI9T76XD44IACT
CRITHMUM MARITIMUM WHOLEJ7IHY79BKYIACT
CUCUMBERYY7C30VXJTIACT
DIISOPROPYL SEBACATEJ8T3X564IHIACT
DIMETHOXYDIPHENYLSILANE02QB6788GCIACT
TRIETHOXYCAPRYLYLSILANELDC331P08EIACT
ETHYLHEXYLGLYCERIN147D247K3PIACT
FUCUS VESICULOSUS535G2ABX9MIACT
.GAMMA.-NONALACTONEI1XGH66S8PIACT
ZINC OXIDESOI2LOH54ZACTIB
TITANIUM DIOXIDE15FIX9V2JPACTIB
HYDROGENATED PALM OIL257THB963HIACT
HYDROGENATED RAPESEED OILK168T6Y0YUIACT
ISOSTEARYL ISOSTEARATEIV0Z586Z4YIACT
POTASSIUM SORBATE1VPU26JZZ4IACT
WATER059QF0KO0RIACT
CASTOR OILD5340Y2I9GIACT
SCLEROCARYA BIRREA SEED OILWDO4TLS35FIACT
SODIUM CHLORIDE451W47IQ8XIACT
SORBITAN ISOSTEARATE01S2G2C1E4IACT
TRIETHYL CITRATE8Z96QXD6UMIACT
XANTHAN GUMTTV12P4NEEIACT
SQUALANEGW89575KF9IACT
POLYGLYCERYL-3 PENTARICINOLEATE7Q0OK5DOT4IACT
.ALPHA.-TOCOPHEROL ACETATE9E8X80D2L0IACT
ISOSTEARYL ALCOHOLQ613OCQ44YIACT
PHENOXYETHANOLHIE492ZZ3TIACT
POLYHYDROXYSTEARIC ACID (2300 MW)YXH47AOU0FIACT
ROSA CANINA FRUIT OILCR7307M3QZIACT

Source Document#

Source XML

Older Hydrated Versions#

Version, Effective date, Source table
VersionEffective dateSourceHydrated
62025-11-12monthly-update2026-06-03 17:38:21
52023-12-05full-release2026-06-01 00:03:32

openFDA label cross-check#

OpenFDA label data provides additional search and identifier links. DailyMed’s Structured Product Label is the canonical label on FDA.report. Matching records are deduplicated before they are shown below.

Matched openFDA labels page 1 of 1 · 1 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Blue Lizard Sheer SPF 50 SunscreenTITANIUM DIOXIDE, ZINC OXIDECrown Laboratoriesc20fce25-8120-fe5d-e053-2a95a90a53a02026-01-12WarningsExact identifier
ndc (package): 0316-2064-30
ndc (product): 0316-2064
ndc11 (package): 00316206430
spl id: 4833ed53-8e4b-0cdb-e063-6394a90a02ec
spl set id: c20fce25-8120-fe5d-e053-2a95a90a53a0

Reported adverse events (FAERS/openFDA)#

Adverse event summaries are temporarily unavailable. Other product information remains available.