FDA.reportPublic FDA data

Blue Lizard Sensitive SPF 50

Manufacturer
Crown Laboratories
Effective date
2026-01-12
Label type
HUMAN OTC DRUG LABEL
Version
8
Source
full-release
Hydrated at
2026-06-01 01:32:41

Label at a glance#

ProductBlue Lizard Sensitive SPF 50
Active ingredientZINC OXIDE
Label structure10 sections

Indications and uses

helps prevent sunburn

Dosage and administration

• apply liberally 15 minutes before sun exposure • children under 6 months of age: Ask a doctor • reapply: after 80 minutes of swimming or sweating immediately after towel drying at least every 2 hours • 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...

Label contents#

Full prescribing information#

Active ingredient

OTC - ACTIVE INGREDIENT SECTION

Zinc Oxide 20%

Purpose

OTC - PURPOSE SECTION

Sunscreen

Uses

INDICATIONS & USAGE SECTION

  • helps prevent sunburn

Warnings

WARNINGS SECTION

For external use only

Do not use

OTC - DO NOT USE SECTION

  • on damaged or broken skin

When using this product

OTC - WHEN USING SECTION

  • keep out of eyes. Rinse with water to remove

Stop use and ask a doctor if

OTC - DO NOT USE SECTION

  • rash occurs

Keep out of reach of children

OTC - KEEP OUT OF REACH OF CHILDREN SECTION

  • if swallowed, get medical help or contact a Poison Control Center right away

Directions

DOSAGE & ADMINISTRATION SECTION

• apply liberally 15 minutes before sun exposure

• children under 6 months of age: Ask a doctor

• reapply:

  • after 80 minutes of swimming or sweating
  • immediately after towel drying
  • at least every 2 hours

• 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

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 Extract, Behenyl Behenate, Butyrospermum Parkii (Shea) Butter, Caprylic/Capric Triglyceride, Cocos Nucifera (Coconut) Oil, Euphorbia Cerifera (Candelilla) Wax, Glycine Soja (Soybean) Oil, Helianthus Annuus (Sunflower) Seed Oil, Helianthus Annuus (Sunflower) Seed Wax, Polyhydroxystearic Acid, Ricinus Communis (Castor) Seed Oil, Simmondsia Chinensis (Jojoba) Seed Oil, Squalane, Theobroma Cacao (Cocoa) Seed Butter, Tocopherol

Blue Lizard Sensitive SPF 50 Stick Label

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

BLUE LIZARD

AUSTRALIAN SUNSCREEN

50

SENSITIVE

MINERAL SUNSCREEN

UVA/UVB PROTECTION

BROAD SPECTRUM SPF 50

WATER RESISTANT (80 Minutes)

Net wt. 0.5 oz (14 g)

labellabel

Blue Lizard Sensitive SPF 50 Stick Backer Card

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

backerbacker

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
baf7f49c-75b6-496b-a00e-8e766a8e4f03Product name120210127
ebc62596-fc97-4d03-9483-7ba095d25db7Product name120151210
0ca1d589-929b-4b33-bc5b-1d84abdafa6aProduct name120150324
fc363c46-397b-4476-ac0f-70e43e8e4592Product name120150324

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
0316-2013-052023-02-13C16284748780-1f386c649-c0bb-0266-e053-dadaa90a7c1aBlue Lizard Sensitive SPF 50 Sunscreen Stick
0316-2013-052023-01-30C16284748780-1f386c649-c0bb-0266-e053-dadaa90a7c1aBlue Lizard Sensitive SPF 50 Sunscreen Stick

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
0316-2013-05Blue Lizard Sensitive SPF 5014 g in 1 CYLINDERSTICK148
0316-2013-05Blue Lizard Sensitive SPF 501 in 1 BLISTER PACKSTICK18

Products#

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

DailyMed product names page 1 of 1 · 17 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
0316-20130316-2013-05

Ingredients#

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

DailyMed ingredient rows page 1 of 1 · 16 matching rows.

Name, UNII, Kind table
NameUNIIKind
SOYBEAN OIL241ATL177AIACT
BEHENYL BEHENATEK8NU647RJ0IACT
COCONUT OILQ9L0O73W7LIACT
POLYHYDROXYSTEARIC ACID STEARATE8KQ7I65XZEIACT
CASTOR OILD5340Y2I9GIACT
.ALPHA.-TOCOPHEROL, D-N9PR3490H9IACT
JOJOBA OIL724GKU717MIACT
ALOE VERA LEAFZY81Z83H0XIACT
MEDIUM-CHAIN TRIGLYCERIDESC9H2L21V7UIACT
SUNFLOWER OIL3W1JG795YIIACT
COCOA BUTTER512OYT1CRRIACT
HELIANTHUS ANNUUS SEED WAX42DG15CHXVIACT
CANDELILLA WAXWL0328HX19IACT
SQUALANEGW89575KF9IACT
SHEA BUTTERK49155WL9YIACT
ZINC OXIDESOI2LOH54ZACTIB

Source Document#

Source XML

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 Sensitive SPF 50ZINC OXIDECrown Laboratories99839894-9695-2cd1-e053-2995a90acba62026-01-12WarningsExact identifier
ndc (package): 0316-2013-05
ndc (product): 0316-2013
ndc11 (package): 00316201305
spl id: 483494ff-2ceb-dd9f-e063-6394a90a0313
spl set id: 99839894-9695-2cd1-e053-2995a90acba6

Reported adverse events (FAERS/openFDA)#

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