FDA.reportPublic FDA data

Blue Lizard SPF 15 Lip Balm

Manufacturer
Crown Laboratories
Effective date
2026-01-12
Label type
HUMAN OTC DRUG LABEL
Version
3
Source
full-release
Hydrated at
2026-06-01 01:32:25

Label at a glance#

ProductBlue Lizard SPF 15 Lip Balm
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 10%

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 - STOP 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

Inactive ingredients

INACTIVE INGREDIENT SECTION

Behenyl Behenate, Butyrospermum Parkii (Shea) Butter, Caprylic/Capric Triglyceride, Cocos Nucifera (Coconut) Oil, Copernicia Cerifera (Carnauba) Wax, Euphorbia Cerifera (Candelilla) Wax, Flavor, Glycine Soja (Soybean) Oil, Helianthus Annuus (Sunflower) Extract, Helianthus Annuus (Sunflower) Seed Oil, Helianthus Annuus (Sunflower) Seed Wax, Melaleuca Alternifolia (Tea Tree) Leaf Oil, Olea Europaea (Olive) Fruit Oil, Oryza Sativa (Rice) Bran Extract, Persea Gratissima (Avocado) Oil, Polyhydroxystearic Acid, Prunus Amygdalus Dulcis (Sweet Almond) Oil, Ricinus Communis (Castor) Seed Oil, Rosmarinus Officinalis (Rosemary) Leaf Extract, Simmondsia Chinensis (Jojoba) Seed Oil, Terminalia Ferdinandiana (Kakadu Plum) Fruit Extract, Tocopherol

Blue Lizard SPF 15 Lip Balm Label

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

BLUE LIZARD

AUSTRALIAN SUNSCREEN

15

LIP BALM

UVA/UVB PROTECTION

BROAD SPECTRUM SPF 15

MINERAL SUNSCREEN LIP BALM

WATER RESISTANT (80 Minutes)

Net wt. 0.13 oz (3.8 g)

LABELLABEL

Blue Lizard SPF 15 Lip Balm Carton

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

CartonCarton

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

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
0316-2085-15Blue Lizard SPF 15 Lip Balm1 in 1 CARTONSTICK13
0316-2085-15Blue Lizard SPF 15 Lip Balm3.8 g in 1 CYLINDERSTICK3.83

Products#

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

DailyMed product names page 1 of 1 · 23 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
0316-20850316-2085-15

Ingredients#

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

DailyMed ingredient rows page 1 of 1 · 22 matching rows.

Name, UNII, Kind table
NameUNIIKind
CASTOR OILD5340Y2I9GIACT
CARNAUBA WAXR12CBM0EIZIACT
.ALPHA.-TOCOPHEROL, D-N9PR3490H9IACT
RICE BRANR60QEP13ICIACT
ALMOND OIL66YXD4DKO9IACT
HELIANTHUS ANNUUS SEED WAX42DG15CHXVIACT
JOJOBA OIL724GKU717MIACT
TEA TREE OILVIF565UC2GIACT
SOYBEAN OIL241ATL177AIACT
ROSEMARYIJ67X351P9IACT
HELIANTHUS ANNUUS FLOWERING TOPBKJ0J3D1BPIACT
BEHENYL BEHENATEK8NU647RJ0IACT
COCONUT OILQ9L0O73W7LIACT
POLYHYDROXYSTEARIC ACID STEARATE8KQ7I65XZEIACT
MEDIUM-CHAIN TRIGLYCERIDESC9H2L21V7UIACT
SUNFLOWER OIL3W1JG795YIIACT
CANDELILLA WAXWL0328HX19IACT
SHEA BUTTERK49155WL9YIACT
ZINC OXIDESOI2LOH54ZACTIB
AVOCADO OIL6VNO72PFC1IACT
KAKADU PLUM0ZQ1D2FDLIIACT
OLIVE OIL6UYK2W1W1EIACT

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 SPF 15 Lip BalmZINC OXIDECrown Laboratories1bf8fb7e-9d5b-86d4-e063-6294a90afddc2026-01-12WarningsExact identifier
ndc (package): 0316-2085-15
ndc (product): 0316-2085
ndc11 (package): 00316208515
spl id: 48349731-ebae-cfc6-e063-6394a90acdf2
spl set id: 1bf8fb7e-9d5b-86d4-e063-6294a90afddc

Reported adverse events (FAERS/openFDA)#

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