FDA.reportPublic FDA data

Blue Lizard Baby SPF 50 Sunscreen

Manufacturer
Crown Laboratories
Effective date
2026-01-12
Label type
HUMAN OTC DRUG LABEL
Version
3
Source
full-release
Hydrated at
2026-06-01 01:32:28

Label at a glance#

ProductBlue Lizard Baby SPF 50 Sunscreen
Active ingredientTITANIUM DIOXIDE, ZINC OXIDE
Label structure9 sections

Indications and uses

helps prevent sunburn

Dosage and administration

• shake well prior to use • 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...

Label contents#

Full prescribing information#

Active ingredients

OTC - ACTIVE INGREDIENT SECTION

Titanium Dioxide 8%

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 • on damaged or broken skin

When using this product • keep out of eyes. Rinse with water to remove

Stop use and ask doctor if • rash occurs

Keep out of reach of children. If swallowed, get medical help or contact a Poison Control Center right away

Directions

DOSAGE & ADMINISTRATION SECTION

• shake well prior to use

• 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.

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

1,2-Hexanediol, Aloe Barbadensis Leaf Juice Powder, Alumina, Aluminum Stearate, Butyloctyl Salicylate, C12-15 Alkyl Benzoate, Calendula Officinalis Flower Extract, Caprylyl Glycol, Cetyl Dimethicone, Cetyl PEG/PPG-10/1 Dimethicone, Dimethicone, Disodium EDTA, Ethylhexyl Palmitate, Ethylhexyl Stearate, Euphorbia Cerifera (Candelilla) Wax, Glycerin, Hexyl Laurate, Hydroxyacetophenone, Methyl Glucose Dioleate, Octyldodecyl Neopentanoate, PEG-7 Hydrogenated Castor Oil, Polyglyceryl-4 Isostearate, Polyhydroxystearic Acid, Propanediol, Tocopherol, (Vitamin E), Tocopheryl Acetate, Triethoxycaprylylsilane, Trimethylsiloxysilicate, VP/Hexadecene Copolymer, Water

Blue Lizard Baby 3 oz Tube

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

Blue Lizard

AUSTRALIAN SUNSCREEN

50

BABY

with soothing calendula extract & organic aloe

MINERAL SUNSCREEN

UVA/UVB PROTECTION

BROAD SPECTRUM SPF 50

WATER RESISTANT (80 MINUTES)

TRUSTED BY PEDIATRICIANS

3 fl oz (89 ml)

BabyBaby

Product Linked Resources#

Resource, Code type, Value table
ResourceCode typeValueEquivalent identifiersSource image
BarcodeEAN-130303162036307GTIN-13: 0303162036307
EAN-13: 0303162036307
GTIN-12: 303162036307
UPC-A: 303162036307
GTIN storage (14 digits): 00303162036307		BLAS Baby SPF 50 Lotion.jpg

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
0316-2036-31Blue Lizard Baby SPF 50 Sunscreen89 mL in 1 TUBELOTION893
0316-2036-47Blue Lizard Baby SPF 50 Sunscreen148 mL in 1 TUBELOTION1483
0316-2036-55Blue Lizard Baby SPF 50 Sunscreen5 mL in 1 PACKETLOTION53

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
0316-2036-30ML - Milliliter0316-20363655f5e4-0f0e-451b-a621-1abaa50fae2912026-04-20
0316-2036-46ML - Milliliter0316-2036d84f5630-7517-4839-bf99-d83e7071f0c112026-04-20

Products#

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

DailyMed product names page 1 of 1 · 34 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
0316-20360316-2036-31, 0316-2036-47, 0316-2036-55

Ingredients#

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

DailyMed ingredient rows page 1 of 1 · 32 matching rows.

Name, UNII, Kind table
NameUNIIKind
.ALPHA.-TOCOPHEROL ACETATE9E8X80D2L0IACT
DIMETHICONE92RU3N3Y1OIACT
TRIMETHYLSILOXYSILICATE (M/Q 0.8-1.0)25LXE464L2IACT
HEXADECYL POVIDONE (4 HEXADECYL BRANCHES/REPEAT)AG75W62QYUIACT
TITANIUM DIOXIDE15FIX9V2JPACTIB
ZINC OXIDESOI2LOH54ZACTIB
POLYHYDROXYSTEARIC ACID (2300 MW)YXH47AOU0FIACT
CETYL DIMETHICONE 25U4AS1BW4ZBIACT
BUTYLOCTYL SALICYLATE2EH13UN8D3IACT
GLYCERINPDC6A3C0OXIACT
EUPHORBIA CERIFERA (CANDELILLA) WAXWL0328HX19IACT
CALENDULA OFFICINALIS FLOWERP0M7O4Y7YDIACT
ALUMINUM OXIDELMI26O6933IACT
ALUMINUM STEARATEU6XF9NP8HMIACT
TRIETHOXYCAPRYLYLSILANELDC331P08EIACT
ALOE BARBADENSIS LEAFZY81Z83H0XIACT
CETYL PEG/PPG-10/1 DIMETHICONE (HLB 5)035JKJ76MTIACT
ALKYL (C12-15) BENZOATEA9EJ3J61HQIACT
EDETATE DISODIUM7FLD91C86KIACT
ETHYLHEXYL PALMITATE2865993309IACT
ETHYLHEXYL STEARATEEG3PA2K3K5IACT
CAPRYLYL GLYCOL00YIU5438UIACT
HEXYL LAURATE4CG9F9W01QIACT
METHYL GLUCOSE DIOLEATEFA9KFJ4Z6PIACT
OCTYLDODECYL NEOPENTANOATEX8725R883TIACT
PEG-7 HYDROGENATED CASTOR OILWE09129TH5IACT
POLYGLYCERYL-4 ISOSTEARATE820DPX33S7IACT
PROPANEDIOL5965N8W85TIACT
WATER059QF0KO0RIACT
TOCOPHEROLR0ZB2556P8IACT
1,2-HEXANEDIOLTR046Y3K1GIACT
HYDROXYACETOPHENONEG1L3HT4CMHIACT

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 · 2 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Blue Lizard Baby SPF 50 SunscreenTITANIUM DIOXIDE AND ZINC OXIDECrown Laboratories9d237fb7-4f5f-521d-e053-2a95a90a97342026-01-12WarningsExact identifier
ndc (product): 0316-2036
Blue Lizard Baby SPF 50 SunscreenTITANIUM DIOXIDE AND ZINC OXIDECrown Laboratories32d6e04a-fa30-ba48-e063-6394a90a1bbf2026-01-12WarningsExact identifier
ndc (package): 0316-2036-47
ndc (package): 0316-2036-31
ndc (package): 0316-2036-55
ndc (product): 0316-2036
ndc11 (package): 00316203655
ndc11 (package): 00316203631
ndc11 (package): 00316203647
spl id: 48348e08-1071-ca3e-e063-6394a90ac9f3
spl set id: 32d6e04a-fa30-ba48-e063-6394a90a1bbf

Reported adverse events (FAERS/openFDA)#

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