Blue Lizard Baby SPF 50 Sunscreen

Product NDC
0316-2036
Requested package NDC
0316-2036-55
11-digit product format
003162036
Labeler code
0316
Product ID
0316-2036_4833f8fa-f0bc-dd53-e063-6294a90a3899
Type
HUMAN OTC DRUG
Nonproprietary name
Titanium Dioxide and Zinc Oxide
Dosage form
LOTION
Route
TOPICAL
Labeler
Crown Laboratories
Application
M020
Marketing category
OTC MONOGRAPH DRUG
Marketing start
2020-01-29
Substance
TITANIUM DIOXIDE; ZINC OXIDE
Active strength
89.6; 112 mg/mL; mg/mL
NDC exclude flag
No
Listing certified through
2027-12-31
Current FDA listing
Yes

Reported adverse events (FAERS/openFDA)#

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

Additional Listing Data#

Finished product
Yes
Brand name base
Blue Lizard Baby SPF 50 Sunscreen
Listing expiration
2027-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
TITANIUM DIOXIDE89.6 mg/mL
ZINC OXIDE112 mg/mL

Harmonized UNII identifiers#

UNII identifiers page 1 of 1 · 2 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
15FIX9V2JPInternal UNII lookup
SOI2LOH54ZInternal UNII lookup

Harmonized SPL set identifiers#

SPL set identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
9d237fb7-4f5f-521d-e053-2a95a90a9734Available on FDA.report

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Related label table
NDCEffectiveRelated label
0316-2036-102023-02-13Blue Lizard Baby SPF 50 Sunscreen
0316-2036-102023-02-13Blue Lizard Baby SPF 50 Sunscreen
0316-2036-102023-02-13Blue Lizard Baby SPF 50 Sunscreen
0316-2036-302023-02-13Blue Lizard Baby SPF 50 Sunscreen
0316-2036-302023-02-13Blue Lizard Baby SPF 50 Sunscreen
0316-2036-302023-02-13Blue Lizard Baby SPF 50 Sunscreen
0316-2036-402023-02-13Blue Lizard Baby SPF 50 Sunscreen
0316-2036-402023-02-13Blue Lizard Baby SPF 50 Sunscreen
0316-2036-402023-02-13Blue Lizard Baby SPF 50 Sunscreen
0316-2036-452023-02-13Blue Lizard Baby SPF 50 Sunscreen
0316-2036-452023-02-13Blue Lizard Baby SPF 50 Sunscreen
0316-2036-452023-02-13Blue Lizard Baby SPF 50 Sunscreen
0316-2036-462023-02-13Blue Lizard Baby SPF 50 Sunscreen
0316-2036-462023-02-13Blue Lizard Baby SPF 50 Sunscreen
0316-2036-462023-02-13Blue Lizard Baby SPF 50 Sunscreen
0316-2036-502023-02-13Blue Lizard Baby SPF 50 Sunscreen
0316-2036-502023-02-13Blue Lizard Baby SPF 50 Sunscreen
0316-2036-502023-02-13Blue Lizard Baby SPF 50 Sunscreen
0316-2036-102023-01-30Blue Lizard Baby SPF 50 Sunscreen
0316-2036-102023-01-30Blue Lizard Baby SPF 50 Sunscreen
0316-2036-102023-01-30Blue Lizard Baby SPF 50 Sunscreen
0316-2036-302023-01-30Blue Lizard Baby SPF 50 Sunscreen
0316-2036-302023-01-30Blue Lizard Baby SPF 50 Sunscreen
0316-2036-302023-01-30Blue Lizard Baby SPF 50 Sunscreen
0316-2036-402023-01-30Blue Lizard Baby SPF 50 Sunscreen
0316-2036-402023-01-30Blue Lizard Baby SPF 50 Sunscreen
0316-2036-402023-01-30Blue Lizard Baby SPF 50 Sunscreen
0316-2036-452023-01-30Blue Lizard Baby SPF 50 Sunscreen
0316-2036-452023-01-30Blue Lizard Baby SPF 50 Sunscreen
0316-2036-452023-01-30Blue Lizard Baby SPF 50 Sunscreen
0316-2036-462023-01-30Blue Lizard Baby SPF 50 Sunscreen
0316-2036-462023-01-30Blue Lizard Baby SPF 50 Sunscreen
0316-2036-462023-01-30Blue Lizard Baby SPF 50 Sunscreen
0316-2036-502023-01-30Blue Lizard Baby SPF 50 Sunscreen
0316-2036-502023-01-30Blue Lizard Baby SPF 50 Sunscreen
0316-2036-502023-01-30Blue Lizard Baby SPF 50 Sunscreen

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
0316-2036-10Blue Lizard Baby SPF 50 Sunscreen5 mL in 1 PACKETLOTION57
0316-2036-30Blue Lizard Baby SPF 50 Sunscreen89 mL in 1 TUBELOTION897
0316-2036-40Blue Lizard Baby SPF 50 Sunscreen148 mL in 1 BOTTLE, PLASTICLOTION1487
0316-2036-45Blue Lizard Baby SPF 50 Sunscreen148 mL in 1 TUBELOTION1487
0316-2036-46Blue Lizard Baby SPF 50 Sunscreen148 mL in 1 TUBELOTION1487
0316-2036-50Blue Lizard Baby SPF 50 Sunscreen259 mL in 1 BOTTLE, PLASTICLOTION2597
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

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
0316-2036BLUE LIZARD BABY SPF 50 SUNSCREEN (TITANIUM DIOXIDE AND ZINC OXIDE) LOTION [CROWN LABORATORIES]5Current NDC, Legacy NDC, 6 package rows20241127_9d237fb7-4f5f-521d-e053-2a95a90a9734.zip
0316-2036BLUE LIZARD BABY SPF 50 SUNSCREEN (TITANIUM DIOXIDE AND ZINC OXIDE) LOTION [CROWN LABORATORIES]2Current NDC, Legacy NDC, 3 package rows20250525_32d6e04a-fa30-ba48-e063-6394a90a1bbf.zip

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 5 of 357 · 7,139 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
HAWAIIAN TROPICAVOBENZONE, HOMOSALATE, OCTOCRYLENEEdgewell Personal Care Brands LLC5990fe66-4fa2-06aa-e063-6294a90a52612026-08-21WarningsExact identifier
application number: M020
Hawaiian TropicAVOBENZONE,HOMOSALATE,OCTISALATE,OCTOCRYLENEEdgewell Personal Care Brands LLC5991466a-e729-16b7-e063-6394a90a11ff2026-08-21WarningsExact identifier
application number: M020
Avobenzone, Homosalate, OctisalateAVOBENZONE, HOMOSALATE, OCTISALATETopco Associates LLC597b78df-83cb-1b21-e063-6294a90a56a82026-08-20Warnings, Adverse reactionsExact identifier
application number: M020
Sunski Base Camp Face and Body Sunscreen SPF 45HOMOSALATE, OCTISALATE, AVOBENZONEStewart Charley Ventures, LLC2fc45f85-a6f8-4893-8b34-4db5e39cb6152026-08-20WarningsExact identifier
application number: M020
Sweat Resistant Sunscreen Body OriginalTITANIUM DIOXIDE, ZINC OXIDEClutch, Inc.4bbde755-e312-123e-e063-6294a90a467f2026-08-20WarningsExact identifier
application number: M020
SunscreenBROAD SPECTRUM SPF 30Concierge Choice LLC5980055b-493e-4763-e063-6294a90a570f2026-08-20WarningsExact identifier
application number: M020
Lip Balm SPF 15AVOBENZONE, OCTINOXATE, OCTISALATE, OCTOCRYLENESkin Script, LLC20c5fde7-ee8f-4b74-e063-6394a90a93ec2026-08-19WarningsExact identifier
application number: M020
Aloe UP .5OZ SPF 50 MINERAL SunscreenZINC OXIDE 14.69%Aloe Care International, LLC6ad80af3-78cd-4211-a5f2-68531aae264a2026-08-19WarningsExact identifier
application number: M020
Utu Broad Spectrum SPF 50 Tinted Sunscreen-StickZINC OXIDEUtu Co596e17d3-3064-1cda-e063-6294a90af9632026-08-19WarningsExact identifier
application number: M020
Mineral sunscreenMINERAL SUNSCREENGuangzhou Origin Beauty Cosmetics Co., Ltd.59713657-a7ef-1aee-e063-6394a90a326e2026-08-19WarningsExact identifier
application number: M020
The Naked Bee SPF 50 Mineral SunscreenZINC OXIDE 14.69%The Naked Beef820a9be-c94d-4fd5-b202-2dda5746a82a2026-08-18WarningsExact identifier
application number: M020
The Naked Bee SPF 50 Mineral SunscreenZINC OXIDE 20%The Naked Bee7dd2b1cd-e229-4eeb-8122-46fde5af10912026-08-18WarningsExact identifier
application number: M020
Sun Zapper - Baby pure zinc sunscreen SPF30ZINC OXIDE SUNSCREENVEGANIC SKN LIMITED3ee52faa-64a8-4bdf-e063-6294a90a65cf2026-08-17WarningsExact identifier
application number: M020
Sun Zapper - Face pure zinc sunscreen SPF30ZINC OXIDE SUNSCREENVEGANIC SKN LIMITED3ee4feb3-6966-67f9-e063-6394a90a16d52026-08-17WarningsExact identifier
application number: M020
HEADHUNTER SURF SCREEN SPF 50 SUNSCREENZINC OXIDE,TITANIUM DIOXIDEGuangzhou Tata Biotechnology Co., Ltd.4339df13-77d3-31a1-e063-6394a90a52082026-08-17WarningsExact identifier
application number: M020
Soleil Defense SunscreenBROAD SPECTRUM SPF 30AMARA MED SPA LLC594244b1-db3b-002b-e063-6394a90a03292026-08-17WarningsExact identifier
application number: M020
Stay Ageless Tinted Mineral SunscreenBROAD SPECTRUM SPF30HAMBLIN DERMATOLOGY5942e64c-416e-7525-e063-6394a90a28392026-08-17WarningsExact identifier
application number: M020
Protect Tinted Mineral SunscreenBROAD SPECTRUM SPF30Opal Day Spa5943413a-48e1-0bdf-e063-6294a90a2fff2026-08-17WarningsExact identifier
application number: M020
Stay Ageless Tinted Mineral SunscreenBROAD SPECTRUM SPF30MedSpa By Beauty Bar LLC5943ba3d-688e-9e9c-e063-6294a90afa9a2026-08-17WarningsExact identifier
application number: M020
SunscreenBROAD SPECTRUM SPF 30Charleston Dermatology, P.C.59440f7f-4213-6e2b-e063-6394a90af4832026-08-17WarningsExact identifier
application number: M020

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startSampleExclude flagStatus
0316-2036-55003162036555 mL in 1 PACKET (0316-2036-55) 5 ml2025-02-01YesNoCurrent