FDA.reportPublic FDA data

Blue Lizard Kids SPF 50

Product NDC
0316-2012
11-digit product format
003162012
Labeler code
0316
Product ID
0316-2012_48349937-7b58-f9d3-e063-6294a90a3602
Type
HUMAN OTC DRUG
Nonproprietary name
zinc oxide
Dosage form
STICK
Route
TOPICAL
Labeler
Crown Laboratories
Application
M020
Marketing category
OTC MONOGRAPH DRUG
Marketing start
2019-11-25
Substance
ZINC OXIDE
Active strength
20 mg/g
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 Kids SPF 50
Listing expiration
2027-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
ZINC OXIDE20 mg/g

Harmonized UNII identifiers#

UNII identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
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
9983563c-1e63-0748-e053-2a95a90a971eAvailable on FDA.report

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
0316-2012-052023-02-13C16284748780-1f386c64a-1b2d-0266-e053-dadaa90a7c1aBlue Lizard Kids SPF 50 Sunscreen Stick
0316-2012-052023-01-30C16284748780-1f386c64a-1b2d-0266-e053-dadaa90a7c1aBlue Lizard Kids SPF 50 Sunscreen Stick

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
0316-2012-05Blue Lizard Kids SPF 5014 g in 1 CYLINDERSTICK147
0316-2012-05Blue Lizard Kids SPF 501 in 1 BLISTER PACKSTICK17

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
0316-2012BLUE LIZARD KIDS SPF 50 (ZINC OXIDE) STICK [CROWN LABORATORIES]6Current NDC, Legacy NDC, 2 package rows20250519_9983563c-1e63-0748-e053-2a95a90a971e.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 86 of 357 · 7,139 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
ST MORIZ SUNCARE BODY SUNSCREEN SPF30SUNCARE BODY SUNSCREEN SPF30Aopline Biotechnology (Guangzhou) Co., Ltd.48026f09-6d15-8fa6-e063-6294a90a17cb2026-01-09WarningsExact identifier
application number: M020
RODAN and FIELDS ENHANCEMENTS MEDIUMTITANIUM DIOXIDE, ZINC OXIDEBentley Laboratories, LLC6aa6ad3f-2c52-4031-9e6c-7526c42de71d2026-01-09WarningsExact identifier
application number: M020
FACE SPF 47 SETTINGFACE SPF 47 SETTING SPRAYAopline Biotechnology (Guangzhou) Co., Ltd.47db9a54-c02f-d2ea-e063-6394a90ab9732026-01-08WarningsExact identifier
application number: M020
BADABOOM SUNSCREENSUNSCREENAopline Biotechnology (Guangzhou) Co., Ltd.47dbf363-2892-4530-e063-6294a90abe1f2026-01-08WarningsExact identifier
application number: M020
ROE WELLNESS SPF 50 MINERALSPF 50 MINERAL POWDERAopline Biotechnology (Guangzhou) Co., Ltd.47dc8155-4abb-4bb7-e063-6294a90af1ad2026-01-08WarningsExact identifier
application number: M020
ALOHA MINERAL BLOCK-BRUSH ON MINERALSUNSCREEN SPF50Aopline Biotechnology (Guangzhou) Co., Ltd.47dd07aa-71b4-5d54-e063-6394a90a41272026-01-08WarningsExact identifier
application number: M020
SUNSCREEN SETTING SPRITZ, SPF 45SUNSCREEN SETTING SPRAYAopline Biotechnology (Guangzhou) Co., Ltd.47ddf752-cae2-313f-e063-6294a90a7e3a2026-01-08WarningsExact identifier
application number: M020
St Moriz suncare face sunscreen spf50OCTOCRYLENE, OCTISALATE , AVOBENZONE , HOMOSALATEAopline Biotechnology (Guangzhou) Co., Ltd.47df072e-151f-eb30-e063-6294a90a4eeb2026-01-08WarningsExact identifier
application number: M020
SUNSCREEN GLOWINGAVOBENZONE ,OCTISALATE ,OCTOCRYLENE , HOMOSALATEAopline Biotechnology (Guangzhou) Co., Ltd.47df0de5-012a-c896-e063-6394a90a9cef2026-01-08WarningsExact identifier
application number: M020
BANANA BOATAVOBENZONE, HOMOSALATE, OCTISALATE, OCTOCRYLENEEdgewell Personal Care Brands LLC616d35f6-63d2-3d26-e053-2991aa0a5b442026-01-08WarningsExact identifier
application number: M020
BANANA BOATAVOBENZONE, HOMOSALATE, OCTISALATE, OCTOCRYLENEEdgewell Personal Care Brands LLC616d35a1-a139-1974-e053-2a91aa0a20b62026-01-08WarningsExact identifier
application number: M020
PIPA SKIN CARE SUN-SATIONAL Mineral SunscreenSPF 30EVI LABS258b7b7c-a3f2-172c-e063-6394a90aec6a2026-01-08WarningsExact identifier
application number: M020
DMK Ultrascreen Mineral SunscreenZINC OXIDEDanne Montague King3f022275-c1e5-2704-e063-6294a90a4a812026-01-08WarningsExact identifier
application number: M020
Anhydrous SPF 30TITANIUM DIOXIDE, ZINC OXIDEOwen Biosciences, Inc.0cc8221d-5ec5-4abf-a4f5-ab06e8dcea682026-01-08WarningsExact identifier
application number: M020
Rejuvaskin Mineral Facial Sunscreen SPF 32 SheerREJUVASKIN MINERAL FACIAL SUNSCREEN SPF 32 SHEERAtlantic Medical Products, LLC47e5198e-7bf6-72a8-e063-6294a90a7ec52026-01-08WarningsExact identifier
application number: M020
inde wild SUN DEFENSE SPF 50 SUNSCREEN GLOW DROPS BROAD SPECTRUMINDE WILD SUN DEFENSE GLOW DROPSINDE WILD PRIVATE LIMITED47e57407-2925-09ca-e063-6294a90a49ec2026-01-08WarningsExact identifier
application number: M020
NIDA Invisible Fit SunscreenSUNSCREENProso Corp47ed3b62-45ef-b67a-e063-6294a90a317b2026-01-08WarningsExact identifier
application number: M020
Organic Matters SPF 50 SunscreenZINC OXIDEVeganic SKN Limited12f37c8d-07f0-3e75-e063-6294a90a2cdf2026-01-08WarningsExact identifier
application number: M020
Ellegreen Sunscreen Broad Spectrum SPF50ZINC OXIDEVeganic SKN Limited161a7209-10d8-928c-e063-6394a90a41392026-01-08WarningsExact identifier
application number: M020
Live Sunny Eco-zinc hydrating mineral sunscreen for body and faceZINC OXIDEVeganic SKN Limited1a97169e-67be-3d25-e063-6294a90a3b882026-01-08WarningsExact identifier
application number: M020

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
0316-2012-05003162012051 CYLINDER in 1 BLISTER PACK (0316-2012-05) / 14 g in 1 CYLINDER1 cylinder2019-11-250000-00-00NoNoCurrent