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_5eeaed97-418b-b040-e063-6294a90af7e5
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#

Effective, Related label table
EffectiveRelated label
2023-02-13Blue Lizard Kids SPF 50 Sunscreen Stick
2023-02-13Blue Lizard Kids SPF 50 Sunscreen Stick
2023-01-30Blue Lizard Kids SPF 50 Sunscreen Stick
2023-01-30Blue 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 327 of 346 · 6,912 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
RADIANCE Silky Mineral Primer Sunscreen SPF-42 HONEYTITANIUM DIOXIDE, ZINC OXIDESANTO REMEDIO LLC867a88df-9a18-447f-8301-2ec91566302e2023-11-06WarningsExact identifier
application number: M020
CALIFORNIA MANGO SPF-30 SUNSCREENAVOBENZONE, OCTISALATE, OCTOCRYLENECALMANGO, INCe0de0504-763d-4518-8a9c-67724077701d2023-11-06WarningsExact identifier
application number: M020
KOVR All-Natural SPF-30 Moisturizing Sunscreen for MenTITANIUM DIOXIDE, ZINC OXIDEACTIVE LIFE INCbf766aab-a52d-41e8-a06a-f2e536d2219b2023-11-06WarningsExact identifier
application number: M020
PROJECT REEF SPF-50ZINC OXIDE, TITANIUM DIOXIDEProject Reef LLC6bcd470c-6994-4d28-8370-4cc9d68e1e782023-11-06WarningsExact identifier
application number: M020
BB OSKIN Broad Spectrum SPF-30TITANIUM DIOXIDE, OCTOCRYLENE, ZINC OXIDEO'Skin Studio NYd84cca38-b673-484e-aa25-df58d904d4d32023-11-06WarningsExact identifier
application number: M020
MIAMI MD SUN SHIELD Broad Spectrum SPF 40AVOBENZONE, HOMOSALATE, OCTISALATE, OCTOCRYLENEBRAND BOLT LLC3a53d53a-129a-41c3-a8e7-c1b1bb98d8bd2023-11-06WarningsExact identifier
application number: M020
JOY SPRING Kids Mineral Sunscreen SPF-30ZINC OXIDEJOYSPRING HOLDINGS LLC76613a3d-f4a8-4961-b36a-d84b4e10dea02023-11-06WarningsExact identifier
application number: M020
Aruba Aloe Sport Line Lip Balm Broad Spectrum SPF 30TITANIUM DIOXIDE, ZINC OXIDEAruba Aloe Balm NV80461b6d-b1b7-4220-894d-8bd4259094742023-11-06WarningsExact identifier
application number: M020
Sport Broad Spectrum SPF50 Water Resistant 80 minutes Mineral Sunscreen UVA UVB Protection StickZINC OXIDEAruba Aloe Balm NV3201cc8b-5fee-4f3b-a826-e349786d1b322023-11-06WarningsExact identifier
application number: M020
Broad Spectrum SPF50 Water Resistant (80 minutes) Mineral Sunscreen UVA UVB Protection Stick for KidsZINC OXIDEAruba Aloe Balm NV25f060eb-628c-4a11-b1d7-06922ee86b242023-11-06WarningsExact identifier
application number: M020
SPF30 SunscreenAVOBENZONE, HOMOSALATE, OCTOCRYLENE, OCITSALATEZhejiang Ayan Biotech Co., Ltd.44321dff-1a61-452f-8324-6de2a196db512023-11-06WarningsExact identifier
application number: M020
SPF30 SunscreenAVOBENZONE, HOMOSALATE, OCTOCRYLENE, OCITSALATEZhejiang Ayan Biotech Co., Ltd.cac6f5e5-91c2-4978-bffd-5ca2a75906372023-11-06WarningsExact identifier
application number: M020
SPF15 SunscreenAVOBENZONE, HOMOSALATE, OCTOCRYLENE, OCTISALATEZhejiang Ayan Biotech Co.,Ltd.68035415-47c3-4eed-93f4-bb6b26c9149a2023-11-06WarningsExact identifier
application number: M020
SPF30 Sunscreen and Antibacterial Hand SanitizerALCOHOL, AVOBENZONE, HOMOSALATE, OCTOCRYLENE, OCTISALATEZhejiang Ayan Biotech Co., Ltd.b5e2458f-8e84-4e57-b6f7-e428a94c97a42023-11-06WarningsExact identifier
application number: M020
SPF30 Sunscreen and SPF15AVOBENZONE, HOMOSALATE, OCTOCRYLENE, OCTISALATEZhejiang Ayan Biotech Co.,Ltd.6c40259b-565a-46d0-90d0-ccc1867645522023-11-06WarningsExact identifier
application number: M020
Image Skincare Prevention Plus Daily Ultimate ProtectionHOMOSALATE, OCTISALATE, OCTOCRYLENE, ZINC OXIDE SUNSCREENSwiss-American CDMO, LLC3473f94c-5faf-4415-9605-f58ec93cd2682023-11-06WarningsExact identifier
application number: M020
Image MD Restoring Lip Enhancer SPF15SUNSCREENSwiss-American CDMO, LLCe296579e-ba30-4a29-afe0-bb51f863369c2023-11-06WarningsExact identifier
application number: M020
Image Prevention Refiner Primer SPF50ZINC OXIDE, TITANIUM DIOXIDE SUNSCREENSwiss-American CDMO, LLC0e490f11-666c-420c-8c12-b45cd238ce472023-11-06WarningsExact identifier
application number: M020
Image Prevention Plus Professional Ultimate Protection Moisturizer SPF50HOMOSALATE, OCTISALATE, OCTOCRYLENE, ZINC OXIDE SUNSCREENSwiss-American CDMO, LLCd807f94a-f933-47d9-938f-b91f663af0782023-11-06WarningsExact identifier
application number: M020
Farmasi BB Beauty Balm Cream SPF 15- 01 LightTITANIUM DIOXIDEFarmasi US LLC97c1da03-b79c-46a3-a9f0-7aeb94ed66da2023-11-05WarningsExact 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