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 9 of 361 · 7,213 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Continuous Correction CreamHOMOSALATE 10% OCTISALATE 4.9% OCTOCRYLENE 4%Baxter of California, LLC14b05c8c-0398-2973-e063-6394a90a8a862026-07-31WarningsExact identifier
application number: M020
Cover CremeTITANIUM DIOXIDEBaxter of California31f5e8c4-523f-4596-e063-6294a90a6a122026-07-31WarningsExact identifier
application number: M020
MELAO GHK-Cu PEPTIDE SUNSCREENBUTYL METHOXYDIBENZOYLMETHANE,ETHYLHEXYL SALICYLATE,HOMOSALATE,OCTOCRYLENEGuangdong Aimu Biological Technology Co., Ltd57a8c34a-d6c9-c03e-e063-6394a90a7af12026-07-29WarningsExact identifier
application number: M020
BelleJoss BROAD SPECTRUM SPF 50BROAD SPECTRUM SPF 50Guangzhou Liyan Cosmetics Technology Co., Ltd.57c07f29-2e23-d18a-e063-6394a90a10202026-07-29WarningsExact identifier
application number: M020
BemeJolie BROAD SPECTRUM SPF 50BROAD SPECTRUM SPF 50Guangzhou Liyan Cosmetics Technology Co., Ltd.57c27cea-bb0c-5d2d-e063-6394a90a1b482026-07-29WarningsExact identifier
application number: M020
DeFlameALLANTOINNoon Aesthetics M.R. Ltd2628bd73-0ca9-497b-bcd9-088444cd62be2026-07-28WarningsExact identifier
application number: M020
Native Mineral Suncare Broad Spectrum SPF 30 UnscentedZINC OXIDEThe Procter & Gamble Manufacturing Company3a89238b-d1ee-d7fa-e063-6294a90ae55f2026-07-28WarningsExact identifier
application number: M020
First Aid Beauty FAB Mineral Sunscreen Broad Spectrum SPF 30ZINC OXIDEThe Procter & Gamble Manufacturing Companydfb1b42e-c821-1a41-e053-2995a90acf952026-07-28WarningsExact identifier
application number: M020
HEB 50 Pumpkin Spice Latte Scent SunscreenAVOBENZONE, HOMOSALATE, OCTISALATE, OCTOCRYLENEH.E.B.579f3274-398e-7eab-e063-6394a90afe352026-07-27WarningsExact identifier
application number: M020
LUXE COLOR FOUNDATIONOCTINOXATE 7% ZINC OXIDE 5%Guangzhou Huixue Biotechnology Co., Ltd.576c3496-702f-808c-e063-6394a90a53c32026-07-25WarningsExact identifier
application number: M020
No7 Restore and Renew Multi Action Day Cream Sunscreen Broad Spectrum SPF 25 KitAVOBENZONE, HOMOSALATE, OCTINOXATE, OCTISALATE, OCTOCRYLENEXact Packing Limited5759058d-e683-f3fc-e063-6394a90abc012026-07-24WarningsExact identifier
application number: M020
No7 Future Renew Defense Shield SPF 50AVOBENZONE, OCTINOXATE, OCTISALATEXact Packing Limited5758b79f-6386-bbea-e063-6394a90aeb342026-07-24WarningsExact identifier
application number: M020
ESIKA COLORFIX POLVOS 32H POLVO COMPACTO FACIAL DE ALTA COBERTURA FPS 15 110-COCTINOXATE, TITANIUM DIOXIDE, ZINC OXIDEBEL STAR S.A.575fb2c3-e332-8a3b-e063-6394a90a9fd92026-07-24WarningsExact identifier
application number: M020
SERVE AND PRIME SUNSCREEN BROAD SPECTRUM SPF 40AVOBENZONE, HOMOSALATE, OCTISALATE, AND OCTOCRYLENEESTEE LAUDER INC575fc04a-794a-93e7-e063-6394a90a7e672026-07-24WarningsExact identifier
application number: M020
Younique Bare You BB Tinted Moisturizer Sunscreen Broad Spectrum SPF-30 LIGHTZINC OXIDEYounique, LLCf93d42a9-b655-4b75-a16d-b29f38f04efc2026-07-23WarningsExact identifier
application number: M020
Younique Bare You BB Tinted Moisturizer Sunscreen Broad Spectrum SPF-30 LIGHT MEDIUMZINC OXIDEYounique, LLC82769819-b229-4864-9b3c-44f49a68a53a2026-07-23WarningsExact identifier
application number: M020
Younique Bare You BB Tinted Moisturizer Sunscreen Broad Spectrum SPF-30 FAIRZINC OXIDEYounique, LLCed700cae-8226-48d9-93ba-03154aa1cae52026-07-23WarningsExact identifier
application number: M020
Younique Bare You BB Tinted Moisturizer Sunscreen Broad Spectrum SPF-30 FAIR LIGHTZINC OXIDEYounique, LLCd728b89c-692f-485b-88c3-929b2f0350d52026-07-23WarningsExact identifier
application number: M020
Younique Bare You BB Tinted Moisturizer Sunscreen Broad Spectrum SPF-30 MEDIUMZINC OXIDEYounique, LLCa49dfff1-e9ec-4573-90b0-ef6a7226aa562026-07-23WarningsExact identifier
application number: M020
Younique Bare You BB Tinted Moisturizer Sunscreen Broad Spectrum SPF-30 MEDIUM DARKZINC OXIDEYounique, LLCcc576b63-caf4-491d-8d7f-027b1127133b2026-07-23WarningsExact 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