Blue Lizard Kids SPF 50 Sunscreen

Product NDC
0316-2062
11-digit product format
003162062
Labeler code
0316
Product ID
0316-2062_50c50605-8947-924b-e063-6294a90a6c7e
Type
HUMAN OTC DRUG
Nonproprietary name
Octisalate and Titanium Dioxide and Zinc Oxide
Dosage form
LOTION
Route
TOPICAL
Labeler
Crown Laboratories
Application
M020
Marketing category
OTC MONOGRAPH DRUG
Marketing start
2021-02-09
Substance
ZINC OXIDE; TITANIUM DIOXIDE; OCTISALATE
Active strength
111; 59.5; 55.5 mg/mL; mg/mL; mg/mL
NDC exclude flag
No
Listing certified through
2027-12-31
Current FDA listing
Yes

NDC auxiliary status#

These records are reproduced from FDA’s unfinished, excluded, and compounder listings. They describe what appeared in the source files; a missing record does not establish a regulatory status. View all current auxiliary records, including entries without an NDC. · View the auxiliary file history.

Current NDC status page 1 of 1 · 2 matching rows.

Dataset, Scope, Product NDC table
DatasetScopeProduct NDCPackage NDCCodeStatusReporting periodSource date
excluded packagepackage0316-20620316-2062-40DDiscontinued by firm2026-10-20
excluded packagepackage0316-20620316-2062-50DDiscontinued by firm2026-10-20

Observed NDC auxiliary status history#

This history shows the information present in each captured FDA auxiliary file. It is not a continuous regulatory timeline, and a missing record does not establish a status.

Historic NDC status page 1 of 1 · 9 matching rows.

View current auxiliary records. · View the auxiliary file history.

Captured / source date, Snapshot, Source SHA-256 table
Captured / source dateSnapshotSource SHA-256
2025-12-14 17:58 UTC · source 2025-12-05d630ba8d3edf…732f749b63fb…
2025-08-27 00:01 UTC · source 2025-08-26f5e01cc5f278…a2eaf40c39c3…
2025-04-01 02:39 UTC · source 2025-03-312ef7874e63bc…57b86245f4fa…
2025-03-28 20:22 UTC · source 2025-03-28a1b67e2a42f9…c4cf2c586c0d…
2025-03-22 03:12 UTC · source 2025-03-21cfe11265f3b6…090c488252e2…
2025-03-10 12:48 UTC · source 2025-03-10cdf11ea48f46…ba0047e9e063…
2025-02-02 03:52 UTC · source 2025-01-31302b2466d912…e7b80fea0513…
2025-01-20 13:05 UTC · source 2025-01-20ed331223b511…672a5bd82f5f…
2025-01-11 03:41 UTC · source 2025-01-100efc9e666f02…f202fb6c5f17…

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 Sunscreen
Listing expiration
2027-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
ZINC OXIDE111 mg/mL
TITANIUM DIOXIDE59.5 mg/mL
OCTISALATE55.5 mg/mL

Harmonized UNII identifiers#

UNII identifiers page 1 of 1 · 3 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
SOI2LOH54ZInternal UNII lookup
15FIX9V2JPInternal UNII lookup
4X49Y0596WInternal UNII lookup

Harmonized SPL set identifiers#

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

Identifier, FDA.report destination table
IdentifierFDA.report destination
ba4ae906-48c0-8384-e053-2995a90afb91Available on FDA.report

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
0ca1d589-929b-4b33-bc5b-1d84abdafa6aProduct name120150324
fc363c46-397b-4476-ac0f-70e43e8e4592Product name120150324
1681bc73-b05f-12c3-1075-382ae39f449cProduct name120140508

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Related label table
NDCEffectiveRelated label
0316-2062-302023-02-13Blue Lizard Kids SPF 50 Sunscreen
0316-2062-302023-02-13Blue Lizard Kids SPF 50 Sunscreen
0316-2062-302023-02-13Blue Lizard Kids SPF 50 Sunscreen
0316-2062-302023-02-13Blue Lizard Kids SPF 50 Sunscreen
0316-2062-402023-02-13Blue Lizard Kids SPF 50 Sunscreen
0316-2062-402023-02-13Blue Lizard Kids SPF 50 Sunscreen
0316-2062-402023-02-13Blue Lizard Kids SPF 50 Sunscreen
0316-2062-402023-02-13Blue Lizard Kids SPF 50 Sunscreen
0316-2062-452023-02-13Blue Lizard Kids SPF 50 Sunscreen
0316-2062-452023-02-13Blue Lizard Kids SPF 50 Sunscreen
0316-2062-452023-02-13Blue Lizard Kids SPF 50 Sunscreen
0316-2062-452023-02-13Blue Lizard Kids SPF 50 Sunscreen
0316-2062-502023-02-13Blue Lizard Kids SPF 50 Sunscreen
0316-2062-502023-02-13Blue Lizard Kids SPF 50 Sunscreen
0316-2062-502023-02-13Blue Lizard Kids SPF 50 Sunscreen
0316-2062-502023-02-13Blue Lizard Kids SPF 50 Sunscreen
0316-2062-302023-01-30Blue Lizard Kids SPF 50 Sunscreen
0316-2062-302023-01-30Blue Lizard Kids SPF 50 Sunscreen
0316-2062-302023-01-30Blue Lizard Kids SPF 50 Sunscreen
0316-2062-302023-01-30Blue Lizard Kids SPF 50 Sunscreen
0316-2062-402023-01-30Blue Lizard Kids SPF 50 Sunscreen
0316-2062-402023-01-30Blue Lizard Kids SPF 50 Sunscreen
0316-2062-402023-01-30Blue Lizard Kids SPF 50 Sunscreen
0316-2062-402023-01-30Blue Lizard Kids SPF 50 Sunscreen
0316-2062-452023-01-30Blue Lizard Kids SPF 50 Sunscreen
0316-2062-452023-01-30Blue Lizard Kids SPF 50 Sunscreen
0316-2062-452023-01-30Blue Lizard Kids SPF 50 Sunscreen
0316-2062-452023-01-30Blue Lizard Kids SPF 50 Sunscreen
0316-2062-502023-01-30Blue Lizard Kids SPF 50 Sunscreen
0316-2062-502023-01-30Blue Lizard Kids SPF 50 Sunscreen
0316-2062-502023-01-30Blue Lizard Kids SPF 50 Sunscreen
0316-2062-502023-01-30Blue Lizard Kids SPF 50 Sunscreen

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
0316-2062-30Blue Lizard Kids SPF 50 Sunscreen89 mL in 1 TUBELOTION898
0316-2062-40Blue Lizard Kids SPF 50 Sunscreen1 in 1 CARTONLOTION18
0316-2062-40Blue Lizard Kids SPF 50 Sunscreen148 mL in 1 BOTTLE, PLASTICLOTION1488
0316-2062-45Blue Lizard Kids SPF 50 Sunscreen148 mL in 1 TUBELOTION1488
0316-2062-50Blue Lizard Kids SPF 50 Sunscreen259 mL in 1 BOTTLE, PLASTICLOTION2598

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
0316-2062BLUE LIZARD KIDS SPF 50 SUNSCREEN (OCTISALATE AND TITANIUM DIOXIDE AND ZINC OXIDE) LOTION [CROWN LABORATORIES]5Current NDC, Legacy NDC, 5 package rows20241127_ba4ae906-48c0-8384-e053-2995a90afb91.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 38 of 357 · 7,139 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
RE SCREEN BROAD SPECTRUM SPF 30 SUNSCREENZINC OXIDEZouck LLC507560fe-c7ad-329a-e063-6394a90a039a2026-04-27WarningsExact identifier
application number: M020
SoloVeganHOMOSALATE, OCTISALATE, OCTOCRYLENE, AVOBENZONEYES SALES INC.435748e6-c39a-efee-e063-6294a90ad0e52026-04-27WarningsExact identifier
application number: M020
SCREEN SCREEN BROAD SPECTRUM SPF 30 SUNSCREENZINC OXIDEZouck LLC50764f40-7881-81a3-e063-6294a90ad1cf2026-04-27WarningsExact identifier
application number: M020
Obagi Skintrinsiq Antioxidant ProtocolAVOBENZONE, HOMOSALATE, OCTISALATE, OCTOCRYLENE, AND OXYBENZONEObagi Cosmeceuticals LLC495bc176-b292-448f-a5a6-00de2e475e542026-04-27WarningsExact identifier
application number: M020
TULA RADIANT SKIN BRIGHTENING SERUM SKIN TINT SUNSCREEN BROAD SPECTRUM SPF 30BRIGHTENING SKIN TINTPML NYC, LLCf45bd7bd-a802-33e4-e053-2a95a90a61a72026-04-23WarningsExact identifier
application number: M020
TRACELESS MINERAL BROAD SPECTRUM SPF SUNSCREEN AND PRIMERTRACELESS MINERAL BROAD SPECTRUM SPF SUNSCREEN AND PRIMERPML NYC, LLC1c2e9b0d-ba0e-1767-e063-6394a90a756c2026-04-23WarningsExact identifier
application number: M020
Skincare LdeL Retinol Day Broad Spectrum SPF 20AVOBENZONE, HOMOSALATE, OXYBENZONE, AND OCTINOXATEBeauty Solutions, Ltd.76e2ed34-c643-402b-9c9d-04eac789d3c22026-04-22WarningsExact identifier
application number: M020
Johnsons Baby Mineral Sunscreen SPF 30TITANIUM DIOXIDE, ZINC OXIDEKenvue Brands LLC4fe04c4b-2751-0561-e063-6394a90af7682026-04-22WarningsExact identifier
application number: M020
Johnsons Baby Mineral Sunscreen Stick SPF 50ZINC OXIDEKenvue Brands LLC4fe1d3c6-7748-d966-e063-6394a90a97ff2026-04-22WarningsExact identifier
application number: M020
OVERLAPS ECTOIN MOIST SUNAVOBENZONE, HOMOSALATE, OCTISALATE, OCTOCRYLENEOverlaps Corp.4c3ed60b-e515-8ff0-e063-6294a90a86df2026-04-22WarningsExact identifier
application number: M020
Lazy Face SPF 30 FacescreenTITANIUM DIOXIDE, ZINC OXIDESunny Day Creations500ee303-7302-68d5-e063-6394a90ac6d42026-04-22WarningsExact identifier
application number: M020
Lazy Face SPF 30 FacestickZINC OXIDESunny Day Creations50101b55-793e-dbe4-e063-6394a90a61992026-04-22WarningsExact identifier
application number: M020
Broad Spectrum Sunscreen SPF 30OCTOCRYLENE 10% HOMOSALATE 10% OCTISALATE 5 % AVOBENZONE 3%S&C Hampton Sun LLCe6103de6-1d80-46fd-b9d4-893f60941def2026-04-22WarningsExact identifier
application number: M020
PhotoAge GuardAVOBENZONE, HOMOSALATE, OCTISALATE, OCTOCRYLENE, ZINC OXIDEMACROMOTION, INC.50164bd8-469d-9ec1-e063-6294a90a543d2026-04-22WarningsExact identifier
application number: M020
THANK YOU FARMER Sun Project Silky Calming Sun StickAVOBENZONE, OCTISALATE, HOMOSALATE, OCTOCRYLENETHANK YOU FARMER CO., LTD49947114-5137-dc45-e063-6394a90ad9d02026-04-22WarningsExact identifier
application number: M020
Sky and Sol Intense Healing Lip JellyNON-NANO ZINC OXIDEDelta Ecommerce LLC2ddaa215-7433-c8fa-e063-6394a90a43162026-04-22WarningsExact identifier
application number: M020
Broad Spectrum SPF45ZINC OXIDE, OCTINOXATEDrmtlgy, LLC0445ee5f-45a8-4fd5-ae4d-62f66e6f0be82026-04-21WarningsExact identifier
application number: M020
BLDG Active Skin Repair Face and Body Performance SunscreenZINC OXIDEInnovacyn, Inc.70cb98cf-739b-4d46-b45a-535ff0a4531c2026-04-21WarningsExact identifier
application number: M020
Freaks of Nature Mineral SunscreenZINC OXIDE MINERAL SUNSCREENEmpack Spraytech Inc.4ffdb1c6-b2c6-628f-e063-6394a90a27692026-04-21WarningsExact identifier
application number: M020
THANK YOU FARMER Sun Project Water Sun CreamAVOBENZONE, ETHYLHEXYL SALICYLATE, HOMOSALATE, OCTOCRYLENETHANK YOU FARMER CO., LTD5004126b-0a9c-21fb-e063-6294a90a52372026-04-21WarningsExact identifier
application number: M020

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
0316-2062-300031620623089 mL in 1 TUBE (0316-2062-30) 89 ml2021-05-010000-00-00NoNoCurrent
0316-2062-40003162062401 BOTTLE, PLASTIC in 1 CARTON (0316-2062-40) > 148 mL in 1 BOTTLE, PLASTIC2021-05-010000-00-00NoNoCurrent
0316-2062-4500316206245148 mL in 1 TUBE (0316-2062-45) 148 ml2021-02-090000-00-00NoNoCurrent
0316-2062-5000316206250259 mL in 1 BOTTLE, PLASTIC (0316-2062-50) 259 ml2021-05-010000-00-00NoNoCurrent