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 firm2026-10-21
excluded packagepackage0316-20620316-2062-50DDiscontinued by firm2026-10-21

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 64 of 354 · 7,077 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Sport Sunscreen SPF 70AVOBENZONE, HOMOSALATE, OCTISALATERetail Business Services, LLC6d1ad14e-afc6-4676-87d7-3e50e3a02fe92026-02-06Warnings, Adverse reactionsExact identifier
application number: M020
Sunscreen for Babies SPF 50AVOBENZONE, HOMOSALATE, OCTISALATERetail Business Services, LLC64766ed9-bd47-498d-bf59-fb30a7bf7e892026-02-06Warnings, Adverse reactionsExact identifier
application number: M020
Broad Spectrum Sunscreen SPF 30AVOBENZONE, HOMOSALATE, OCTISALATERetail Business Services, LLCccb651f6-e567-4c5f-9109-8767270cc4be2026-02-06Warnings, Adverse reactionsExact identifier
application number: M020
SunscreenAVOBENZONE, HOMOSALATE, OCTISALATERetail Business Services, LLC80dcd255-3a6c-4b79-b081-519c9dac990a2026-02-06Warnings, Adverse reactionsExact identifier
application number: M020
Moisturizing Sunscreen SPF 50AVOBENZONE, HOMOSALATE, OCTISALATERetail Business Service, LLC9de8b6b1-024b-4b71-96e6-fea68088d3ab2026-02-06Warnings, Adverse reactionsExact identifier
application number: M020
SunscreenSUNSCREENRetail Business Services, LLC96221c10-ebfe-4385-b6b5-d504258df36c2026-02-06Warnings, Adverse reactionsExact identifier
application number: M020
Moisturizing Sunscreen SPF 30AVOBENZONE, HOMOSALATE, OCTISALATERetail Business Services, LLCe2adbde9-3c8b-45f3-b4ef-4936b88d812d2026-02-06Warnings, Adverse reactionsExact identifier
application number: M020
NUDESCREEN DEWY ILLUMINATING GLOW SPF 30 - Sunkissed GlowZINC OXIDE SUNSCREENBentley Laboratories, LLCbf1a237b-b27e-4c55-8ded-e348240a5b9a2026-02-06WarningsExact identifier
application number: M020
SEYTU Body SunscreenTITANIUM DIOXIDE AND ZINC OXIDEOmnilife USA, Inc.c411e9a6-b2ea-446b-a886-b92c61736e6c2026-02-05WarningsExact identifier
application number: M020
SEYTU Facial SunscreenTITANIUM DIOXIDE AND ZINC OXIDEOmnilife USA, Inc.96fd37fb-c3ff-413f-b2c8-50754f320ecc2026-02-05WarningsExact identifier
application number: M020
Sun Veil IlluminatingElixir Face Sunscreen SPF 38OCTISALATE, OCTOCRYLENE, ZINC OXIDEKoco Life LLC4a15c479-d676-9e52-e063-6394a90a4eb42026-02-05WarningsExact identifier
application number: M020
Golden Sunglaze Sheer Body Mist Sunscreen SPF50AVOBENZONE, HOMOSALATE, OCTISALATE, OCTOCRYLENEKoco Life LLC22d0a5db-6af1-a3ca-e063-6394a90a68ef2026-02-05WarningsExact identifier
application number: M020
Sunglaze Sheer Setting Mist Sunscreen SPF50AVOBENZONE, HOMOSALATE, OCTISALATE, OCTYOCRYLENEKoco Life LLC22ce9b26-2bf8-c1ea-e063-6394a90a8ec22026-02-05WarningsExact identifier
application number: M020
Peppermint SPF 15 Sunscreen Lip BalmAVOBENZONE, OCTINOXATE, OCTISALATE, OCTOCRYLENENaples Soap Company, Inc.24adffd4-5177-f5d5-e063-6294a90a78502026-02-05WarningsExact identifier
application number: M020
No7 Restore and Renew Multi Action Serum Foundation Sunscreen Broad Spectrum SPF 20 BambooOCTINOXATE, TITANIUM DIOXIDEBCM Cosmetique SASebfe03e7-614f-44b1-b1f1-78edc7e274cc2026-02-05WarningsExact identifier
application number: M020
Serious Skincare Serious-C3 Plasma Bio Technology C Cream SPF 30AVOBENZONE, OCTOCRYLENE, OCTINOXATE, OCTISALATE, OXYBENZONEFlageoli Limited66f29201-6cbe-46d0-b54c-005a1ecefac42026-02-04WarningsExact identifier
application number: M020
Tanning Club Mineral Sunscreen SPF 30ZINC OXIDETanning Club LLCd674ccbc-7bae-435c-a531-a79e569e69a92026-02-04WarningsExact identifier
application number: M020
Derma B Everyday Fit Sunscreen SPF 50AVOBEZONE, HOMOSALATE, OCTISALATE, OCTOCRYLENENeoPharm Co., Ltd.ba38a43d-7a8a-4814-ba34-0e99124f5fca2026-02-04WarningsExact identifier
application number: M020
SHISEIDO URBAN ENVIRONMENT oil-free MINERAL SUNSCREEN SPF 42TITANIUM DIOXIDE AND ZINC OXIDESHISEIDO AMERICAS CORPORATION86630e82-f249-4866-82dd-3e21feb266c42026-02-04WarningsExact identifier
application number: M020
SHISEIDO URBAN ENVIRONMENT FRESH-MOISTURE SUNSCREEN SPF 42AVOBENZONE, HOMOSALATE, OCTISALATE, AND OCTOCRYLENESHISEIDO AMERICAS CORPORATION42adc51f-f500-485d-82a0-1266721412622026-02-04WarningsExact 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