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 37 of 357 · 7,139 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
SPF Lip ColourZINC OXIDELauren Brooke Cosmetiques, LLC50b344b5-e39d-48ef-e063-6394a90ae41c2026-04-30WarningsExact identifier
application number: M020
No 7 Prime Forever SPF 50 PrimerNO 7 PRIME FOREVER BROAD SPECTRUM SUNSCREEN SPF50 PRIMERBoots Retail USA50b3e9fa-faf8-0026-e063-6294a90a08232026-04-30WarningsExact identifier
application number: M020
Tru Skin Rituals SPF 25TITANIUM DIOXIDE, ZINC OXIDESpa de Soleilf725cd5c-999e-2393-e053-6394a90a09dc2026-04-30WarningsExact identifier
application number: M020
Moisture Sunscreen SPF 50TITANIUM DIOXIDE, ZINC OXIDESpa de Soleilcb95975f-060d-23c2-e053-2a95a90adf1b2026-04-30WarningsExact identifier
application number: M020
Day Cream SPF 30OCTOCRYLENE, OCTINOXATE, AVOBENZONEAnthony Skin LLC5070e8cc-12c0-c2c4-e063-6294a90a14222026-04-29WarningsExact identifier
application number: M020
Steak n Shake Beef Tallow Sunscreen SPF 30ZINC OXIDEHRR Enterprises, Inc0eb122d8-6826-4843-bed1-9e0cb8316e6d2026-04-29WarningsExact identifier
application number: M020
EQUATE SUNSCREEN SPF 50 SPORT BROAD SPECTRUMAVOBENZONE, HOMOSALATE, OCTISALATE, OCTOCRYLENEWalmart509b6c7d-8a28-2d3a-e063-6394a90af0682026-04-29WarningsExact identifier
application number: M020
Freaks of Nature Solar Shield Broad Spectrum SPF 30FREAKS OF NATURE SOLAR SHIELD BROAD SPECTRUM SPF 30THE FREAKS OF NATURE, INC.509b8610-6dbe-611f-e063-6394a90a9fd12026-04-29WarningsExact identifier
application number: M020
TiZO2TITANIUM DIOXIDE, ZINC OXIDEFallien Cosmeceuticals Ltd.509cad98-0321-2a0a-e063-6294a90a6ea92026-04-29WarningsExact identifier
application number: M020
TiZO2TITANIUM DIOXIDE, ZINC OXIDEFallien Cosmeceuticals Ltd.509d7206-0cc1-c997-e063-6294a90a89e02026-04-29WarningsExact identifier
application number: M020
COTZ FACE MOISTUREZINC OXIDEFallien Cosmeceuticals Ltd.509d9a74-bc8d-c9c1-e063-6394a90a403d2026-04-29WarningsExact identifier
application number: M020
JMSOLUTION MARINE LUMINOUS PEARL SUNSCREENAVOBENZONE, HOMOSALATE, OCTISALATE, OCTOCRYLENEGPNY CORP212d4563-2fad-31a5-e063-6394a90aff712026-04-29WarningsExact identifier
application number: M020
JMSOLUTION SKIN BOOST NIACINAMIDE SUNSCREENHOMOSALATE, OCTISALATE, OCTOCRYLENE, TITANIUM DIOXIDEGPNY CORP211dea04-faad-8ffc-e063-6294a90a8d682026-04-29WarningsExact identifier
application number: M020
La Roche Posay Laboratoire Dermatologique Anthelios Glow Daily Glow Sunscreen Bronze Cell OX Shield Broad Spectrum SPF 35AVOBENZONE, HOMOSALATE, OCTISALATE AND OCTOCRYLENEL'Oreal USA Products Inc5e19577b-9911-4fa1-a2b7-7ca2e02d1fd82026-04-28WarningsExact identifier
application number: M020
Daily Defence Moisturising Sunscreen Broad Spectrum SPF 50AVOBENZONE, HOMOSALATE, OCTISALATE, OCTOCRYLENEUltraceuticals Pty Ltd50888d3f-46ae-e2c2-e063-6394a90ad6af2026-04-28WarningsExact identifier
application number: M020
Anything SPFOCTINOXATE, OCTISALATE, ZINC OXIDE, AVOBENZONE, HOMOSALATE, TITANIUM DIOXIDEAnything SPF LLC508b8dcb-6600-6dad-e063-6294a90a565a2026-04-28WarningsExact identifier
application number: M020
Fusion Water MagicOCTOCRYLENE, HOMOSALATE, OCTISALATE, AND AVOBENZONEISDIN Corp.d4f91d5a-600a-4255-a6e1-e7e7197848c72026-04-28WarningsExact identifier
application number: M020
La Roche Posay Laboratoire Dermatologique Anthelios Glow Daily Glow Sunscreen Pearl Cell OX Shield Broad Spectrum SPF 35AVOBENZONE, HOMOSALATE, OCTISALATE AND OCTOCRYLENEL'Oreal USA Products Incc6a1b995-1898-4a92-b128-7d5ebd6d8d3d2026-04-28WarningsExact identifier
application number: M020
Obagi Skintrinsiq Antioxidant ProtocolAVOBENZONE, HOMOSALATE, OCTISALATE. OCTOCRYLENE, AND OXYBENZONEObagi Cosmeceuticals LLC53023b16-8d64-4dfc-bc75-b4f248425c4d2026-04-27WarningsExact identifier
application number: M020
TONEfitSUN Sebum Control Vegan SunscreenAVOBENZONE, HOMOSALATE, OCTISALATE, OCTOCRYLENEHankook Cosmetics Manufacturing Co.,Ltd_Eumseong Factory506b96ae-eb2a-edad-e063-6294a90a470e2026-04-27WarningsExact 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