FDA.reportPublic FDA data

SPF 50 plus Sunscreen

Product NDC
59062-1000
11-digit product format
590621000
Labeler code
59062
Product ID
59062-1000_a7636b53-d9d4-4c4f-929a-515a8cc78659
Type
HUMAN OTC DRUG
Nonproprietary name
Titanium Dioxide, OCTISALATE, and ZINC OXIDE
Dosage form
LOTION
Route
TOPICAL
Labeler
KAS Direct LLC dba BabyGanics
Application
M020
Marketing category
OTC MONOGRAPH DRUG
Marketing start
2017-07-24
Marketing end
2026-12-31
Substance
TITANIUM DIOXIDE; OCTISALATE; ZINC OXIDE
Active strength
30; 50; 60 mg/mL; mg/mL; mg/mL
NDC exclude flag
No
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 · 3 matching rows.

Dataset, Scope, Product NDC table
DatasetScopeProduct NDCPackage NDCCodeStatusReporting periodSource date
excluded packagepackage59062-100059062-1000-1DDiscontinued by firm2026-10-21
excluded packagepackage59062-100059062-1000-2DDiscontinued by firm2026-10-21
excluded packagepackage59062-100059062-1000-6DDiscontinued by firm2026-10-21

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
SPF 50 plus Sunscreen

Active Ingredients#

Ingredient, Strength table
IngredientStrength
TITANIUM DIOXIDE30 mg/mL
OCTISALATE50 mg/mL
ZINC OXIDE60 mg/mL

Harmonized UNII identifiers#

UNII identifiers page 1 of 1 · 3 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
15FIX9V2JPInternal UNII lookup
4X49Y0596WInternal UNII lookup
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
5a4c71fc-aa6f-47f7-8d1d-2af2e726cf9bAvailable 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

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
59062-1000-1SPF 50 plus Sunscreen354 mL in 1 TUBELOTION3542
59062-1000-2SPF 50 plus Sunscreen59 mL in 1 TUBELOTION592
59062-1000-2outdoor explorer set59 mL in 1 TUBELOTION59 mL50 mg in 1mL2
59062-1000-6SPF 50 plus Sunscreen177 mL in 1 TUBELOTION1772
59062-1000-8SPF 50 plus Sunscreen236 mL in 1 TUBELOTION2362

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
59062-1000OUTDOOR EXPLORER SET (TITANIUM DIOXIDE, OCTISALATE, AND ZINC OXIDE) KIT [KAS DIRECT LLC DBA BABYGANICS]2Current NDC, Legacy NDC20210720_726096c2-514a-439a-9697-346ca684c493.zip
59062-1000SPF 50 PLUS SUNSCREEN (TITANIUM DIOXIDE, OCTISALATE, AND ZINC OXIDE) LOTION [KAS DIRECT LLC DBA BABYGANICS]2Current NDC, Legacy NDC, 4 package rows20241220_5a4c71fc-aa6f-47f7-8d1d-2af2e726cf9b.zip
59062-1000SUNCARE ESSENTIALS (TITANIUM DIOXIDE, OCTISALATE, AND ZINC OXIDE) KIT [KAS DIRECT LLC DBA BABYGANICS]2Current NDC, Legacy NDC20250104_96fd2cf8-cb07-4ec1-8946-8e862f6d8377.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 95 of 357 · 7,139 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Coppertone Kids Sport Sunscreen SPF 100AVOBENZONE 3%, HOMOSALATE 15%, OCTINOXATE 2% OCTISALATE 5%, OCTOCRYLENE 10%, OXYBENZONE 6%Beiersdorf Incc068a6e7-260f-0766-e053-2995a90a422f2025-12-31WarningsExact identifier
application number: M020
Coppertone Sport Suncreen SPF 50AVOBENZONE 3%, HOMOSALATE 10%, OCTISALATE 5%, OCTOCRYLENE 5%Beiersdorf Inccc43f433-51ff-ed6a-e053-2a95a90ad3c52025-12-31WarningsExact identifier
application number: M020
Coppertone Sport Mineral Sunscreen SPF 50ZINC OXIDEBeiersdorf Incb5bb6eb6-3356-e2a5-e053-2995a90aa6842025-12-31WarningsExact identifier
application number: M020
Coppertone Limited Edition Sunscreen SPF 50AVOBENZONE 3%, HOMOSALATE 10%, OCTISALATE 5%, OCTOCRYLENE 5%Beiersdorf Incccbf7795-e153-1a43-e053-2a95a90ad4b62025-12-31WarningsExact identifier
application number: M020
Eucerin Advanced Hydration SPF 50 SunscreenAVOBENZONE, HOMOSALATE, OCTISALATE, OCTOCRYLENEBeiersdorf Inccd9cbdb4-42f1-3063-e053-2a95a90a08aa2025-12-31WarningsExact identifier
application number: M020
Eucerin Baby Sensitive Mineral SPF 50 SunscreenZINC OXIDEBeiersdorf Inccdb19c82-9845-eabc-e053-2a95a90a31f72025-12-31WarningsExact identifier
application number: M020
Eucerin Advance Hydration Sunscreen SPF 30AVOBENZONE, HOMOSALATE, OCTISALATE, OCTOCRYLENEBeiersdorf Inccd61e4d7-776d-8d84-e053-2995a90a48192025-12-31WarningsExact identifier
application number: M020
Eucerin Oil-Control SPF 50 SunscreenAVOBENZONE, HOMOSALATE, OCTISALATE, OCTOCRYLENEBeiersdorf Inccda04484-ba84-2276-e053-2a95a90a41c82025-12-31WarningsExact identifier
application number: M020
Coppertone Kids Sunscreen SPF 60AVOBENZONE 3%, HOMOSALATE 15%, OCTISALATE 5%, OCTOCRYLENE 10%Beiersdorf Inc240dd76a-8f39-caec-e063-6294a90abbbc2025-12-31WarningsExact identifier
application number: M020
Coppertone Protect and Tan SPF 30AVOBENZONE 3%, HOMOSALATE 14%, OCTISALATE 4.5%, OCTOCRYLENE 9%Beiersdorf Incd3994886-2ebe-a9d2-e053-2995a90aaf9a2025-12-31WarningsExact identifier
application number: M020
Coppertone Waterbabies Pure and Simple Sunscreen SPF 50AVOBENZONE 3%, HOMOSALATE 9%, OCTISALATE 4.5%, OCTOCRYLENE 9%Beiersdorf Incd3d471b8-7430-98b0-e053-2995a90aba4b2025-12-31WarningsExact identifier
application number: M020
Coppertone Sport Sunscreen SPF 60AVOBENZONE 3%, HOMOSALATE 15%, OCTISALATE 5%, OCTOCRYLENE 10%Beiersdorf Inc241f78be-0d7f-c5ca-e063-6294a90a997a2025-12-31WarningsExact identifier
application number: M020
Coppertone Protect and Tan Sunscreen SPF 45AVOBENZONE 3%, HOMOSALATE 15%, OCTISALATE 5%, OCTOCRYLENE 10%Beiersdort Incd39a009d-1f33-88bb-e053-2a95a90a03a02025-12-31WarningsExact identifier
application number: M020
Coppertone Sport Sunscreen SPF 30AVOBENZONE 2%, HOMOSALATE 8%, OCTISALATE 4.5%, OCTOCRYLENE 7%Beiersdorf Incd460d669-42df-46c0-e053-2a95a90ad77b2025-12-31WarningsExact identifier
application number: M020
Coppertone Tanning Sunscreen SPF 8AVOBENZONE 2%, HOMOSALATE 5%, OCTISALATE 4.5%, OCTOCRYLENE 3%Beiersdorf Incd370094c-3373-594b-e053-2a95a90a114a2025-12-31WarningsExact identifier
application number: M020
Coppertone Tanning Sunscreen SPF 15(TO DELIVER) AVOBENZONE 2%, OCTISALATE 4.5%, OCTOCRYLENE 7%Beiersdorf Inc0a5a35be-9e24-18dd-e063-6394a90a097f2025-12-31WarningsExact identifier
application number: M020
Coppertone Sport Sunscreen SPF 50AVOBENZONE 3%, HOMOSALATE 10%, OCTISALATE 5%, OCTOCRYLENE 5%Beiersdorf Incd462081f-f082-5df2-e053-2995a90aa1d92025-12-31WarningsExact identifier
application number: M020
Coppertone Waterbabies Pure and Simple Sunscreen SPF 50AVOBENZONE 3%, HOMOSALATE 9%, OCTISALATE 4.5%, OCTOCRYLENE 9%Beiersdorf Incd3e66496-bc3c-d189-e053-2a95a90a06b62025-12-31WarningsExact identifier
application number: M020
Coppertone Kids Sunscreen SPF 50AVOBENZONE 3%, HOMOSALATE 10%, OCTISALATE 5%, OCTOCRYLENE 5%Beiersdorf Inc.c05388dc-4282-ee79-e053-2a95a90a376a2025-12-31WarningsExact identifier
application number: M020
Coppertone Glow Sunscreen SPF 50AVOBENZONE 3%, HOMOSALATE 9%, OCTISALATE 4.5%, OCTOCRYLENE 9%Beiersdorf Incb60dcbd1-42d0-646f-e053-2a95a90a497d2025-12-31WarningsExact identifier
application number: M020

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
59062-1000-159062100001354 mL in 1 TUBE (59062-1000-1) 354 ml2017-07-240000-00-00NoNoCurrent
59062-1000-25906210000259 mL in 1 TUBE (59062-1000-2) 59 ml2017-07-240000-00-00NoNoCurrent
59062-1000-659062100006177 mL in 1 TUBE (59062-1000-6) 177 ml2017-07-240000-00-00NoNoCurrent
59062-1000-859062100008236 mL in 1 TUBE (59062-1000-8) 236 ml2017-07-242026-12-31NoNoCurrent