FDA.reportPublic FDA data

SPF 50 Mineral Sunscreen

Product NDC
59062-2201
11-digit product format
590622201
Labeler code
59062
Product ID
59062-2201_dc9ac864-32ee-4bc1-948f-da5c962bb422
Type
HUMAN OTC DRUG
Nonproprietary name
Zinc Oxide
Dosage form
STICK
Route
TOPICAL
Labeler
KAS Direct LLC dba BabyGanics
Application
M020
Marketing category
OTC MONOGRAPH DRUG
Marketing start
2021-03-01
Marketing end
2027-12-31
Substance
ZINC OXIDE
Active strength
216 mg/g
NDC exclude flag
No
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
SPF 50 Mineral Sunscreen
Brand name suffix
bkids

Active Ingredients#

Ingredient, Strength table
IngredientStrength
ZINC OXIDE216 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
f717cd89-194b-42e3-a079-24b2903deb29Available on FDA.report

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
59062-2201-4SPF 50 Mineral Sunscreen bkids45 g in 1 CONTAINERSTICK454

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
59062-2201SPF 50 MINERAL SUNSCREEN BKIDS (ZINC OXIDE) STICK [KAS DIRECT LLC DBA BABYGANICS]3Current NDC, Legacy NDC, 1 package rows20241222_f717cd89-194b-42e3-a079-24b2903deb29.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 251 of 353 · 7,041 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Leg Body MakeupOCTISALATE, OCTOCRYLENECOSMAX USA, CORPORATION0d338ec2-dca0-e032-e063-6394a90a69aa2024-12-25WarningsExact identifier
application number: M020
Leg Body MakeupOCTISALATE, OCTOCRYLENECOSMAX USA, CORPORATION0752d79d-5d82-0367-e063-6394a90a4f1c2024-12-25WarningsExact identifier
application number: M020
Leg Body MakeupOCTISALATE, OCTOCRYLENECOSMAX USA, CORPORATION0d33888d-20b3-f912-e063-6394a90a25dc2024-12-25WarningsExact identifier
application number: M020
Leg Body MakeupOCTISALATE, OCTOCRYLENECOSMAX USA, CORPORATION0d3379ba-465c-a889-e063-6394a90aaf232024-12-25WarningsExact identifier
application number: M020
Buildable BlurHOMOSALATE, OCTISALATE, ZINC OXIDECOSMAX USA, CORPORATION06b25290-33a0-bafd-e063-6394a90a7a942024-12-25WarningsExact identifier
application number: M020
Leg Body MakeupOCTISALATE, OCTOCRYLENECOSMAX USA, CORPORATION0751b356-607f-f3cb-e063-6294a90a40922024-12-25WarningsExact identifier
application number: M020
Buildable BlurHOMOSALATE, OCTISALATE, ZINC OXIDECOSMAX USA, CORPORATION06b14a17-cace-1b3e-e063-6394a90afe5d2024-12-25WarningsExact identifier
application number: M020
Leg Body MakeupOCTISALATE, OCTOCRYLENECOSMAX USA, CORPORATION07530636-cd21-3022-e063-6394a90a89d62024-12-25WarningsExact identifier
application number: M020
Leg Body MakeupOCTISALATE, OCTOCRYLENECOSMAX USA, CORPORATION0752753e-cac9-9166-e063-6394a90a4d8d2024-12-25WarningsExact identifier
application number: M020
Buildable BlurHOMOSALATE, OCTISALATE, ZINC OXIDECOSMAX USA, CORPORATION06ad3c09-9f1b-b25c-e063-6294a90aebe12024-12-25WarningsExact identifier
application number: M020
Buildable BlurHOMOSALATE, OCTISALATE, ZINC OXIDECOSMAX USA, CORPORATION06c57ff5-7013-d35f-e063-6394a90a6ee22024-12-25WarningsExact identifier
application number: M020
Buildable BlurHOMOSALATE, OCTISALATE, ZINC OXIDECOSMAX USA, CORPORATION06b1f8bc-8b29-451a-e063-6294a90a34bd2024-12-25WarningsExact identifier
application number: M020
Buildable BlurHOMOSALATE, OCTISALATE, ZINC OXIDECOSMAX USA, CORPORATION06b26dd0-44de-91a7-e063-6394a90a603a2024-12-25WarningsExact identifier
application number: M020
Buildable BlurHOMOSALATE, OCTISALATE, ZINC OXIDECOSMAX USA, CORPORATION06b26dd0-44ef-91a7-e063-6394a90a603a2024-12-25WarningsExact identifier
application number: M020
Buildable BlurHOMOSALATE, OCTISALATE, ZINC OXIDECOSMAX USA, CORPORATION06b25290-33a3-bafd-e063-6394a90a7a942024-12-25WarningsExact identifier
application number: M020
Buildable BlurHOMOSALATE, OCTISALATE, ZINC OXIDECOSMAX USA, CORPORATION06b1f8bc-8b2b-451a-e063-6294a90a34bd2024-12-25WarningsExact identifier
application number: M020
Buildable BlurHOMOSALATE, OCTISALATE, ZINC OXIDECOSMAX USA, CORPORATION06b26dd0-44cb-91a7-e063-6394a90a603a2024-12-25WarningsExact identifier
application number: M020
Buildable BlurHOMOSALATE, OCTISALATE, ZINC OXIDECOSMAX USA, CORPORATION06b2b996-e02c-e40a-e063-6394a90aa0d92024-12-25WarningsExact identifier
application number: M020
Buildable BlurHOMOSALATE, OCTISALATE, ZINC OXIDECOSMAX USA, CORPORATION06c5efde-42e1-e4fc-e063-6394a90a491d2024-12-25WarningsExact identifier
application number: M020
Buildable BlurHOMOSALATE, OCTISALATE, ZINC OXIDECOSMAX USA, CORPORATION06c5efde-42d0-e4fc-e063-6394a90a491d2024-12-25WarningsExact identifier
application number: M020

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
59062-2201-45906222010445 g in 1 CONTAINER (59062-2201-4) 45 g2021-03-012027-12-31NoNoCurrent