FDA.reportPublic FDA data

Tulip Dew Sunscreen

Product NDC
82548-4530
11-digit product format
825484530
Labeler code
82548
Product ID
82548-4530_eb3ddc5d-c661-9388-e053-2a95a90ad398
Type
HUMAN OTC DRUG
Nonproprietary name
ZINC OXIDE
Dosage form
LOTION
Route
TOPICAL
Labeler
Bloomeffects, Inc.
Application
part352
Marketing category
OTC MONOGRAPH NOT FINAL
Marketing start
2022-05-01
Marketing end
0000-00-00
Substance
ZINC OXIDE
Active strength
120 mg/mL
Pharmacologic classes
Copper Absorption Inhibitor [EPC], Decreased Copper Ion Absorption [PE]
NDC exclude flag
No
Listing certified through
2023-12-31
Current FDA listing
Historical FDA.report record

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 productproduct82548-4530DDiscontinued by firm2026-10-16
excluded packagepackage82548-453082548-4530-1DDiscontinued by firm2026-10-16

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 · 2 matching rows.

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

Captured / source date, Dataset, Scope table
Captured / source dateDatasetScopeProduct NDCPackage NDCCodeStatusReporting periodArchiveSnapshotSource SHA-256
2025-12-14 17:58 UTC · source 2025-12-05excluded productproduct82548-4530DDiscontinued by firmexcluded / ndc_excluded.zipd630ba8d3edf…732f749b63fb…
2025-12-14 17:58 UTC · source 2025-12-05excluded packagepackage82548-453082548-4530-1DDiscontinued by firmexcluded / ndc_excluded.zipd630ba8d3edf…732f749b63fb…

Reported adverse events (FAERS/openFDA)#

Adverse event summaries are temporarily unavailable. Other product information remains available.

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
82548-4530TULIP DEW SUNSCREEN (ZINC OXIDE) LOTION [BLOOMEFFECTS, INC.]3Legacy NDC20231020_c7951aea-d9b2-4662-a0c2-b8604cffc5a4.zip

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionMarketing startMarketing endSampleExclude flagStatus
82548-4530-1825484530011 BOTTLE, PUMP in 1 CARTON (82548-4530-1) > 55 mL in 1 BOTTLE, PUMP2022-05-010000-00-00NoNoCurrent