FDA.reportPublic FDA data

Broad Spectrum SPF 30 Tropical Sunscreen

Product NDC
65692-0519
Requested package NDC
65692-0519-1
11-digit product format
656920519
Labeler code
65692
Product ID
65692-0519_b7b31b21-4510-4026-e053-2a95a90ac8a1
Type
HUMAN OTC DRUG
Nonproprietary name
Broad Spectrum SPF 30 Tropical Sunscreen
Dosage form
LOTION
Route
TOPICAL
Labeler
Raining Rose, Inc
Application
part352
Marketing category
OTC MONOGRAPH FINAL
Marketing start
2020-02-17
Marketing end
0000-00-00
Substance
OXYBENZONE; OCTISALATE; AVOBENZONE; OCTOCRYLENE; HOMOSALATE
Active strength
3 g/44mL; g/44mL; g/44mL; g/44mL; g/44mL
NDC exclude flag
No
Listing certified through
2021-12-31
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 · 1 matching rows.

Dataset, Scope, Product NDC table
DatasetScopeProduct NDCPackage NDCCodeStatusReporting periodSource date
excluded packagepackage65692-051965692-0519-1DDiscontinued by firm2026-10-05

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 packagepackage65692-051965692-0519-1DDiscontinued by firmexcluded / ndc_excluded.zipd630ba8d3edf…732f749b63fb…
2025-08-27 00:01 UTC · source 2025-08-26excluded packagepackage65692-051965692-0519-1DDiscontinued by firmexcluded / ndc_excluded.zipf5e01cc5f278…a2eaf40c39c3…

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
65692-0519BROAD SPECTRUM SPF 30 TROPICAL SUNSCREEN LOTION [RAINING ROSE, INC]4Legacy NDC20240518_a3831db0-5832-093f-e053-2a95a90acb8f.zip

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
65692-0519-16569205190130 mL in 1 BOTTLE, PLASTIC (65692-0519-1) 30 ml2020-02-170000-00-00NoNoCurrent