FDA.reportPublic FDA data

STAY HOT BURN NOT Broad Spectrum SPF 25 Sunscreen

Product NDC
82704-2650
Requested package NDC
82704-2650-2
11-digit product format
827042650
Labeler code
82704
Product ID
82704-2650_e7773622-71ca-103e-e053-2995a90aa296
Type
HUMAN OTC DRUG
Nonproprietary name
Octinoxate and Zinc Oxide
Dosage form
LOTION
Route
TOPICAL
Labeler
SKNVCARE,LLC
Application
part352
Marketing category
OTC MONOGRAPH NOT FINAL
Marketing start
2022-08-01
Marketing end
0000-00-00
Substance
OCTINOXATE; ZINC OXIDE
Active strength
7 g/100mL; g/100mL
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 · 1 matching rows.

Dataset, Scope, Product NDC table
DatasetScopeProduct NDCPackage NDCCodeStatusReporting periodSource date
excluded packagepackage82704-265082704-2650-2IInactivated by FDA2026-10-12

Reported adverse events (FAERS/openFDA)#

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

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
bee4fa8d-8d82-423a-a0b5-40a89dd13a99Product name120250618

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
82704-2650-22026-01-29C16284748780-149896155-abeb-586f-e063-e6dba90add90STAY HOT BURN NOT Broad Spectrum SPF 25 Sunscreen

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
82704-2650-2STAY HOT BURN NOT Broad Spectrum SPF 25 Sunscreen50 mL in 1 BOTTLE, PUMPLOTION503

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
82704-2650STAY HOT BURN NOT BROAD SPECTRUM SPF 25 SUNSCREEN (OCTINOXATE AND ZINC OXIDE) LOTION [SKNVCARE,LLC]3Legacy NDC, 1 package rows20240117_e7773a9b-6373-46cb-e053-2995a90a62e8.zip

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
82704-2650-28270426500250 mL in 1 BOTTLE, PUMP (82704-2650-2) 50 ml2022-08-010000-00-00NoNoCurrent