FDA.reportPublic FDA data

Soleil Superieur Body SPF 50 US

Product NDC
82691-145
11-digit product format
826910145
Labeler code
82691
Product ID
82691-145_efdf9bd6-9813-f3ce-e053-2995a90a1130
Type
HUMAN OTC DRUG
Nonproprietary name
AVOBENZONE, HOMOSALATE, OCTISALATE, OCTOCRYLENE
Dosage form
CREAM
Route
TOPICAL
Labeler
RV Skincare LLC
Application
part352
Marketing category
OTC MONOGRAPH NOT FINAL
Marketing start
2020-04-01
Marketing end
0000-00-00
Substance
AVOBENZONE; HOMOSALATE; OCTISALATE; OCTOCRYLENE
Active strength
30 mg/mL; mg/mL; mg/mL; mg/mL
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 productproduct82691-145IInactivated by FDA2026-10-05
excluded packagepackage82691-14582691-145-00IInactivated by FDA2026-10-05

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
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
82691-145-00Soleil Superieur Body SPF 50 US1 in 1 CARTONCREAM13
82691-145-00Soleil Superieur Body SPF 50 US120 mL in 1 BOTTLE, PUMPCREAM1203

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
82691-145SOLEIL SUPERIEUR BODY SPF 50 US (AVOBENZONE, HOMOSALATE, OCTISALATE, OCTOCRYLENE) CREAM [RV SKINCARE LLC]3Legacy NDC, 2 package rows20231108_1e94e04e-e264-44d2-991c-d6229cf034b0.zip

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionMarketing startMarketing endSampleExclude flagStatus
82691-145-00826910145001 BOTTLE, PUMP in 1 CARTON (82691-145-00) > 120 mL in 1 BOTTLE, PUMP2020-04-010000-00-00NoNoCurrent