FDA.reportPublic FDA data

Soleil Superieur Broad Spectrum SPF 50 Sunscreen US

Product NDC
82691-146
11-digit product format
826910146
Labeler code
82691
Product ID
82691-146_efdf98c1-7e66-f770-e053-2995a90a7113
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
2017-12-01
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 productproduct82691-146IInactivated by FDA2026-10-05
excluded packagepackage82691-14682691-146-00IInactivated 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
d676a241-be05-4740-b3ee-1a5f2ed422d2Product name420180615
dd8bd48f-20d6-43c7-b471-3ae872868afaProduct name320180125
ebc62596-fc97-4d03-9483-7ba095d25db7Product name120151210
d41954ff-bc63-4b2c-aba0-9146707659d7Product name220151117
0ca1d589-929b-4b33-bc5b-1d84abdafa6aProduct name120150324
fc363c46-397b-4476-ac0f-70e43e8e4592Product name120150324

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
82691-146-00Soleil Superieur Broad Spectrum SPF 50 Sunscreen US1 in 1 CARTONCREAM13
82691-146-00Soleil Superieur Broad Spectrum SPF 50 Sunscreen US50 mL in 1 BOTTLE, PUMPCREAM503

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
82691-146SOLEIL SUPERIEUR BROAD SPECTRUM SPF 50 SUNSCREEN US (AVOBENZONE, HOMOSALATE, OCTISALATE, OCTOCRYLENE) CREAM [RV SKINCARE LLC]3Legacy NDC, 2 package rows20231108_cf0000e8-98f8-4e36-bbdd-8c301b73b3e1.zip

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionMarketing startMarketing endSampleExclude flagStatus
82691-146-00826910146001 BOTTLE, PUMP in 1 CARTON (82691-146-00) > 50 mL in 1 BOTTLE, PUMP2017-12-010000-00-00NoNoCurrent