FDA.reportPublic FDA data

Moisturizing Renewal Cream Broad Spectrum SPF 30 US

Product NDC
82691-143
Requested package NDC
82691-143-00
11-digit product format
826910143
Labeler code
82691
Product ID
82691-143_efd16204-aaec-75d1-e053-2995a90aaada
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
2022-01-01
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 · 1 matching rows.

Dataset, Scope, Product NDC table
DatasetScopeProduct NDCPackage NDCCodeStatusReporting periodSource date
excluded packagepackage82691-14382691-143-00IInactivated 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
c6f86816-7da6-43ea-8c25-ac9758311cc5Product name120220118
baf7f49c-75b6-496b-a00e-8e766a8e4f03Product name120210127
d676a241-be05-4740-b3ee-1a5f2ed422d2Product name420180615
dd8bd48f-20d6-43c7-b471-3ae872868afaProduct name320180125
252e11b6-1a9a-4283-a242-df2c129c496dProduct name320170717
ebc62596-fc97-4d03-9483-7ba095d25db7Product name120151210
d41954ff-bc63-4b2c-aba0-9146707659d7Product name220151117
0ca1d589-929b-4b33-bc5b-1d84abdafa6aProduct name120150324
fc363c46-397b-4476-ac0f-70e43e8e4592Product name120150324

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
82691-143-002026-01-29C16284748780-149896155-bfee-586f-e063-e6dba90add90Moisturizing Renewal Cream Broad Spectrum SPF 30 US
82691-143-012026-01-29C16284748780-149896155-bfee-586f-e063-e6dba90add90Moisturizing Renewal Cream Broad Spectrum SPF 30 US

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
82691-143-00Moisturizing Renewal Cream Broad Spectrum SPF 30 US1 in 1 CARTONCREAM14
82691-143-00Moisturizing Renewal Cream Broad Spectrum SPF 30 US50 mL in 1 JARCREAM504
82691-143-01Moisturizing Renewal Cream Broad Spectrum SPF 30 US5 mL in 1 JARCREAM54

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
82691-143MOISTURIZING RENEWAL CREAM BROAD SPECTRUM SPF 30 US (AVOBENZONE, HOMOSALATE, OCTISALATE, OCTOCRYLENE) CREAM [RV SKINCARE LLC]4Legacy NDC, 3 package rows20231108_2e69011b-5cc8-4df4-b4d8-0948d0b4a33d.zip

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
82691-143-00826910143001 JAR in 1 CARTON (82691-143-00) > 50 mL in 1 JAR1 jar2022-01-010000-00-00NoNoCurrent