FDA.reportPublic FDA data

CLINIQUE SMART BROAD SPECTRUM SPF 15 CUSTOM-REPAIR MOISTURIZER DRY COMBINATION

Product NDC
49527-051
11-digit product format
495270051
Labeler code
49527
Product ID
49527-051_f0d6f4b9-e3bb-02d6-e053-2995a90aac75
Type
HUMAN OTC DRUG
Nonproprietary name
avobenzone and octisalate
Dosage form
CREAM
Route
TOPICAL
Labeler
CLINIQUE LABORATORIES LLC
Application
part352
Marketing category
OTC MONOGRAPH NOT FINAL
Marketing start
2015-10-01
Marketing end
0000-00-00
Substance
AVOBENZONE; OCTISALATE
Active strength
30 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 · 6 matching rows.

Dataset, Scope, Product NDC table
DatasetScopeProduct NDCPackage NDCCodeStatusReporting periodSource date
excluded productproduct49527-051IInactivated by FDA2026-10-05
excluded packagepackage49527-05149527-051-01IInactivated by FDA2026-10-05
excluded packagepackage49527-05149527-051-02IInactivated by FDA2026-10-05
excluded packagepackage49527-05149527-051-03IInactivated by FDA2026-10-05
excluded packagepackage49527-05149527-051-04DDiscontinued by firm2026-10-05
excluded packagepackage49527-05149527-051-05IInactivated by FDA2026-10-05

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 · 12 matching rows.

View current auxiliary records. · View the auxiliary file history.

Captured / source date, Snapshot, Source SHA-256 table
Captured / source dateSnapshotSource SHA-256
2025-12-14 17:58 UTC · source 2025-12-05d630ba8d3edf…732f749b63fb…
2025-08-27 00:01 UTC · source 2025-08-26f5e01cc5f278…a2eaf40c39c3…
2025-04-01 02:39 UTC · source 2025-03-312ef7874e63bc…57b86245f4fa…
2025-03-28 20:22 UTC · source 2025-03-28a1b67e2a42f9…c4cf2c586c0d…
2025-03-22 03:12 UTC · source 2025-03-21cfe11265f3b6…090c488252e2…
2025-03-10 12:48 UTC · source 2025-03-10cdf11ea48f46…ba0047e9e063…
2025-02-02 03:52 UTC · source 2025-01-31302b2466d912…e7b80fea0513…
2025-01-20 13:05 UTC · source 2025-01-20ed331223b511…672a5bd82f5f…
2025-01-11 03:41 UTC · source 2025-01-100efc9e666f02…f202fb6c5f17…
2024-11-09 02:27 UTC · source 2024-11-08ad56d346431e…cc804d4bbf1e…
2024-10-04 04:10 UTC · source 2024-10-03367a005e9d99…383a685ebd0f…
2024-07-10 04:00 UTC · source 2024-07-09557ba5c1ecfa…9c80585c8c6e…

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
30b0ac6e-02aa-0e5c-0d8b-cffdf3a282b2Product name520250304
7dea7767-9f52-b60a-5435-33cb9cc28baeProduct name420250124
6338270f-96cb-0ecb-6fbb-0a9bc78001f4Product name720250116
0ca83774-3f79-b837-5d6f-c210102f3bc8Product name620250114
41b814f3-0166-1c53-c9ef-a0794c7daf9dProduct name320221110
a590be26-846c-8659-a5a1-fb25907965dcProduct name220221110
c6f86816-7da6-43ea-8c25-ac9758311cc5Product name120220118
2dc76302-91c0-4c35-ad78-99adfb049c4bProduct name120200603
444b3e50-f226-46ef-bfca-2e7035d140cdProduct name120190611
7cda52fc-125f-421c-8fea-bc1974370c49Product name220180703
e6065d4b-5ae1-476f-a40e-f2851cbb5d2bProduct name220180221
252e11b6-1a9a-4283-a242-df2c129c496dProduct name320170717
f212291f-05fe-9603-fc7e-bd73e38ce1e6Product name220161129
182f9ab4-4ab5-c449-200f-87ce2ce8e550Product name220151105
d5e51f11-ad28-caa4-4b49-4143974782adProduct name120150831
0ca1d589-929b-4b33-bc5b-1d84abdafa6aProduct name120150324
fc363c46-397b-4476-ac0f-70e43e8e4592Product name120150324
332e86c3-7875-ca6e-f934-2206d2b31996Product name120140508
56625fcc-aa34-9d30-d0e9-1c1beb37ea21Product name120140508
7dfac40f-a405-cd2e-7c06-3059ec0e1092Product name120140508
87711080-88eb-65c5-b2dd-bf99e700a372Product name120140508
96c2be53-8e44-452d-56a2-d255b2f1af2dProduct name120140508
bf8bd5f7-495f-4022-2780-7ded7ea7ea44Product name120140508
d223c173-c39b-d764-47d4-d671d3088815Product name120140508
e01133ad-4dcd-c7f3-454b-2ff569ee160aProduct name120140508
ec2149b3-5c6d-5344-f757-c86411073075Product name120140508

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
49527-051-01CLINIQUE SMART BROAD SPECTRUM SPF 15 CUSTOM-REPAIR MOISTURIZER DRY COMBINATION1 in 1 CARTONCREAM112
49527-051-01CLINIQUE SMART BROAD SPECTRUM SPF 15 CUSTOM-REPAIR MOISTURIZER DRY COMBINATION50 mL in 1 JARCREAM5012
49527-051-02CLINIQUE SMART BROAD SPECTRUM SPF 15 CUSTOM-REPAIR MOISTURIZER DRY COMBINATION1 in 1 CARTONCREAM112
49527-051-02CLINIQUE SMART BROAD SPECTRUM SPF 15 CUSTOM-REPAIR MOISTURIZER DRY COMBINATION75 mL in 1 JARCREAM7512
49527-051-03CLINIQUE SMART BROAD SPECTRUM SPF 15 CUSTOM-REPAIR MOISTURIZER DRY COMBINATION1 in 1 CARTONCREAM112
49527-051-03CLINIQUE SMART BROAD SPECTRUM SPF 15 CUSTOM-REPAIR MOISTURIZER DRY COMBINATION15 mL in 1 JARCREAM1512
49527-051-04CLINIQUE SMART BROAD SPECTRUM SPF 15 CUSTOM-REPAIR MOISTURIZER DRY COMBINATION7 mL in 1 PACKETCREAM712
49527-051-05CLINIQUE SMART BROAD SPECTRUM SPF 15 CUSTOM-REPAIR MOISTURIZER DRY COMBINATION1 in 1 CARTONCREAM112
49527-051-05CLINIQUE SMART BROAD SPECTRUM SPF 15 CUSTOM-REPAIR MOISTURIZER DRY COMBINATION7 mL in 1 JARCREAM712

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
49527-051CLINIQUE SMART BROAD SPECTRUM SPF 15 CUSTOM-REPAIR MOISTURIZER DRY COMBINATION (AVOBENZONE AND OCTISALATE) CREAM [CLINIQUE LABORATORIES LLC]12Legacy NDC, 9 package rows20241226_228db004-3afa-479a-be38-8e4c4c959cb4.zip

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
49527-051-01495270051011 JAR in 1 CARTON (49527-051-01) > 50 mL in 1 JAR1 jar2015-10-010000-00-00NoNoCurrent
49527-051-02495270051021 JAR in 1 CARTON (49527-051-02) > 75 mL in 1 JAR1 jar2022-07-120000-00-00NoNoCurrent
49527-051-03495270051031 JAR in 1 CARTON (49527-051-03) > 15 mL in 1 JAR1 jar2022-07-120000-00-00NoNoCurrent
49527-051-04495270051047 mL in 1 PACKET (49527-051-04) 7 ml2022-07-120000-00-00NoNoCurrent
49527-051-05495270051051 in 1 CARTONHistorical