Home NDC 49527-953 CLINIQUE CX
Product NDC 49527-953
11-digit product format 495270953
Labeler code 49527
Product ID 49527-953_3db07dee-3ef4-417d-a4ac-1a18421ddcb4
Type HUMAN OTC DRUG
Nonproprietary name OCTINOXATE, OCTISALATE, ZINC OXIDE,TITANIUM DIOXIDE
Dosage form CREAM
Route TOPICAL
Labeler CLINIQUE LABORATORIES INC
Application part352
Marketing category OTC MONOGRAPH NOT FINAL
Marketing start 2005-05-01
Marketing end 0000-00-00
Substance OCTINOXATE; OCTISALATE; ZINC OXIDE; TITANIUM DIOXIDE
Active strength 8 mL/100mL; mL/100mL; mL/100mL; mL/100mL
NDC exclude flag E
Listing certified through 2018-12-31
Current FDA listing Historical FDA.report record 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 · 44 matching rows.
View current auxiliary records. · View the auxiliary file history.
Captured / source date, Dataset, Scope table Captured / source date Dataset Scope Package NDC Code Status Snapshot Source SHA-256 2025-12-14 17:58 UTC · source 2025-12-05 excluded product product I Inactivated by FDA d630ba8d3edf…732f749b63fb…2025-12-14 17:58 UTC · source 2025-12-05 excluded package package 49527-953-01 I Inactivated by FDA d630ba8d3edf…732f749b63fb…2025-08-27 00:01 UTC · source 2025-08-26 excluded product product I Inactivated by FDA f5e01cc5f278…a2eaf40c39c3…2025-08-27 00:01 UTC · source 2025-08-26 excluded package package 49527-953-01 I Inactivated by FDA f5e01cc5f278…a2eaf40c39c3…2025-04-01 02:39 UTC · source 2025-03-31 excluded product product I Inactivated by FDA 2ef7874e63bc…57b86245f4fa…2025-04-01 02:39 UTC · source 2025-03-31 excluded package package 49527-953-01 I Inactivated by FDA 2ef7874e63bc…57b86245f4fa…2025-03-28 20:22 UTC · source 2025-03-28 excluded product product I Inactivated by FDA a1b67e2a42f9…c4cf2c586c0d…2025-03-28 20:22 UTC · source 2025-03-28 excluded package package 49527-953-01 I Inactivated by FDA a1b67e2a42f9…c4cf2c586c0d…2025-03-22 03:12 UTC · source 2025-03-21 excluded product product I Inactivated by FDA cfe11265f3b6…090c488252e2…2025-03-22 03:12 UTC · source 2025-03-21 excluded package package 49527-953-01 I Inactivated by FDA cfe11265f3b6…090c488252e2…2025-03-10 12:48 UTC · source 2025-03-10 excluded product product I Inactivated by FDA cdf11ea48f46…ba0047e9e063…2025-03-10 12:48 UTC · source 2025-03-10 excluded package package 49527-953-01 I Inactivated by FDA cdf11ea48f46…ba0047e9e063…2025-02-02 03:52 UTC · source 2025-01-31 excluded product product I Inactivated by FDA 302b2466d912…e7b80fea0513…2025-02-02 03:52 UTC · source 2025-01-31 excluded package package 49527-953-01 I Inactivated by FDA 302b2466d912…e7b80fea0513…2025-01-20 13:05 UTC · source 2025-01-20 excluded product product I Inactivated by FDA ed331223b511…672a5bd82f5f…2025-01-20 13:05 UTC · source 2025-01-20 excluded package package 49527-953-01 I Inactivated by FDA ed331223b511…672a5bd82f5f…2025-01-11 03:41 UTC · source 2025-01-10 excluded product product I Inactivated by FDA 0efc9e666f02…f202fb6c5f17…2025-01-11 03:41 UTC · source 2025-01-10 excluded package package 49527-953-01 I Inactivated by FDA 0efc9e666f02…f202fb6c5f17…2024-11-09 02:27 UTC · source 2024-11-08 excluded product product I Inactivated by FDA ad56d346431e…cc804d4bbf1e…2024-11-09 02:27 UTC · source 2024-11-08 excluded package package 49527-953-01 I Inactivated by FDA ad56d346431e…cc804d4bbf1e…2024-10-04 04:10 UTC · source 2024-10-03 excluded product product I Inactivated by FDA 367a005e9d99…383a685ebd0f…2024-10-04 04:10 UTC · source 2024-10-03 excluded package package 49527-953-01 I Inactivated by FDA 367a005e9d99…383a685ebd0f…2024-07-10 04:00 UTC · source 2024-07-09 excluded product product I Inactivated by FDA 557ba5c1ecfa…9c80585c8c6e…2024-07-10 04:00 UTC · source 2024-07-09 excluded package package 49527-953-01 I Inactivated by FDA 557ba5c1ecfa…9c80585c8c6e…2024-05-28 21:12 UTC · source 2024-05-28 excluded product product I Inactivated by FDA 8af77b9d5b6f…d9bbb34c5368…2024-05-28 21:12 UTC · source 2024-05-28 excluded package package 49527-953-01 I Inactivated by FDA 8af77b9d5b6f…d9bbb34c5368…2024-05-15 03:39 UTC · source 2024-05-14 excluded product product I Inactivated by FDA 834df4deac94…adcc014656a3…2024-05-15 03:39 UTC · source 2024-05-14 excluded package package 49527-953-01 I Inactivated by FDA 834df4deac94…adcc014656a3…2024-03-11 06:39 UTC · source 2024-03-08 excluded product product I Inactivated by FDA 1332a3947898…d4bfe170f9cd…2024-03-11 06:39 UTC · source 2024-03-08 excluded package package 49527-953-01 I Inactivated by FDA 1332a3947898…d4bfe170f9cd…2022-08-30 03:57 UTC · source 2022-08-29 excluded product product I Inactivated by FDA fb8cb913e6d1…eb8c232b6be0…2022-08-30 03:57 UTC · source 2022-08-29 excluded package package 49527-953-01 I Inactivated by FDA fb8cb913e6d1…eb8c232b6be0…2022-04-09 23:13 UTC · source 2022-04-08 excluded product product I Inactivated by FDA 86f5da6cb304…a595104c45d7…2022-04-09 23:13 UTC · source 2022-04-08 excluded package package 49527-953-01 I Inactivated by FDA 86f5da6cb304…a595104c45d7…2022-04-04 05:40 UTC · source 2022-04-01 excluded product product I Inactivated by FDA bd6a592717d7…303034d00443…2022-04-04 05:40 UTC · source 2022-04-01 excluded package package 49527-953-01 I Inactivated by FDA bd6a592717d7…303034d00443…2021-12-27 23:28 UTC · source 2021-12-27 excluded product product I Inactivated by FDA 8dfbde2a14a4…c9ff85d89658…2021-12-27 23:28 UTC · source 2021-12-27 excluded package package 49527-953-01 I Inactivated by FDA 8dfbde2a14a4…c9ff85d89658…2020-12-18 03:04 UTC · source 2020-12-17 excluded product product I Inactivated by FDA e2bbac7714bc…27bdfed8d636…2020-12-18 03:04 UTC · source 2020-12-17 excluded package package 49527-953-01 I Inactivated by FDA e2bbac7714bc…27bdfed8d636…2020-06-10 20:45 UTC · source 2020-06-10 excluded product product I Inactivated by FDA 9bebd1f3094a…5416666fcb17…2020-06-10 20:45 UTC · source 2020-06-10 excluded package package 49527-953-01 I Inactivated by FDA 9bebd1f3094a…5416666fcb17…2019-12-08 06:16 UTC · source 2019-12-05 excluded product product E Excluded after deficient or non-compliant submission was not corrected 110d247fa046…a55b01930146…2019-12-08 06:16 UTC · source 2019-12-05 excluded package package 49527-953-01 E Excluded after deficient or non-compliant submission was not corrected 110d247fa046…a55b01930146…
Reported adverse events (FAERS/openFDA)# Adverse event summaries are temporarily unavailable. Other product information remains available.
FDA-Initiated Inactive NDC Indexing# DailyMed Package Descriptions# Package NDC, Product, Description table Package NDC Product Description Form Quantity Strength SPL version 49527-953-01 CLINIQUE CXPROTECTIVE BASE SPF 40 1 in 1 CARTON CREAM 1 1 49527-953-02 CLINIQUE CXPROTECTIVE BASE SPF 40 50 mL in 1 TUBE CREAM 50 1
DailyMed Socrata Ingredients# Ingredient, Type, UNII table Ingredient Type UNII DailyMed label SPL version Uploaded OCTINOXATE ACTIVE INGREDIENT 4Y5P7MUD51 CLINIQUE CX PROTECTIVE BASE SPF 40 (OCTINOXATE, OCTISALATE, ZINC OXIDE,TITANIUM DIOXIDE) CREAM [CLINIQUE LABORATORIES INC] 1 OCTISALATE ACTIVE INGREDIENT 4X49Y0596W CLINIQUE CX PROTECTIVE BASE SPF 40 (OCTINOXATE, OCTISALATE, ZINC OXIDE,TITANIUM DIOXIDE) CREAM [CLINIQUE LABORATORIES INC] 1 TITANIUM DIOXIDE ACTIVE INGREDIENT 15FIX9V2JP CLINIQUE CX PROTECTIVE BASE SPF 40 (OCTINOXATE, OCTISALATE, ZINC OXIDE,TITANIUM DIOXIDE) CREAM [CLINIQUE LABORATORIES INC] 1 ZINC OXIDE ACTIVE INGREDIENT SOI2LOH54Z CLINIQUE CX PROTECTIVE BASE SPF 40 (OCTINOXATE, OCTISALATE, ZINC OXIDE,TITANIUM DIOXIDE) CREAM [CLINIQUE LABORATORIES INC] 1 OCTINOXATE ACTIVE MOIETY 4Y5P7MUD51 CLINIQUE CX PROTECTIVE BASE SPF 40 (OCTINOXATE, OCTISALATE, ZINC OXIDE,TITANIUM DIOXIDE) CREAM [CLINIQUE LABORATORIES INC] 1 OCTISALATE ACTIVE MOIETY 4X49Y0596W CLINIQUE CX PROTECTIVE BASE SPF 40 (OCTINOXATE, OCTISALATE, ZINC OXIDE,TITANIUM DIOXIDE) CREAM [CLINIQUE LABORATORIES INC] 1 TITANIUM DIOXIDE ACTIVE MOIETY 15FIX9V2JP CLINIQUE CX PROTECTIVE BASE SPF 40 (OCTINOXATE, OCTISALATE, ZINC OXIDE,TITANIUM DIOXIDE) CREAM [CLINIQUE LABORATORIES INC] 1 ZINC OXIDE ACTIVE MOIETY SOI2LOH54Z CLINIQUE CX PROTECTIVE BASE SPF 40 (OCTINOXATE, OCTISALATE, ZINC OXIDE,TITANIUM DIOXIDE) CREAM [CLINIQUE LABORATORIES INC] 1 BUTYLENE GLYCOL INACTIVE INGREDIENT 3XUS85K0RA CLINIQUE CX PROTECTIVE BASE SPF 40 (OCTINOXATE, OCTISALATE, ZINC OXIDE,TITANIUM DIOXIDE) CREAM [CLINIQUE LABORATORIES INC] 1 C12-15 ALKYL BENZOATE INACTIVE INGREDIENT A9EJ3J61HQ CLINIQUE CX PROTECTIVE BASE SPF 40 (OCTINOXATE, OCTISALATE, ZINC OXIDE,TITANIUM DIOXIDE) CREAM [CLINIQUE LABORATORIES INC] 1
DailyMed Dashboard NDC Coverage# NDC, Dashboard title, SPL version table NDC Dashboard title SPL version Validation Dashboard ZIP 49527-953 CLINIQUE CX PROTECTIVE BASE SPF 40 (OCTINOXATE, OCTISALATE, ZINC OXIDE,TITANIUM DIOXIDE) CREAM [CLINIQUE LABORATORIES INC] 1 Legacy NDC, 2 package rows 20101104_75201871-e084-48e0-9e18-a0b2bf280626.zip
Packages# Package NDC, 11-digit format, Description table Package NDC 11-digit format Description Units Status 49527-953-01 49527095301 1 in 1 CARTON Historical 49527-953-02 49527095302 50 mL in 1 TUBE 50 ml Historical