Home NDC 49527-736 CLINIQUE
Product NDC 49527-736
11-digit product format 495270736
Labeler code 49527
Product ID 49527-736_dfbb4a0f-2878-48b2-b2d6-96c58c877f14
Type HUMAN OTC DRUG
Nonproprietary name octisalate, homosalate, oxybenzone, avobenzone, octocrylene
Dosage form CREAM
Route TOPICAL
Labeler CLINIQUE LABS INC
Application part352
Marketing category OTC MONOGRAPH NOT FINAL
Marketing start 2010-06-01
Marketing end 0000-00-00
Substance OCTISALATE; HOMOSALATE; OXYBENZONE; AVOBENZONE; OCTOCRYLENE
Active strength 5 mL/100mL; 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 49527-736-01 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 49527-736-01 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 49527-736-01 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 49527-736-01 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 49527-736-01 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 49527-736-01 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 49527-736-01 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 49527-736-01 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 49527-736-01 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 49527-736-01 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 49527-736-01 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 49527-736-01 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 49527-736-01 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 49527-736-01 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 49527-736-01 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 49527-736-01 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 49527-736-01 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 49527-736-01 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 49527-736-01 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 49527-736-01 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 49527-736-01 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 49527-736-01 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 49527-736-01 CLINIQUESPF 30 ADVANCED PROTECTION BODY CREAM with SOLAR SMART 1 in 1 CARTON CREAM 1 2 49527-736-02 CLINIQUESPF 30 ADVANCED PROTECTION BODY CREAM with SOLAR SMART 150 mL in 1 TUBE CREAM 150 2
DailyMed Socrata Ingredients# Ingredient, Type, UNII table Ingredient Type UNII DailyMed label SPL version Uploaded AVOBENZONE ACTIVE INGREDIENT G63QQF2NOX CLINIQUE SPF 30 ADVANCED PROTECTION BODY CREAM WITH SOLAR SMART (OCTISALATE, HOMOSALATE, OXYBENZONE, AVOBENZONE, OCTOCRYLENE) CREAM [CLINIQUE LABS INC] 2 HOMOSALATE ACTIVE INGREDIENT V06SV4M95S CLINIQUE SPF 30 ADVANCED PROTECTION BODY CREAM WITH SOLAR SMART (OCTISALATE, HOMOSALATE, OXYBENZONE, AVOBENZONE, OCTOCRYLENE) CREAM [CLINIQUE LABS INC] 2 OCTISALATE ACTIVE INGREDIENT 4X49Y0596W CLINIQUE SPF 30 ADVANCED PROTECTION BODY CREAM WITH SOLAR SMART (OCTISALATE, HOMOSALATE, OXYBENZONE, AVOBENZONE, OCTOCRYLENE) CREAM [CLINIQUE LABS INC] 2 OCTOCRYLENE ACTIVE INGREDIENT 5A68WGF6WM CLINIQUE SPF 30 ADVANCED PROTECTION BODY CREAM WITH SOLAR SMART (OCTISALATE, HOMOSALATE, OXYBENZONE, AVOBENZONE, OCTOCRYLENE) CREAM [CLINIQUE LABS INC] 2 OXYBENZONE ACTIVE INGREDIENT 95OOS7VE0Y CLINIQUE SPF 30 ADVANCED PROTECTION BODY CREAM WITH SOLAR SMART (OCTISALATE, HOMOSALATE, OXYBENZONE, AVOBENZONE, OCTOCRYLENE) CREAM [CLINIQUE LABS INC] 2 AVOBENZONE ACTIVE MOIETY G63QQF2NOX CLINIQUE SPF 30 ADVANCED PROTECTION BODY CREAM WITH SOLAR SMART (OCTISALATE, HOMOSALATE, OXYBENZONE, AVOBENZONE, OCTOCRYLENE) CREAM [CLINIQUE LABS INC] 2 HOMOSALATE ACTIVE MOIETY V06SV4M95S CLINIQUE SPF 30 ADVANCED PROTECTION BODY CREAM WITH SOLAR SMART (OCTISALATE, HOMOSALATE, OXYBENZONE, AVOBENZONE, OCTOCRYLENE) CREAM [CLINIQUE LABS INC] 2 OCTISALATE ACTIVE MOIETY 4X49Y0596W CLINIQUE SPF 30 ADVANCED PROTECTION BODY CREAM WITH SOLAR SMART (OCTISALATE, HOMOSALATE, OXYBENZONE, AVOBENZONE, OCTOCRYLENE) CREAM [CLINIQUE LABS INC] 2 OCTOCRYLENE ACTIVE MOIETY 5A68WGF6WM CLINIQUE SPF 30 ADVANCED PROTECTION BODY CREAM WITH SOLAR SMART (OCTISALATE, HOMOSALATE, OXYBENZONE, AVOBENZONE, OCTOCRYLENE) CREAM [CLINIQUE LABS INC] 2 OXYBENZONE ACTIVE MOIETY 95OOS7VE0Y CLINIQUE SPF 30 ADVANCED PROTECTION BODY CREAM WITH SOLAR SMART (OCTISALATE, HOMOSALATE, OXYBENZONE, AVOBENZONE, OCTOCRYLENE) CREAM [CLINIQUE LABS INC] 2 BUTYLENE GLYCOL INACTIVE INGREDIENT 3XUS85K0RA CLINIQUE SPF 30 ADVANCED PROTECTION BODY CREAM WITH SOLAR SMART (OCTISALATE, HOMOSALATE, OXYBENZONE, AVOBENZONE, OCTOCRYLENE) CREAM [CLINIQUE LABS INC] 2 DIMETHICONE INACTIVE INGREDIENT 92RU3N3Y1O CLINIQUE SPF 30 ADVANCED PROTECTION BODY CREAM WITH SOLAR SMART (OCTISALATE, HOMOSALATE, OXYBENZONE, AVOBENZONE, OCTOCRYLENE) CREAM [CLINIQUE LABS INC] 2 GLYCERYL MONOSTEARATE INACTIVE INGREDIENT 230OU9XXE4 CLINIQUE SPF 30 ADVANCED PROTECTION BODY CREAM WITH SOLAR SMART (OCTISALATE, HOMOSALATE, OXYBENZONE, AVOBENZONE, OCTOCRYLENE) CREAM [CLINIQUE LABS INC] 2 LECITHIN, SOYBEAN INACTIVE INGREDIENT 1DI56QDM62 CLINIQUE SPF 30 ADVANCED PROTECTION BODY CREAM WITH SOLAR SMART (OCTISALATE, HOMOSALATE, OXYBENZONE, AVOBENZONE, OCTOCRYLENE) CREAM [CLINIQUE LABS INC] 2 METHYL TRIMETHICONE INACTIVE INGREDIENT S73ZQI0GXM CLINIQUE SPF 30 ADVANCED PROTECTION BODY CREAM WITH SOLAR SMART (OCTISALATE, HOMOSALATE, OXYBENZONE, AVOBENZONE, OCTOCRYLENE) CREAM [CLINIQUE LABS INC] 2 MICA INACTIVE INGREDIENT V8A1AW0880 CLINIQUE SPF 30 ADVANCED PROTECTION BODY CREAM WITH SOLAR SMART (OCTISALATE, HOMOSALATE, OXYBENZONE, AVOBENZONE, OCTOCRYLENE) CREAM [CLINIQUE LABS INC] 2 PHENOXYETHANOL INACTIVE INGREDIENT HIE492ZZ3T CLINIQUE SPF 30 ADVANCED PROTECTION BODY CREAM WITH SOLAR SMART (OCTISALATE, HOMOSALATE, OXYBENZONE, AVOBENZONE, OCTOCRYLENE) CREAM [CLINIQUE LABS INC] 2 SHEA BUTTER INACTIVE INGREDIENT K49155WL9Y CLINIQUE SPF 30 ADVANCED PROTECTION BODY CREAM WITH SOLAR SMART (OCTISALATE, HOMOSALATE, OXYBENZONE, AVOBENZONE, OCTOCRYLENE) CREAM [CLINIQUE LABS INC] 2 SILICON DIOXIDE INACTIVE INGREDIENT ETJ7Z6XBU4 CLINIQUE SPF 30 ADVANCED PROTECTION BODY CREAM WITH SOLAR SMART (OCTISALATE, HOMOSALATE, OXYBENZONE, AVOBENZONE, OCTOCRYLENE) CREAM [CLINIQUE LABS INC] 2 SUCROSE INACTIVE INGREDIENT C151H8M554 CLINIQUE SPF 30 ADVANCED PROTECTION BODY CREAM WITH SOLAR SMART (OCTISALATE, HOMOSALATE, OXYBENZONE, AVOBENZONE, OCTOCRYLENE) CREAM [CLINIQUE LABS INC] 2 WATER INACTIVE INGREDIENT 059QF0KO0R CLINIQUE SPF 30 ADVANCED PROTECTION BODY CREAM WITH SOLAR SMART (OCTISALATE, HOMOSALATE, OXYBENZONE, AVOBENZONE, OCTOCRYLENE) CREAM [CLINIQUE LABS INC] 2 XANTHAN GUM INACTIVE INGREDIENT TTV12P4NEE CLINIQUE SPF 30 ADVANCED PROTECTION BODY CREAM WITH SOLAR SMART (OCTISALATE, HOMOSALATE, OXYBENZONE, AVOBENZONE, OCTOCRYLENE) CREAM [CLINIQUE LABS INC] 2
DailyMed Dashboard NDC Coverage# NDC, Dashboard title, SPL version table NDC Dashboard title SPL version Validation Dashboard ZIP 49527-736 CLINIQUE SPF 30 ADVANCED PROTECTION BODY CREAM WITH SOLAR SMART (OCTISALATE, HOMOSALATE, OXYBENZONE, AVOBENZONE, OCTOCRYLENE) CREAM [CLINIQUE LABS INC] 2 Legacy NDC, 2 package rows 20110323_53bf57fd-a46f-4c73-aecc-c7fa4e90676b.zip
Packages# Package NDC, 11-digit format, Description table Package NDC 11-digit format Description Units Status 49527-736-01 49527073601 1 in 1 CARTON Historical 49527-736-02 49527073602 150 mL in 1 TUBE 150 ml Historical