Home NDC 49527-008 DERMA WHITE
Product NDC 49527-008
11-digit product format 495270008
Labeler code 49527
Product ID 49527-008_ff0d1114-24c2-4367-a60d-b1e144649925
Type HUMAN OTC DRUG
Nonproprietary name OCTINOXATE, TITANIUM DIOXIDE, OCTISALATE
Dosage form CREAM
Route TOPICAL
Labeler CLINIQUE LABS INC
Application part352
Marketing category OTC MONOGRAPH NOT FINAL
Marketing start 2010-10-01
Marketing end 0000-00-00
Substance OCTINOXATE; TITANIUM DIOXIDE; OCTISALATE
Active strength 8 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 49527-008-01 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 49527-008-01 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 49527-008-01 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 49527-008-01 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 49527-008-01 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 49527-008-01 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 49527-008-01 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 49527-008-01 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 49527-008-01 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 49527-008-01 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 49527-008-01 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 49527-008-01 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 49527-008-01 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 49527-008-01 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 49527-008-01 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 49527-008-01 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 49527-008-01 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 49527-008-01 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 49527-008-01 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 49527-008-01 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 49527-008-01 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 49527-008-01 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 49527-008-01 DERMA WHITECITY BLOCK ANTI-POLLUTION SPF40 1 in 1 CARTON CREAM 1 1 49527-008-02 DERMA WHITECITY BLOCK ANTI-POLLUTION SPF40 30 mL in 1 TUBE CREAM 30 1
DailyMed Socrata Ingredients# Ingredient, Type, UNII table Ingredient Type UNII DailyMed label SPL version Uploaded OCTINOXATE ACTIVE INGREDIENT 4Y5P7MUD51 DERMA WHITE CITY BLOCK ANTI-POLLUTION SPF40 (OCTINOXATE, TITANIUM DIOXIDE, OCTISALATE) CREAM [CLINIQUE LABS INC] 1 OCTISALATE ACTIVE INGREDIENT 4X49Y0596W DERMA WHITE CITY BLOCK ANTI-POLLUTION SPF40 (OCTINOXATE, TITANIUM DIOXIDE, OCTISALATE) CREAM [CLINIQUE LABS INC] 1 TITANIUM DIOXIDE ACTIVE INGREDIENT 15FIX9V2JP DERMA WHITE CITY BLOCK ANTI-POLLUTION SPF40 (OCTINOXATE, TITANIUM DIOXIDE, OCTISALATE) CREAM [CLINIQUE LABS INC] 1 OCTINOXATE ACTIVE MOIETY 4Y5P7MUD51 DERMA WHITE CITY BLOCK ANTI-POLLUTION SPF40 (OCTINOXATE, TITANIUM DIOXIDE, OCTISALATE) CREAM [CLINIQUE LABS INC] 1 OCTISALATE ACTIVE MOIETY 4X49Y0596W DERMA WHITE CITY BLOCK ANTI-POLLUTION SPF40 (OCTINOXATE, TITANIUM DIOXIDE, OCTISALATE) CREAM [CLINIQUE LABS INC] 1 TITANIUM DIOXIDE ACTIVE MOIETY 15FIX9V2JP DERMA WHITE CITY BLOCK ANTI-POLLUTION SPF40 (OCTINOXATE, TITANIUM DIOXIDE, OCTISALATE) CREAM [CLINIQUE LABS INC] 1 .ALPHA.-TOCOPHEROL ACETATE, DL- INACTIVE INGREDIENT WR1WPI7EW8 DERMA WHITE CITY BLOCK ANTI-POLLUTION SPF40 (OCTINOXATE, TITANIUM DIOXIDE, OCTISALATE) CREAM [CLINIQUE LABS INC] 1 BUTYLENE GLYCOL INACTIVE INGREDIENT 3XUS85K0RA DERMA WHITE CITY BLOCK ANTI-POLLUTION SPF40 (OCTINOXATE, TITANIUM DIOXIDE, OCTISALATE) CREAM [CLINIQUE LABS INC] 1 CETYL ALCOHOL INACTIVE INGREDIENT 936JST6JCN DERMA WHITE CITY BLOCK ANTI-POLLUTION SPF40 (OCTINOXATE, TITANIUM DIOXIDE, OCTISALATE) CREAM [CLINIQUE LABS INC] 1 CHAMAEMELUM NOBILE INACTIVE INGREDIENT 7NF3GE7IWR DERMA WHITE CITY BLOCK ANTI-POLLUTION SPF40 (OCTINOXATE, TITANIUM DIOXIDE, OCTISALATE) CREAM [CLINIQUE LABS INC] 1 HIGH DENSITY POLYETHYLENE INACTIVE INGREDIENT UG00KM4WR7 DERMA WHITE CITY BLOCK ANTI-POLLUTION SPF40 (OCTINOXATE, TITANIUM DIOXIDE, OCTISALATE) CREAM [CLINIQUE LABS INC] 1 LECITHIN, SOYBEAN INACTIVE INGREDIENT 1DI56QDM62 DERMA WHITE CITY BLOCK ANTI-POLLUTION SPF40 (OCTINOXATE, TITANIUM DIOXIDE, OCTISALATE) CREAM [CLINIQUE LABS INC] 1 POLYSORBATE 20 INACTIVE INGREDIENT 7T1F30V5YH DERMA WHITE CITY BLOCK ANTI-POLLUTION SPF40 (OCTINOXATE, TITANIUM DIOXIDE, OCTISALATE) CREAM [CLINIQUE LABS INC] 1 SQUALANE INACTIVE INGREDIENT GW89575KF9 DERMA WHITE CITY BLOCK ANTI-POLLUTION SPF40 (OCTINOXATE, TITANIUM DIOXIDE, OCTISALATE) CREAM [CLINIQUE LABS INC] 1 WATER INACTIVE INGREDIENT 059QF0KO0R DERMA WHITE CITY BLOCK ANTI-POLLUTION SPF40 (OCTINOXATE, TITANIUM DIOXIDE, OCTISALATE) CREAM [CLINIQUE LABS INC] 1
DailyMed Dashboard NDC Coverage# NDC, Dashboard title, SPL version table NDC Dashboard title SPL version Validation Dashboard ZIP 49527-008 DERMA WHITE CITY BLOCK ANTI-POLLUTION SPF40 (OCTINOXATE, TITANIUM DIOXIDE, OCTISALATE) CREAM [CLINIQUE LABS INC] 1 Legacy NDC, 2 package rows 20110214_97ceb066-d93a-4be7-90ec-6f82965501b3.zip
Packages# Package NDC, 11-digit format, Description table Package NDC 11-digit format Description Units Status 49527-008-01 49527000801 1 in 1 CARTON Historical 49527-008-02 49527000802 30 mL in 1 TUBE 30 ml Historical