Home NDC 76351-100 Tinted Moisturizer
Product NDC 76351-100
11-digit product format 763510100
Labeler code 76351
Product ID 76351-100_9fcf3934-4860-4dcb-99a4-bbcc5ae2c9ee
Type HUMAN OTC DRUG
Nonproprietary name Octinoxate, Octisalate and Titanium Dioxide
Dosage form CREAM
Route TOPICAL
Labeler Femme Couture International, Inc
Application part352
Marketing category OTC MONOGRAPH NOT FINAL
Marketing start 2011-10-26
Marketing end 0000-00-00
Substance OCTINOXATE; OCTISALATE; TITANIUM DIOXIDE
Active strength 3 g/51.03g; g/51.03g; g/51.03g
NDC exclude flag E
Listing certified through 2017-12-31
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 Snapshot Source SHA-256 2025-12-14 17:58 UTC · source 2025-12-05 excluded product product d630ba8d3edf…732f749b63fb…2025-12-14 17:58 UTC · source 2025-12-05 excluded package package 76351-100-01 d630ba8d3edf…732f749b63fb…2025-08-27 00:01 UTC · source 2025-08-26 excluded product product f5e01cc5f278…a2eaf40c39c3…2025-08-27 00:01 UTC · source 2025-08-26 excluded package package 76351-100-01 f5e01cc5f278…a2eaf40c39c3…2025-04-01 02:39 UTC · source 2025-03-31 excluded product product 2ef7874e63bc…57b86245f4fa…2025-04-01 02:39 UTC · source 2025-03-31 excluded package package 76351-100-01 2ef7874e63bc…57b86245f4fa…2025-03-28 20:22 UTC · source 2025-03-28 excluded product product a1b67e2a42f9…c4cf2c586c0d…2025-03-28 20:22 UTC · source 2025-03-28 excluded package package 76351-100-01 a1b67e2a42f9…c4cf2c586c0d…2025-03-22 03:12 UTC · source 2025-03-21 excluded product product cfe11265f3b6…090c488252e2…2025-03-22 03:12 UTC · source 2025-03-21 excluded package package 76351-100-01 cfe11265f3b6…090c488252e2…2025-03-10 12:48 UTC · source 2025-03-10 excluded product product cdf11ea48f46…ba0047e9e063…2025-03-10 12:48 UTC · source 2025-03-10 excluded package package 76351-100-01 cdf11ea48f46…ba0047e9e063…2025-02-02 03:52 UTC · source 2025-01-31 excluded product product 302b2466d912…e7b80fea0513…2025-02-02 03:52 UTC · source 2025-01-31 excluded package package 76351-100-01 302b2466d912…e7b80fea0513…2025-01-20 13:05 UTC · source 2025-01-20 excluded product product ed331223b511…672a5bd82f5f…2025-01-20 13:05 UTC · source 2025-01-20 excluded package package 76351-100-01 ed331223b511…672a5bd82f5f…2025-01-11 03:41 UTC · source 2025-01-10 excluded product product 0efc9e666f02…f202fb6c5f17…2025-01-11 03:41 UTC · source 2025-01-10 excluded package package 76351-100-01 0efc9e666f02…f202fb6c5f17…2024-11-09 02:27 UTC · source 2024-11-08 excluded product product ad56d346431e…cc804d4bbf1e…2024-11-09 02:27 UTC · source 2024-11-08 excluded package package 76351-100-01 ad56d346431e…cc804d4bbf1e…2024-10-04 04:10 UTC · source 2024-10-03 excluded product product 367a005e9d99…383a685ebd0f…2024-10-04 04:10 UTC · source 2024-10-03 excluded package package 76351-100-01 367a005e9d99…383a685ebd0f…2024-07-10 04:00 UTC · source 2024-07-09 excluded product product 557ba5c1ecfa…9c80585c8c6e…2024-07-10 04:00 UTC · source 2024-07-09 excluded package package 76351-100-01 557ba5c1ecfa…9c80585c8c6e…2024-05-28 21:12 UTC · source 2024-05-28 excluded product product 8af77b9d5b6f…d9bbb34c5368…2024-05-28 21:12 UTC · source 2024-05-28 excluded package package 76351-100-01 8af77b9d5b6f…d9bbb34c5368…2024-05-15 03:39 UTC · source 2024-05-14 excluded product product 834df4deac94…adcc014656a3…2024-05-15 03:39 UTC · source 2024-05-14 excluded package package 76351-100-01 834df4deac94…adcc014656a3…2024-03-11 06:39 UTC · source 2024-03-08 excluded product product 1332a3947898…d4bfe170f9cd…2024-03-11 06:39 UTC · source 2024-03-08 excluded package package 76351-100-01 1332a3947898…d4bfe170f9cd…2022-08-30 03:57 UTC · source 2022-08-29 excluded product product fb8cb913e6d1…eb8c232b6be0…2022-08-30 03:57 UTC · source 2022-08-29 excluded package package 76351-100-01 fb8cb913e6d1…eb8c232b6be0…2022-04-09 23:13 UTC · source 2022-04-08 excluded product product 86f5da6cb304…a595104c45d7…2022-04-09 23:13 UTC · source 2022-04-08 excluded package package 76351-100-01 86f5da6cb304…a595104c45d7…2022-04-04 05:40 UTC · source 2022-04-01 excluded product product bd6a592717d7…303034d00443…2022-04-04 05:40 UTC · source 2022-04-01 excluded package package 76351-100-01 bd6a592717d7…303034d00443…2021-12-27 23:28 UTC · source 2021-12-27 excluded product product 8dfbde2a14a4…c9ff85d89658…2021-12-27 23:28 UTC · source 2021-12-27 excluded package package 76351-100-01 8dfbde2a14a4…c9ff85d89658…2020-12-18 03:04 UTC · source 2020-12-17 excluded product product e2bbac7714bc…27bdfed8d636…2020-12-18 03:04 UTC · source 2020-12-17 excluded package package 76351-100-01 e2bbac7714bc…27bdfed8d636…2020-06-10 20:45 UTC · source 2020-06-10 excluded product product 9bebd1f3094a…5416666fcb17…2020-06-10 20:45 UTC · source 2020-06-10 excluded package package 76351-100-01 9bebd1f3094a…5416666fcb17…2019-12-08 06:16 UTC · source 2019-12-05 excluded product product 110d247fa046…a55b01930146…2019-12-08 06:16 UTC · source 2019-12-05 excluded package package 76351-100-01 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 76351-100-01 Tinted Moisturizer SPF-15 51.03 g in 1 TUBE CREAM 51.03 1
DailyMed Socrata Ingredients# Ingredient, Type, UNII table Ingredient Type UNII DailyMed label SPL version Uploaded Octinoxate ACTIVE INGREDIENT 4Y5P7MUD51 TINTED MOISTURIZER (OCTINOXATE, OCTISALATE AND TITANIUM DIOXIDE) CREAM [FEMME COUTURE INTERNATIONAL, INC] 1 Octisalate ACTIVE INGREDIENT 4X49Y0596W TINTED MOISTURIZER (OCTINOXATE, OCTISALATE AND TITANIUM DIOXIDE) CREAM [FEMME COUTURE INTERNATIONAL, INC] 1 Titanium Dioxide ACTIVE INGREDIENT 15FIX9V2JP TINTED MOISTURIZER (OCTINOXATE, OCTISALATE AND TITANIUM DIOXIDE) CREAM [FEMME COUTURE INTERNATIONAL, INC] 1 Octinoxate ACTIVE MOIETY 4Y5P7MUD51 TINTED MOISTURIZER (OCTINOXATE, OCTISALATE AND TITANIUM DIOXIDE) CREAM [FEMME COUTURE INTERNATIONAL, INC] 1 Octisalate ACTIVE MOIETY 4X49Y0596W TINTED MOISTURIZER (OCTINOXATE, OCTISALATE AND TITANIUM DIOXIDE) CREAM [FEMME COUTURE INTERNATIONAL, INC] 1 Titanium Dioxide ACTIVE MOIETY 15FIX9V2JP TINTED MOISTURIZER (OCTINOXATE, OCTISALATE AND TITANIUM DIOXIDE) CREAM [FEMME COUTURE INTERNATIONAL, INC] 1 .ALPHA.-TOCOPHEROL ACETATE, D- INACTIVE INGREDIENT A7E6112E4N TINTED MOISTURIZER (OCTINOXATE, OCTISALATE AND TITANIUM DIOXIDE) CREAM [FEMME COUTURE INTERNATIONAL, INC] 1 Brown Iron Oxide INACTIVE INGREDIENT 1N032N7MFO TINTED MOISTURIZER (OCTINOXATE, OCTISALATE AND TITANIUM DIOXIDE) CREAM [FEMME COUTURE INTERNATIONAL, INC] 1 Caprylyl Glycol INACTIVE INGREDIENT 00YIU5438U TINTED MOISTURIZER (OCTINOXATE, OCTISALATE AND TITANIUM DIOXIDE) CREAM [FEMME COUTURE INTERNATIONAL, INC] 1 Carbomer 934 INACTIVE INGREDIENT Z135WT9208 TINTED MOISTURIZER (OCTINOXATE, OCTISALATE AND TITANIUM DIOXIDE) CREAM [FEMME COUTURE INTERNATIONAL, INC] 1 Cetostearyl Alcohol INACTIVE INGREDIENT 2DMT128M1S TINTED MOISTURIZER (OCTINOXATE, OCTISALATE AND TITANIUM DIOXIDE) CREAM [FEMME COUTURE INTERNATIONAL, INC] 1 Dimethicone INACTIVE INGREDIENT 92RU3N3Y1O TINTED MOISTURIZER (OCTINOXATE, OCTISALATE AND TITANIUM DIOXIDE) CREAM [FEMME COUTURE INTERNATIONAL, INC] 1 EDETATE TRISODIUM INACTIVE INGREDIENT 420IP921MB TINTED MOISTURIZER (OCTINOXATE, OCTISALATE AND TITANIUM DIOXIDE) CREAM [FEMME COUTURE INTERNATIONAL, INC] 1 Ferric Oxide Red INACTIVE INGREDIENT 1K09F3G675 TINTED MOISTURIZER (OCTINOXATE, OCTISALATE AND TITANIUM DIOXIDE) CREAM [FEMME COUTURE INTERNATIONAL, INC] 1 Ferric Oxide Yellow INACTIVE INGREDIENT EX438O2MRT TINTED MOISTURIZER (OCTINOXATE, OCTISALATE AND TITANIUM DIOXIDE) CREAM [FEMME COUTURE INTERNATIONAL, INC] 1 Ferrosoferric Oxide INACTIVE INGREDIENT XM0M87F357 TINTED MOISTURIZER (OCTINOXATE, OCTISALATE AND TITANIUM DIOXIDE) CREAM [FEMME COUTURE INTERNATIONAL, INC] 1 Glycerin INACTIVE INGREDIENT PDC6A3C0OX TINTED MOISTURIZER (OCTINOXATE, OCTISALATE AND TITANIUM DIOXIDE) CREAM [FEMME COUTURE INTERNATIONAL, INC] 1 Hexyl Laurate INACTIVE INGREDIENT 4CG9F9W01Q TINTED MOISTURIZER (OCTINOXATE, OCTISALATE AND TITANIUM DIOXIDE) CREAM [FEMME COUTURE INTERNATIONAL, INC] 1 HYALURONATE SODIUM INACTIVE INGREDIENT YSE9PPT4TH TINTED MOISTURIZER (OCTINOXATE, OCTISALATE AND TITANIUM DIOXIDE) CREAM [FEMME COUTURE INTERNATIONAL, INC] 1 HYDROGENATED POLYBUTENE (370 MW) INACTIVE INGREDIENT V5H8103878 TINTED MOISTURIZER (OCTINOXATE, OCTISALATE AND TITANIUM DIOXIDE) CREAM [FEMME COUTURE INTERNATIONAL, INC] 1 Magnesium Aluminum Silicate INACTIVE INGREDIENT 6M3P64V0NC TINTED MOISTURIZER (OCTINOXATE, OCTISALATE AND TITANIUM DIOXIDE) CREAM [FEMME COUTURE INTERNATIONAL, INC] 1 Mica INACTIVE INGREDIENT V8A1AW0880 TINTED MOISTURIZER (OCTINOXATE, OCTISALATE AND TITANIUM DIOXIDE) CREAM [FEMME COUTURE INTERNATIONAL, INC] 1 Phenoxyethanol INACTIVE INGREDIENT HIE492ZZ3T TINTED MOISTURIZER (OCTINOXATE, OCTISALATE AND TITANIUM DIOXIDE) CREAM [FEMME COUTURE INTERNATIONAL, INC] 1 Polyglyceryl-4 Isostearate INACTIVE INGREDIENT 820DPX33S7 TINTED MOISTURIZER (OCTINOXATE, OCTISALATE AND TITANIUM DIOXIDE) CREAM [FEMME COUTURE INTERNATIONAL, INC] 1 SIMMONDSIA CHINENSIS SEED WAX INACTIVE INGREDIENT 47X6Y9FJJ2 TINTED MOISTURIZER (OCTINOXATE, OCTISALATE AND TITANIUM DIOXIDE) CREAM [FEMME COUTURE INTERNATIONAL, INC] 1 SODIUM STEAROYL LACTYLATE INACTIVE INGREDIENT IN99IT31LN TINTED MOISTURIZER (OCTINOXATE, OCTISALATE AND TITANIUM DIOXIDE) CREAM [FEMME COUTURE INTERNATIONAL, INC] 1 Sorbic Acid INACTIVE INGREDIENT X045WJ989B TINTED MOISTURIZER (OCTINOXATE, OCTISALATE AND TITANIUM DIOXIDE) CREAM [FEMME COUTURE INTERNATIONAL, INC] 1 Squalane INACTIVE INGREDIENT GW89575KF9 TINTED MOISTURIZER (OCTINOXATE, OCTISALATE AND TITANIUM DIOXIDE) CREAM [FEMME COUTURE INTERNATIONAL, INC] 1 Titanium Dioxide INACTIVE INGREDIENT 15FIX9V2JP TINTED MOISTURIZER (OCTINOXATE, OCTISALATE AND TITANIUM DIOXIDE) CREAM [FEMME COUTURE INTERNATIONAL, INC] 1 Trolamine INACTIVE INGREDIENT 9O3K93S3TK TINTED MOISTURIZER (OCTINOXATE, OCTISALATE AND TITANIUM DIOXIDE) CREAM [FEMME COUTURE INTERNATIONAL, INC] 1 Water INACTIVE INGREDIENT 059QF0KO0R TINTED MOISTURIZER (OCTINOXATE, OCTISALATE AND TITANIUM DIOXIDE) CREAM [FEMME COUTURE INTERNATIONAL, INC] 1
DailyMed Dashboard NDC Coverage# NDC, Dashboard title, SPL version table NDC Dashboard title SPL version Validation Dashboard ZIP 76351-100 TINTED MOISTURIZER (OCTINOXATE, OCTISALATE AND TITANIUM DIOXIDE) CREAM [FEMME COUTURE INTERNATIONAL, INC] 1 Legacy NDC, 1 package rows 20111026_2ece9e34-4ca1-41d5-9c48-306ba9388643.zip
Packages# Package NDC, 11-digit format, Description table Package NDC 11-digit format Description Units Status 76351-100-01 76351010001 51.03 g in 1 TUBE 51.03 g Historical