Home NDC 68990-001 SYS
Product NDC 68990-001
11-digit product format 689900001
Labeler code 68990
Product ID 68990-001_af1ae44b-daee-435f-92f3-fc332e54f383
Type HUMAN OTC DRUG
Nonproprietary name Octinoxate, Titanium Dioxide
Dosage form LOTION
Route TOPICAL
Labeler AdvoCare International L.P.
Application part352
Marketing category OTC MONOGRAPH FINAL
Marketing start 2014-06-01
Marketing end 0000-00-00
Substance OCTINOXATE; TITANIUM DIOXIDE
Active strength 4 g/50mL; g/50mL
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 68990-001-01 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 68990-001-01 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 68990-001-01 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 68990-001-01 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 68990-001-01 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 68990-001-01 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 68990-001-01 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 68990-001-01 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 68990-001-01 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 68990-001-01 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 68990-001-01 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 68990-001-01 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 68990-001-01 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 68990-001-01 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 68990-001-01 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 68990-001-01 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 68990-001-01 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 68990-001-01 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 68990-001-01 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 68990-001-01 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 68990-001-01 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 68990-001-01 110d247fa046…a55b01930146…
Reported adverse events (FAERS/openFDA)# Adverse event summaries are temporarily unavailable. Other product information remains available.
DailyMed Product Concepts# FDA-Initiated Inactive NDC Indexing# DailyMed Package Descriptions# Package NDC, Product, Description table Package NDC Product Description Form Quantity Strength SPL version 68990-001-01 SYS 50 mL in 1 BOTTLE LOTION 50 1
DailyMed Socrata Ingredients# Ingredient, Type, UNII table Ingredient Type UNII DailyMed label SPL version Uploaded OCTINOXATE ACTIVE INGREDIENT 4Y5P7MUD51 SYS (OCTINOXATE, TITANIUM DIOXIDE) LOTION [ADVOCARE INTERNATIONAL L.P.] 1 TITANIUM DIOXIDE ACTIVE INGREDIENT 15FIX9V2JP SYS (OCTINOXATE, TITANIUM DIOXIDE) LOTION [ADVOCARE INTERNATIONAL L.P.] 1 OCTINOXATE ACTIVE MOIETY 4Y5P7MUD51 SYS (OCTINOXATE, TITANIUM DIOXIDE) LOTION [ADVOCARE INTERNATIONAL L.P.] 1 TITANIUM DIOXIDE ACTIVE MOIETY 15FIX9V2JP SYS (OCTINOXATE, TITANIUM DIOXIDE) LOTION [ADVOCARE INTERNATIONAL L.P.] 1 1,2-HEXANEDIOL INACTIVE INGREDIENT TR046Y3K1G SYS (OCTINOXATE, TITANIUM DIOXIDE) LOTION [ADVOCARE INTERNATIONAL L.P.] 1 4-HYDROXY ACETOPHENONE INACTIVE INGREDIENT G1L3HT4CMH SYS (OCTINOXATE, TITANIUM DIOXIDE) LOTION [ADVOCARE INTERNATIONAL L.P.] 1 ALOE VERA LEAF INACTIVE INGREDIENT ZY81Z83H0X SYS (OCTINOXATE, TITANIUM DIOXIDE) LOTION [ADVOCARE INTERNATIONAL L.P.] 1 ALUMINUM HYDROXIDE INACTIVE INGREDIENT 5QB0T2IUN0 SYS (OCTINOXATE, TITANIUM DIOXIDE) LOTION [ADVOCARE INTERNATIONAL L.P.] 1 ASCORBIC ACID INACTIVE INGREDIENT PQ6CK8PD0R SYS (OCTINOXATE, TITANIUM DIOXIDE) LOTION [ADVOCARE INTERNATIONAL L.P.] 1 CAPRYLYL GLYCOL INACTIVE INGREDIENT 00YIU5438U SYS (OCTINOXATE, TITANIUM DIOXIDE) LOTION [ADVOCARE INTERNATIONAL L.P.] 1 CETYL ALCOHOL INACTIVE INGREDIENT 936JST6JCN SYS (OCTINOXATE, TITANIUM DIOXIDE) LOTION [ADVOCARE INTERNATIONAL L.P.] 1 CETYL ETHYLHEXANOATE INACTIVE INGREDIENT 134647WMX4 SYS (OCTINOXATE, TITANIUM DIOXIDE) LOTION [ADVOCARE INTERNATIONAL L.P.] 1 CYCLOMETHICONE 5 INACTIVE INGREDIENT 0THT5PCI0R SYS (OCTINOXATE, TITANIUM DIOXIDE) LOTION [ADVOCARE INTERNATIONAL L.P.] 1 DIMETHICONE INACTIVE INGREDIENT 92RU3N3Y1O SYS (OCTINOXATE, TITANIUM DIOXIDE) LOTION [ADVOCARE INTERNATIONAL L.P.] 1 EDETATE DISODIUM INACTIVE INGREDIENT 7FLD91C86K SYS (OCTINOXATE, TITANIUM DIOXIDE) LOTION [ADVOCARE INTERNATIONAL L.P.] 1 ERGOCALCIFEROL INACTIVE INGREDIENT VS041H42XC SYS (OCTINOXATE, TITANIUM DIOXIDE) LOTION [ADVOCARE INTERNATIONAL L.P.] 1 GLYCERIN INACTIVE INGREDIENT PDC6A3C0OX SYS (OCTINOXATE, TITANIUM DIOXIDE) LOTION [ADVOCARE INTERNATIONAL L.P.] 1 GREEN TEA LEAF INACTIVE INGREDIENT W2ZU1RY8B0 SYS (OCTINOXATE, TITANIUM DIOXIDE) LOTION [ADVOCARE INTERNATIONAL L.P.] 1 HYALURONATE SODIUM INACTIVE INGREDIENT YSE9PPT4TH SYS (OCTINOXATE, TITANIUM DIOXIDE) LOTION [ADVOCARE INTERNATIONAL L.P.] 1 ICODEXTRIN INACTIVE INGREDIENT 2NX48Z0A9G SYS (OCTINOXATE, TITANIUM DIOXIDE) LOTION [ADVOCARE INTERNATIONAL L.P.] 1 ISOHEXADECANE INACTIVE INGREDIENT 918X1OUF1E SYS (OCTINOXATE, TITANIUM DIOXIDE) LOTION [ADVOCARE INTERNATIONAL L.P.] 1 LINOLEIC ACID INACTIVE INGREDIENT 9KJL21T0QJ SYS (OCTINOXATE, TITANIUM DIOXIDE) LOTION [ADVOCARE INTERNATIONAL L.P.] 1 LINOLENIC ACID INACTIVE INGREDIENT 0RBV727H71 SYS (OCTINOXATE, TITANIUM DIOXIDE) LOTION [ADVOCARE INTERNATIONAL L.P.] 1 NYLON-12 INACTIVE INGREDIENT 446U8J075B SYS (OCTINOXATE, TITANIUM DIOXIDE) LOTION [ADVOCARE INTERNATIONAL L.P.] 1 PALMITOYL TRIPEPTIDE-5 INACTIVE INGREDIENT 2A3916MQHO SYS (OCTINOXATE, TITANIUM DIOXIDE) LOTION [ADVOCARE INTERNATIONAL L.P.] 1 POLYSORBATE 80 INACTIVE INGREDIENT 6OZP39ZG8H SYS (OCTINOXATE, TITANIUM DIOXIDE) LOTION [ADVOCARE INTERNATIONAL L.P.] 1 POTASSIUM SORBATE INACTIVE INGREDIENT 1VPU26JZZ4 SYS (OCTINOXATE, TITANIUM DIOXIDE) LOTION [ADVOCARE INTERNATIONAL L.P.] 1 SODIUM ACRYLATE/SODIUM ACRYLOYLDIMETHYLTAURATE COPOLYMER (4000000 MW) INACTIVE INGREDIENT 1DXE3F3OZX SYS (OCTINOXATE, TITANIUM DIOXIDE) LOTION [ADVOCARE INTERNATIONAL L.P.] 1 SODIUM BENZOATE INACTIVE INGREDIENT OJ245FE5EU SYS (OCTINOXATE, TITANIUM DIOXIDE) LOTION [ADVOCARE INTERNATIONAL L.P.] 1 SODIUM HYDROXIDE INACTIVE INGREDIENT 55X04QC32I SYS (OCTINOXATE, TITANIUM DIOXIDE) LOTION [ADVOCARE INTERNATIONAL L.P.] 1 SOYBEAN INACTIVE INGREDIENT L7HT8F1ZOD SYS (OCTINOXATE, TITANIUM DIOXIDE) LOTION [ADVOCARE INTERNATIONAL L.P.] 1 SOYBEAN OIL INACTIVE INGREDIENT 241ATL177A SYS (OCTINOXATE, TITANIUM DIOXIDE) LOTION [ADVOCARE INTERNATIONAL L.P.] 1 SQUALANE INACTIVE INGREDIENT GW89575KF9 SYS (OCTINOXATE, TITANIUM DIOXIDE) LOTION [ADVOCARE INTERNATIONAL L.P.] 1 STEARIC ACID INACTIVE INGREDIENT 4ELV7Z65AP SYS (OCTINOXATE, TITANIUM DIOXIDE) LOTION [ADVOCARE INTERNATIONAL L.P.] 1 TOCOPHEROL INACTIVE INGREDIENT R0ZB2556P8 SYS (OCTINOXATE, TITANIUM DIOXIDE) LOTION [ADVOCARE INTERNATIONAL L.P.] 1 TRIBEHENIN PEG-20 ESTERS INACTIVE INGREDIENT 84K9EH29Y9 SYS (OCTINOXATE, TITANIUM DIOXIDE) LOTION [ADVOCARE INTERNATIONAL L.P.] 1 VITIS VINIFERA SEED INACTIVE INGREDIENT C34U15ICXA SYS (OCTINOXATE, TITANIUM DIOXIDE) LOTION [ADVOCARE INTERNATIONAL L.P.] 1 WATER INACTIVE INGREDIENT 059QF0KO0R SYS (OCTINOXATE, TITANIUM DIOXIDE) LOTION [ADVOCARE INTERNATIONAL L.P.] 1 XANTHAN GUM INACTIVE INGREDIENT TTV12P4NEE SYS (OCTINOXATE, TITANIUM DIOXIDE) LOTION [ADVOCARE INTERNATIONAL L.P.] 1
DailyMed Dashboard NDC Coverage# NDC, Dashboard title, SPL version table NDC Dashboard title SPL version Validation Dashboard ZIP 68990-001 SYS (OCTINOXATE, TITANIUM DIOXIDE) LOTION [ADVOCARE INTERNATIONAL L.P.] 1 Legacy NDC, 1 package rows 20140702_dfc6b304-6786-436d-8760-a8222cd807cd.zip
Packages# Package NDC, 11-digit format, Description table Package NDC 11-digit format Description Units Status 68990-001-01 68990000101 50 mL in 1 BOTTLE 50 ml Historical