Home NDC 68327-004 Mint Glaze FX
Product NDC 68327-004
11-digit product format 683270004
Labeler code 68327
Product ID 68327-004_bc82ac98-ca84-407d-98fc-af300754202e
Type HUMAN OTC DRUG
Nonproprietary name OCTINOXATE, OXYBENZONE
Dosage form OINTMENT
Route TOPICAL
Labeler Cover FX Skin Care, Inc.
Application part352
Marketing category OTC MONOGRAPH NOT FINAL
Marketing start 2010-04-09
Marketing end 0000-00-00
Substance OCTINOXATE; OXYBENZONE
Active strength 8 g/100mL; g/100mL
NDC exclude flag No
Listing certified through 2019-12-31
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 · 42 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 68327-004-01 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 68327-004-01 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 68327-004-01 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 68327-004-01 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 68327-004-01 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 68327-004-01 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 68327-004-01 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 68327-004-01 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 68327-004-01 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 68327-004-01 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 68327-004-01 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 68327-004-01 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 68327-004-01 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 68327-004-01 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 68327-004-01 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 68327-004-01 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 68327-004-01 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 68327-004-01 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 68327-004-01 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 68327-004-01 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 68327-004-01 9bebd1f3094a…5416666fcb17…
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 68327-004-01 Mint Glaze FX 3 mL in 1 VIAL OINTMENT 3 1
DailyMed Socrata Ingredients# Ingredient, Type, UNII table Ingredient Type UNII DailyMed label SPL version Uploaded OCTINOXATE ACTIVE INGREDIENT 4Y5P7MUD51 MINT GLAZE FX (OCTINOXATE, OXYBENZONE) OINTMENT [COVER FX SKIN CARE, INC.] 1 OXYBENZONE ACTIVE INGREDIENT 95OOS7VE0Y MINT GLAZE FX (OCTINOXATE, OXYBENZONE) OINTMENT [COVER FX SKIN CARE, INC.] 1 OCTINOXATE ACTIVE MOIETY 4Y5P7MUD51 MINT GLAZE FX (OCTINOXATE, OXYBENZONE) OINTMENT [COVER FX SKIN CARE, INC.] 1 OXYBENZONE ACTIVE MOIETY 95OOS7VE0Y MINT GLAZE FX (OCTINOXATE, OXYBENZONE) OINTMENT [COVER FX SKIN CARE, INC.] 1 ALPHA-TOCOPHEROL ACETATE INACTIVE INGREDIENT 9E8X80D2L0 MINT GLAZE FX (OCTINOXATE, OXYBENZONE) OINTMENT [COVER FX SKIN CARE, INC.] 1 BUTYLENE GLYCOL INACTIVE INGREDIENT 3XUS85K0RA MINT GLAZE FX (OCTINOXATE, OXYBENZONE) OINTMENT [COVER FX SKIN CARE, INC.] 1 C10-30 CHOLESTEROL/LANOSTEROL ESTERS INACTIVE INGREDIENT 137SL7IL0Y MINT GLAZE FX (OCTINOXATE, OXYBENZONE) OINTMENT [COVER FX SKIN CARE, INC.] 1 CAPRYLYL GLYCOL INACTIVE INGREDIENT 00YIU5438U MINT GLAZE FX (OCTINOXATE, OXYBENZONE) OINTMENT [COVER FX SKIN CARE, INC.] 1 CHOLESTERYL HYDROXYSTEARATE INACTIVE INGREDIENT O6K1LG6N4D MINT GLAZE FX (OCTINOXATE, OXYBENZONE) OINTMENT [COVER FX SKIN CARE, INC.] 1 COCHINEAL INACTIVE INGREDIENT TZ8Z31B35M MINT GLAZE FX (OCTINOXATE, OXYBENZONE) OINTMENT [COVER FX SKIN CARE, INC.] 1 CYCLOMETHICONE 5 INACTIVE INGREDIENT 0THT5PCI0R MINT GLAZE FX (OCTINOXATE, OXYBENZONE) OINTMENT [COVER FX SKIN CARE, INC.] 1 D&C RED NO. 27 INACTIVE INGREDIENT 2LRS185U6K MINT GLAZE FX (OCTINOXATE, OXYBENZONE) OINTMENT [COVER FX SKIN CARE, INC.] 1 D&C RED NO. 6 INACTIVE INGREDIENT 481744AI4O MINT GLAZE FX (OCTINOXATE, OXYBENZONE) OINTMENT [COVER FX SKIN CARE, INC.] 1 D&C RED NO. 7 INACTIVE INGREDIENT ECW0LZ41X8 MINT GLAZE FX (OCTINOXATE, OXYBENZONE) OINTMENT [COVER FX SKIN CARE, INC.] 1 DIPALMITOYL HYDROXYPROLINE INACTIVE INGREDIENT E6AHA53N1H MINT GLAZE FX (OCTINOXATE, OXYBENZONE) OINTMENT [COVER FX SKIN CARE, INC.] 1 ETHYLHEXYL PALMITATE INACTIVE INGREDIENT 2865993309 MINT GLAZE FX (OCTINOXATE, OXYBENZONE) OINTMENT [COVER FX SKIN CARE, INC.] 1 FD&C YELLOW NO. 5 INACTIVE INGREDIENT I753WB2F1M MINT GLAZE FX (OCTINOXATE, OXYBENZONE) OINTMENT [COVER FX SKIN CARE, INC.] 1 FERRIC OXIDE RED INACTIVE INGREDIENT 1K09F3G675 MINT GLAZE FX (OCTINOXATE, OXYBENZONE) OINTMENT [COVER FX SKIN CARE, INC.] 1 HEXYLENE GLYCOL INACTIVE INGREDIENT KEH0A3F75J MINT GLAZE FX (OCTINOXATE, OXYBENZONE) OINTMENT [COVER FX SKIN CARE, INC.] 1 HIGH DENSITY POLYETHYLENE INACTIVE INGREDIENT UG00KM4WR7 MINT GLAZE FX (OCTINOXATE, OXYBENZONE) OINTMENT [COVER FX SKIN CARE, INC.] 1 HYALURONATE SODIUM INACTIVE INGREDIENT YSE9PPT4TH MINT GLAZE FX (OCTINOXATE, OXYBENZONE) OINTMENT [COVER FX SKIN CARE, INC.] 1 HYDROGENATED POLYBUTENE (1300 MW) INACTIVE INGREDIENT 7D1YQ9Y5EZ MINT GLAZE FX (OCTINOXATE, OXYBENZONE) OINTMENT [COVER FX SKIN CARE, INC.] 1 LINOLEIC ACID INACTIVE INGREDIENT 9KJL21T0QJ MINT GLAZE FX (OCTINOXATE, OXYBENZONE) OINTMENT [COVER FX SKIN CARE, INC.] 1 LINOLENIC ACID INACTIVE INGREDIENT 0RBV727H71 MINT GLAZE FX (OCTINOXATE, OXYBENZONE) OINTMENT [COVER FX SKIN CARE, INC.] 1 MENTHA PIPERITA INACTIVE INGREDIENT 79M2M2UDA9 MINT GLAZE FX (OCTINOXATE, OXYBENZONE) OINTMENT [COVER FX SKIN CARE, INC.] 1 MICA INACTIVE INGREDIENT V8A1AW0880 MINT GLAZE FX (OCTINOXATE, OXYBENZONE) OINTMENT [COVER FX SKIN CARE, INC.] 1 PALMITOYL OLIGOPEPTIDE INACTIVE INGREDIENT HO4ZT5S86C MINT GLAZE FX (OCTINOXATE, OXYBENZONE) OINTMENT [COVER FX SKIN CARE, INC.] 1 PHENOXYETHANOL INACTIVE INGREDIENT HIE492ZZ3T MINT GLAZE FX (OCTINOXATE, OXYBENZONE) OINTMENT [COVER FX SKIN CARE, INC.] 1 SHEA BUTTER INACTIVE INGREDIENT K49155WL9Y MINT GLAZE FX (OCTINOXATE, OXYBENZONE) OINTMENT [COVER FX SKIN CARE, INC.] 1 SILICA DIMETHYL SILYLATE INACTIVE INGREDIENT EU2PSP0G0W MINT GLAZE FX (OCTINOXATE, OXYBENZONE) OINTMENT [COVER FX SKIN CARE, INC.] 1 SILICON DIOXIDE INACTIVE INGREDIENT ETJ7Z6XBU4 MINT GLAZE FX (OCTINOXATE, OXYBENZONE) OINTMENT [COVER FX SKIN CARE, INC.] 1 SORBITAN ISOSTEARATE INACTIVE INGREDIENT 01S2G2C1E4 MINT GLAZE FX (OCTINOXATE, OXYBENZONE) OINTMENT [COVER FX SKIN CARE, INC.] 1 STANNIC OXIDE INACTIVE INGREDIENT KM7N50LOS6 MINT GLAZE FX (OCTINOXATE, OXYBENZONE) OINTMENT [COVER FX SKIN CARE, INC.] 1 TETRAHEXYLDECYL ASCORBATE INACTIVE INGREDIENT 9LBV3F07AZ MINT GLAZE FX (OCTINOXATE, OXYBENZONE) OINTMENT [COVER FX SKIN CARE, INC.] 1 TITANIUM DIOXIDE INACTIVE INGREDIENT 15FIX9V2JP MINT GLAZE FX (OCTINOXATE, OXYBENZONE) OINTMENT [COVER FX SKIN CARE, INC.] 1 TRIBEHENIN INACTIVE INGREDIENT 8OC9U7TQZ0 MINT GLAZE FX (OCTINOXATE, OXYBENZONE) OINTMENT [COVER FX SKIN CARE, INC.] 1 TRIDECYL TRIMELLITATE INACTIVE INGREDIENT FY36J270ES MINT GLAZE FX (OCTINOXATE, OXYBENZONE) OINTMENT [COVER FX SKIN CARE, INC.] 1
DailyMed Dashboard NDC Coverage# NDC, Dashboard title, SPL version table NDC Dashboard title SPL version Validation Dashboard ZIP 68327-004 MINT GLAZE FX (OCTINOXATE, OXYBENZONE) OINTMENT [COVER FX SKIN CARE, INC.] 1 Legacy NDC, 1 package rows 20130220_4df1ea18-59e3-4e1b-b1c5-c7a0fa6a6b7e.zip
Packages# Package NDC, 11-digit format, Description table Package NDC 11-digit format Description Units Status 68327-004-01 68327000401 3 mL in 1 VIAL 3 ml Historical