Skin Tint FX

Product NDC
68327-003
11-digit product format
683270003
Labeler code
68327
Product ID
68327-003_d9d95792-6a64-4b61-9fe7-10ca55c7f0c4
Type
HUMAN OTC DRUG
Nonproprietary name
OCTINOXATE, OCTISALATE, OXYBENZONE, TITANIUM DIOXIDE, ZINC OXIDE
Dosage form
CREAM
Route
TOPICAL
Labeler
Cover FX Skin Care, Inc.
Application
part352
Marketing category
OTC MONOGRAPH NOT FINAL
Marketing start
2011-09-20
Marketing end
0000-00-00
Substance
OCTINOXATE; OCTISALATE; OXYBENZONE; TITANIUM DIOXIDE; ZINC OXIDE
Active strength
7 g/100mL; g/100mL; g/100mL; g/100mL; g/100mL
NDC exclude flag
No
Listing certified through
2019-12-31
Current FDA listing
Historical FDA.report record

NDC auxiliary status#

These records are reproduced from FDA’s unfinished, excluded, and compounder listings. They describe what appeared in the source files; a missing record does not establish a regulatory status. View all current auxiliary records, including entries without an NDC. · View the auxiliary file history.

Current NDC status page 1 of 1 · 2 matching rows.

Dataset, Scope, Product NDC table
DatasetScopeProduct NDCPackage NDCCodeStatusReporting periodSource date
excluded productproduct68327-003IInactivated by FDA2026-10-12
excluded packagepackage68327-00368327-003-01IInactivated by FDA2026-10-12

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 dateDatasetScopePackage NDCSnapshotSource SHA-256
2025-12-14 17:58 UTC · source 2025-12-05excluded productproductd630ba8d3edf…732f749b63fb…
2025-12-14 17:58 UTC · source 2025-12-05excluded packagepackage68327-003-01d630ba8d3edf…732f749b63fb…
2025-08-27 00:01 UTC · source 2025-08-26excluded productproductf5e01cc5f278…a2eaf40c39c3…
2025-08-27 00:01 UTC · source 2025-08-26excluded packagepackage68327-003-01f5e01cc5f278…a2eaf40c39c3…
2025-04-01 02:39 UTC · source 2025-03-31excluded productproduct2ef7874e63bc…57b86245f4fa…
2025-04-01 02:39 UTC · source 2025-03-31excluded packagepackage68327-003-012ef7874e63bc…57b86245f4fa…
2025-03-28 20:22 UTC · source 2025-03-28excluded productproducta1b67e2a42f9…c4cf2c586c0d…
2025-03-28 20:22 UTC · source 2025-03-28excluded packagepackage68327-003-01a1b67e2a42f9…c4cf2c586c0d…
2025-03-22 03:12 UTC · source 2025-03-21excluded productproductcfe11265f3b6…090c488252e2…
2025-03-22 03:12 UTC · source 2025-03-21excluded packagepackage68327-003-01cfe11265f3b6…090c488252e2…
2025-03-10 12:48 UTC · source 2025-03-10excluded productproductcdf11ea48f46…ba0047e9e063…
2025-03-10 12:48 UTC · source 2025-03-10excluded packagepackage68327-003-01cdf11ea48f46…ba0047e9e063…
2025-02-02 03:52 UTC · source 2025-01-31excluded productproduct302b2466d912…e7b80fea0513…
2025-02-02 03:52 UTC · source 2025-01-31excluded packagepackage68327-003-01302b2466d912…e7b80fea0513…
2025-01-20 13:05 UTC · source 2025-01-20excluded productproducted331223b511…672a5bd82f5f…
2025-01-20 13:05 UTC · source 2025-01-20excluded packagepackage68327-003-01ed331223b511…672a5bd82f5f…
2025-01-11 03:41 UTC · source 2025-01-10excluded productproduct0efc9e666f02…f202fb6c5f17…
2025-01-11 03:41 UTC · source 2025-01-10excluded packagepackage68327-003-010efc9e666f02…f202fb6c5f17…
2024-11-09 02:27 UTC · source 2024-11-08excluded productproductad56d346431e…cc804d4bbf1e…
2024-11-09 02:27 UTC · source 2024-11-08excluded packagepackage68327-003-01ad56d346431e…cc804d4bbf1e…
2024-10-04 04:10 UTC · source 2024-10-03excluded productproduct367a005e9d99…383a685ebd0f…
2024-10-04 04:10 UTC · source 2024-10-03excluded packagepackage68327-003-01367a005e9d99…383a685ebd0f…
2024-07-10 04:00 UTC · source 2024-07-09excluded productproduct557ba5c1ecfa…9c80585c8c6e…
2024-07-10 04:00 UTC · source 2024-07-09excluded packagepackage68327-003-01557ba5c1ecfa…9c80585c8c6e…
2024-05-28 21:12 UTC · source 2024-05-28excluded productproduct8af77b9d5b6f…d9bbb34c5368…
2024-05-28 21:12 UTC · source 2024-05-28excluded packagepackage68327-003-018af77b9d5b6f…d9bbb34c5368…
2024-05-15 03:39 UTC · source 2024-05-14excluded productproduct834df4deac94…adcc014656a3…
2024-05-15 03:39 UTC · source 2024-05-14excluded packagepackage68327-003-01834df4deac94…adcc014656a3…
2024-03-11 06:39 UTC · source 2024-03-08excluded productproduct1332a3947898…d4bfe170f9cd…
2024-03-11 06:39 UTC · source 2024-03-08excluded packagepackage68327-003-011332a3947898…d4bfe170f9cd…
2022-08-30 03:57 UTC · source 2022-08-29excluded productproductfb8cb913e6d1…eb8c232b6be0…
2022-08-30 03:57 UTC · source 2022-08-29excluded packagepackage68327-003-01fb8cb913e6d1…eb8c232b6be0…
2022-04-09 23:13 UTC · source 2022-04-08excluded productproduct86f5da6cb304…a595104c45d7…
2022-04-09 23:13 UTC · source 2022-04-08excluded packagepackage68327-003-0186f5da6cb304…a595104c45d7…
2022-04-04 05:40 UTC · source 2022-04-01excluded productproductbd6a592717d7…303034d00443…
2022-04-04 05:40 UTC · source 2022-04-01excluded packagepackage68327-003-01bd6a592717d7…303034d00443…
2021-12-27 23:28 UTC · source 2021-12-27excluded productproduct8dfbde2a14a4…c9ff85d89658…
2021-12-27 23:28 UTC · source 2021-12-27excluded packagepackage68327-003-018dfbde2a14a4…c9ff85d89658…
2020-12-18 03:04 UTC · source 2020-12-17excluded productproducte2bbac7714bc…27bdfed8d636…
2020-12-18 03:04 UTC · source 2020-12-17excluded packagepackage68327-003-01e2bbac7714bc…27bdfed8d636…
2020-06-10 20:45 UTC · source 2020-06-10excluded productproduct9bebd1f3094a…5416666fcb17…
2020-06-10 20:45 UTC · source 2020-06-10excluded packagepackage68327-003-019bebd1f3094a…5416666fcb17…

Reported adverse events (FAERS/openFDA)#

Adverse event summaries are temporarily unavailable. Other product information remains available.

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
c6f86816-7da6-43ea-8c25-ac9758311cc5Product name120220118
252e11b6-1a9a-4283-a242-df2c129c496dProduct name320170717
9869efd7-d6dd-0665-5b67-53adbe6ef15eProduct name120140508

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
68327-003-012020-01-31C16284748780-19d75b9d0-b407-f424-e053-dadaa90a57ce3bf327e1-becf-4981-bc79-d5403ba532ac

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
68327-003-01Skin Tint FX30 mL in 1 TUBECREAM301

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIIDailyMed labelSPL versionUploaded
OCTINOXATEACTIVE INGREDIENT4Y5P7MUD51SKIN TINT FX (OCTINOXATE, OCTISALATE, OXYBENZONE, TITANIUM DIOXIDE, ZINC OXIDE) CREAM [COVER FX SKIN CARE, INC.]1
OCTISALATEACTIVE INGREDIENT4X49Y0596WSKIN TINT FX (OCTINOXATE, OCTISALATE, OXYBENZONE, TITANIUM DIOXIDE, ZINC OXIDE) CREAM [COVER FX SKIN CARE, INC.]1
OXYBENZONEACTIVE INGREDIENT95OOS7VE0YSKIN TINT FX (OCTINOXATE, OCTISALATE, OXYBENZONE, TITANIUM DIOXIDE, ZINC OXIDE) CREAM [COVER FX SKIN CARE, INC.]1
TITANIUM DIOXIDEACTIVE INGREDIENT15FIX9V2JPSKIN TINT FX (OCTINOXATE, OCTISALATE, OXYBENZONE, TITANIUM DIOXIDE, ZINC OXIDE) CREAM [COVER FX SKIN CARE, INC.]1
ZINC OXIDEACTIVE INGREDIENTSOI2LOH54ZSKIN TINT FX (OCTINOXATE, OCTISALATE, OXYBENZONE, TITANIUM DIOXIDE, ZINC OXIDE) CREAM [COVER FX SKIN CARE, INC.]1
OCTINOXATEACTIVE MOIETY4Y5P7MUD51SKIN TINT FX (OCTINOXATE, OCTISALATE, OXYBENZONE, TITANIUM DIOXIDE, ZINC OXIDE) CREAM [COVER FX SKIN CARE, INC.]1
OCTISALATEACTIVE MOIETY4X49Y0596WSKIN TINT FX (OCTINOXATE, OCTISALATE, OXYBENZONE, TITANIUM DIOXIDE, ZINC OXIDE) CREAM [COVER FX SKIN CARE, INC.]1
OXYBENZONEACTIVE MOIETY95OOS7VE0YSKIN TINT FX (OCTINOXATE, OCTISALATE, OXYBENZONE, TITANIUM DIOXIDE, ZINC OXIDE) CREAM [COVER FX SKIN CARE, INC.]1
TITANIUM DIOXIDEACTIVE MOIETY15FIX9V2JPSKIN TINT FX (OCTINOXATE, OCTISALATE, OXYBENZONE, TITANIUM DIOXIDE, ZINC OXIDE) CREAM [COVER FX SKIN CARE, INC.]1
ZINC OXIDEACTIVE MOIETYSOI2LOH54ZSKIN TINT FX (OCTINOXATE, OCTISALATE, OXYBENZONE, TITANIUM DIOXIDE, ZINC OXIDE) CREAM [COVER FX SKIN CARE, INC.]1
.ALPHA.-TOCOPHEROL ACETATEINACTIVE INGREDIENT9E8X80D2L0SKIN TINT FX (OCTINOXATE, OCTISALATE, OXYBENZONE, TITANIUM DIOXIDE, ZINC OXIDE) CREAM [COVER FX SKIN CARE, INC.]1
ALKYL (C12-15) BENZOATEINACTIVE INGREDIENTA9EJ3J61HQSKIN TINT FX (OCTINOXATE, OCTISALATE, OXYBENZONE, TITANIUM DIOXIDE, ZINC OXIDE) CREAM [COVER FX SKIN CARE, INC.]1
ALUMINUM OXIDEINACTIVE INGREDIENTLMI26O6933SKIN TINT FX (OCTINOXATE, OCTISALATE, OXYBENZONE, TITANIUM DIOXIDE, ZINC OXIDE) CREAM [COVER FX SKIN CARE, INC.]1
BENZOIC ACIDINACTIVE INGREDIENT8SKN0B0MIMSKIN TINT FX (OCTINOXATE, OCTISALATE, OXYBENZONE, TITANIUM DIOXIDE, ZINC OXIDE) CREAM [COVER FX SKIN CARE, INC.]1
BENZYL ALCOHOLINACTIVE INGREDIENTLKG8494WBHSKIN TINT FX (OCTINOXATE, OCTISALATE, OXYBENZONE, TITANIUM DIOXIDE, ZINC OXIDE) CREAM [COVER FX SKIN CARE, INC.]1
BUTYLENE GLYCOLINACTIVE INGREDIENT3XUS85K0RASKIN TINT FX (OCTINOXATE, OCTISALATE, OXYBENZONE, TITANIUM DIOXIDE, ZINC OXIDE) CREAM [COVER FX SKIN CARE, INC.]1
CAPRYLYL GLYCOLINACTIVE INGREDIENT00YIU5438USKIN TINT FX (OCTINOXATE, OCTISALATE, OXYBENZONE, TITANIUM DIOXIDE, ZINC OXIDE) CREAM [COVER FX SKIN CARE, INC.]1
CERAMIDE 2INACTIVE INGREDIENTC04977SRJ5SKIN TINT FX (OCTINOXATE, OCTISALATE, OXYBENZONE, TITANIUM DIOXIDE, ZINC OXIDE) CREAM [COVER FX SKIN CARE, INC.]1
CETYL PEG/PPG-10/1 DIMETHICONE (HLB 5)INACTIVE INGREDIENT035JKJ76MTSKIN TINT FX (OCTINOXATE, OCTISALATE, OXYBENZONE, TITANIUM DIOXIDE, ZINC OXIDE) CREAM [COVER FX SKIN CARE, INC.]1
CHROMIC OXIDEINACTIVE INGREDIENTX5Z09SU859SKIN TINT FX (OCTINOXATE, OCTISALATE, OXYBENZONE, TITANIUM DIOXIDE, ZINC OXIDE) CREAM [COVER FX SKIN CARE, INC.]1
CYCLOMETHICONE 5INACTIVE INGREDIENT0THT5PCI0RSKIN TINT FX (OCTINOXATE, OCTISALATE, OXYBENZONE, TITANIUM DIOXIDE, ZINC OXIDE) CREAM [COVER FX SKIN CARE, INC.]1
DEHYDROACETIC ACIDINACTIVE INGREDIENT2KAG279R6RSKIN TINT FX (OCTINOXATE, OCTISALATE, OXYBENZONE, TITANIUM DIOXIDE, ZINC OXIDE) CREAM [COVER FX SKIN CARE, INC.]1
DIMETHICONE/DIENE DIMETHICONE CROSSPOLYMERINACTIVE INGREDIENTRSA9I561OKSKIN TINT FX (OCTINOXATE, OCTISALATE, OXYBENZONE, TITANIUM DIOXIDE, ZINC OXIDE) CREAM [COVER FX SKIN CARE, INC.]1
DIMETHICONE/VINYL DIMETHICONE CROSSPOLYMER (SOFT PARTICLE)INACTIVE INGREDIENT9E4CO0W6C5SKIN TINT FX (OCTINOXATE, OCTISALATE, OXYBENZONE, TITANIUM DIOXIDE, ZINC OXIDE) CREAM [COVER FX SKIN CARE, INC.]1
DIMETHICONOL (41 MPA.S)INACTIVE INGREDIENT343C7U75XWSKIN TINT FX (OCTINOXATE, OCTISALATE, OXYBENZONE, TITANIUM DIOXIDE, ZINC OXIDE) CREAM [COVER FX SKIN CARE, INC.]1
ETHYLHEXYL PALMITATEINACTIVE INGREDIENT2865993309SKIN TINT FX (OCTINOXATE, OCTISALATE, OXYBENZONE, TITANIUM DIOXIDE, ZINC OXIDE) CREAM [COVER FX SKIN CARE, INC.]1
FERRIC OXIDE REDINACTIVE INGREDIENT1K09F3G675SKIN TINT FX (OCTINOXATE, OCTISALATE, OXYBENZONE, TITANIUM DIOXIDE, ZINC OXIDE) CREAM [COVER FX SKIN CARE, INC.]1
FERRIC OXIDE YELLOWINACTIVE INGREDIENTEX438O2MRTSKIN TINT FX (OCTINOXATE, OCTISALATE, OXYBENZONE, TITANIUM DIOXIDE, ZINC OXIDE) CREAM [COVER FX SKIN CARE, INC.]1
FERROSOFERRIC OXIDEINACTIVE INGREDIENTXM0M87F357SKIN TINT FX (OCTINOXATE, OCTISALATE, OXYBENZONE, TITANIUM DIOXIDE, ZINC OXIDE) CREAM [COVER FX SKIN CARE, INC.]1
GLYCERININACTIVE INGREDIENTPDC6A3C0OXSKIN TINT FX (OCTINOXATE, OCTISALATE, OXYBENZONE, TITANIUM DIOXIDE, ZINC OXIDE) CREAM [COVER FX SKIN CARE, INC.]1
HEXYLENE GLYCOLINACTIVE INGREDIENTKEH0A3F75JSKIN TINT FX (OCTINOXATE, OCTISALATE, OXYBENZONE, TITANIUM DIOXIDE, ZINC OXIDE) CREAM [COVER FX SKIN CARE, INC.]1
HYALURONATE SODIUMINACTIVE INGREDIENTYSE9PPT4THSKIN TINT FX (OCTINOXATE, OCTISALATE, OXYBENZONE, TITANIUM DIOXIDE, ZINC OXIDE) CREAM [COVER FX SKIN CARE, INC.]1
LAVENDER OILINACTIVE INGREDIENTZBP1YXW0H8SKIN TINT FX (OCTINOXATE, OCTISALATE, OXYBENZONE, TITANIUM DIOXIDE, ZINC OXIDE) CREAM [COVER FX SKIN CARE, INC.]1
LEVOMENOLINACTIVE INGREDIENT24WE03BX2TSKIN TINT FX (OCTINOXATE, OCTISALATE, OXYBENZONE, TITANIUM DIOXIDE, ZINC OXIDE) CREAM [COVER FX SKIN CARE, INC.]1
LINOLEIC ACIDINACTIVE INGREDIENT9KJL21T0QJSKIN TINT FX (OCTINOXATE, OCTISALATE, OXYBENZONE, TITANIUM DIOXIDE, ZINC OXIDE) CREAM [COVER FX SKIN CARE, INC.]1
LINOLENIC ACIDINACTIVE INGREDIENT0RBV727H71SKIN TINT FX (OCTINOXATE, OCTISALATE, OXYBENZONE, TITANIUM DIOXIDE, ZINC OXIDE) CREAM [COVER FX SKIN CARE, INC.]1
MICAINACTIVE INGREDIENTV8A1AW0880SKIN TINT FX (OCTINOXATE, OCTISALATE, OXYBENZONE, TITANIUM DIOXIDE, ZINC OXIDE) CREAM [COVER FX SKIN CARE, INC.]1
PALMITOYL OLIGOPEPTIDEINACTIVE INGREDIENTHO4ZT5S86CSKIN TINT FX (OCTINOXATE, OCTISALATE, OXYBENZONE, TITANIUM DIOXIDE, ZINC OXIDE) CREAM [COVER FX SKIN CARE, INC.]1
PEG-10 RAPESEED STEROLINACTIVE INGREDIENT258O76T85MSKIN TINT FX (OCTINOXATE, OCTISALATE, OXYBENZONE, TITANIUM DIOXIDE, ZINC OXIDE) CREAM [COVER FX SKIN CARE, INC.]1
PEG/PPG-20/15 DIMETHICONEINACTIVE INGREDIENT06R6X77P9CSKIN TINT FX (OCTINOXATE, OCTISALATE, OXYBENZONE, TITANIUM DIOXIDE, ZINC OXIDE) CREAM [COVER FX SKIN CARE, INC.]1
PHENOXYETHANOLINACTIVE INGREDIENTHIE492ZZ3TSKIN TINT FX (OCTINOXATE, OCTISALATE, OXYBENZONE, TITANIUM DIOXIDE, ZINC OXIDE) CREAM [COVER FX SKIN CARE, INC.]1
SILICA DIMETHYL SILYLATEINACTIVE INGREDIENTEU2PSP0G0WSKIN TINT FX (OCTINOXATE, OCTISALATE, OXYBENZONE, TITANIUM DIOXIDE, ZINC OXIDE) CREAM [COVER FX SKIN CARE, INC.]1
SILICON DIOXIDEINACTIVE INGREDIENTETJ7Z6XBU4SKIN TINT FX (OCTINOXATE, OCTISALATE, OXYBENZONE, TITANIUM DIOXIDE, ZINC OXIDE) CREAM [COVER FX SKIN CARE, INC.]1
SORBIC ACIDINACTIVE INGREDIENTX045WJ989BSKIN TINT FX (OCTINOXATE, OCTISALATE, OXYBENZONE, TITANIUM DIOXIDE, ZINC OXIDE) CREAM [COVER FX SKIN CARE, INC.]1
SQUALANEINACTIVE INGREDIENTGW89575KF9SKIN TINT FX (OCTINOXATE, OCTISALATE, OXYBENZONE, TITANIUM DIOXIDE, ZINC OXIDE) CREAM [COVER FX SKIN CARE, INC.]1
TETRAHEXYLDECYL ASCORBATEINACTIVE INGREDIENT9LBV3F07AZSKIN TINT FX (OCTINOXATE, OCTISALATE, OXYBENZONE, TITANIUM DIOXIDE, ZINC OXIDE) CREAM [COVER FX SKIN CARE, INC.]1
TITANIUM DIOXIDEINACTIVE INGREDIENT15FIX9V2JPSKIN TINT FX (OCTINOXATE, OCTISALATE, OXYBENZONE, TITANIUM DIOXIDE, ZINC OXIDE) CREAM [COVER FX SKIN CARE, INC.]1
TRIBEHENININACTIVE INGREDIENT8OC9U7TQZ0SKIN TINT FX (OCTINOXATE, OCTISALATE, OXYBENZONE, TITANIUM DIOXIDE, ZINC OXIDE) CREAM [COVER FX SKIN CARE, INC.]1
TRIDECYL TRIMELLITATEINACTIVE INGREDIENTFY36J270ESSKIN TINT FX (OCTINOXATE, OCTISALATE, OXYBENZONE, TITANIUM DIOXIDE, ZINC OXIDE) CREAM [COVER FX SKIN CARE, INC.]1
TRIETHOXYCAPRYLYLSILANEINACTIVE INGREDIENTLDC331P08ESKIN TINT FX (OCTINOXATE, OCTISALATE, OXYBENZONE, TITANIUM DIOXIDE, ZINC OXIDE) CREAM [COVER FX SKIN CARE, INC.]1
VITAMIN A PALMITATEINACTIVE INGREDIENT1D1K0N0VVCSKIN TINT FX (OCTINOXATE, OCTISALATE, OXYBENZONE, TITANIUM DIOXIDE, ZINC OXIDE) CREAM [COVER FX SKIN CARE, INC.]1

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
68327-003SKIN TINT FX (OCTINOXATE, OCTISALATE, OXYBENZONE, TITANIUM DIOXIDE, ZINC OXIDE) CREAM [COVER FX SKIN CARE, INC.]1Legacy NDC, 1 package rows20130220_3bf327e1-becf-4981-bc79-d5403ba532ac.zip

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsStatus
68327-003-016832700030130 mL in 1 TUBE30 mlHistorical