Natural FX

Product NDC
68327-002
11-digit product format
683270002
Labeler code
68327
Product ID
68327-002_45f8e99c-9a20-44ad-bf4b-1cd53d0fb2e5
Type
HUMAN OTC DRUG
Nonproprietary name
OCTINOXATE, OCTOCRYLENE, OXYBENZONE
Dosage form
CREAM
Route
TOPICAL
Labeler
Cover FX Skin Care, Inc.
Application
part352
Marketing category
OTC MONOGRAPH NOT FINAL
Marketing start
2012-08-01
Marketing end
0000-00-00
Substance
OCTINOXATE; OCTOCRYLENE; OXYBENZONE
Active strength
3 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 productproduct68327-002IInactivated by FDA2026-10-20
excluded packagepackage68327-00268327-002-01IInactivated by FDA2026-10-20

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 packagepackage68327-002-01d630ba8d3edf…732f749b63fb…
2025-08-27 00:01 UTC · source 2025-08-26excluded productproductf5e01cc5f278…a2eaf40c39c3…
2025-08-27 00:01 UTC · source 2025-08-26excluded packagepackage68327-002-01f5e01cc5f278…a2eaf40c39c3…
2025-04-01 02:39 UTC · source 2025-03-31excluded productproduct2ef7874e63bc…57b86245f4fa…
2025-04-01 02:39 UTC · source 2025-03-31excluded packagepackage68327-002-012ef7874e63bc…57b86245f4fa…
2025-03-28 20:22 UTC · source 2025-03-28excluded productproducta1b67e2a42f9…c4cf2c586c0d…
2025-03-28 20:22 UTC · source 2025-03-28excluded packagepackage68327-002-01a1b67e2a42f9…c4cf2c586c0d…
2025-03-22 03:12 UTC · source 2025-03-21excluded productproductcfe11265f3b6…090c488252e2…
2025-03-22 03:12 UTC · source 2025-03-21excluded packagepackage68327-002-01cfe11265f3b6…090c488252e2…
2025-03-10 12:48 UTC · source 2025-03-10excluded productproductcdf11ea48f46…ba0047e9e063…
2025-03-10 12:48 UTC · source 2025-03-10excluded packagepackage68327-002-01cdf11ea48f46…ba0047e9e063…
2025-02-02 03:52 UTC · source 2025-01-31excluded productproduct302b2466d912…e7b80fea0513…
2025-02-02 03:52 UTC · source 2025-01-31excluded packagepackage68327-002-01302b2466d912…e7b80fea0513…
2025-01-20 13:05 UTC · source 2025-01-20excluded productproducted331223b511…672a5bd82f5f…
2025-01-20 13:05 UTC · source 2025-01-20excluded packagepackage68327-002-01ed331223b511…672a5bd82f5f…
2025-01-11 03:41 UTC · source 2025-01-10excluded productproduct0efc9e666f02…f202fb6c5f17…
2025-01-11 03:41 UTC · source 2025-01-10excluded packagepackage68327-002-010efc9e666f02…f202fb6c5f17…
2024-11-09 02:27 UTC · source 2024-11-08excluded productproductad56d346431e…cc804d4bbf1e…
2024-11-09 02:27 UTC · source 2024-11-08excluded packagepackage68327-002-01ad56d346431e…cc804d4bbf1e…
2024-10-04 04:10 UTC · source 2024-10-03excluded productproduct367a005e9d99…383a685ebd0f…
2024-10-04 04:10 UTC · source 2024-10-03excluded packagepackage68327-002-01367a005e9d99…383a685ebd0f…
2024-07-10 04:00 UTC · source 2024-07-09excluded productproduct557ba5c1ecfa…9c80585c8c6e…
2024-07-10 04:00 UTC · source 2024-07-09excluded packagepackage68327-002-01557ba5c1ecfa…9c80585c8c6e…
2024-05-28 21:12 UTC · source 2024-05-28excluded productproduct8af77b9d5b6f…d9bbb34c5368…
2024-05-28 21:12 UTC · source 2024-05-28excluded packagepackage68327-002-018af77b9d5b6f…d9bbb34c5368…
2024-05-15 03:39 UTC · source 2024-05-14excluded productproduct834df4deac94…adcc014656a3…
2024-05-15 03:39 UTC · source 2024-05-14excluded packagepackage68327-002-01834df4deac94…adcc014656a3…
2024-03-11 06:39 UTC · source 2024-03-08excluded productproduct1332a3947898…d4bfe170f9cd…
2024-03-11 06:39 UTC · source 2024-03-08excluded packagepackage68327-002-011332a3947898…d4bfe170f9cd…
2022-08-30 03:57 UTC · source 2022-08-29excluded productproductfb8cb913e6d1…eb8c232b6be0…
2022-08-30 03:57 UTC · source 2022-08-29excluded packagepackage68327-002-01fb8cb913e6d1…eb8c232b6be0…
2022-04-09 23:13 UTC · source 2022-04-08excluded productproduct86f5da6cb304…a595104c45d7…
2022-04-09 23:13 UTC · source 2022-04-08excluded packagepackage68327-002-0186f5da6cb304…a595104c45d7…
2022-04-04 05:40 UTC · source 2022-04-01excluded productproductbd6a592717d7…303034d00443…
2022-04-04 05:40 UTC · source 2022-04-01excluded packagepackage68327-002-01bd6a592717d7…303034d00443…
2021-12-27 23:28 UTC · source 2021-12-27excluded productproduct8dfbde2a14a4…c9ff85d89658…
2021-12-27 23:28 UTC · source 2021-12-27excluded packagepackage68327-002-018dfbde2a14a4…c9ff85d89658…
2020-12-18 03:04 UTC · source 2020-12-17excluded productproducte2bbac7714bc…27bdfed8d636…
2020-12-18 03:04 UTC · source 2020-12-17excluded packagepackage68327-002-01e2bbac7714bc…27bdfed8d636…
2020-06-10 20:45 UTC · source 2020-06-10excluded productproduct9bebd1f3094a…5416666fcb17…
2020-06-10 20:45 UTC · source 2020-06-10excluded packagepackage68327-002-019bebd1f3094a…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

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
68327-002-012020-01-31C16284748780-19d75b9d0-885a-f424-e053-dadaa90a57ce91070828-a997-4fdb-9829-a71186a4f778

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
68327-002-01Natural FX30 mL in 1 TUBECREAM301

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIIDailyMed labelSPL versionUploaded
OCTINOXATEACTIVE INGREDIENT4Y5P7MUD51NATURAL FX (OCTINOXATE, OCTOCRYLENE, OXYBENZONE) CREAM [COVER FX SKIN CARE, INC.]1
OCTOCRYLENEACTIVE INGREDIENT5A68WGF6WMNATURAL FX (OCTINOXATE, OCTOCRYLENE, OXYBENZONE) CREAM [COVER FX SKIN CARE, INC.]1
OXYBENZONEACTIVE INGREDIENT95OOS7VE0YNATURAL FX (OCTINOXATE, OCTOCRYLENE, OXYBENZONE) CREAM [COVER FX SKIN CARE, INC.]1
OCTINOXATEACTIVE MOIETY4Y5P7MUD51NATURAL FX (OCTINOXATE, OCTOCRYLENE, OXYBENZONE) CREAM [COVER FX SKIN CARE, INC.]1
OCTOCRYLENEACTIVE MOIETY5A68WGF6WMNATURAL FX (OCTINOXATE, OCTOCRYLENE, OXYBENZONE) CREAM [COVER FX SKIN CARE, INC.]1
OXYBENZONEACTIVE MOIETY95OOS7VE0YNATURAL FX (OCTINOXATE, OCTOCRYLENE, OXYBENZONE) CREAM [COVER FX SKIN CARE, INC.]1
ALKYL (C12-15) BENZOATEINACTIVE INGREDIENTA9EJ3J61HQNATURAL FX (OCTINOXATE, OCTOCRYLENE, OXYBENZONE) CREAM [COVER FX SKIN CARE, INC.]1
BENZETHONIUM CHLORIDEINACTIVE INGREDIENTPH41D05744NATURAL FX (OCTINOXATE, OCTOCRYLENE, OXYBENZONE) CREAM [COVER FX SKIN CARE, INC.]1
BENZOIC ACIDINACTIVE INGREDIENT8SKN0B0MIMNATURAL FX (OCTINOXATE, OCTOCRYLENE, OXYBENZONE) CREAM [COVER FX SKIN CARE, INC.]1
BENZYL ALCOHOLINACTIVE INGREDIENTLKG8494WBHNATURAL FX (OCTINOXATE, OCTOCRYLENE, OXYBENZONE) CREAM [COVER FX SKIN CARE, INC.]1
BUTYLATED HYDROXYTOLUENEINACTIVE INGREDIENT1P9D0Z171KNATURAL FX (OCTINOXATE, OCTOCRYLENE, OXYBENZONE) CREAM [COVER FX SKIN CARE, INC.]1
BUTYLENE GLYCOLINACTIVE INGREDIENT3XUS85K0RANATURAL FX (OCTINOXATE, OCTOCRYLENE, OXYBENZONE) CREAM [COVER FX SKIN CARE, INC.]1
CARNAUBA WAXINACTIVE INGREDIENTR12CBM0EIZNATURAL FX (OCTINOXATE, OCTOCRYLENE, OXYBENZONE) CREAM [COVER FX SKIN CARE, INC.]1
CETYL PEG/PPG-10/1 DIMETHICONE (HLB 5)INACTIVE INGREDIENT035JKJ76MTNATURAL FX (OCTINOXATE, OCTOCRYLENE, OXYBENZONE) CREAM [COVER FX SKIN CARE, INC.]1
CHOLESTERYL HYDROXYSTEARATEINACTIVE INGREDIENTO6K1LG6N4DNATURAL FX (OCTINOXATE, OCTOCRYLENE, OXYBENZONE) CREAM [COVER FX SKIN CARE, INC.]1
CHROMIC OXIDEINACTIVE INGREDIENTX5Z09SU859NATURAL FX (OCTINOXATE, OCTOCRYLENE, OXYBENZONE) CREAM [COVER FX SKIN CARE, INC.]1
CYCLOMETHICONEINACTIVE INGREDIENTNMQ347994ZNATURAL FX (OCTINOXATE, OCTOCRYLENE, OXYBENZONE) CREAM [COVER FX SKIN CARE, INC.]1
DEHYDROACETIC ACIDINACTIVE INGREDIENT2KAG279R6RNATURAL FX (OCTINOXATE, OCTOCRYLENE, OXYBENZONE) CREAM [COVER FX SKIN CARE, INC.]1
DIISOSTEARYL MALATEINACTIVE INGREDIENTQBS8A3XZGQNATURAL FX (OCTINOXATE, OCTOCRYLENE, OXYBENZONE) CREAM [COVER FX SKIN CARE, INC.]1
FERRIC OXIDE REDINACTIVE INGREDIENT1K09F3G675NATURAL FX (OCTINOXATE, OCTOCRYLENE, OXYBENZONE) CREAM [COVER FX SKIN CARE, INC.]1
GLYCERYL DIBEHENATEINACTIVE INGREDIENTR8WTH25YS2NATURAL FX (OCTINOXATE, OCTOCRYLENE, OXYBENZONE) CREAM [COVER FX SKIN CARE, INC.]1
HYDROGENATED POLYBUTENE (370 MW)INACTIVE INGREDIENTV5H8103878NATURAL FX (OCTINOXATE, OCTOCRYLENE, OXYBENZONE) CREAM [COVER FX SKIN CARE, INC.]1
LEVOMENOLINACTIVE INGREDIENT24WE03BX2TNATURAL FX (OCTINOXATE, OCTOCRYLENE, OXYBENZONE) CREAM [COVER FX SKIN CARE, INC.]1
MAGNESIUM ALUMINUM SILICATEINACTIVE INGREDIENT6M3P64V0NCNATURAL FX (OCTINOXATE, OCTOCRYLENE, OXYBENZONE) CREAM [COVER FX SKIN CARE, INC.]1
MAGNESIUM SILICATEINACTIVE INGREDIENT9B9691B2N9NATURAL FX (OCTINOXATE, OCTOCRYLENE, OXYBENZONE) CREAM [COVER FX SKIN CARE, INC.]1
NEOPENTYL GLYCOL DICAPRATEINACTIVE INGREDIENT77T908SE82NATURAL FX (OCTINOXATE, OCTOCRYLENE, OXYBENZONE) CREAM [COVER FX SKIN CARE, INC.]1
PHENOXYETHANOLINACTIVE INGREDIENTHIE492ZZ3TNATURAL FX (OCTINOXATE, OCTOCRYLENE, OXYBENZONE) CREAM [COVER FX SKIN CARE, INC.]1
SALICYLIC ACIDINACTIVE INGREDIENTO414PZ4LPZNATURAL FX (OCTINOXATE, OCTOCRYLENE, OXYBENZONE) CREAM [COVER FX SKIN CARE, INC.]1
SODIUM CHLORIDEINACTIVE INGREDIENT451W47IQ8XNATURAL FX (OCTINOXATE, OCTOCRYLENE, OXYBENZONE) CREAM [COVER FX SKIN CARE, INC.]1
SORBIC ACIDINACTIVE INGREDIENTX045WJ989BNATURAL FX (OCTINOXATE, OCTOCRYLENE, OXYBENZONE) CREAM [COVER FX SKIN CARE, INC.]1
TITANIUM DIOXIDEINACTIVE INGREDIENT15FIX9V2JPNATURAL FX (OCTINOXATE, OCTOCRYLENE, OXYBENZONE) CREAM [COVER FX SKIN CARE, INC.]1
TOCOPHEROLINACTIVE INGREDIENTR0ZB2556P8NATURAL FX (OCTINOXATE, OCTOCRYLENE, OXYBENZONE) CREAM [COVER FX SKIN CARE, INC.]1
TRIACONTANYL PVP (WP-660)INACTIVE INGREDIENTN0SS3Q238DNATURAL FX (OCTINOXATE, OCTOCRYLENE, OXYBENZONE) CREAM [COVER FX SKIN CARE, INC.]1
TRIBEHENININACTIVE INGREDIENT8OC9U7TQZ0NATURAL FX (OCTINOXATE, OCTOCRYLENE, OXYBENZONE) CREAM [COVER FX SKIN CARE, INC.]1
TRIETHOXYCAPRYLYLSILANEINACTIVE INGREDIENTLDC331P08ENATURAL FX (OCTINOXATE, OCTOCRYLENE, OXYBENZONE) CREAM [COVER FX SKIN CARE, INC.]1
WATERINACTIVE INGREDIENT059QF0KO0RNATURAL FX (OCTINOXATE, OCTOCRYLENE, OXYBENZONE) CREAM [COVER FX SKIN CARE, INC.]1

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
68327-002NATURAL FX (OCTINOXATE, OCTOCRYLENE, OXYBENZONE) CREAM [COVER FX SKIN CARE, INC.]1Legacy NDC, 1 package rows20130221_91070828-a997-4fdb-9829-a71186a4f778.zip

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsStatus
68327-002-016832700020130 mL in 1 TUBE30 mlHistorical