WESTERN FAMILY OIL FREE FACES

Product NDC
55312-015
11-digit product format
553120015
Labeler code
55312
Product ID
55312-015_e7236d55-23f7-4f0e-b0a7-1e6cb3d636d8
Type
HUMAN OTC DRUG
Nonproprietary name
AVOBENZONE HOMOSALATE OCTISALATE OCTOCRYLENE OXYBENZONE
Dosage form
LOTION
Route
TOPICAL
Labeler
WESTERN FAMILY FOODS, INC.
Application
part352
Marketing category
OTC MONOGRAPH NOT FINAL
Marketing start
2014-07-02
Marketing end
0000-00-00
Substance
AVOBENZONE; HOMOSALATE; OCTISALATE; OCTOCRYLENE; OXYBENZONE
Active strength
2 g/100g; g/100g; g/100g; g/100g; g/100g
NDC exclude flag
E
Listing certified through
2018-12-31
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 productproduct55312-015IInactivated by FDA2026-10-15
excluded packagepackage55312-01555312-015-22IInactivated by FDA2026-10-15

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 dateDatasetScopePackage NDCCodeStatusSnapshotSource SHA-256
2025-12-14 17:58 UTC · source 2025-12-05excluded productproductIInactivated by FDAd630ba8d3edf…732f749b63fb…
2025-12-14 17:58 UTC · source 2025-12-05excluded packagepackage55312-015-22IInactivated by FDAd630ba8d3edf…732f749b63fb…
2025-08-27 00:01 UTC · source 2025-08-26excluded productproductIInactivated by FDAf5e01cc5f278…a2eaf40c39c3…
2025-08-27 00:01 UTC · source 2025-08-26excluded packagepackage55312-015-22IInactivated by FDAf5e01cc5f278…a2eaf40c39c3…
2025-04-01 02:39 UTC · source 2025-03-31excluded productproductIInactivated by FDA2ef7874e63bc…57b86245f4fa…
2025-04-01 02:39 UTC · source 2025-03-31excluded packagepackage55312-015-22IInactivated by FDA2ef7874e63bc…57b86245f4fa…
2025-03-28 20:22 UTC · source 2025-03-28excluded productproductIInactivated by FDAa1b67e2a42f9…c4cf2c586c0d…
2025-03-28 20:22 UTC · source 2025-03-28excluded packagepackage55312-015-22IInactivated by FDAa1b67e2a42f9…c4cf2c586c0d…
2025-03-22 03:12 UTC · source 2025-03-21excluded productproductIInactivated by FDAcfe11265f3b6…090c488252e2…
2025-03-22 03:12 UTC · source 2025-03-21excluded packagepackage55312-015-22IInactivated by FDAcfe11265f3b6…090c488252e2…
2025-03-10 12:48 UTC · source 2025-03-10excluded productproductIInactivated by FDAcdf11ea48f46…ba0047e9e063…
2025-03-10 12:48 UTC · source 2025-03-10excluded packagepackage55312-015-22IInactivated by FDAcdf11ea48f46…ba0047e9e063…
2025-02-02 03:52 UTC · source 2025-01-31excluded productproductIInactivated by FDA302b2466d912…e7b80fea0513…
2025-02-02 03:52 UTC · source 2025-01-31excluded packagepackage55312-015-22IInactivated by FDA302b2466d912…e7b80fea0513…
2025-01-20 13:05 UTC · source 2025-01-20excluded productproductIInactivated by FDAed331223b511…672a5bd82f5f…
2025-01-20 13:05 UTC · source 2025-01-20excluded packagepackage55312-015-22IInactivated by FDAed331223b511…672a5bd82f5f…
2025-01-11 03:41 UTC · source 2025-01-10excluded productproductIInactivated by FDA0efc9e666f02…f202fb6c5f17…
2025-01-11 03:41 UTC · source 2025-01-10excluded packagepackage55312-015-22IInactivated by FDA0efc9e666f02…f202fb6c5f17…
2024-11-09 02:27 UTC · source 2024-11-08excluded productproductIInactivated by FDAad56d346431e…cc804d4bbf1e…
2024-11-09 02:27 UTC · source 2024-11-08excluded packagepackage55312-015-22IInactivated by FDAad56d346431e…cc804d4bbf1e…
2024-10-04 04:10 UTC · source 2024-10-03excluded productproductIInactivated by FDA367a005e9d99…383a685ebd0f…
2024-10-04 04:10 UTC · source 2024-10-03excluded packagepackage55312-015-22IInactivated by FDA367a005e9d99…383a685ebd0f…
2024-07-10 04:00 UTC · source 2024-07-09excluded productproductIInactivated by FDA557ba5c1ecfa…9c80585c8c6e…
2024-07-10 04:00 UTC · source 2024-07-09excluded packagepackage55312-015-22IInactivated by FDA557ba5c1ecfa…9c80585c8c6e…
2024-05-28 21:12 UTC · source 2024-05-28excluded productproductIInactivated by FDA8af77b9d5b6f…d9bbb34c5368…
2024-05-28 21:12 UTC · source 2024-05-28excluded packagepackage55312-015-22IInactivated by FDA8af77b9d5b6f…d9bbb34c5368…
2024-05-15 03:39 UTC · source 2024-05-14excluded productproductIInactivated by FDA834df4deac94…adcc014656a3…
2024-05-15 03:39 UTC · source 2024-05-14excluded packagepackage55312-015-22IInactivated by FDA834df4deac94…adcc014656a3…
2024-03-11 06:39 UTC · source 2024-03-08excluded productproductIInactivated by FDA1332a3947898…d4bfe170f9cd…
2024-03-11 06:39 UTC · source 2024-03-08excluded packagepackage55312-015-22IInactivated by FDA1332a3947898…d4bfe170f9cd…
2022-08-30 03:57 UTC · source 2022-08-29excluded productproductIInactivated by FDAfb8cb913e6d1…eb8c232b6be0…
2022-08-30 03:57 UTC · source 2022-08-29excluded packagepackage55312-015-22IInactivated by FDAfb8cb913e6d1…eb8c232b6be0…
2022-04-09 23:13 UTC · source 2022-04-08excluded productproductIInactivated by FDA86f5da6cb304…a595104c45d7…
2022-04-09 23:13 UTC · source 2022-04-08excluded packagepackage55312-015-22IInactivated by FDA86f5da6cb304…a595104c45d7…
2022-04-04 05:40 UTC · source 2022-04-01excluded productproductIInactivated by FDAbd6a592717d7…303034d00443…
2022-04-04 05:40 UTC · source 2022-04-01excluded packagepackage55312-015-22IInactivated by FDAbd6a592717d7…303034d00443…
2021-12-27 23:28 UTC · source 2021-12-27excluded productproductIInactivated by FDA8dfbde2a14a4…c9ff85d89658…
2021-12-27 23:28 UTC · source 2021-12-27excluded packagepackage55312-015-22IInactivated by FDA8dfbde2a14a4…c9ff85d89658…
2020-12-18 03:04 UTC · source 2020-12-17excluded productproductIInactivated by FDAe2bbac7714bc…27bdfed8d636…
2020-12-18 03:04 UTC · source 2020-12-17excluded packagepackage55312-015-22IInactivated by FDAe2bbac7714bc…27bdfed8d636…
2020-06-10 20:45 UTC · source 2020-06-10excluded productproductIInactivated by FDA9bebd1f3094a…5416666fcb17…
2020-06-10 20:45 UTC · source 2020-06-10excluded packagepackage55312-015-22IInactivated by FDA9bebd1f3094a…5416666fcb17…
2019-12-08 06:16 UTC · source 2019-12-05excluded productproductEExcluded after deficient or non-compliant submission was not corrected110d247fa046…a55b01930146…
2019-12-08 06:16 UTC · source 2019-12-05excluded packagepackage55312-015-22EExcluded after deficient or non-compliant submission was not corrected110d247fa046…a55b01930146…

Reported adverse events (FAERS/openFDA)#

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

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
55312-015-222020-01-31C16284748780-19d75b9d0-7375-f424-e053-dadaa90a57ceDrug Facts

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
55312-015-22WESTERN FAMILY OIL FREE FACES SPF 3085 g in 1 BOTTLE, PLASTICLOTION851

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIIDailyMed labelSPL versionUploaded
AVOBENZONEACTIVE INGREDIENTG63QQF2NOXWESTERN FAMILY OIL FREE FACES SPF 30 (AVOBENZONE HOMOSALATE OCTISALATE OCTOCRYLENE OXYBENZONE) LOTION [WESTERN FAMILY FOODS, INC.]1
HOMOSALATEACTIVE INGREDIENTV06SV4M95SWESTERN FAMILY OIL FREE FACES SPF 30 (AVOBENZONE HOMOSALATE OCTISALATE OCTOCRYLENE OXYBENZONE) LOTION [WESTERN FAMILY FOODS, INC.]1
OCTISALATEACTIVE INGREDIENT4X49Y0596WWESTERN FAMILY OIL FREE FACES SPF 30 (AVOBENZONE HOMOSALATE OCTISALATE OCTOCRYLENE OXYBENZONE) LOTION [WESTERN FAMILY FOODS, INC.]1
OCTOCRYLENEACTIVE INGREDIENT5A68WGF6WMWESTERN FAMILY OIL FREE FACES SPF 30 (AVOBENZONE HOMOSALATE OCTISALATE OCTOCRYLENE OXYBENZONE) LOTION [WESTERN FAMILY FOODS, INC.]1
OXYBENZONEACTIVE INGREDIENT95OOS7VE0YWESTERN FAMILY OIL FREE FACES SPF 30 (AVOBENZONE HOMOSALATE OCTISALATE OCTOCRYLENE OXYBENZONE) LOTION [WESTERN FAMILY FOODS, INC.]1
AVOBENZONEACTIVE MOIETYG63QQF2NOXWESTERN FAMILY OIL FREE FACES SPF 30 (AVOBENZONE HOMOSALATE OCTISALATE OCTOCRYLENE OXYBENZONE) LOTION [WESTERN FAMILY FOODS, INC.]1
HOMOSALATEACTIVE MOIETYV06SV4M95SWESTERN FAMILY OIL FREE FACES SPF 30 (AVOBENZONE HOMOSALATE OCTISALATE OCTOCRYLENE OXYBENZONE) LOTION [WESTERN FAMILY FOODS, INC.]1
OCTISALATEACTIVE MOIETY4X49Y0596WWESTERN FAMILY OIL FREE FACES SPF 30 (AVOBENZONE HOMOSALATE OCTISALATE OCTOCRYLENE OXYBENZONE) LOTION [WESTERN FAMILY FOODS, INC.]1
OCTOCRYLENEACTIVE MOIETY5A68WGF6WMWESTERN FAMILY OIL FREE FACES SPF 30 (AVOBENZONE HOMOSALATE OCTISALATE OCTOCRYLENE OXYBENZONE) LOTION [WESTERN FAMILY FOODS, INC.]1
OXYBENZONEACTIVE MOIETY95OOS7VE0YWESTERN FAMILY OIL FREE FACES SPF 30 (AVOBENZONE HOMOSALATE OCTISALATE OCTOCRYLENE OXYBENZONE) LOTION [WESTERN FAMILY FOODS, INC.]1
ALUMINUM STARCH OCTENYLSUCCINATEINACTIVE INGREDIENTI9PJ0O6294WESTERN FAMILY OIL FREE FACES SPF 30 (AVOBENZONE HOMOSALATE OCTISALATE OCTOCRYLENE OXYBENZONE) LOTION [WESTERN FAMILY FOODS, INC.]1
BENZYL ALCOHOLINACTIVE INGREDIENTLKG8494WBHWESTERN FAMILY OIL FREE FACES SPF 30 (AVOBENZONE HOMOSALATE OCTISALATE OCTOCRYLENE OXYBENZONE) LOTION [WESTERN FAMILY FOODS, INC.]1
DIMETHICONEINACTIVE INGREDIENT92RU3N3Y1OWESTERN FAMILY OIL FREE FACES SPF 30 (AVOBENZONE HOMOSALATE OCTISALATE OCTOCRYLENE OXYBENZONE) LOTION [WESTERN FAMILY FOODS, INC.]1
EDETATE DISODIUMINACTIVE INGREDIENT7FLD91C86KWESTERN FAMILY OIL FREE FACES SPF 30 (AVOBENZONE HOMOSALATE OCTISALATE OCTOCRYLENE OXYBENZONE) LOTION [WESTERN FAMILY FOODS, INC.]1
METHYLPARABENINACTIVE INGREDIENTA2I8C7HI9TWESTERN FAMILY OIL FREE FACES SPF 30 (AVOBENZONE HOMOSALATE OCTISALATE OCTOCRYLENE OXYBENZONE) LOTION [WESTERN FAMILY FOODS, INC.]1
POLYGLYCERYL-3 DISTEARATEINACTIVE INGREDIENTZI1LK470XVWESTERN FAMILY OIL FREE FACES SPF 30 (AVOBENZONE HOMOSALATE OCTISALATE OCTOCRYLENE OXYBENZONE) LOTION [WESTERN FAMILY FOODS, INC.]1
PROPYLPARABENINACTIVE INGREDIENTZ8IX2SC1OHWESTERN FAMILY OIL FREE FACES SPF 30 (AVOBENZONE HOMOSALATE OCTISALATE OCTOCRYLENE OXYBENZONE) LOTION [WESTERN FAMILY FOODS, INC.]1
SORBITAN ISOSTEARATEINACTIVE INGREDIENT01S2G2C1E4WESTERN FAMILY OIL FREE FACES SPF 30 (AVOBENZONE HOMOSALATE OCTISALATE OCTOCRYLENE OXYBENZONE) LOTION [WESTERN FAMILY FOODS, INC.]1
SORBITOLINACTIVE INGREDIENT506T60A25RWESTERN FAMILY OIL FREE FACES SPF 30 (AVOBENZONE HOMOSALATE OCTISALATE OCTOCRYLENE OXYBENZONE) LOTION [WESTERN FAMILY FOODS, INC.]1
STEARIC ACIDINACTIVE INGREDIENT4ELV7Z65APWESTERN FAMILY OIL FREE FACES SPF 30 (AVOBENZONE HOMOSALATE OCTISALATE OCTOCRYLENE OXYBENZONE) LOTION [WESTERN FAMILY FOODS, INC.]1
TOCOPHEROLINACTIVE INGREDIENTR0ZB2556P8WESTERN FAMILY OIL FREE FACES SPF 30 (AVOBENZONE HOMOSALATE OCTISALATE OCTOCRYLENE OXYBENZONE) LOTION [WESTERN FAMILY FOODS, INC.]1
TROLAMINEINACTIVE INGREDIENT9O3K93S3TKWESTERN FAMILY OIL FREE FACES SPF 30 (AVOBENZONE HOMOSALATE OCTISALATE OCTOCRYLENE OXYBENZONE) LOTION [WESTERN FAMILY FOODS, INC.]1
WATERINACTIVE INGREDIENT059QF0KO0RWESTERN FAMILY OIL FREE FACES SPF 30 (AVOBENZONE HOMOSALATE OCTISALATE OCTOCRYLENE OXYBENZONE) LOTION [WESTERN FAMILY FOODS, INC.]1

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
55312-015WESTERN FAMILY OIL FREE FACES SPF 30 (AVOBENZONE HOMOSALATE OCTISALATE OCTOCRYLENE OXYBENZONE) LOTION [WESTERN FAMILY FOODS, INC.]1Legacy NDC, 1 package rows20140705_b9d16d1a-ad94-4bcd-a592-80931a8339b0.zip

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsStatus
55312-015-225531200152285 g in 1 BOTTLE, PLASTIC85 gHistorical