Western Family Broad Spectrum Sunscreen

Product NDC
55312-000
11-digit product format
553120000
Labeler code
55312
Product ID
55312-000_5930aae2-0c91-4643-aa0b-001a7e8b3411
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
2014-03-03
Marketing end
0000-00-00
Substance
AVOBENZONE; HOMOSALATE; OCTISALATE; OCTOCRYLENE; OXYBENZONE
Active strength
3 g/100g; g/100g; g/100g; g/100g; g/100g
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 productproduct55312-000IInactivated by FDA2026-10-21
excluded packagepackage55312-00055312-000-56IInactivated by FDA2026-10-21

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 packagepackage55312-000-56d630ba8d3edf…732f749b63fb…
2025-08-27 00:01 UTC · source 2025-08-26excluded productproductf5e01cc5f278…a2eaf40c39c3…
2025-08-27 00:01 UTC · source 2025-08-26excluded packagepackage55312-000-56f5e01cc5f278…a2eaf40c39c3…
2025-04-01 02:39 UTC · source 2025-03-31excluded productproduct2ef7874e63bc…57b86245f4fa…
2025-04-01 02:39 UTC · source 2025-03-31excluded packagepackage55312-000-562ef7874e63bc…57b86245f4fa…
2025-03-28 20:22 UTC · source 2025-03-28excluded productproducta1b67e2a42f9…c4cf2c586c0d…
2025-03-28 20:22 UTC · source 2025-03-28excluded packagepackage55312-000-56a1b67e2a42f9…c4cf2c586c0d…
2025-03-22 03:12 UTC · source 2025-03-21excluded productproductcfe11265f3b6…090c488252e2…
2025-03-22 03:12 UTC · source 2025-03-21excluded packagepackage55312-000-56cfe11265f3b6…090c488252e2…
2025-03-10 12:48 UTC · source 2025-03-10excluded productproductcdf11ea48f46…ba0047e9e063…
2025-03-10 12:48 UTC · source 2025-03-10excluded packagepackage55312-000-56cdf11ea48f46…ba0047e9e063…
2025-02-02 03:52 UTC · source 2025-01-31excluded productproduct302b2466d912…e7b80fea0513…
2025-02-02 03:52 UTC · source 2025-01-31excluded packagepackage55312-000-56302b2466d912…e7b80fea0513…
2025-01-20 13:05 UTC · source 2025-01-20excluded productproducted331223b511…672a5bd82f5f…
2025-01-20 13:05 UTC · source 2025-01-20excluded packagepackage55312-000-56ed331223b511…672a5bd82f5f…
2025-01-11 03:41 UTC · source 2025-01-10excluded productproduct0efc9e666f02…f202fb6c5f17…
2025-01-11 03:41 UTC · source 2025-01-10excluded packagepackage55312-000-560efc9e666f02…f202fb6c5f17…
2024-11-09 02:27 UTC · source 2024-11-08excluded productproductad56d346431e…cc804d4bbf1e…
2024-11-09 02:27 UTC · source 2024-11-08excluded packagepackage55312-000-56ad56d346431e…cc804d4bbf1e…
2024-10-04 04:10 UTC · source 2024-10-03excluded productproduct367a005e9d99…383a685ebd0f…
2024-10-04 04:10 UTC · source 2024-10-03excluded packagepackage55312-000-56367a005e9d99…383a685ebd0f…
2024-07-10 04:00 UTC · source 2024-07-09excluded productproduct557ba5c1ecfa…9c80585c8c6e…
2024-07-10 04:00 UTC · source 2024-07-09excluded packagepackage55312-000-56557ba5c1ecfa…9c80585c8c6e…
2024-05-28 21:12 UTC · source 2024-05-28excluded productproduct8af77b9d5b6f…d9bbb34c5368…
2024-05-28 21:12 UTC · source 2024-05-28excluded packagepackage55312-000-568af77b9d5b6f…d9bbb34c5368…
2024-05-15 03:39 UTC · source 2024-05-14excluded productproduct834df4deac94…adcc014656a3…
2024-05-15 03:39 UTC · source 2024-05-14excluded packagepackage55312-000-56834df4deac94…adcc014656a3…
2024-03-11 06:39 UTC · source 2024-03-08excluded productproduct1332a3947898…d4bfe170f9cd…
2024-03-11 06:39 UTC · source 2024-03-08excluded packagepackage55312-000-561332a3947898…d4bfe170f9cd…
2022-08-30 03:57 UTC · source 2022-08-29excluded productproductfb8cb913e6d1…eb8c232b6be0…
2022-08-30 03:57 UTC · source 2022-08-29excluded packagepackage55312-000-56fb8cb913e6d1…eb8c232b6be0…
2022-04-09 23:13 UTC · source 2022-04-08excluded productproduct86f5da6cb304…a595104c45d7…
2022-04-09 23:13 UTC · source 2022-04-08excluded packagepackage55312-000-5686f5da6cb304…a595104c45d7…
2022-04-04 05:40 UTC · source 2022-04-01excluded productproductbd6a592717d7…303034d00443…
2022-04-04 05:40 UTC · source 2022-04-01excluded packagepackage55312-000-56bd6a592717d7…303034d00443…
2021-12-27 23:28 UTC · source 2021-12-27excluded productproduct8dfbde2a14a4…c9ff85d89658…
2021-12-27 23:28 UTC · source 2021-12-27excluded packagepackage55312-000-568dfbde2a14a4…c9ff85d89658…
2020-12-18 03:04 UTC · source 2020-12-17excluded productproducte2bbac7714bc…27bdfed8d636…
2020-12-18 03:04 UTC · source 2020-12-17excluded packagepackage55312-000-56e2bbac7714bc…27bdfed8d636…
2020-06-10 20:45 UTC · source 2020-06-10excluded productproduct9bebd1f3094a…5416666fcb17…
2020-06-10 20:45 UTC · source 2020-06-10excluded packagepackage55312-000-569bebd1f3094a…5416666fcb17…

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
55312-000-562020-01-31C16284748780-19d75b9d0-a324-f424-e053-dadaa90a57ceDrug Facts

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
55312-000-56Western Family Broad Spectrum SunscreenSPF 70226 g in 1 BOTTLE, PLASTICLOTION2262

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIIDailyMed labelSPL versionUploaded
AVOBENZONEACTIVE INGREDIENTG63QQF2NOXWESTERN FAMILY BROAD SPECTRUM SUNSCREEN SPF 70 (AVOBENZONE, HOMOSALATE, OCTISALATE, OCTOCRYLENE, OXYBENZONE) LOTION [WESTERN FAMILY FOODS, INC.]2
HOMOSALATEACTIVE INGREDIENTV06SV4M95SWESTERN FAMILY BROAD SPECTRUM SUNSCREEN SPF 70 (AVOBENZONE, HOMOSALATE, OCTISALATE, OCTOCRYLENE, OXYBENZONE) LOTION [WESTERN FAMILY FOODS, INC.]2
OCTISALATEACTIVE INGREDIENT4X49Y0596WWESTERN FAMILY BROAD SPECTRUM SUNSCREEN SPF 70 (AVOBENZONE, HOMOSALATE, OCTISALATE, OCTOCRYLENE, OXYBENZONE) LOTION [WESTERN FAMILY FOODS, INC.]2
OCTOCRYLENEACTIVE INGREDIENT5A68WGF6WMWESTERN FAMILY BROAD SPECTRUM SUNSCREEN SPF 70 (AVOBENZONE, HOMOSALATE, OCTISALATE, OCTOCRYLENE, OXYBENZONE) LOTION [WESTERN FAMILY FOODS, INC.]2
OXYBENZONEACTIVE INGREDIENT95OOS7VE0YWESTERN FAMILY BROAD SPECTRUM SUNSCREEN SPF 70 (AVOBENZONE, HOMOSALATE, OCTISALATE, OCTOCRYLENE, OXYBENZONE) LOTION [WESTERN FAMILY FOODS, INC.]2
AVOBENZONEACTIVE MOIETYG63QQF2NOXWESTERN FAMILY BROAD SPECTRUM SUNSCREEN SPF 70 (AVOBENZONE, HOMOSALATE, OCTISALATE, OCTOCRYLENE, OXYBENZONE) LOTION [WESTERN FAMILY FOODS, INC.]2
HOMOSALATEACTIVE MOIETYV06SV4M95SWESTERN FAMILY BROAD SPECTRUM SUNSCREEN SPF 70 (AVOBENZONE, HOMOSALATE, OCTISALATE, OCTOCRYLENE, OXYBENZONE) LOTION [WESTERN FAMILY FOODS, INC.]2
OCTISALATEACTIVE MOIETY4X49Y0596WWESTERN FAMILY BROAD SPECTRUM SUNSCREEN SPF 70 (AVOBENZONE, HOMOSALATE, OCTISALATE, OCTOCRYLENE, OXYBENZONE) LOTION [WESTERN FAMILY FOODS, INC.]2
OCTOCRYLENEACTIVE MOIETY5A68WGF6WMWESTERN FAMILY BROAD SPECTRUM SUNSCREEN SPF 70 (AVOBENZONE, HOMOSALATE, OCTISALATE, OCTOCRYLENE, OXYBENZONE) LOTION [WESTERN FAMILY FOODS, INC.]2
OXYBENZONEACTIVE MOIETY95OOS7VE0YWESTERN FAMILY BROAD SPECTRUM SUNSCREEN SPF 70 (AVOBENZONE, HOMOSALATE, OCTISALATE, OCTOCRYLENE, OXYBENZONE) LOTION [WESTERN FAMILY FOODS, INC.]2
BENZYL ALCOHOLINACTIVE INGREDIENTLKG8494WBHWESTERN FAMILY BROAD SPECTRUM SUNSCREEN SPF 70 (AVOBENZONE, HOMOSALATE, OCTISALATE, OCTOCRYLENE, OXYBENZONE) LOTION [WESTERN FAMILY FOODS, INC.]2
BUTYLENE GLYCOLINACTIVE INGREDIENT3XUS85K0RAWESTERN FAMILY BROAD SPECTRUM SUNSCREEN SPF 70 (AVOBENZONE, HOMOSALATE, OCTISALATE, OCTOCRYLENE, OXYBENZONE) LOTION [WESTERN FAMILY FOODS, INC.]2
CARBOXYMETHYLCELLULOSE SODIUMINACTIVE INGREDIENTK679OBS311WESTERN FAMILY BROAD SPECTRUM SUNSCREEN SPF 70 (AVOBENZONE, HOMOSALATE, OCTISALATE, OCTOCRYLENE, OXYBENZONE) LOTION [WESTERN FAMILY FOODS, INC.]2
CELLULOSE, MICROCRYSTALLINEINACTIVE INGREDIENTOP1R32D61UWESTERN FAMILY BROAD SPECTRUM SUNSCREEN SPF 70 (AVOBENZONE, HOMOSALATE, OCTISALATE, OCTOCRYLENE, OXYBENZONE) LOTION [WESTERN FAMILY FOODS, INC.]2
CHLORPHENESININACTIVE INGREDIENTI670DAL4SZWESTERN FAMILY BROAD SPECTRUM SUNSCREEN SPF 70 (AVOBENZONE, HOMOSALATE, OCTISALATE, OCTOCRYLENE, OXYBENZONE) LOTION [WESTERN FAMILY FOODS, INC.]2
DIETHYLHEXYL SYRINGYLIDENEMALONATEINACTIVE INGREDIENT3V5U97P248WESTERN FAMILY BROAD SPECTRUM SUNSCREEN SPF 70 (AVOBENZONE, HOMOSALATE, OCTISALATE, OCTOCRYLENE, OXYBENZONE) LOTION [WESTERN FAMILY FOODS, INC.]2
DOCOSANOLINACTIVE INGREDIENT9G1OE216XYWESTERN FAMILY BROAD SPECTRUM SUNSCREEN SPF 70 (AVOBENZONE, HOMOSALATE, OCTISALATE, OCTOCRYLENE, OXYBENZONE) LOTION [WESTERN FAMILY FOODS, INC.]2
EDETATE DISODIUMINACTIVE INGREDIENT7FLD91C86KWESTERN FAMILY BROAD SPECTRUM SUNSCREEN SPF 70 (AVOBENZONE, HOMOSALATE, OCTISALATE, OCTOCRYLENE, OXYBENZONE) LOTION [WESTERN FAMILY FOODS, INC.]2
GLYCERYL MONOSTEARATEINACTIVE INGREDIENT230OU9XXE4WESTERN FAMILY BROAD SPECTRUM SUNSCREEN SPF 70 (AVOBENZONE, HOMOSALATE, OCTISALATE, OCTOCRYLENE, OXYBENZONE) LOTION [WESTERN FAMILY FOODS, INC.]2
PALMITIC ACIDINACTIVE INGREDIENT2V16EO95H1WESTERN FAMILY BROAD SPECTRUM SUNSCREEN SPF 70 (AVOBENZONE, HOMOSALATE, OCTISALATE, OCTOCRYLENE, OXYBENZONE) LOTION [WESTERN FAMILY FOODS, INC.]2
PEG-100 STEARATEINACTIVE INGREDIENTYD01N1999RWESTERN FAMILY BROAD SPECTRUM SUNSCREEN SPF 70 (AVOBENZONE, HOMOSALATE, OCTISALATE, OCTOCRYLENE, OXYBENZONE) LOTION [WESTERN FAMILY FOODS, INC.]2
SODIUM ASCORBYL PHOSPHATEINACTIVE INGREDIENT836SJG51DRWESTERN FAMILY BROAD SPECTRUM SUNSCREEN SPF 70 (AVOBENZONE, HOMOSALATE, OCTISALATE, OCTOCRYLENE, OXYBENZONE) LOTION [WESTERN FAMILY FOODS, INC.]2
STEARIC ACIDINACTIVE INGREDIENT4ELV7Z65APWESTERN FAMILY BROAD SPECTRUM SUNSCREEN SPF 70 (AVOBENZONE, HOMOSALATE, OCTISALATE, OCTOCRYLENE, OXYBENZONE) LOTION [WESTERN FAMILY FOODS, INC.]2
TOCOPHEROLINACTIVE INGREDIENTR0ZB2556P8WESTERN FAMILY BROAD SPECTRUM SUNSCREEN SPF 70 (AVOBENZONE, HOMOSALATE, OCTISALATE, OCTOCRYLENE, OXYBENZONE) LOTION [WESTERN FAMILY FOODS, INC.]2
TRICAPRYLININACTIVE INGREDIENT6P92858988WESTERN FAMILY BROAD SPECTRUM SUNSCREEN SPF 70 (AVOBENZONE, HOMOSALATE, OCTISALATE, OCTOCRYLENE, OXYBENZONE) LOTION [WESTERN FAMILY FOODS, INC.]2
VITAMIN A PALMITATEINACTIVE INGREDIENT1D1K0N0VVCWESTERN FAMILY BROAD SPECTRUM SUNSCREEN SPF 70 (AVOBENZONE, HOMOSALATE, OCTISALATE, OCTOCRYLENE, OXYBENZONE) LOTION [WESTERN FAMILY FOODS, INC.]2
WATERINACTIVE INGREDIENT059QF0KO0RWESTERN FAMILY BROAD SPECTRUM SUNSCREEN SPF 70 (AVOBENZONE, HOMOSALATE, OCTISALATE, OCTOCRYLENE, OXYBENZONE) LOTION [WESTERN FAMILY FOODS, INC.]2

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
55312-000WESTERN FAMILY BROAD SPECTRUM SUNSCREEN SPF 70 (AVOBENZONE, HOMOSALATE, OCTISALATE, OCTOCRYLENE, OXYBENZONE) LOTION [WESTERN FAMILY FOODS, INC.]2Legacy NDC, 1 package rows20140303_a72e6720-2883-401f-84ab-77d898f87b66.zip

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsStatus
55312-000-5655312000056226 g in 1 BOTTLE, PLASTIC226 gHistorical