Home NDC 55312-017 Western FAMILY
Product NDC 55312-017
11-digit product format 553120017
Labeler code 55312
Product ID 55312-017_192ccbf8-52eb-4781-9465-d3b7c430d803
Type HUMAN OTC DRUG
Nonproprietary name AVOBENZONE, HOMOSALATE, OCTISALATE, OCTOCRYLENE
Dosage form LOTION
Route TOPICAL
Labeler WESTERN FAMILY FOODS, INC.
Application part352
Marketing category OTC MONOGRAPH NOT FINAL
Marketing start 2014-07-07
Marketing end 0000-00-00
Substance AVOBENZONE; HOMOSALATE; OCTISALATE; OCTOCRYLENE
Active strength 2 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 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 date Dataset Scope Package NDC Code Status Snapshot Source SHA-256 2025-12-14 17:58 UTC · source 2025-12-05 excluded product product I Inactivated by FDA d630ba8d3edf…732f749b63fb…2025-12-14 17:58 UTC · source 2025-12-05 excluded package package 55312-017-57 I Inactivated by FDA d630ba8d3edf…732f749b63fb…2025-08-27 00:01 UTC · source 2025-08-26 excluded product product I Inactivated by FDA f5e01cc5f278…a2eaf40c39c3…2025-08-27 00:01 UTC · source 2025-08-26 excluded package package 55312-017-57 I Inactivated by FDA f5e01cc5f278…a2eaf40c39c3…2025-04-01 02:39 UTC · source 2025-03-31 excluded product product I Inactivated by FDA 2ef7874e63bc…57b86245f4fa…2025-04-01 02:39 UTC · source 2025-03-31 excluded package package 55312-017-57 I Inactivated by FDA 2ef7874e63bc…57b86245f4fa…2025-03-28 20:22 UTC · source 2025-03-28 excluded product product I Inactivated by FDA a1b67e2a42f9…c4cf2c586c0d…2025-03-28 20:22 UTC · source 2025-03-28 excluded package package 55312-017-57 I Inactivated by FDA a1b67e2a42f9…c4cf2c586c0d…2025-03-22 03:12 UTC · source 2025-03-21 excluded product product I Inactivated by FDA cfe11265f3b6…090c488252e2…2025-03-22 03:12 UTC · source 2025-03-21 excluded package package 55312-017-57 I Inactivated by FDA cfe11265f3b6…090c488252e2…2025-03-10 12:48 UTC · source 2025-03-10 excluded product product I Inactivated by FDA cdf11ea48f46…ba0047e9e063…2025-03-10 12:48 UTC · source 2025-03-10 excluded package package 55312-017-57 I Inactivated by FDA cdf11ea48f46…ba0047e9e063…2025-02-02 03:52 UTC · source 2025-01-31 excluded product product I Inactivated by FDA 302b2466d912…e7b80fea0513…2025-02-02 03:52 UTC · source 2025-01-31 excluded package package 55312-017-57 I Inactivated by FDA 302b2466d912…e7b80fea0513…2025-01-20 13:05 UTC · source 2025-01-20 excluded product product I Inactivated by FDA ed331223b511…672a5bd82f5f…2025-01-20 13:05 UTC · source 2025-01-20 excluded package package 55312-017-57 I Inactivated by FDA ed331223b511…672a5bd82f5f…2025-01-11 03:41 UTC · source 2025-01-10 excluded product product I Inactivated by FDA 0efc9e666f02…f202fb6c5f17…2025-01-11 03:41 UTC · source 2025-01-10 excluded package package 55312-017-57 I Inactivated by FDA 0efc9e666f02…f202fb6c5f17…2024-11-09 02:27 UTC · source 2024-11-08 excluded product product I Inactivated by FDA ad56d346431e…cc804d4bbf1e…2024-11-09 02:27 UTC · source 2024-11-08 excluded package package 55312-017-57 I Inactivated by FDA ad56d346431e…cc804d4bbf1e…2024-10-04 04:10 UTC · source 2024-10-03 excluded product product I Inactivated by FDA 367a005e9d99…383a685ebd0f…2024-10-04 04:10 UTC · source 2024-10-03 excluded package package 55312-017-57 I Inactivated by FDA 367a005e9d99…383a685ebd0f…2024-07-10 04:00 UTC · source 2024-07-09 excluded product product I Inactivated by FDA 557ba5c1ecfa…9c80585c8c6e…2024-07-10 04:00 UTC · source 2024-07-09 excluded package package 55312-017-57 I Inactivated by FDA 557ba5c1ecfa…9c80585c8c6e…2024-05-28 21:12 UTC · source 2024-05-28 excluded product product I Inactivated by FDA 8af77b9d5b6f…d9bbb34c5368…2024-05-28 21:12 UTC · source 2024-05-28 excluded package package 55312-017-57 I Inactivated by FDA 8af77b9d5b6f…d9bbb34c5368…2024-05-15 03:39 UTC · source 2024-05-14 excluded product product I Inactivated by FDA 834df4deac94…adcc014656a3…2024-05-15 03:39 UTC · source 2024-05-14 excluded package package 55312-017-57 I Inactivated by FDA 834df4deac94…adcc014656a3…2024-03-11 06:39 UTC · source 2024-03-08 excluded product product I Inactivated by FDA 1332a3947898…d4bfe170f9cd…2024-03-11 06:39 UTC · source 2024-03-08 excluded package package 55312-017-57 I Inactivated by FDA 1332a3947898…d4bfe170f9cd…2022-08-30 03:57 UTC · source 2022-08-29 excluded product product I Inactivated by FDA fb8cb913e6d1…eb8c232b6be0…2022-08-30 03:57 UTC · source 2022-08-29 excluded package package 55312-017-57 I Inactivated by FDA fb8cb913e6d1…eb8c232b6be0…2022-04-09 23:13 UTC · source 2022-04-08 excluded product product I Inactivated by FDA 86f5da6cb304…a595104c45d7…2022-04-09 23:13 UTC · source 2022-04-08 excluded package package 55312-017-57 I Inactivated by FDA 86f5da6cb304…a595104c45d7…2022-04-04 05:40 UTC · source 2022-04-01 excluded product product I Inactivated by FDA bd6a592717d7…303034d00443…2022-04-04 05:40 UTC · source 2022-04-01 excluded package package 55312-017-57 I Inactivated by FDA bd6a592717d7…303034d00443…2021-12-27 23:28 UTC · source 2021-12-27 excluded product product I Inactivated by FDA 8dfbde2a14a4…c9ff85d89658…2021-12-27 23:28 UTC · source 2021-12-27 excluded package package 55312-017-57 I Inactivated by FDA 8dfbde2a14a4…c9ff85d89658…2020-12-18 03:04 UTC · source 2020-12-17 excluded product product I Inactivated by FDA e2bbac7714bc…27bdfed8d636…2020-12-18 03:04 UTC · source 2020-12-17 excluded package package 55312-017-57 I Inactivated by FDA e2bbac7714bc…27bdfed8d636…2020-06-10 20:45 UTC · source 2020-06-10 excluded product product I Inactivated by FDA 9bebd1f3094a…5416666fcb17…2020-06-10 20:45 UTC · source 2020-06-10 excluded package package 55312-017-57 I Inactivated by FDA 9bebd1f3094a…5416666fcb17…2019-12-08 06:16 UTC · source 2019-12-05 excluded product product E Excluded after deficient or non-compliant submission was not corrected 110d247fa046…a55b01930146…2019-12-08 06:16 UTC · source 2019-12-05 excluded package package 55312-017-57 E Excluded after deficient or non-compliant submission was not corrected 110d247fa046…a55b01930146…
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 55312-017-57 Western FAMILYSPF 15 290 g in 1 BOTTLE, PLASTIC LOTION 290 2
DailyMed Socrata Ingredients# Ingredient, Type, UNII table Ingredient Type UNII DailyMed label SPL version Uploaded AVOBENZONE ACTIVE INGREDIENT G63QQF2NOX WESTERN FAMILY SPF 15 (AVOBENZONE, HOMOSALATE, OCTISALATE, OCTOCRYLENE) LOTION [WESTERN FAMILY FOODS, INC.] 2 HOMOSALATE ACTIVE INGREDIENT V06SV4M95S WESTERN FAMILY SPF 15 (AVOBENZONE, HOMOSALATE, OCTISALATE, OCTOCRYLENE) LOTION [WESTERN FAMILY FOODS, INC.] 2 OCTISALATE ACTIVE INGREDIENT 4X49Y0596W WESTERN FAMILY SPF 15 (AVOBENZONE, HOMOSALATE, OCTISALATE, OCTOCRYLENE) LOTION [WESTERN FAMILY FOODS, INC.] 2 OCTOCRYLENE ACTIVE INGREDIENT 5A68WGF6WM WESTERN FAMILY SPF 15 (AVOBENZONE, HOMOSALATE, OCTISALATE, OCTOCRYLENE) LOTION [WESTERN FAMILY FOODS, INC.] 2 AVOBENZONE ACTIVE MOIETY G63QQF2NOX WESTERN FAMILY SPF 15 (AVOBENZONE, HOMOSALATE, OCTISALATE, OCTOCRYLENE) LOTION [WESTERN FAMILY FOODS, INC.] 2 HOMOSALATE ACTIVE MOIETY V06SV4M95S WESTERN FAMILY SPF 15 (AVOBENZONE, HOMOSALATE, OCTISALATE, OCTOCRYLENE) LOTION [WESTERN FAMILY FOODS, INC.] 2 OCTISALATE ACTIVE MOIETY 4X49Y0596W WESTERN FAMILY SPF 15 (AVOBENZONE, HOMOSALATE, OCTISALATE, OCTOCRYLENE) LOTION [WESTERN FAMILY FOODS, INC.] 2 OCTOCRYLENE ACTIVE MOIETY 5A68WGF6WM WESTERN FAMILY SPF 15 (AVOBENZONE, HOMOSALATE, OCTISALATE, OCTOCRYLENE) LOTION [WESTERN FAMILY FOODS, INC.] 2 ALOE VERA LEAF INACTIVE INGREDIENT ZY81Z83H0X WESTERN FAMILY SPF 15 (AVOBENZONE, HOMOSALATE, OCTISALATE, OCTOCRYLENE) LOTION [WESTERN FAMILY FOODS, INC.] 2 BENZYL ALCOHOL INACTIVE INGREDIENT LKG8494WBH WESTERN FAMILY SPF 15 (AVOBENZONE, HOMOSALATE, OCTISALATE, OCTOCRYLENE) LOTION [WESTERN FAMILY FOODS, INC.] 2 CHLORPHENESIN INACTIVE INGREDIENT I670DAL4SZ WESTERN FAMILY SPF 15 (AVOBENZONE, HOMOSALATE, OCTISALATE, OCTOCRYLENE) LOTION [WESTERN FAMILY FOODS, INC.] 2 DIMETHICONE INACTIVE INGREDIENT 92RU3N3Y1O WESTERN FAMILY SPF 15 (AVOBENZONE, HOMOSALATE, OCTISALATE, OCTOCRYLENE) LOTION [WESTERN FAMILY FOODS, INC.] 2 EDETATE DISODIUM INACTIVE INGREDIENT 7FLD91C86K WESTERN FAMILY SPF 15 (AVOBENZONE, HOMOSALATE, OCTISALATE, OCTOCRYLENE) LOTION [WESTERN FAMILY FOODS, INC.] 2 ETHYLHEXYL PALMITATE INACTIVE INGREDIENT 2865993309 WESTERN FAMILY SPF 15 (AVOBENZONE, HOMOSALATE, OCTISALATE, OCTOCRYLENE) LOTION [WESTERN FAMILY FOODS, INC.] 2 GLYCERYL MONOSTEARATE INACTIVE INGREDIENT 230OU9XXE4 WESTERN FAMILY SPF 15 (AVOBENZONE, HOMOSALATE, OCTISALATE, OCTOCRYLENE) LOTION [WESTERN FAMILY FOODS, INC.] 2 PEG-100 STEARATE INACTIVE INGREDIENT YD01N1999R WESTERN FAMILY SPF 15 (AVOBENZONE, HOMOSALATE, OCTISALATE, OCTOCRYLENE) LOTION [WESTERN FAMILY FOODS, INC.] 2 SORBITOL INACTIVE INGREDIENT 506T60A25R WESTERN FAMILY SPF 15 (AVOBENZONE, HOMOSALATE, OCTISALATE, OCTOCRYLENE) LOTION [WESTERN FAMILY FOODS, INC.] 2 TOCOPHEROL INACTIVE INGREDIENT R0ZB2556P8 WESTERN FAMILY SPF 15 (AVOBENZONE, HOMOSALATE, OCTISALATE, OCTOCRYLENE) LOTION [WESTERN FAMILY FOODS, INC.] 2 TROLAMINE INACTIVE INGREDIENT 9O3K93S3TK WESTERN FAMILY SPF 15 (AVOBENZONE, HOMOSALATE, OCTISALATE, OCTOCRYLENE) LOTION [WESTERN FAMILY FOODS, INC.] 2 WATER INACTIVE INGREDIENT 059QF0KO0R WESTERN FAMILY SPF 15 (AVOBENZONE, HOMOSALATE, OCTISALATE, OCTOCRYLENE) LOTION [WESTERN FAMILY FOODS, INC.] 2
DailyMed Dashboard NDC Coverage# NDC, Dashboard title, SPL version table NDC Dashboard title SPL version Validation Dashboard ZIP 55312-017 WESTERN FAMILY SPF 15 (AVOBENZONE, HOMOSALATE, OCTISALATE, OCTOCRYLENE) LOTION [WESTERN FAMILY FOODS, INC.] 2 Legacy NDC, 1 package rows 20140707_dda7975f-29f2-4870-89cc-cea8828b64e4.zip
Packages# Package NDC, 11-digit format, Description table Package NDC 11-digit format Description Units Status 55312-017-57 55312001757 290 g in 1 BOTTLE, PLASTIC 290 g Historical