Home NDC 55312-007 Western Family Baby Broad Spectrum Sunscreen
Product NDC 55312-007
11-digit product format 553120007
Labeler code 55312
Product ID 55312-007_d45b3eca-ca25-4cff-a003-5444c782662d
Type HUMAN OTC DRUG
Nonproprietary name AVOBENZONE,HOMOSALATE, OCTOCRYLENE, OCTISALATE, 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 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 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 date Dataset Scope Package NDC Snapshot Source SHA-256 2025-12-14 17:58 UTC · source 2025-12-05 excluded product product d630ba8d3edf…732f749b63fb…2025-12-14 17:58 UTC · source 2025-12-05 excluded package package 55312-007-57 d630ba8d3edf…732f749b63fb…2025-08-27 00:01 UTC · source 2025-08-26 excluded product product f5e01cc5f278…a2eaf40c39c3…2025-08-27 00:01 UTC · source 2025-08-26 excluded package package 55312-007-57 f5e01cc5f278…a2eaf40c39c3…2025-04-01 02:39 UTC · source 2025-03-31 excluded product product 2ef7874e63bc…57b86245f4fa…2025-04-01 02:39 UTC · source 2025-03-31 excluded package package 55312-007-57 2ef7874e63bc…57b86245f4fa…2025-03-28 20:22 UTC · source 2025-03-28 excluded product product a1b67e2a42f9…c4cf2c586c0d…2025-03-28 20:22 UTC · source 2025-03-28 excluded package package 55312-007-57 a1b67e2a42f9…c4cf2c586c0d…2025-03-22 03:12 UTC · source 2025-03-21 excluded product product cfe11265f3b6…090c488252e2…2025-03-22 03:12 UTC · source 2025-03-21 excluded package package 55312-007-57 cfe11265f3b6…090c488252e2…2025-03-10 12:48 UTC · source 2025-03-10 excluded product product cdf11ea48f46…ba0047e9e063…2025-03-10 12:48 UTC · source 2025-03-10 excluded package package 55312-007-57 cdf11ea48f46…ba0047e9e063…2025-02-02 03:52 UTC · source 2025-01-31 excluded product product 302b2466d912…e7b80fea0513…2025-02-02 03:52 UTC · source 2025-01-31 excluded package package 55312-007-57 302b2466d912…e7b80fea0513…2025-01-20 13:05 UTC · source 2025-01-20 excluded product product ed331223b511…672a5bd82f5f…2025-01-20 13:05 UTC · source 2025-01-20 excluded package package 55312-007-57 ed331223b511…672a5bd82f5f…2025-01-11 03:41 UTC · source 2025-01-10 excluded product product 0efc9e666f02…f202fb6c5f17…2025-01-11 03:41 UTC · source 2025-01-10 excluded package package 55312-007-57 0efc9e666f02…f202fb6c5f17…2024-11-09 02:27 UTC · source 2024-11-08 excluded product product ad56d346431e…cc804d4bbf1e…2024-11-09 02:27 UTC · source 2024-11-08 excluded package package 55312-007-57 ad56d346431e…cc804d4bbf1e…2024-10-04 04:10 UTC · source 2024-10-03 excluded product product 367a005e9d99…383a685ebd0f…2024-10-04 04:10 UTC · source 2024-10-03 excluded package package 55312-007-57 367a005e9d99…383a685ebd0f…2024-07-10 04:00 UTC · source 2024-07-09 excluded product product 557ba5c1ecfa…9c80585c8c6e…2024-07-10 04:00 UTC · source 2024-07-09 excluded package package 55312-007-57 557ba5c1ecfa…9c80585c8c6e…2024-05-28 21:12 UTC · source 2024-05-28 excluded product product 8af77b9d5b6f…d9bbb34c5368…2024-05-28 21:12 UTC · source 2024-05-28 excluded package package 55312-007-57 8af77b9d5b6f…d9bbb34c5368…2024-05-15 03:39 UTC · source 2024-05-14 excluded product product 834df4deac94…adcc014656a3…2024-05-15 03:39 UTC · source 2024-05-14 excluded package package 55312-007-57 834df4deac94…adcc014656a3…2024-03-11 06:39 UTC · source 2024-03-08 excluded product product 1332a3947898…d4bfe170f9cd…2024-03-11 06:39 UTC · source 2024-03-08 excluded package package 55312-007-57 1332a3947898…d4bfe170f9cd…2022-08-30 03:57 UTC · source 2022-08-29 excluded product product fb8cb913e6d1…eb8c232b6be0…2022-08-30 03:57 UTC · source 2022-08-29 excluded package package 55312-007-57 fb8cb913e6d1…eb8c232b6be0…2022-04-09 23:13 UTC · source 2022-04-08 excluded product product 86f5da6cb304…a595104c45d7…2022-04-09 23:13 UTC · source 2022-04-08 excluded package package 55312-007-57 86f5da6cb304…a595104c45d7…2022-04-04 05:40 UTC · source 2022-04-01 excluded product product bd6a592717d7…303034d00443…2022-04-04 05:40 UTC · source 2022-04-01 excluded package package 55312-007-57 bd6a592717d7…303034d00443…2021-12-27 23:28 UTC · source 2021-12-27 excluded product product 8dfbde2a14a4…c9ff85d89658…2021-12-27 23:28 UTC · source 2021-12-27 excluded package package 55312-007-57 8dfbde2a14a4…c9ff85d89658…2020-12-18 03:04 UTC · source 2020-12-17 excluded product product e2bbac7714bc…27bdfed8d636…2020-12-18 03:04 UTC · source 2020-12-17 excluded package package 55312-007-57 e2bbac7714bc…27bdfed8d636…2020-06-10 20:45 UTC · source 2020-06-10 excluded product product 9bebd1f3094a…5416666fcb17…2020-06-10 20:45 UTC · source 2020-06-10 excluded package package 55312-007-57 9bebd1f3094a…5416666fcb17…
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 55312-007-57 Western Family Baby Broad Spectrum SunscreenSPF 50 290 g in 1 BOTTLE, PLASTIC LOTION 290 1
DailyMed Socrata Ingredients# Ingredient, Type, UNII table Ingredient Type UNII DailyMed label SPL version Uploaded AVOBENZONE ACTIVE INGREDIENT G63QQF2NOX WESTERN FAMILY BABY BROAD SPECTRUM SUNSCREEN SPF 50 (AVOBENZONE,HOMOSALATE, OCTOCRYLENE, OCTISALATE, OXYBENZONE) LOTION [WESTERN FAMILY FOODS, INC.] 1 HOMOSALATE ACTIVE INGREDIENT V06SV4M95S WESTERN FAMILY BABY BROAD SPECTRUM SUNSCREEN SPF 50 (AVOBENZONE,HOMOSALATE, OCTOCRYLENE, OCTISALATE, OXYBENZONE) LOTION [WESTERN FAMILY FOODS, INC.] 1 OCTISALATE ACTIVE INGREDIENT 4X49Y0596W WESTERN FAMILY BABY BROAD SPECTRUM SUNSCREEN SPF 50 (AVOBENZONE,HOMOSALATE, OCTOCRYLENE, OCTISALATE, OXYBENZONE) LOTION [WESTERN FAMILY FOODS, INC.] 1 OCTOCRYLENE ACTIVE INGREDIENT 5A68WGF6WM WESTERN FAMILY BABY BROAD SPECTRUM SUNSCREEN SPF 50 (AVOBENZONE,HOMOSALATE, OCTOCRYLENE, OCTISALATE, OXYBENZONE) LOTION [WESTERN FAMILY FOODS, INC.] 1 OXYBENZONE ACTIVE INGREDIENT 95OOS7VE0Y WESTERN FAMILY BABY BROAD SPECTRUM SUNSCREEN SPF 50 (AVOBENZONE,HOMOSALATE, OCTOCRYLENE, OCTISALATE, OXYBENZONE) LOTION [WESTERN FAMILY FOODS, INC.] 1 AVOBENZONE ACTIVE MOIETY G63QQF2NOX WESTERN FAMILY BABY BROAD SPECTRUM SUNSCREEN SPF 50 (AVOBENZONE,HOMOSALATE, OCTOCRYLENE, OCTISALATE, OXYBENZONE) LOTION [WESTERN FAMILY FOODS, INC.] 1 HOMOSALATE ACTIVE MOIETY V06SV4M95S WESTERN FAMILY BABY BROAD SPECTRUM SUNSCREEN SPF 50 (AVOBENZONE,HOMOSALATE, OCTOCRYLENE, OCTISALATE, OXYBENZONE) LOTION [WESTERN FAMILY FOODS, INC.] 1 OCTISALATE ACTIVE MOIETY 4X49Y0596W WESTERN FAMILY BABY BROAD SPECTRUM SUNSCREEN SPF 50 (AVOBENZONE,HOMOSALATE, OCTOCRYLENE, OCTISALATE, OXYBENZONE) LOTION [WESTERN FAMILY FOODS, INC.] 1 OCTOCRYLENE ACTIVE MOIETY 5A68WGF6WM WESTERN FAMILY BABY BROAD SPECTRUM SUNSCREEN SPF 50 (AVOBENZONE,HOMOSALATE, OCTOCRYLENE, OCTISALATE, OXYBENZONE) LOTION [WESTERN FAMILY FOODS, INC.] 1 OXYBENZONE ACTIVE MOIETY 95OOS7VE0Y WESTERN FAMILY BABY BROAD SPECTRUM SUNSCREEN SPF 50 (AVOBENZONE,HOMOSALATE, OCTOCRYLENE, OCTISALATE, OXYBENZONE) LOTION [WESTERN FAMILY FOODS, INC.] 1 ALUMINUM STARCH OCTENYLSUCCINATE INACTIVE INGREDIENT I9PJ0O6294 WESTERN FAMILY BABY BROAD SPECTRUM SUNSCREEN SPF 50 (AVOBENZONE,HOMOSALATE, OCTOCRYLENE, OCTISALATE, OXYBENZONE) LOTION [WESTERN FAMILY FOODS, INC.] 1 BENZYL ALCOHOL INACTIVE INGREDIENT LKG8494WBH WESTERN FAMILY BABY BROAD SPECTRUM SUNSCREEN SPF 50 (AVOBENZONE,HOMOSALATE, OCTOCRYLENE, OCTISALATE, OXYBENZONE) LOTION [WESTERN FAMILY FOODS, INC.] 1 EDETATE DISODIUM INACTIVE INGREDIENT 7FLD91C86K WESTERN FAMILY BABY BROAD SPECTRUM SUNSCREEN SPF 50 (AVOBENZONE,HOMOSALATE, OCTOCRYLENE, OCTISALATE, OXYBENZONE) LOTION [WESTERN FAMILY FOODS, INC.] 1 METHYLPARABEN INACTIVE INGREDIENT A2I8C7HI9T WESTERN FAMILY BABY BROAD SPECTRUM SUNSCREEN SPF 50 (AVOBENZONE,HOMOSALATE, OCTOCRYLENE, OCTISALATE, OXYBENZONE) LOTION [WESTERN FAMILY FOODS, INC.] 1 POLYGLYCERYL-3 DISTEARATE INACTIVE INGREDIENT ZI1LK470XV WESTERN FAMILY BABY BROAD SPECTRUM SUNSCREEN SPF 50 (AVOBENZONE,HOMOSALATE, OCTOCRYLENE, OCTISALATE, OXYBENZONE) LOTION [WESTERN FAMILY FOODS, INC.] 1 PROPYLPARABEN INACTIVE INGREDIENT Z8IX2SC1OH WESTERN FAMILY BABY BROAD SPECTRUM SUNSCREEN SPF 50 (AVOBENZONE,HOMOSALATE, OCTOCRYLENE, OCTISALATE, OXYBENZONE) LOTION [WESTERN FAMILY FOODS, INC.] 1 SORBITAN ISOSTEARATE INACTIVE INGREDIENT 01S2G2C1E4 WESTERN FAMILY BABY BROAD SPECTRUM SUNSCREEN SPF 50 (AVOBENZONE,HOMOSALATE, OCTOCRYLENE, OCTISALATE, OXYBENZONE) LOTION [WESTERN FAMILY FOODS, INC.] 1 SORBITOL INACTIVE INGREDIENT 506T60A25R WESTERN FAMILY BABY BROAD SPECTRUM SUNSCREEN SPF 50 (AVOBENZONE,HOMOSALATE, OCTOCRYLENE, OCTISALATE, OXYBENZONE) LOTION [WESTERN FAMILY FOODS, INC.] 1 STEARIC ACID INACTIVE INGREDIENT 4ELV7Z65AP WESTERN FAMILY BABY BROAD SPECTRUM SUNSCREEN SPF 50 (AVOBENZONE,HOMOSALATE, OCTOCRYLENE, OCTISALATE, OXYBENZONE) LOTION [WESTERN FAMILY FOODS, INC.] 1 TOCOPHEROL INACTIVE INGREDIENT R0ZB2556P8 WESTERN FAMILY BABY BROAD SPECTRUM SUNSCREEN SPF 50 (AVOBENZONE,HOMOSALATE, OCTOCRYLENE, OCTISALATE, OXYBENZONE) LOTION [WESTERN FAMILY FOODS, INC.] 1 TROLAMINE INACTIVE INGREDIENT 9O3K93S3TK WESTERN FAMILY BABY BROAD SPECTRUM SUNSCREEN SPF 50 (AVOBENZONE,HOMOSALATE, OCTOCRYLENE, OCTISALATE, OXYBENZONE) LOTION [WESTERN FAMILY FOODS, INC.] 1 WATER INACTIVE INGREDIENT 059QF0KO0R WESTERN FAMILY BABY BROAD SPECTRUM SUNSCREEN SPF 50 (AVOBENZONE,HOMOSALATE, OCTOCRYLENE, OCTISALATE, OXYBENZONE) LOTION [WESTERN FAMILY FOODS, INC.] 1
DailyMed Dashboard NDC Coverage# NDC, Dashboard title, SPL version table NDC Dashboard title SPL version Validation Dashboard ZIP 55312-007 WESTERN FAMILY BABY BROAD SPECTRUM SUNSCREEN SPF 50 (AVOBENZONE,HOMOSALATE, OCTOCRYLENE, OCTISALATE, OXYBENZONE) LOTION [WESTERN FAMILY FOODS, INC.] 1 Legacy NDC, 1 package rows 20140703_9af87cf6-367a-45a6-8080-944713bbd3d6.zip
Packages# Package NDC, 11-digit format, Description table Package NDC 11-digit format Description Units Status 55312-007-57 55312000757 290 g in 1 BOTTLE, PLASTIC 290 g Historical