Home NDC 55910-012 Sunscreen
Product NDC 55910-012
11-digit product format 559100012
Labeler code 55910
Product ID 55910-012_4c10c12b-2e1f-8b32-e063-6294a90a18e9
Type HUMAN OTC DRUG
Nonproprietary name Avobenzone, Homosalate,Otisalate, Octocrylene
Dosage form SPRAY
Route TOPICAL
Labeler Old East Main Co.
Application M020
Marketing category OTC MONOGRAPH DRUG
Marketing start 2019-10-01
Substance AVOBENZONE; HOMOSALATE; OCTISALATE; OCTOCRYLENE
Active strength 30; 150; 50; 100 mg/g; mg/g; mg/g; mg/g
NDC exclude flag No
Listing certified through 2027-12-31
Current FDA listing Yes 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 · 10 matching rows.
View current auxiliary records. · View the auxiliary file history.
Captured / source date, Snapshot, Source SHA-256 table Captured / source date Snapshot Source SHA-256 2025-12-14 17:58 UTC · source 2025-12-05 d630ba8d3edf…732f749b63fb…2025-08-27 00:01 UTC · source 2025-08-26 f5e01cc5f278…a2eaf40c39c3…2025-04-01 02:39 UTC · source 2025-03-31 2ef7874e63bc…57b86245f4fa…2025-03-28 20:22 UTC · source 2025-03-28 a1b67e2a42f9…c4cf2c586c0d…2025-03-22 03:12 UTC · source 2025-03-21 cfe11265f3b6…090c488252e2…2025-03-10 12:48 UTC · source 2025-03-10 cdf11ea48f46…ba0047e9e063…2025-02-02 03:52 UTC · source 2025-01-31 302b2466d912…e7b80fea0513…2025-01-20 13:05 UTC · source 2025-01-20 ed331223b511…672a5bd82f5f…2025-01-11 03:41 UTC · source 2025-01-10 0efc9e666f02…f202fb6c5f17…2024-11-09 02:27 UTC · source 2024-11-08 ad56d346431e…cc804d4bbf1e…
Reported adverse events (FAERS/openFDA)# Adverse event summaries are temporarily unavailable. Other product information remains available.
Additional Listing Data#
Finished product Yes
Brand name base Sunscreen
Listing expiration 2027-12-31 Active Ingredients# Ingredient, Strength table Ingredient Strength AVOBENZONE 30 mg/g HOMOSALATE 150 mg/g OCTISALATE 50 mg/g OCTOCRYLENE 100 mg/g
Harmonized UNII identifiers# UNII identifiers page 1 of 1 · 4 matching rows.
Harmonized SPL set identifiers# SPL set identifiers page 1 of 1 · 1 matching rows.
DailyMed Package Descriptions# Package NDC, Product, Description table Package NDC Product Description Form Quantity Strength SPL version 55910-012-14 Sunscreen 156 g in 1 CAN SPRAY 156 20 55910-012-15 Sunscreen 258 g in 1 CAN SPRAY 258 20 55910-012-39 Sunscreen 312 g in 1 CAN SPRAY 312 20
DailyMed Dashboard NDC Coverage# NDC, Dashboard title, SPL version table NDC Dashboard title SPL version Validation Dashboard ZIP 55910-012 SUNSCREEN (AVOBENZONE, HOMOSALATE,OTISALATE, OCTOCRYLENE) SPRAY [OLD EAST MAIN CO] 18 Current NDC, Legacy NDC, 3 package rows 20241013_2ea288fe-815d-4568-9592-55ea428448fa.zip
openFDA label cross-check# OpenFDA label data provides additional search and identifier links. DailyMed’s Structured Product Label is the canonical label on FDA.report. Matching records are deduplicated before they are shown below.
Matched openFDA labels page 26 of 357 · 7,139 matching rows.
Packages# Package NDC, 11-digit format, Description table Package NDC 11-digit format Description Units Marketing start Marketing end Sample Exclude flag Status 55910-012-14 55910001214 156 g in 1 CAN (55910-012-14) 156 g 2019-10-01 0000-00-00 No No Current 55910-012-15 55910001215 258 g in 1 CAN (55910-012-15) 258 g 2019-10-01 0000-00-00 No No Current 55910-012-39 55910001239 312 g in 1 CAN (55910-012-39) 312 g 2019-10-01 0000-00-00 No No Current