Home NDC 76354-861-01 BB Cream SPF 20 Fair
Product NDC 76354-861
Requested package NDC 76354-861-01
11-digit product format 763540861
Labeler code 76354
Product ID 76354-861_b6aff558-c521-4978-e053-2995a90a311d
Type HUMAN OTC DRUG
Nonproprietary name Octinoxate, Octisalate, Oxybenzone
Dosage form CREAM
Route TOPICAL
Labeler J. A. Cosmetics U.S. INC
Application part352
Marketing category OTC MONOGRAPH NOT FINAL
Marketing start 2018-06-07
Marketing end 0000-00-00
Substance OCTINOXATE; OXYBENZONE; OCTISALATE
Active strength 60 mg/mL; mg/mL; mg/mL
NDC exclude flag No
Listing certified through 2021-12-31
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 · 15 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…2024-10-04 04:10 UTC · source 2024-10-03 367a005e9d99…383a685ebd0f…2024-07-10 04:00 UTC · source 2024-07-09 557ba5c1ecfa…9c80585c8c6e…2024-05-28 21:12 UTC · source 2024-05-28 8af77b9d5b6f…d9bbb34c5368…2024-05-15 03:39 UTC · source 2024-05-14 834df4deac94…adcc014656a3…2024-03-11 06:39 UTC · source 2024-03-08 1332a3947898…d4bfe170f9cd…
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 76354-861-01 BB Cream SPF 20 Fair 28.5 mL in 1 BOTTLE CREAM 28.5 1
DailyMed Dashboard NDC Coverage# NDC, Dashboard title, SPL version table NDC Dashboard title SPL version Validation Dashboard ZIP 76354-861 BB CREAM SPF 20 FAIR (OCTINOXATE, OCTISALATE, OXYBENZONE) CREAM [J. A. COSMETICS U.S. INC] 1 Legacy NDC, 1 package rows 20201223_b7059009-a0d2-6fc2-e053-2a95a90ae1a2.zip
Packages# Package NDC, 11-digit format, Description table Package NDC 11-digit format Description Units Marketing start Marketing end Sample Exclude flag Status 76354-861-01 76354086101 28.5 mL in 1 BOTTLE (76354-861-01) 28.5 ml 2018-06-07 0000-00-00 No No Current