Home NDC 81688-0650-3 Elevated Ultimate Tinted Sun Defense Broad Spectrum SPF 30 (UVA/UVB) Sunscreen
Product NDC 81688-0650
Requested package NDC 81688-0650-3
11-digit product format 816880650
Labeler code 81688
Product ID 81688-0650_c16e2c15-0645-4c41-e053-2995a90a4324
Type HUMAN OTC DRUG
Nonproprietary name Titanium Dioxide and Zinc Oxide
Dosage form CREAM
Route TOPICAL
Labeler Elevated Dermatology and Skin
Application part352
Marketing category OTC MONOGRAPH NOT FINAL
Marketing start 2021-02-01
Marketing end 0000-00-00
Substance TITANIUM DIOXIDE; ZINC OXIDE
Active strength 8 g/100mL; g/100mL
NDC exclude flag No
Listing certified through 2022-12-31
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 81688-0650-3 Elevated Ultimate Tinted Sun Defense Broad Spectrum SPF 30 (UVA/UVB) Sunscreen 50 mL in 1 BOTTLE, PUMP CREAM 50 1
DailyMed Dashboard NDC Coverage# NDC, Dashboard title, SPL version table NDC Dashboard title SPL version Validation Dashboard ZIP 81688-0650 ELEVATED ULTIMATE TINTED SUN DEFENSE BROAD SPECTRUM SPF 30 (UVA/UVB) SUNSCREEN (TITANIUM DIOXIDE AND ZINC OXIDE) CREAM [ELEVATED DERMATOLOGY AND SKIN] 1 Legacy NDC, 1 package rows 20210504_c16e2c01-6167-9fff-e053-2995a90a2c40.zip
Packages# Package NDC, 11-digit format, Description table Package NDC 11-digit format Description Units Marketing start Marketing end Sample Exclude flag Status 81688-0650-3 81688065003 50 mL in 1 BOTTLE, PUMP (81688-0650-3) 50 ml 2021-02-01 0000-00-00 No No Current