Home NDC 58418-295-15 Skin Crave spf15 lip balm
Product NDC 58418-295
Requested package NDC 58418-295-15
11-digit product format 584180295
Labeler code 58418
Product ID 58418-295_70bbafcd-0992-71b9-e053-2991aa0a2422
Type HUMAN OTC DRUG
Nonproprietary name spf15 lip balm (chemical)
Dosage form LIPSTICK
Route TOPICAL
Labeler Tropical Enterprises International, Inc.
Application part352
Marketing category OTC MONOGRAPH FINAL
Marketing start 2012-08-01
Marketing end 0000-00-00
Substance OCTOCRYLENE; OCTISALATE; AVOBENZONE; OCTINOXATE
Active strength 2 mg/15mL; mg/15mL; g/15mL; mg/15mL
NDC exclude flag No
Listing certified through 2020-12-31
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 · 18 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…2022-08-30 03:57 UTC · source 2022-08-29 fb8cb913e6d1…eb8c232b6be0…2022-04-09 23:13 UTC · source 2022-04-08 86f5da6cb304…a595104c45d7…2022-04-04 05:40 UTC · source 2022-04-01 bd6a592717d7…303034d00443…
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 58418-295-15 Skin Crave spf15 lip balm 15 mL in 1 CANISTER LIPSTICK 15 3
DailyMed Dashboard NDC Coverage# NDC, Dashboard title, SPL version table NDC Dashboard title SPL version Validation Dashboard ZIP 58418-295 SKIN CRAVE SPF15 LIP BALM (SPF15 LIP BALM (CHEMICAL)) LIPSTICK [TROPICAL ENTERPRISES INTERNATIONAL, INC.] 3 Legacy NDC, 1 package rows 20180711_484dcd16-27c2-1113-e054-00144ff8d46c.zip
Packages# Package NDC, 11-digit format, Description table Package NDC 11-digit format Description Units Marketing start Marketing end Sample Exclude flag Status 58418-295-15 58418029515 15 mL in 1 CANISTER (58418-295-15) 15 ml 2012-08-01 0000-00-00 No No Current