Home NDC 65753-105-38 Sun XSPF 30 Broad Spectrum Sunscreen Lip Balm
Product NDC 65753-105
Requested package NDC 65753-105-38
11-digit product format 657530105
Labeler code 65753
Product ID 65753-105_983350fa-921a-265c-e053-2995a90aea0e
Type HUMAN OTC DRUG
Nonproprietary name Avobenzone, Homosalate, Octisalate, Octocrylene, Oxybenzone
Dosage form LIPSTICK
Route TOPICAL
Labeler CoreTex Products, INC
Application part352
Marketing category OTC MONOGRAPH NOT FINAL
Marketing start 2017-01-01
Marketing end 0000-00-00
Substance OCTISALATE; OCTOCRYLENE; OXYBENZONE; AVOBENZONE; HOMOSALATE
Active strength 5 g/100mL; g/100mL; g/100mL; g/100mL; g/100mL
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 · 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 65753-105-23 Sun XSPF 30 Broad Spectrum Sunscreen Lip Balm 4.44 mL in 1 APPLICATOR LIPSTICK 4.44 3 65753-105-23 Sun XSPF 30 Broad Spectrum Sunscreen Lip Balm 50 in 1 CONTAINER LIPSTICK 50 3 65753-105-36 Sun XSPF 30 Broad Spectrum Sunscreen Lip Balm 24 in 1 CONTAINER LIPSTICK 24 3 65753-105-36 Sun XSPF 30 Broad Spectrum Sunscreen Lip Balm 4.44 mL in 1 APPLICATOR LIPSTICK 4.44 3 65753-105-38 Sun XSPF 30 Broad Spectrum Sunscreen Lip Balm 72 in 1 CONTAINER LIPSTICK 72 3 65753-105-38 Sun XSPF 30 Broad Spectrum Sunscreen Lip Balm 4.44 mL in 1 APPLICATOR LIPSTICK 4.44 3
DailyMed Dashboard NDC Coverage# NDC, Dashboard title, SPL version table NDC Dashboard title SPL version Validation Dashboard ZIP 65753-105 SUN XSPF 30 BROAD SPECTRUM SUNSCREEN LIP BALM (AVOBENZONE, HOMOSALATE, OCTISALATE, OCTOCRYLENE, OXYBENZONE) LIPSTICK [CORETEX PRODUCTS, INC] 3 Legacy NDC, 6 package rows 20191126_5f0b530a-d4a7-cd6f-e053-2991aa0a1d03.zip
Packages# Package NDC, 11-digit format, Description table Package NDC 11-digit format Description Units Marketing start Marketing end Sample Exclude flag Status 65753-105-38 65753010538 72 APPLICATOR in 1 CONTAINER (65753-105-38) > 4.44 mL in 1 APPLICATOR 72 applicator 2017-01-01 0000-00-00 No No Current