Home NDC 11523-7094 Bain de Soleil
Product NDC 11523-7094
11-digit product format 115237094
Labeler code 11523
Product ID 11523-7094_eb00010c-72b7-04ea-e053-2995a90a456e
Type HUMAN OTC DRUG
Nonproprietary name Octinoxate and Octocrylene
Dosage form LOTION
Route TOPICAL
Labeler Bayer HealthCare LLC.
Application part352
Marketing category OTC MONOGRAPH FINAL
Marketing start 1999-05-21
Marketing end 0000-00-00
Substance OCTINOXATE; OCTOCRYLENE
Active strength 35 mg/mL; mg/mL
NDC exclude flag No
Listing certified through 2023-12-31
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 · 21 matching rows.
View current auxiliary records. · View the auxiliary file history.
Captured / source date, Dataset, Scope table Captured / source date Dataset Scope Package NDC Code Status Snapshot Source SHA-256 2025-12-14 17:58 UTC · source 2025-12-05 excluded product product I Inactivated by FDA d630ba8d3edf…732f749b63fb…2025-12-14 17:58 UTC · source 2025-12-05 excluded package package 11523-7094-1 D Discontinued by firm d630ba8d3edf…732f749b63fb…2025-08-27 00:01 UTC · source 2025-08-26 excluded product product I Inactivated by FDA f5e01cc5f278…a2eaf40c39c3…2025-08-27 00:01 UTC · source 2025-08-26 excluded package package 11523-7094-1 D Discontinued by firm f5e01cc5f278…a2eaf40c39c3…2025-04-01 02:39 UTC · source 2025-03-31 excluded product product I Inactivated by FDA 2ef7874e63bc…57b86245f4fa…2025-04-01 02:39 UTC · source 2025-03-31 excluded package package 11523-7094-1 D Discontinued by firm 2ef7874e63bc…57b86245f4fa…2025-03-28 20:22 UTC · source 2025-03-28 excluded product product I Inactivated by FDA a1b67e2a42f9…c4cf2c586c0d…2025-03-28 20:22 UTC · source 2025-03-28 excluded package package 11523-7094-1 D Discontinued by firm a1b67e2a42f9…c4cf2c586c0d…2025-03-22 03:12 UTC · source 2025-03-21 excluded product product I Inactivated by FDA cfe11265f3b6…090c488252e2…2025-03-22 03:12 UTC · source 2025-03-21 excluded package package 11523-7094-1 D Discontinued by firm cfe11265f3b6…090c488252e2…2025-03-10 12:48 UTC · source 2025-03-10 excluded product product I Inactivated by FDA cdf11ea48f46…ba0047e9e063…2025-03-10 12:48 UTC · source 2025-03-10 excluded package package 11523-7094-1 D Discontinued by firm cdf11ea48f46…ba0047e9e063…2025-02-02 03:52 UTC · source 2025-01-31 excluded product product U Excluded because listing certification expired 302b2466d912…e7b80fea0513…2025-02-02 03:52 UTC · source 2025-01-31 excluded package package 11523-7094-1 D Discontinued by firm 302b2466d912…e7b80fea0513…2025-01-20 13:05 UTC · source 2025-01-20 excluded product product U Excluded because listing certification expired ed331223b511…672a5bd82f5f…2025-01-20 13:05 UTC · source 2025-01-20 excluded package package 11523-7094-1 D Discontinued by firm ed331223b511…672a5bd82f5f…2025-01-11 03:41 UTC · source 2025-01-10 excluded product product U Excluded because listing certification expired 0efc9e666f02…f202fb6c5f17…2025-01-11 03:41 UTC · source 2025-01-10 excluded package package 11523-7094-1 D Discontinued by firm 0efc9e666f02…f202fb6c5f17…2024-11-09 02:27 UTC · source 2024-11-08 excluded package package 11523-7094-1 D Discontinued by firm ad56d346431e…cc804d4bbf1e…2024-10-04 04:10 UTC · source 2024-10-03 excluded package package 11523-7094-1 D Discontinued by firm 367a005e9d99…383a685ebd0f…2024-07-10 04:00 UTC · source 2024-07-09 excluded package package 11523-7094-1 D Discontinued by firm 557ba5c1ecfa…9c80585c8c6e…
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 11523-7094-1 Bain de SoleilMega Tan SPF 4 1 in 1 CARTON LOTION 1 7 11523-7094-1 Bain de SoleilMega Tan SPF 4 118 mL in 1 TUBE LOTION 118 7
DailyMed Socrata Ingredients# Ingredient, Type, UNII table Ingredient Type UNII DailyMed label SPL version Uploaded Octinoxate ACTIVE INGREDIENT 4Y5P7MUD51 BAIN DE SOLEIL MEGA TAN SPF 4 (OCTINOXATE AND OCTOCRYLENE) LOTION [MSD CONSUMER CARE, INC.] 1 Octocrylene ACTIVE INGREDIENT 5A68WGF6WM BAIN DE SOLEIL MEGA TAN SPF 4 (OCTINOXATE AND OCTOCRYLENE) LOTION [MSD CONSUMER CARE, INC.] 1 Octinoxate ACTIVE MOIETY 4Y5P7MUD51 BAIN DE SOLEIL MEGA TAN SPF 4 (OCTINOXATE AND OCTOCRYLENE) LOTION [MSD CONSUMER CARE, INC.] 1 Octocrylene ACTIVE MOIETY 5A68WGF6WM BAIN DE SOLEIL MEGA TAN SPF 4 (OCTINOXATE AND OCTOCRYLENE) LOTION [MSD CONSUMER CARE, INC.] 1 aloe vera leaf INACTIVE INGREDIENT ZY81Z83H0X BAIN DE SOLEIL MEGA TAN SPF 4 (OCTINOXATE AND OCTOCRYLENE) LOTION [MSD CONSUMER CARE, INC.] 1 apricot INACTIVE INGREDIENT 269CJD5GZ9 BAIN DE SOLEIL MEGA TAN SPF 4 (OCTINOXATE AND OCTOCRYLENE) LOTION [MSD CONSUMER CARE, INC.] 1 butylene glycol INACTIVE INGREDIENT 3XUS85K0RA BAIN DE SOLEIL MEGA TAN SPF 4 (OCTINOXATE AND OCTOCRYLENE) LOTION [MSD CONSUMER CARE, INC.] 1 cetyl alcohol INACTIVE INGREDIENT 936JST6JCN BAIN DE SOLEIL MEGA TAN SPF 4 (OCTINOXATE AND OCTOCRYLENE) LOTION [MSD CONSUMER CARE, INC.] 1 cetyl palmitate INACTIVE INGREDIENT 5ZA2S6B08X BAIN DE SOLEIL MEGA TAN SPF 4 (OCTINOXATE AND OCTOCRYLENE) LOTION [MSD CONSUMER CARE, INC.] 1 chamomile INACTIVE INGREDIENT FGL3685T2X BAIN DE SOLEIL MEGA TAN SPF 4 (OCTINOXATE AND OCTOCRYLENE) LOTION [MSD CONSUMER CARE, INC.] 1 cocoa INACTIVE INGREDIENT D9108TZ9KG BAIN DE SOLEIL MEGA TAN SPF 4 (OCTINOXATE AND OCTOCRYLENE) LOTION [MSD CONSUMER CARE, INC.] 1 cyclomethicone 5 INACTIVE INGREDIENT 0THT5PCI0R BAIN DE SOLEIL MEGA TAN SPF 4 (OCTINOXATE AND OCTOCRYLENE) LOTION [MSD CONSUMER CARE, INC.] 1 dihydroxyacetone INACTIVE INGREDIENT O10DDW6JOO BAIN DE SOLEIL MEGA TAN SPF 4 (OCTINOXATE AND OCTOCRYLENE) LOTION [MSD CONSUMER CARE, INC.] 1 distearyldimonium chloride INACTIVE INGREDIENT OM9573ZX3X BAIN DE SOLEIL MEGA TAN SPF 4 (OCTINOXATE AND OCTOCRYLENE) LOTION [MSD CONSUMER CARE, INC.] 1 DMDM hydantoin INACTIVE INGREDIENT BYR0546TOW BAIN DE SOLEIL MEGA TAN SPF 4 (OCTINOXATE AND OCTOCRYLENE) LOTION [MSD CONSUMER CARE, INC.] 1 Edetate Disodium INACTIVE INGREDIENT 7FLD91C86K BAIN DE SOLEIL MEGA TAN SPF 4 (OCTINOXATE AND OCTOCRYLENE) LOTION [MSD CONSUMER CARE, INC.] 1 eucalyptus globulus leaf INACTIVE INGREDIENT S546YLW6E6 BAIN DE SOLEIL MEGA TAN SPF 4 (OCTINOXATE AND OCTOCRYLENE) LOTION [MSD CONSUMER CARE, INC.] 1 iodopropynyl butylcarbamate INACTIVE INGREDIENT 603P14DHEB BAIN DE SOLEIL MEGA TAN SPF 4 (OCTINOXATE AND OCTOCRYLENE) LOTION [MSD CONSUMER CARE, INC.] 1 isohexadecane INACTIVE INGREDIENT 918X1OUF1E BAIN DE SOLEIL MEGA TAN SPF 4 (OCTINOXATE AND OCTOCRYLENE) LOTION [MSD CONSUMER CARE, INC.] 1 lanolin INACTIVE INGREDIENT 7EV65EAW6H BAIN DE SOLEIL MEGA TAN SPF 4 (OCTINOXATE AND OCTOCRYLENE) LOTION [MSD CONSUMER CARE, INC.] 1 mineral oil INACTIVE INGREDIENT T5L8T28FGP BAIN DE SOLEIL MEGA TAN SPF 4 (OCTINOXATE AND OCTOCRYLENE) LOTION [MSD CONSUMER CARE, INC.] 1 palm kernel oil INACTIVE INGREDIENT B0S90M0233 BAIN DE SOLEIL MEGA TAN SPF 4 (OCTINOXATE AND OCTOCRYLENE) LOTION [MSD CONSUMER CARE, INC.] 1 PPG-1 trideceth-6 INACTIVE INGREDIENT 1K7417JX6Q BAIN DE SOLEIL MEGA TAN SPF 4 (OCTINOXATE AND OCTOCRYLENE) LOTION [MSD CONSUMER CARE, INC.] 1 tribehenin INACTIVE INGREDIENT 8OC9U7TQZ0 BAIN DE SOLEIL MEGA TAN SPF 4 (OCTINOXATE AND OCTOCRYLENE) LOTION [MSD CONSUMER CARE, INC.] 1 water INACTIVE INGREDIENT 059QF0KO0R BAIN DE SOLEIL MEGA TAN SPF 4 (OCTINOXATE AND OCTOCRYLENE) LOTION [MSD CONSUMER CARE, INC.] 1
DailyMed Dashboard NDC Coverage# NDC, Dashboard title, SPL version table NDC Dashboard title SPL version Validation Dashboard ZIP 11523-7094 BAIN DE SOLEIL MEGA TAN SPF 4 (OCTINOXATE AND OCTOCRYLENE) LOTION [BAYER HEALTHCARE LLC.] 7 Legacy NDC, 2 package rows 20230910_6c517222-35fe-4d93-8fc9-bd38ccda65fc.zip
Packages# Package NDC, 11-digit format, Description table Package NDC 11-digit format Description Units Marketing start Marketing end Sample Exclude flag Status 11523-7094-1 11523709401 1 TUBE in 1 CARTON (11523-7094-1) > 118 mL in 1 TUBE 1 tube 1999-05-21 0000-00-00 No No Current