Home NDC 65371-025 BB ANTI-FATIGUE ABSOLUTE SPF 25
Product NDC 65371-025
11-digit product format 653710025
Labeler code 65371
Product ID 65371-025_a248570a-8143-440d-8395-fc2be4548b08
Type HUMAN OTC DRUG
Nonproprietary name HOMOSALATE, OCTISALATE, and OXYBENZONE
Dosage form CREAM
Route TOPICAL
Labeler ORLANE S.A.
Application part352
Marketing category OTC MONOGRAPH FINAL
Marketing start 2013-04-01
Marketing end 0000-00-00
Substance HOMOSALATE; OCTISALATE; OXYBENZONE
Active strength 90 mg/mL; mg/mL; mg/mL
NDC exclude flag E
Listing certified through 2017-12-31
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 · 28 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 D Discontinued by firm d630ba8d3edf…732f749b63fb…2025-12-14 17:58 UTC · source 2025-12-05 excluded package package 65371-025-02 D Discontinued by firm d630ba8d3edf…732f749b63fb…2025-08-27 00:01 UTC · source 2025-08-26 excluded product product D Discontinued by firm f5e01cc5f278…a2eaf40c39c3…2025-08-27 00:01 UTC · source 2025-08-26 excluded package package 65371-025-02 D Discontinued by firm f5e01cc5f278…a2eaf40c39c3…2025-04-01 02:39 UTC · source 2025-03-31 excluded product product D Discontinued by firm 2ef7874e63bc…57b86245f4fa…2025-04-01 02:39 UTC · source 2025-03-31 excluded package package 65371-025-02 D Discontinued by firm 2ef7874e63bc…57b86245f4fa…2025-03-28 20:22 UTC · source 2025-03-28 excluded product product D Discontinued by firm a1b67e2a42f9…c4cf2c586c0d…2025-03-28 20:22 UTC · source 2025-03-28 excluded package package 65371-025-02 D Discontinued by firm a1b67e2a42f9…c4cf2c586c0d…2025-03-22 03:12 UTC · source 2025-03-21 excluded product product D Discontinued by firm cfe11265f3b6…090c488252e2…2025-03-22 03:12 UTC · source 2025-03-21 excluded package package 65371-025-02 D Discontinued by firm cfe11265f3b6…090c488252e2…2025-03-10 12:48 UTC · source 2025-03-10 excluded product product D Discontinued by firm cdf11ea48f46…ba0047e9e063…2025-03-10 12:48 UTC · source 2025-03-10 excluded package package 65371-025-02 D Discontinued by firm cdf11ea48f46…ba0047e9e063…2025-02-02 03:52 UTC · source 2025-01-31 excluded product product D Discontinued by firm 302b2466d912…e7b80fea0513…2025-02-02 03:52 UTC · source 2025-01-31 excluded package package 65371-025-02 D Discontinued by firm 302b2466d912…e7b80fea0513…2025-01-20 13:05 UTC · source 2025-01-20 excluded product product D Discontinued by firm ed331223b511…672a5bd82f5f…2025-01-20 13:05 UTC · source 2025-01-20 excluded package package 65371-025-02 D Discontinued by firm ed331223b511…672a5bd82f5f…2025-01-11 03:41 UTC · source 2025-01-10 excluded product product D Discontinued by firm 0efc9e666f02…f202fb6c5f17…2025-01-11 03:41 UTC · source 2025-01-10 excluded package package 65371-025-02 D Discontinued by firm 0efc9e666f02…f202fb6c5f17…2024-11-09 02:27 UTC · source 2024-11-08 excluded product product D Discontinued by firm ad56d346431e…cc804d4bbf1e…2024-11-09 02:27 UTC · source 2024-11-08 excluded package package 65371-025-02 D Discontinued by firm ad56d346431e…cc804d4bbf1e…2024-10-04 04:10 UTC · source 2024-10-03 excluded product product D Discontinued by firm 367a005e9d99…383a685ebd0f…2024-10-04 04:10 UTC · source 2024-10-03 excluded package package 65371-025-02 D Discontinued by firm 367a005e9d99…383a685ebd0f…2024-07-10 04:00 UTC · source 2024-07-09 excluded product product D Discontinued by firm 557ba5c1ecfa…9c80585c8c6e…2024-07-10 04:00 UTC · source 2024-07-09 excluded package package 65371-025-02 D Discontinued by firm 557ba5c1ecfa…9c80585c8c6e…2020-06-10 20:45 UTC · source 2020-06-10 excluded product product I Inactivated by FDA 9bebd1f3094a…5416666fcb17…2020-06-10 20:45 UTC · source 2020-06-10 excluded package package 65371-025-02 I Inactivated by FDA 9bebd1f3094a…5416666fcb17…2019-12-08 06:16 UTC · source 2019-12-05 excluded product product I Inactivated by FDA 110d247fa046…a55b01930146…2019-12-08 06:16 UTC · source 2019-12-05 excluded package package 65371-025-02 I Inactivated by FDA 110d247fa046…a55b01930146…
FDA-Initiated Inactive NDC Indexing# DailyMed Socrata Ingredients# Ingredient, Type, UNII table Ingredient Type UNII DailyMed label SPL version Uploaded HOMOSALATE ACTIVE INGREDIENT V06SV4M95S BB ANTI-FATIGUE ABSOLUTE SPF 25 (HOMOSALATE, OCTISALATE, AND OXYBENZONE) CREAM [ORLANE S.A.] 1 OCTISALATE ACTIVE INGREDIENT 4X49Y0596W BB ANTI-FATIGUE ABSOLUTE SPF 25 (HOMOSALATE, OCTISALATE, AND OXYBENZONE) CREAM [ORLANE S.A.] 1 OXYBENZONE ACTIVE INGREDIENT 95OOS7VE0Y BB ANTI-FATIGUE ABSOLUTE SPF 25 (HOMOSALATE, OCTISALATE, AND OXYBENZONE) CREAM [ORLANE S.A.] 1 HOMOSALATE ACTIVE MOIETY V06SV4M95S BB ANTI-FATIGUE ABSOLUTE SPF 25 (HOMOSALATE, OCTISALATE, AND OXYBENZONE) CREAM [ORLANE S.A.] 1 OCTISALATE ACTIVE MOIETY 4X49Y0596W BB ANTI-FATIGUE ABSOLUTE SPF 25 (HOMOSALATE, OCTISALATE, AND OXYBENZONE) CREAM [ORLANE S.A.] 1 OXYBENZONE ACTIVE MOIETY 95OOS7VE0Y BB ANTI-FATIGUE ABSOLUTE SPF 25 (HOMOSALATE, OCTISALATE, AND OXYBENZONE) CREAM [ORLANE S.A.] 1 Asian Ginseng INACTIVE INGREDIENT CUQ3A77YXI BB ANTI-FATIGUE ABSOLUTE SPF 25 (HOMOSALATE, OCTISALATE, AND OXYBENZONE) CREAM [ORLANE S.A.] 1 Butylene Glycol INACTIVE INGREDIENT 3XUS85K0RA BB ANTI-FATIGUE ABSOLUTE SPF 25 (HOMOSALATE, OCTISALATE, AND OXYBENZONE) CREAM [ORLANE S.A.] 1 Ceteth-20 INACTIVE INGREDIENT I835H2IHHX BB ANTI-FATIGUE ABSOLUTE SPF 25 (HOMOSALATE, OCTISALATE, AND OXYBENZONE) CREAM [ORLANE S.A.] 1 Cetyl Alcohol INACTIVE INGREDIENT 936JST6JCN BB ANTI-FATIGUE ABSOLUTE SPF 25 (HOMOSALATE, OCTISALATE, AND OXYBENZONE) CREAM [ORLANE S.A.] 1 Dimethicone INACTIVE INGREDIENT 92RU3N3Y1O BB ANTI-FATIGUE ABSOLUTE SPF 25 (HOMOSALATE, OCTISALATE, AND OXYBENZONE) CREAM [ORLANE S.A.] 1 Edetate Sodium INACTIVE INGREDIENT MP1J8420LU BB ANTI-FATIGUE ABSOLUTE SPF 25 (HOMOSALATE, OCTISALATE, AND OXYBENZONE) CREAM [ORLANE S.A.] 1 Glycerin INACTIVE INGREDIENT PDC6A3C0OX BB ANTI-FATIGUE ABSOLUTE SPF 25 (HOMOSALATE, OCTISALATE, AND OXYBENZONE) CREAM [ORLANE S.A.] 1 Glyceryl Monostearate INACTIVE INGREDIENT 230OU9XXE4 BB ANTI-FATIGUE ABSOLUTE SPF 25 (HOMOSALATE, OCTISALATE, AND OXYBENZONE) CREAM [ORLANE S.A.] 1 Hyaluronate Sodium INACTIVE INGREDIENT YSE9PPT4TH BB ANTI-FATIGUE ABSOLUTE SPF 25 (HOMOSALATE, OCTISALATE, AND OXYBENZONE) CREAM [ORLANE S.A.] 1 O-Cymen-5-OL INACTIVE INGREDIENT H41B6Q1I9L BB ANTI-FATIGUE ABSOLUTE SPF 25 (HOMOSALATE, OCTISALATE, AND OXYBENZONE) CREAM [ORLANE S.A.] 1 PEG-100 Stearate INACTIVE INGREDIENT YD01N1999R BB ANTI-FATIGUE ABSOLUTE SPF 25 (HOMOSALATE, OCTISALATE, AND OXYBENZONE) CREAM [ORLANE S.A.] 1 Phenoxyethanol INACTIVE INGREDIENT HIE492ZZ3T BB ANTI-FATIGUE ABSOLUTE SPF 25 (HOMOSALATE, OCTISALATE, AND OXYBENZONE) CREAM [ORLANE S.A.] 1 Polyglycerin-3 INACTIVE INGREDIENT 4A0NCJ6RD6 BB ANTI-FATIGUE ABSOLUTE SPF 25 (HOMOSALATE, OCTISALATE, AND OXYBENZONE) CREAM [ORLANE S.A.] 1 Propanediol INACTIVE INGREDIENT 5965N8W85T BB ANTI-FATIGUE ABSOLUTE SPF 25 (HOMOSALATE, OCTISALATE, AND OXYBENZONE) CREAM [ORLANE S.A.] 1 Propylene Glycol INACTIVE INGREDIENT 6DC9Q167V3 BB ANTI-FATIGUE ABSOLUTE SPF 25 (HOMOSALATE, OCTISALATE, AND OXYBENZONE) CREAM [ORLANE S.A.] 1 Tetradium Ruticarpum Fruit INACTIVE INGREDIENT Q413WWJ3X9 BB ANTI-FATIGUE ABSOLUTE SPF 25 (HOMOSALATE, OCTISALATE, AND OXYBENZONE) CREAM [ORLANE S.A.] 1 Water INACTIVE INGREDIENT 059QF0KO0R BB ANTI-FATIGUE ABSOLUTE SPF 25 (HOMOSALATE, OCTISALATE, AND OXYBENZONE) CREAM [ORLANE S.A.] 1 Xanthan Gum INACTIVE INGREDIENT TTV12P4NEE BB ANTI-FATIGUE ABSOLUTE SPF 25 (HOMOSALATE, OCTISALATE, AND OXYBENZONE) CREAM [ORLANE S.A.] 1