Home NDC 49527-044 ACNE BB BROAD SPECTRUM SPF 40
Product NDC 49527-044
11-digit product format 495270044
Labeler code 49527
Product ID 49527-044_607b8b2c-9634-4562-9d6c-84881c1577cf
Type HUMAN OTC DRUG
Nonproprietary name OCTINOXATE, OCTISALATE, and TITANIUM DIOXIDE
Dosage form CREAM
Route TOPICAL
Labeler CLINIQUE LABORATORIES LLC
Application part352
Marketing category OTC MONOGRAPH NOT FINAL
Marketing start 2014-11-01
Marketing end 0000-00-00
Substance OCTINOXATE; OCTISALATE; TITANIUM DIOXIDE
Active strength 0 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 · 24 matching rows.
View current auxiliary records. · View the auxiliary file history.
Captured / source date, Dataset, Scope table Captured / source date Dataset Scope Package NDC Snapshot Source SHA-256 2025-12-14 17:58 UTC · source 2025-12-05 excluded product product d630ba8d3edf…732f749b63fb…2025-12-14 17:58 UTC · source 2025-12-05 excluded package package 49527-044-01 d630ba8d3edf…732f749b63fb…2025-08-27 00:01 UTC · source 2025-08-26 excluded product product f5e01cc5f278…a2eaf40c39c3…2025-08-27 00:01 UTC · source 2025-08-26 excluded package package 49527-044-01 f5e01cc5f278…a2eaf40c39c3…2025-04-01 02:39 UTC · source 2025-03-31 excluded product product 2ef7874e63bc…57b86245f4fa…2025-04-01 02:39 UTC · source 2025-03-31 excluded package package 49527-044-01 2ef7874e63bc…57b86245f4fa…2025-03-28 20:22 UTC · source 2025-03-28 excluded product product a1b67e2a42f9…c4cf2c586c0d…2025-03-28 20:22 UTC · source 2025-03-28 excluded package package 49527-044-01 a1b67e2a42f9…c4cf2c586c0d…2025-03-22 03:12 UTC · source 2025-03-21 excluded product product cfe11265f3b6…090c488252e2…2025-03-22 03:12 UTC · source 2025-03-21 excluded package package 49527-044-01 cfe11265f3b6…090c488252e2…2025-03-10 12:48 UTC · source 2025-03-10 excluded product product cdf11ea48f46…ba0047e9e063…2025-03-10 12:48 UTC · source 2025-03-10 excluded package package 49527-044-01 cdf11ea48f46…ba0047e9e063…2025-02-02 03:52 UTC · source 2025-01-31 excluded product product 302b2466d912…e7b80fea0513…2025-02-02 03:52 UTC · source 2025-01-31 excluded package package 49527-044-01 302b2466d912…e7b80fea0513…2025-01-20 13:05 UTC · source 2025-01-20 excluded product product ed331223b511…672a5bd82f5f…2025-01-20 13:05 UTC · source 2025-01-20 excluded package package 49527-044-01 ed331223b511…672a5bd82f5f…2025-01-11 03:41 UTC · source 2025-01-10 excluded product product 0efc9e666f02…f202fb6c5f17…2025-01-11 03:41 UTC · source 2025-01-10 excluded package package 49527-044-01 0efc9e666f02…f202fb6c5f17…2024-11-09 02:27 UTC · source 2024-11-08 excluded product product ad56d346431e…cc804d4bbf1e…2024-11-09 02:27 UTC · source 2024-11-08 excluded package package 49527-044-01 ad56d346431e…cc804d4bbf1e…2024-10-04 04:10 UTC · source 2024-10-03 excluded product product 367a005e9d99…383a685ebd0f…2024-10-04 04:10 UTC · source 2024-10-03 excluded package package 49527-044-01 367a005e9d99…383a685ebd0f…2024-07-10 04:00 UTC · source 2024-07-09 excluded product product 557ba5c1ecfa…9c80585c8c6e…2024-07-10 04:00 UTC · source 2024-07-09 excluded package package 49527-044-01 557ba5c1ecfa…9c80585c8c6e…
Reported adverse events (FAERS/openFDA)# Adverse event summaries are temporarily unavailable. Other product information remains available.
DailyMed Socrata Ingredients# Ingredient, Type, UNII table Ingredient Type UNII DailyMed label SPL version Uploaded OCTINOXATE ACTIVE INGREDIENT 4Y5P7MUD51 ACNE BB BROAD SPECTRUM SPF 40 (OCTINOXATE, OCTISALATE, AND TITANIUM DIOXIDE) CREAM [CLINIQUE LABORATORIES INC.] 2 OCTISALATE ACTIVE INGREDIENT 4X49Y0596W ACNE BB BROAD SPECTRUM SPF 40 (OCTINOXATE, OCTISALATE, AND TITANIUM DIOXIDE) CREAM [CLINIQUE LABORATORIES INC.] 2 TITANIUM DIOXIDE ACTIVE INGREDIENT 15FIX9V2JP ACNE BB BROAD SPECTRUM SPF 40 (OCTINOXATE, OCTISALATE, AND TITANIUM DIOXIDE) CREAM [CLINIQUE LABORATORIES INC.] 2 OCTINOXATE ACTIVE MOIETY 4Y5P7MUD51 ACNE BB BROAD SPECTRUM SPF 40 (OCTINOXATE, OCTISALATE, AND TITANIUM DIOXIDE) CREAM [CLINIQUE LABORATORIES INC.] 2 OCTISALATE ACTIVE MOIETY 4X49Y0596W ACNE BB BROAD SPECTRUM SPF 40 (OCTINOXATE, OCTISALATE, AND TITANIUM DIOXIDE) CREAM [CLINIQUE LABORATORIES INC.] 2 TITANIUM DIOXIDE ACTIVE MOIETY 15FIX9V2JP ACNE BB BROAD SPECTRUM SPF 40 (OCTINOXATE, OCTISALATE, AND TITANIUM DIOXIDE) CREAM [CLINIQUE LABORATORIES INC.] 2 .ALPHA.-TOCOPHEROL ACETATE INACTIVE INGREDIENT 9E8X80D2L0 ACNE BB BROAD SPECTRUM SPF 40 (OCTINOXATE, OCTISALATE, AND TITANIUM DIOXIDE) CREAM [CLINIQUE LABORATORIES INC.] 2 ALCOHOL INACTIVE INGREDIENT 3K9958V90M ACNE BB BROAD SPECTRUM SPF 40 (OCTINOXATE, OCTISALATE, AND TITANIUM DIOXIDE) CREAM [CLINIQUE LABORATORIES INC.] 2 ALUMINUM HYDROXIDE INACTIVE INGREDIENT 5QB0T2IUN0 ACNE BB BROAD SPECTRUM SPF 40 (OCTINOXATE, OCTISALATE, AND TITANIUM DIOXIDE) CREAM [CLINIQUE LABORATORIES INC.] 2 DIMETHICONE INACTIVE INGREDIENT 92RU3N3Y1O ACNE BB BROAD SPECTRUM SPF 40 (OCTINOXATE, OCTISALATE, AND TITANIUM DIOXIDE) CREAM [CLINIQUE LABORATORIES INC.] 2 ETHYLHEXYL PALMITATE INACTIVE INGREDIENT 2865993309 ACNE BB BROAD SPECTRUM SPF 40 (OCTINOXATE, OCTISALATE, AND TITANIUM DIOXIDE) CREAM [CLINIQUE LABORATORIES INC.] 2 FERRIC OXIDE RED INACTIVE INGREDIENT 1K09F3G675 ACNE BB BROAD SPECTRUM SPF 40 (OCTINOXATE, OCTISALATE, AND TITANIUM DIOXIDE) CREAM [CLINIQUE LABORATORIES INC.] 2 FERRIC OXIDE YELLOW INACTIVE INGREDIENT EX438O2MRT ACNE BB BROAD SPECTRUM SPF 40 (OCTINOXATE, OCTISALATE, AND TITANIUM DIOXIDE) CREAM [CLINIQUE LABORATORIES INC.] 2 FERROSOFERRIC OXIDE INACTIVE INGREDIENT XM0M87F357 ACNE BB BROAD SPECTRUM SPF 40 (OCTINOXATE, OCTISALATE, AND TITANIUM DIOXIDE) CREAM [CLINIQUE LABORATORIES INC.] 2 GLYCERIN INACTIVE INGREDIENT PDC6A3C0OX ACNE BB BROAD SPECTRUM SPF 40 (OCTINOXATE, OCTISALATE, AND TITANIUM DIOXIDE) CREAM [CLINIQUE LABORATORIES INC.] 2 GLYCERYL CAPRYLATE INACTIVE INGREDIENT TM2TZD4G4A ACNE BB BROAD SPECTRUM SPF 40 (OCTINOXATE, OCTISALATE, AND TITANIUM DIOXIDE) CREAM [CLINIQUE LABORATORIES INC.] 2 HESPERIDIN METHYLCHALCONE INACTIVE INGREDIENT 4T2GVA922X ACNE BB BROAD SPECTRUM SPF 40 (OCTINOXATE, OCTISALATE, AND TITANIUM DIOXIDE) CREAM [CLINIQUE LABORATORIES INC.] 2 HYALURONATE SODIUM INACTIVE INGREDIENT YSE9PPT4TH ACNE BB BROAD SPECTRUM SPF 40 (OCTINOXATE, OCTISALATE, AND TITANIUM DIOXIDE) CREAM [CLINIQUE LABORATORIES INC.] 2 METHYL TRIMETHICONE INACTIVE INGREDIENT S73ZQI0GXM ACNE BB BROAD SPECTRUM SPF 40 (OCTINOXATE, OCTISALATE, AND TITANIUM DIOXIDE) CREAM [CLINIQUE LABORATORIES INC.] 2 MICA INACTIVE INGREDIENT V8A1AW0880 ACNE BB BROAD SPECTRUM SPF 40 (OCTINOXATE, OCTISALATE, AND TITANIUM DIOXIDE) CREAM [CLINIQUE LABORATORIES INC.] 2 PALMITOYL TETRAPEPTIDE-7 INACTIVE INGREDIENT Q41S464P1R ACNE BB BROAD SPECTRUM SPF 40 (OCTINOXATE, OCTISALATE, AND TITANIUM DIOXIDE) CREAM [CLINIQUE LABORATORIES INC.] 2 PEG-9 POLYDIMETHYLSILOXYETHYL DIMETHICONE INACTIVE INGREDIENT TYP81E471F ACNE BB BROAD SPECTRUM SPF 40 (OCTINOXATE, OCTISALATE, AND TITANIUM DIOXIDE) CREAM [CLINIQUE LABORATORIES INC.] 2 PHENOXYETHANOL INACTIVE INGREDIENT HIE492ZZ3T ACNE BB BROAD SPECTRUM SPF 40 (OCTINOXATE, OCTISALATE, AND TITANIUM DIOXIDE) CREAM [CLINIQUE LABORATORIES INC.] 2 PROPANEDIOL INACTIVE INGREDIENT 5965N8W85T ACNE BB BROAD SPECTRUM SPF 40 (OCTINOXATE, OCTISALATE, AND TITANIUM DIOXIDE) CREAM [CLINIQUE LABORATORIES INC.] 2 PYRIDOXINE HYDROCHLORIDE INACTIVE INGREDIENT 68Y4CF58BV ACNE BB BROAD SPECTRUM SPF 40 (OCTINOXATE, OCTISALATE, AND TITANIUM DIOXIDE) CREAM [CLINIQUE LABORATORIES INC.] 2 SILICON DIOXIDE INACTIVE INGREDIENT ETJ7Z6XBU4 ACNE BB BROAD SPECTRUM SPF 40 (OCTINOXATE, OCTISALATE, AND TITANIUM DIOXIDE) CREAM [CLINIQUE LABORATORIES INC.] 2 SODIUM CHLORIDE INACTIVE INGREDIENT 451W47IQ8X ACNE BB BROAD SPECTRUM SPF 40 (OCTINOXATE, OCTISALATE, AND TITANIUM DIOXIDE) CREAM [CLINIQUE LABORATORIES INC.] 2 SODIUM CITRATE INACTIVE INGREDIENT 1Q73Q2JULR ACNE BB BROAD SPECTRUM SPF 40 (OCTINOXATE, OCTISALATE, AND TITANIUM DIOXIDE) CREAM [CLINIQUE LABORATORIES INC.] 2 STEARETH-20 INACTIVE INGREDIENT L0Q8IK9E08 ACNE BB BROAD SPECTRUM SPF 40 (OCTINOXATE, OCTISALATE, AND TITANIUM DIOXIDE) CREAM [CLINIQUE LABORATORIES INC.] 2 STEARIC ACID INACTIVE INGREDIENT 4ELV7Z65AP ACNE BB BROAD SPECTRUM SPF 40 (OCTINOXATE, OCTISALATE, AND TITANIUM DIOXIDE) CREAM [CLINIQUE LABORATORIES INC.] 2 STEARYL GLYCYRRHETINATE INACTIVE INGREDIENT 3YYE6VJS0P ACNE BB BROAD SPECTRUM SPF 40 (OCTINOXATE, OCTISALATE, AND TITANIUM DIOXIDE) CREAM [CLINIQUE LABORATORIES INC.] 2 TRIETHOXYCAPRYLYLSILANE INACTIVE INGREDIENT LDC331P08E ACNE BB BROAD SPECTRUM SPF 40 (OCTINOXATE, OCTISALATE, AND TITANIUM DIOXIDE) CREAM [CLINIQUE LABORATORIES INC.] 2 VALYLTRYPTOPHAN INACTIVE INGREDIENT 3G64B4AFQN ACNE BB BROAD SPECTRUM SPF 40 (OCTINOXATE, OCTISALATE, AND TITANIUM DIOXIDE) CREAM [CLINIQUE LABORATORIES INC.] 2 WATER INACTIVE INGREDIENT 059QF0KO0R ACNE BB BROAD SPECTRUM SPF 40 (OCTINOXATE, OCTISALATE, AND TITANIUM DIOXIDE) CREAM [CLINIQUE LABORATORIES INC.] 2
Packages# Package NDC, 11-digit format, Description table Package NDC 11-digit format Description Units Marketing start Marketing end Sample Exclude flag Status 49527-044-01 49527004401 1 TUBE in 1 CARTON (49527-044-01) > 30 mL in 1 TUBE 1 tube 2014-11-01 0000-00-00 No No Current