CLINIQUE FOR MEN UV DEFENSE BROAD SPECTRUM SPF50

Product NDC
49527-046
11-digit product format
495270046
Labeler code
49527
Product ID
49527-046_c8fdecd2-36a1-415e-a276-f2345d21d072
Type
HUMAN OTC DRUG
Nonproprietary name
titanium dioxide and zinc oxide
Dosage form
LOTION
Route
TOPICAL
Labeler
CLINIQUE LABORATORIES LLC
Application
part352
Marketing category
OTC MONOGRAPH NOT FINAL
Marketing start
2015-04-01
Marketing end
0000-00-00
Substance
TITANIUM DIOXIDE; ZINC OXIDE
Active strength
0 g/100mL; g/100mL
NDC exclude flag
No
Listing certified through
2020-12-31
Current FDA listing
Historical FDA.report record

NDC auxiliary status#

These records are reproduced from FDA’s unfinished, excluded, and compounder listings. They describe what appeared in the source files; a missing record does not establish a regulatory status. View all current auxiliary records, including entries without an NDC. · View the auxiliary file history.

Current NDC status page 1 of 1 · 2 matching rows.

Dataset, Scope, Product NDC table
DatasetScopeProduct NDCPackage NDCCodeStatusReporting periodSource date
excluded productproduct49527-046DDiscontinued by firm2026-10-05
excluded packagepackage49527-04649527-046-01DDiscontinued by firm2026-10-05

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 dateDatasetScopePackage NDCSnapshotSource SHA-256
2025-12-14 17:58 UTC · source 2025-12-05excluded productproductd630ba8d3edf…732f749b63fb…
2025-12-14 17:58 UTC · source 2025-12-05excluded packagepackage49527-046-01d630ba8d3edf…732f749b63fb…
2025-08-27 00:01 UTC · source 2025-08-26excluded productproductf5e01cc5f278…a2eaf40c39c3…
2025-08-27 00:01 UTC · source 2025-08-26excluded packagepackage49527-046-01f5e01cc5f278…a2eaf40c39c3…
2025-04-01 02:39 UTC · source 2025-03-31excluded productproduct2ef7874e63bc…57b86245f4fa…
2025-04-01 02:39 UTC · source 2025-03-31excluded packagepackage49527-046-012ef7874e63bc…57b86245f4fa…
2025-03-28 20:22 UTC · source 2025-03-28excluded productproducta1b67e2a42f9…c4cf2c586c0d…
2025-03-28 20:22 UTC · source 2025-03-28excluded packagepackage49527-046-01a1b67e2a42f9…c4cf2c586c0d…
2025-03-22 03:12 UTC · source 2025-03-21excluded productproductcfe11265f3b6…090c488252e2…
2025-03-22 03:12 UTC · source 2025-03-21excluded packagepackage49527-046-01cfe11265f3b6…090c488252e2…
2025-03-10 12:48 UTC · source 2025-03-10excluded productproductcdf11ea48f46…ba0047e9e063…
2025-03-10 12:48 UTC · source 2025-03-10excluded packagepackage49527-046-01cdf11ea48f46…ba0047e9e063…
2025-02-02 03:52 UTC · source 2025-01-31excluded productproduct302b2466d912…e7b80fea0513…
2025-02-02 03:52 UTC · source 2025-01-31excluded packagepackage49527-046-01302b2466d912…e7b80fea0513…
2025-01-20 13:05 UTC · source 2025-01-20excluded productproducted331223b511…672a5bd82f5f…
2025-01-20 13:05 UTC · source 2025-01-20excluded packagepackage49527-046-01ed331223b511…672a5bd82f5f…
2025-01-11 03:41 UTC · source 2025-01-10excluded productproduct0efc9e666f02…f202fb6c5f17…
2025-01-11 03:41 UTC · source 2025-01-10excluded packagepackage49527-046-010efc9e666f02…f202fb6c5f17…
2024-11-09 02:27 UTC · source 2024-11-08excluded productproductad56d346431e…cc804d4bbf1e…
2024-11-09 02:27 UTC · source 2024-11-08excluded packagepackage49527-046-01ad56d346431e…cc804d4bbf1e…
2024-10-04 04:10 UTC · source 2024-10-03excluded productproduct367a005e9d99…383a685ebd0f…
2024-10-04 04:10 UTC · source 2024-10-03excluded packagepackage49527-046-01367a005e9d99…383a685ebd0f…
2024-07-10 04:00 UTC · source 2024-07-09excluded productproduct557ba5c1ecfa…9c80585c8c6e…
2024-07-10 04:00 UTC · source 2024-07-09excluded packagepackage49527-046-01557ba5c1ecfa…9c80585c8c6e…

Reported adverse events (FAERS/openFDA)#

Adverse event summaries are temporarily unavailable. Other product information remains available.

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIIDailyMed labelSPL versionUploaded
titanium dioxideACTIVE INGREDIENT15FIX9V2JPCLINIQUE FOR MEN UV DEFENSE BROAD SPECTRUM SPF50 (TITANIUM DIOXIDE AND ZINC OXIDE) LOTION [CLINIQUE LABORATORIES INC.]1
zinc oxideACTIVE INGREDIENTSOI2LOH54ZCLINIQUE FOR MEN UV DEFENSE BROAD SPECTRUM SPF50 (TITANIUM DIOXIDE AND ZINC OXIDE) LOTION [CLINIQUE LABORATORIES INC.]1
titanium dioxideACTIVE MOIETY15FIX9V2JPCLINIQUE FOR MEN UV DEFENSE BROAD SPECTRUM SPF50 (TITANIUM DIOXIDE AND ZINC OXIDE) LOTION [CLINIQUE LABORATORIES INC.]1
zinc oxideACTIVE MOIETYSOI2LOH54ZCLINIQUE FOR MEN UV DEFENSE BROAD SPECTRUM SPF50 (TITANIUM DIOXIDE AND ZINC OXIDE) LOTION [CLINIQUE LABORATORIES INC.]1
alkyl (c12-15) benzoateINACTIVE INGREDIENTA9EJ3J61HQCLINIQUE FOR MEN UV DEFENSE BROAD SPECTRUM SPF50 (TITANIUM DIOXIDE AND ZINC OXIDE) LOTION [CLINIQUE LABORATORIES INC.]1
butylene glycolINACTIVE INGREDIENT3XUS85K0RACLINIQUE FOR MEN UV DEFENSE BROAD SPECTRUM SPF50 (TITANIUM DIOXIDE AND ZINC OXIDE) LOTION [CLINIQUE LABORATORIES INC.]1
butyloctyl salicylateINACTIVE INGREDIENT2EH13UN8D3CLINIQUE FOR MEN UV DEFENSE BROAD SPECTRUM SPF50 (TITANIUM DIOXIDE AND ZINC OXIDE) LOTION [CLINIQUE LABORATORIES INC.]1
caprylyl glycolINACTIVE INGREDIENT00YIU5438UCLINIQUE FOR MEN UV DEFENSE BROAD SPECTRUM SPF50 (TITANIUM DIOXIDE AND ZINC OXIDE) LOTION [CLINIQUE LABORATORIES INC.]1
diethylhexyl succinateINACTIVE INGREDIENT69W9UMG3P8CLINIQUE FOR MEN UV DEFENSE BROAD SPECTRUM SPF50 (TITANIUM DIOXIDE AND ZINC OXIDE) LOTION [CLINIQUE LABORATORIES INC.]1
dimethiconeINACTIVE INGREDIENT92RU3N3Y1OCLINIQUE FOR MEN UV DEFENSE BROAD SPECTRUM SPF50 (TITANIUM DIOXIDE AND ZINC OXIDE) LOTION [CLINIQUE LABORATORIES INC.]1
dipropylene glycolINACTIVE INGREDIENTE107L85C40CLINIQUE FOR MEN UV DEFENSE BROAD SPECTRUM SPF50 (TITANIUM DIOXIDE AND ZINC OXIDE) LOTION [CLINIQUE LABORATORIES INC.]1
ethylhexyl methoxycryleneINACTIVE INGREDIENTS3KFG6Q5X8CLINIQUE FOR MEN UV DEFENSE BROAD SPECTRUM SPF50 (TITANIUM DIOXIDE AND ZINC OXIDE) LOTION [CLINIQUE LABORATORIES INC.]1
ferric oxide redINACTIVE INGREDIENT1K09F3G675CLINIQUE FOR MEN UV DEFENSE BROAD SPECTRUM SPF50 (TITANIUM DIOXIDE AND ZINC OXIDE) LOTION [CLINIQUE LABORATORIES INC.]1
ferric oxide yellowINACTIVE INGREDIENTEX438O2MRTCLINIQUE FOR MEN UV DEFENSE BROAD SPECTRUM SPF50 (TITANIUM DIOXIDE AND ZINC OXIDE) LOTION [CLINIQUE LABORATORIES INC.]1
isononyl isononanoateINACTIVE INGREDIENTS4V5BS6GCXCLINIQUE FOR MEN UV DEFENSE BROAD SPECTRUM SPF50 (TITANIUM DIOXIDE AND ZINC OXIDE) LOTION [CLINIQUE LABORATORIES INC.]1
isostearic acidINACTIVE INGREDIENTX33R8U0062CLINIQUE FOR MEN UV DEFENSE BROAD SPECTRUM SPF50 (TITANIUM DIOXIDE AND ZINC OXIDE) LOTION [CLINIQUE LABORATORIES INC.]1
laureth-4INACTIVE INGREDIENT6HQ855798JCLINIQUE FOR MEN UV DEFENSE BROAD SPECTRUM SPF50 (TITANIUM DIOXIDE AND ZINC OXIDE) LOTION [CLINIQUE LABORATORIES INC.]1
lauryl peg-9 polydimethylsiloxyethyl dimethiconeINACTIVE INGREDIENT25G622K2RACLINIQUE FOR MEN UV DEFENSE BROAD SPECTRUM SPF50 (TITANIUM DIOXIDE AND ZINC OXIDE) LOTION [CLINIQUE LABORATORIES INC.]1
methyl trimethiconeINACTIVE INGREDIENTS73ZQI0GXMCLINIQUE FOR MEN UV DEFENSE BROAD SPECTRUM SPF50 (TITANIUM DIOXIDE AND ZINC OXIDE) LOTION [CLINIQUE LABORATORIES INC.]1
neopentyl glycol diheptanoateINACTIVE INGREDIENT5LKW3C543XCLINIQUE FOR MEN UV DEFENSE BROAD SPECTRUM SPF50 (TITANIUM DIOXIDE AND ZINC OXIDE) LOTION [CLINIQUE LABORATORIES INC.]1
phenoxyethanolINACTIVE INGREDIENTHIE492ZZ3TCLINIQUE FOR MEN UV DEFENSE BROAD SPECTRUM SPF50 (TITANIUM DIOXIDE AND ZINC OXIDE) LOTION [CLINIQUE LABORATORIES INC.]1
silicon dioxideINACTIVE INGREDIENTETJ7Z6XBU4CLINIQUE FOR MEN UV DEFENSE BROAD SPECTRUM SPF50 (TITANIUM DIOXIDE AND ZINC OXIDE) LOTION [CLINIQUE LABORATORIES INC.]1
triethoxycaprylylsilaneINACTIVE INGREDIENTLDC331P08ECLINIQUE FOR MEN UV DEFENSE BROAD SPECTRUM SPF50 (TITANIUM DIOXIDE AND ZINC OXIDE) LOTION [CLINIQUE LABORATORIES INC.]1
waterINACTIVE INGREDIENT059QF0KO0RCLINIQUE FOR MEN UV DEFENSE BROAD SPECTRUM SPF50 (TITANIUM DIOXIDE AND ZINC OXIDE) LOTION [CLINIQUE LABORATORIES INC.]1

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
49527-046-01495270046011 BOTTLE in 1 CARTON (49527-046-01) > 30 mL in 1 BOTTLE1 bottle2015-04-010000-00-00NoNoCurrent