FDA.reportPublic FDA data

CLINIQUE REDNESS SOLUTIONS

Product NDC
49527-722
11-digit product format
495270722
Labeler code
49527
Product ID
49527-722_f22e64e9-8b07-4af1-9bbc-1978bf835562
Type
HUMAN OTC DRUG
Nonproprietary name
TITANIUM DIOXIDE and ZINC OXIDE
Dosage form
CREAM
Route
TOPICAL
Labeler
CLINIQUE LABORATORIES INC
Application
part352
Marketing category
OTC MONOGRAPH NOT FINAL
Marketing start
2007-12-01
Marketing end
0000-00-00
Substance
TITANIUM DIOXIDE; ZINC OXIDE
Active strength
6 mL/100mL; mL/100mL
NDC exclude flag
E
Listing certified through
2018-12-31
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 productproduct49527-722IInactivated by FDA2026-10-05
excluded packagepackage49527-72249527-722-01IInactivated by FDA2026-10-05

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 · 44 matching rows.

View current auxiliary records. · View the auxiliary file history.

Captured / source date, Dataset, Scope table
Captured / source dateDatasetScopePackage NDCCodeStatusSnapshotSource SHA-256
2025-12-14 17:58 UTC · source 2025-12-05excluded productproductIInactivated by FDAd630ba8d3edf…732f749b63fb…
2025-12-14 17:58 UTC · source 2025-12-05excluded packagepackage49527-722-01IInactivated by FDAd630ba8d3edf…732f749b63fb…
2025-08-27 00:01 UTC · source 2025-08-26excluded productproductIInactivated by FDAf5e01cc5f278…a2eaf40c39c3…
2025-08-27 00:01 UTC · source 2025-08-26excluded packagepackage49527-722-01IInactivated by FDAf5e01cc5f278…a2eaf40c39c3…
2025-04-01 02:39 UTC · source 2025-03-31excluded productproductIInactivated by FDA2ef7874e63bc…57b86245f4fa…
2025-04-01 02:39 UTC · source 2025-03-31excluded packagepackage49527-722-01IInactivated by FDA2ef7874e63bc…57b86245f4fa…
2025-03-28 20:22 UTC · source 2025-03-28excluded productproductIInactivated by FDAa1b67e2a42f9…c4cf2c586c0d…
2025-03-28 20:22 UTC · source 2025-03-28excluded packagepackage49527-722-01IInactivated by FDAa1b67e2a42f9…c4cf2c586c0d…
2025-03-22 03:12 UTC · source 2025-03-21excluded productproductIInactivated by FDAcfe11265f3b6…090c488252e2…
2025-03-22 03:12 UTC · source 2025-03-21excluded packagepackage49527-722-01IInactivated by FDAcfe11265f3b6…090c488252e2…
2025-03-10 12:48 UTC · source 2025-03-10excluded productproductIInactivated by FDAcdf11ea48f46…ba0047e9e063…
2025-03-10 12:48 UTC · source 2025-03-10excluded packagepackage49527-722-01IInactivated by FDAcdf11ea48f46…ba0047e9e063…
2025-02-02 03:52 UTC · source 2025-01-31excluded productproductIInactivated by FDA302b2466d912…e7b80fea0513…
2025-02-02 03:52 UTC · source 2025-01-31excluded packagepackage49527-722-01IInactivated by FDA302b2466d912…e7b80fea0513…
2025-01-20 13:05 UTC · source 2025-01-20excluded productproductIInactivated by FDAed331223b511…672a5bd82f5f…
2025-01-20 13:05 UTC · source 2025-01-20excluded packagepackage49527-722-01IInactivated by FDAed331223b511…672a5bd82f5f…
2025-01-11 03:41 UTC · source 2025-01-10excluded productproductIInactivated by FDA0efc9e666f02…f202fb6c5f17…
2025-01-11 03:41 UTC · source 2025-01-10excluded packagepackage49527-722-01IInactivated by FDA0efc9e666f02…f202fb6c5f17…
2024-11-09 02:27 UTC · source 2024-11-08excluded productproductIInactivated by FDAad56d346431e…cc804d4bbf1e…
2024-11-09 02:27 UTC · source 2024-11-08excluded packagepackage49527-722-01IInactivated by FDAad56d346431e…cc804d4bbf1e…
2024-10-04 04:10 UTC · source 2024-10-03excluded productproductIInactivated by FDA367a005e9d99…383a685ebd0f…
2024-10-04 04:10 UTC · source 2024-10-03excluded packagepackage49527-722-01IInactivated by FDA367a005e9d99…383a685ebd0f…
2024-07-10 04:00 UTC · source 2024-07-09excluded productproductIInactivated by FDA557ba5c1ecfa…9c80585c8c6e…
2024-07-10 04:00 UTC · source 2024-07-09excluded packagepackage49527-722-01IInactivated by FDA557ba5c1ecfa…9c80585c8c6e…
2024-05-28 21:12 UTC · source 2024-05-28excluded productproductIInactivated by FDA8af77b9d5b6f…d9bbb34c5368…
2024-05-28 21:12 UTC · source 2024-05-28excluded packagepackage49527-722-01IInactivated by FDA8af77b9d5b6f…d9bbb34c5368…
2024-05-15 03:39 UTC · source 2024-05-14excluded productproductIInactivated by FDA834df4deac94…adcc014656a3…
2024-05-15 03:39 UTC · source 2024-05-14excluded packagepackage49527-722-01IInactivated by FDA834df4deac94…adcc014656a3…
2024-03-11 06:39 UTC · source 2024-03-08excluded productproductIInactivated by FDA1332a3947898…d4bfe170f9cd…
2024-03-11 06:39 UTC · source 2024-03-08excluded packagepackage49527-722-01IInactivated by FDA1332a3947898…d4bfe170f9cd…
2022-08-30 03:57 UTC · source 2022-08-29excluded productproductIInactivated by FDAfb8cb913e6d1…eb8c232b6be0…
2022-08-30 03:57 UTC · source 2022-08-29excluded packagepackage49527-722-01IInactivated by FDAfb8cb913e6d1…eb8c232b6be0…
2022-04-09 23:13 UTC · source 2022-04-08excluded productproductIInactivated by FDA86f5da6cb304…a595104c45d7…
2022-04-09 23:13 UTC · source 2022-04-08excluded packagepackage49527-722-01IInactivated by FDA86f5da6cb304…a595104c45d7…
2022-04-04 05:40 UTC · source 2022-04-01excluded productproductIInactivated by FDAbd6a592717d7…303034d00443…
2022-04-04 05:40 UTC · source 2022-04-01excluded packagepackage49527-722-01IInactivated by FDAbd6a592717d7…303034d00443…
2021-12-27 23:28 UTC · source 2021-12-27excluded productproductIInactivated by FDA8dfbde2a14a4…c9ff85d89658…
2021-12-27 23:28 UTC · source 2021-12-27excluded packagepackage49527-722-01IInactivated by FDA8dfbde2a14a4…c9ff85d89658…
2020-12-18 03:04 UTC · source 2020-12-17excluded productproductIInactivated by FDAe2bbac7714bc…27bdfed8d636…
2020-12-18 03:04 UTC · source 2020-12-17excluded packagepackage49527-722-01IInactivated by FDAe2bbac7714bc…27bdfed8d636…
2020-06-10 20:45 UTC · source 2020-06-10excluded productproductIInactivated by FDA9bebd1f3094a…5416666fcb17…
2020-06-10 20:45 UTC · source 2020-06-10excluded packagepackage49527-722-01IInactivated by FDA9bebd1f3094a…5416666fcb17…
2019-12-08 06:16 UTC · source 2019-12-05excluded productproductEExcluded after deficient or non-compliant submission was not corrected110d247fa046…a55b01930146…
2019-12-08 06:16 UTC · source 2019-12-05excluded packagepackage49527-722-01EExcluded after deficient or non-compliant submission was not corrected110d247fa046…a55b01930146…

Reported adverse events (FAERS/openFDA)#

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

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
7dea7767-9f52-b60a-5435-33cb9cc28baeProduct name420250124
6338270f-96cb-0ecb-6fbb-0a9bc78001f4Product name720250116
0ca83774-3f79-b837-5d6f-c210102f3bc8Product name620250114
41b814f3-0166-1c53-c9ef-a0794c7daf9dProduct name320221110
a590be26-846c-8659-a5a1-fb25907965dcProduct name220221110
5dbf91a8-ec29-4ffc-807c-e3bae7fb67b1Product name120201123
2dc76302-91c0-4c35-ad78-99adfb049c4bProduct name120200603
85bed648-23ca-4804-98e6-e36aee999cadProduct name120190717
80de93b4-8a94-428d-beb7-d644353ee70bProduct name120180424
e6065d4b-5ae1-476f-a40e-f2851cbb5d2bProduct name220180221
eb4f7d5b-1286-40dc-b8bf-ad87ff51c688Product name120170522
db8eb201-78c7-4590-8a71-fac0a539bd8cProduct name120170404
141092be-5eb5-452e-9f69-2d350aa70a87Product name120161208
f212291f-05fe-9603-fc7e-bd73e38ce1e6Product name220161129
182f9ab4-4ab5-c449-200f-87ce2ce8e550Product name220151105
332e86c3-7875-ca6e-f934-2206d2b31996Product name120140508
56625fcc-aa34-9d30-d0e9-1c1beb37ea21Product name120140508
7dfac40f-a405-cd2e-7c06-3059ec0e1092Product name120140508
96c2be53-8e44-452d-56a2-d255b2f1af2dProduct name120140508
bf8bd5f7-495f-4022-2780-7ded7ea7ea44Product name120140508
d223c173-c39b-d764-47d4-d671d3088815Product name120140508
e01133ad-4dcd-c7f3-454b-2ff569ee160aProduct name120140508

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
49527-722-012020-01-31C16284748780-19d75b9d0-1378-f424-e053-dadaa90a57ceCLINIQUE redness solutions

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
49527-722-01CLINIQUE REDNESS SOLUTIONS DAILY PROTECTIVE BASE SPF 151 in 1 CARTONCREAM11
49527-722-01CLINIQUE REDNESS SOLUTIONS DAILY PROTECTIVE BASE SPF 1540 mL in 1 BOTTLECREAM401

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIIDailyMed labelSPL versionUploaded
TITANIUM DIOXIDEACTIVE INGREDIENT15FIX9V2JPCLINIQUE REDNESS SOLUTIONS DAILY PROTECTIVE BASE SPF 15 (TITANIUM DIOXIDE AND ZINC OXIDE) CREAM [CLINIQUE LABORATORIES INC]1
ZINC OXIDEACTIVE INGREDIENTSOI2LOH54ZCLINIQUE REDNESS SOLUTIONS DAILY PROTECTIVE BASE SPF 15 (TITANIUM DIOXIDE AND ZINC OXIDE) CREAM [CLINIQUE LABORATORIES INC]1
TITANIUM DIOXIDEACTIVE MOIETY15FIX9V2JPCLINIQUE REDNESS SOLUTIONS DAILY PROTECTIVE BASE SPF 15 (TITANIUM DIOXIDE AND ZINC OXIDE) CREAM [CLINIQUE LABORATORIES INC]1
ZINC OXIDEACTIVE MOIETYSOI2LOH54ZCLINIQUE REDNESS SOLUTIONS DAILY PROTECTIVE BASE SPF 15 (TITANIUM DIOXIDE AND ZINC OXIDE) CREAM [CLINIQUE LABORATORIES INC]1
alkyl (c12-15) benzoateINACTIVE INGREDIENTA9EJ3J61HQCLINIQUE REDNESS SOLUTIONS DAILY PROTECTIVE BASE SPF 15 (TITANIUM DIOXIDE AND ZINC OXIDE) CREAM [CLINIQUE LABORATORIES INC]1
alpha-tocopherol acetateINACTIVE INGREDIENT9E8X80D2L0CLINIQUE REDNESS SOLUTIONS DAILY PROTECTIVE BASE SPF 15 (TITANIUM DIOXIDE AND ZINC OXIDE) CREAM [CLINIQUE LABORATORIES INC]1
aluminum stearateINACTIVE INGREDIENTU6XF9NP8HMCLINIQUE REDNESS SOLUTIONS DAILY PROTECTIVE BASE SPF 15 (TITANIUM DIOXIDE AND ZINC OXIDE) CREAM [CLINIQUE LABORATORIES INC]1
ascophyllum nodosumINACTIVE INGREDIENT168S4EO8YJCLINIQUE REDNESS SOLUTIONS DAILY PROTECTIVE BASE SPF 15 (TITANIUM DIOXIDE AND ZINC OXIDE) CREAM [CLINIQUE LABORATORIES INC]1
asparagopsis armataINACTIVE INGREDIENT2936KN6I1GCLINIQUE REDNESS SOLUTIONS DAILY PROTECTIVE BASE SPF 15 (TITANIUM DIOXIDE AND ZINC OXIDE) CREAM [CLINIQUE LABORATORIES INC]1
barium sulfateINACTIVE INGREDIENT25BB7EKE2ECLINIQUE REDNESS SOLUTIONS DAILY PROTECTIVE BASE SPF 15 (TITANIUM DIOXIDE AND ZINC OXIDE) CREAM [CLINIQUE LABORATORIES INC]1
butylene glycolINACTIVE INGREDIENT3XUS85K0RACLINIQUE REDNESS SOLUTIONS DAILY PROTECTIVE BASE SPF 15 (TITANIUM DIOXIDE AND ZINC OXIDE) CREAM [CLINIQUE LABORATORIES INC]1
caffeineINACTIVE INGREDIENT3G6A5W338ECLINIQUE REDNESS SOLUTIONS DAILY PROTECTIVE BASE SPF 15 (TITANIUM DIOXIDE AND ZINC OXIDE) CREAM [CLINIQUE LABORATORIES INC]1
caprylyl glycolINACTIVE INGREDIENT00YIU5438UCLINIQUE REDNESS SOLUTIONS DAILY PROTECTIVE BASE SPF 15 (TITANIUM DIOXIDE AND ZINC OXIDE) CREAM [CLINIQUE LABORATORIES INC]1
ceteth-2INACTIVE INGREDIENT7H8VAM7778CLINIQUE REDNESS SOLUTIONS DAILY PROTECTIVE BASE SPF 15 (TITANIUM DIOXIDE AND ZINC OXIDE) CREAM [CLINIQUE LABORATORIES INC]1
cetostearyl alcoholINACTIVE INGREDIENT2DMT128M1SCLINIQUE REDNESS SOLUTIONS DAILY PROTECTIVE BASE SPF 15 (TITANIUM DIOXIDE AND ZINC OXIDE) CREAM [CLINIQUE LABORATORIES INC]1
cyclomethicone 5INACTIVE INGREDIENT0THT5PCI0RCLINIQUE REDNESS SOLUTIONS DAILY PROTECTIVE BASE SPF 15 (TITANIUM DIOXIDE AND ZINC OXIDE) CREAM [CLINIQUE LABORATORIES INC]1
dimethiconeINACTIVE INGREDIENT92RU3N3Y1OCLINIQUE REDNESS SOLUTIONS DAILY PROTECTIVE BASE SPF 15 (TITANIUM DIOXIDE AND ZINC OXIDE) CREAM [CLINIQUE LABORATORIES INC]1
edetate disodiumINACTIVE INGREDIENT7FLD91C86KCLINIQUE REDNESS SOLUTIONS DAILY PROTECTIVE BASE SPF 15 (TITANIUM DIOXIDE AND ZINC OXIDE) CREAM [CLINIQUE LABORATORIES INC]1
ferric oxide redINACTIVE INGREDIENT1K09F3G675CLINIQUE REDNESS SOLUTIONS DAILY PROTECTIVE BASE SPF 15 (TITANIUM DIOXIDE AND ZINC OXIDE) CREAM [CLINIQUE LABORATORIES INC]1
ferric oxide yellowINACTIVE INGREDIENTEX438O2MRTCLINIQUE REDNESS SOLUTIONS DAILY PROTECTIVE BASE SPF 15 (TITANIUM DIOXIDE AND ZINC OXIDE) CREAM [CLINIQUE LABORATORIES INC]1
ferrosoferric oxideINACTIVE INGREDIENTXM0M87F357CLINIQUE REDNESS SOLUTIONS DAILY PROTECTIVE BASE SPF 15 (TITANIUM DIOXIDE AND ZINC OXIDE) CREAM [CLINIQUE LABORATORIES INC]1
glyceryl monostearateINACTIVE INGREDIENT230OU9XXE4CLINIQUE REDNESS SOLUTIONS DAILY PROTECTIVE BASE SPF 15 (TITANIUM DIOXIDE AND ZINC OXIDE) CREAM [CLINIQUE LABORATORIES INC]1
hexylene glycolINACTIVE INGREDIENTKEH0A3F75JCLINIQUE REDNESS SOLUTIONS DAILY PROTECTIVE BASE SPF 15 (TITANIUM DIOXIDE AND ZINC OXIDE) CREAM [CLINIQUE LABORATORIES INC]1
levomenolINACTIVE INGREDIENT24WE03BX2TCLINIQUE REDNESS SOLUTIONS DAILY PROTECTIVE BASE SPF 15 (TITANIUM DIOXIDE AND ZINC OXIDE) CREAM [CLINIQUE LABORATORIES INC]1
magnesium aluminum silicateINACTIVE INGREDIENT6M3P64V0NCCLINIQUE REDNESS SOLUTIONS DAILY PROTECTIVE BASE SPF 15 (TITANIUM DIOXIDE AND ZINC OXIDE) CREAM [CLINIQUE LABORATORIES INC]1
magnesium ascorbyl phosphateINACTIVE INGREDIENT0R822556M5CLINIQUE REDNESS SOLUTIONS DAILY PROTECTIVE BASE SPF 15 (TITANIUM DIOXIDE AND ZINC OXIDE) CREAM [CLINIQUE LABORATORIES INC]1
octyldodecyl neopentanoateINACTIVE INGREDIENTX8725R883TCLINIQUE REDNESS SOLUTIONS DAILY PROTECTIVE BASE SPF 15 (TITANIUM DIOXIDE AND ZINC OXIDE) CREAM [CLINIQUE LABORATORIES INC]1
pantethineINACTIVE INGREDIENT7K81IL792LCLINIQUE REDNESS SOLUTIONS DAILY PROTECTIVE BASE SPF 15 (TITANIUM DIOXIDE AND ZINC OXIDE) CREAM [CLINIQUE LABORATORIES INC]1
peg-100 stearateINACTIVE INGREDIENTYD01N1999RCLINIQUE REDNESS SOLUTIONS DAILY PROTECTIVE BASE SPF 15 (TITANIUM DIOXIDE AND ZINC OXIDE) CREAM [CLINIQUE LABORATORIES INC]1
peg-40 stearateINACTIVE INGREDIENTECU18C66Q7CLINIQUE REDNESS SOLUTIONS DAILY PROTECTIVE BASE SPF 15 (TITANIUM DIOXIDE AND ZINC OXIDE) CREAM [CLINIQUE LABORATORIES INC]1
phenoxyethanolINACTIVE INGREDIENTHIE492ZZ3TCLINIQUE REDNESS SOLUTIONS DAILY PROTECTIVE BASE SPF 15 (TITANIUM DIOXIDE AND ZINC OXIDE) CREAM [CLINIQUE LABORATORIES INC]1
pseudopterogorgia elisabethaeINACTIVE INGREDIENTUDY3H1OUX5CLINIQUE REDNESS SOLUTIONS DAILY PROTECTIVE BASE SPF 15 (TITANIUM DIOXIDE AND ZINC OXIDE) CREAM [CLINIQUE LABORATORIES INC]1
silicon dioxideINACTIVE INGREDIENTETJ7Z6XBU4CLINIQUE REDNESS SOLUTIONS DAILY PROTECTIVE BASE SPF 15 (TITANIUM DIOXIDE AND ZINC OXIDE) CREAM [CLINIQUE LABORATORIES INC]1
sodium stearateINACTIVE INGREDIENTQU7E2XA9TGCLINIQUE REDNESS SOLUTIONS DAILY PROTECTIVE BASE SPF 15 (TITANIUM DIOXIDE AND ZINC OXIDE) CREAM [CLINIQUE LABORATORIES INC]1
sorbitan tristearateINACTIVE INGREDIENT6LUM696811CLINIQUE REDNESS SOLUTIONS DAILY PROTECTIVE BASE SPF 15 (TITANIUM DIOXIDE AND ZINC OXIDE) CREAM [CLINIQUE LABORATORIES INC]1
sorbitolINACTIVE INGREDIENT506T60A25RCLINIQUE REDNESS SOLUTIONS DAILY PROTECTIVE BASE SPF 15 (TITANIUM DIOXIDE AND ZINC OXIDE) CREAM [CLINIQUE LABORATORIES INC]1
steareth-2INACTIVE INGREDIENTV56DFE46J5CLINIQUE REDNESS SOLUTIONS DAILY PROTECTIVE BASE SPF 15 (TITANIUM DIOXIDE AND ZINC OXIDE) CREAM [CLINIQUE LABORATORIES INC]1
steareth-20INACTIVE INGREDIENTL0Q8IK9E08CLINIQUE REDNESS SOLUTIONS DAILY PROTECTIVE BASE SPF 15 (TITANIUM DIOXIDE AND ZINC OXIDE) CREAM [CLINIQUE LABORATORIES INC]1
stearic acidINACTIVE INGREDIENT4ELV7Z65APCLINIQUE REDNESS SOLUTIONS DAILY PROTECTIVE BASE SPF 15 (TITANIUM DIOXIDE AND ZINC OXIDE) CREAM [CLINIQUE LABORATORIES INC]1
sucroseINACTIVE INGREDIENTC151H8M554CLINIQUE REDNESS SOLUTIONS DAILY PROTECTIVE BASE SPF 15 (TITANIUM DIOXIDE AND ZINC OXIDE) CREAM [CLINIQUE LABORATORIES INC]1
tricaprylyl citrateINACTIVE INGREDIENTBXW1GAI4TACLINIQUE REDNESS SOLUTIONS DAILY PROTECTIVE BASE SPF 15 (TITANIUM DIOXIDE AND ZINC OXIDE) CREAM [CLINIQUE LABORATORIES INC]1
waterINACTIVE INGREDIENT059QF0KO0RCLINIQUE REDNESS SOLUTIONS DAILY PROTECTIVE BASE SPF 15 (TITANIUM DIOXIDE AND ZINC OXIDE) CREAM [CLINIQUE LABORATORIES INC]1
xanthan gumINACTIVE INGREDIENTTTV12P4NEECLINIQUE REDNESS SOLUTIONS DAILY PROTECTIVE BASE SPF 15 (TITANIUM DIOXIDE AND ZINC OXIDE) CREAM [CLINIQUE LABORATORIES INC]1

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
49527-722CLINIQUE REDNESS SOLUTIONS DAILY PROTECTIVE BASE SPF 15 (TITANIUM DIOXIDE AND ZINC OXIDE) CREAM [CLINIQUE LABORATORIES INC]1Legacy NDC, 2 package rows20111207_cf49d7f3-01d8-490c-b9a4-ff69aee1e183.zip

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionStatus
49527-722-01495270722011 in 1 CARTONHistorical