FDA.reportPublic FDA data

CLINIQUE SPF 50 BROAD SPECTRUM MINERAL SUNSCREEN FLUID FOR FACE

Product NDC
49527-752
11-digit product format
495270752
Labeler code
49527
Product ID
49527-752_f1e9db9c-d185-21da-e053-2a95a90acf90
Type
HUMAN OTC DRUG
Nonproprietary name
TITANIUM DIOXIDE and ZINC OXIDE
Dosage form
LOTION
Route
TOPICAL
Labeler
CLINIQUE LABORATORIES LLC
Application
M020
Marketing category
OTC MONOGRAPH FINAL
Marketing start
2016-06-01
Marketing end
0000-00-00
Substance
TITANIUM DIOXIDE; ZINC OXIDE
Active strength
63 mg/mL; mg/mL
NDC exclude flag
No
Listing certified through
2024-12-31
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 productproduct49527-752IInactivated by FDA2026-10-16
excluded packagepackage49527-75249527-752-01IInactivated by FDA2026-10-16

Reported adverse events (FAERS/openFDA)#

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

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
49527-752-012022-08-05C16284748780-1e4f33bdf-a50f-d8a0-e053-dadaa90a6e4eCLINIQUE SPF 50 BROAD SPECTRUM MINERAL SUNSCREEN FLUID FOR FACE
49527-752-012022-07-29C16284748780-1e4f33bdf-a50f-d8a0-e053-dadaa90a6e4eCLINIQUE SPF 50 BROAD SPECTRUM MINERAL SUNSCREEN FLUID FOR FACE

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
49527-752-01CLINIQUE SPF 50 BROAD SPECTRUM MINERAL SUNSCREEN FLUID FOR FACE1 in 1 CARTONLOTION19
49527-752-01CLINIQUE SPF 50 BROAD SPECTRUM MINERAL SUNSCREEN FLUID FOR FACE30 mL in 1 BOTTLELOTION309

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
49527-752CLINIQUE SPF 50 BROAD SPECTRUM MINERAL SUNSCREEN FLUID FOR FACE (TITANIUM DIOXIDE AND ZINC OXIDE) LOTION [CLINIQUE LABORATORIES LLC]9Legacy NDC, 2 package rows20241226_58338786-82a7-45ae-930f-dcb2c70aa5cd.zip

openFDA label cross-check#

OpenFDA label data provides additional search and identifier links. DailyMed’s Structured Product Label is the canonical label on FDA.report. Matching records are deduplicated before they are shown below.

Matched openFDA labels page 124 of 357 · 7,139 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Tined Mineral Sunscreen Whipped MousseTITANIUM DIOXIDE, ZINC OXIDEESTILO SALON & SPA LLC36999510-88f0-64fc-e063-6294a90a3d092025-12-15Exact identifier
application number: M020
Parasol Daily Mineral Sunscreen Non-TintedZINC OXIDEBodi & Wax, LLC35d3486c-c6e8-4d31-e063-6294a90a12192025-12-15Exact identifier
application number: M020
Tinted Mineral Sunscreen CreamZINC OXIDEESTILO SALON & SPA LLC3699f6df-63b8-f255-e063-6394a90af2c42025-12-15Exact identifier
application number: M020
Tinted Mineral Sunscreen CreamZINC OXIDEESTILO SALON & SPA LLC369a5997-7dbe-254d-e063-6394a90a5bef2025-12-15Exact identifier
application number: M020
Non Tinted Mineral Sunscreen 20Percent Zinc OxideZINC OXIDEESTILO SALON & SPA LLC369a8a99-c755-3c7f-e063-6394a90ac16c2025-12-15Exact identifier
application number: M020
Non Tinted Mineral Sunscreen 20Percent Zinc OxideZINC OXIDEESTILO SALON & SPA LLC369abc9d-9c20-5397-e063-6394a90a17232025-12-15Exact identifier
application number: M020
Sunshade Tinted Mineral SunscreenTITANIUM DIOXIDE, ZINC OXIDEBELLAGENA SKINCARE STUDIO & SPA37dec631-fdaf-fbdf-e063-6394a90a6c2b2025-12-15Exact identifier
application number: M020
Matte Tinted Mineral SunscreenTITANIUM DIOXIDE, ZINC OXIDEEDIT EUROSPA, LLC37527317-0f10-d7e6-e063-6394a90a35a62025-12-15Exact identifier
application number: M020
Sunshade Mineral Stick SunscreenTITANIUM DIOXIDE, ZINC OXIDEBELLAGENA SKINCARE STUDIO & SPA37ee31be-bfda-f052-e063-6294a90ac0bb2025-12-15Exact identifier
application number: M020
Matte Tinted Mineral SunscreenTITANIUM DIOXIDE, ZINC OXIDEEDIT EUROSPA, LLC3751544d-e093-3d19-e063-6394a90aefc32025-12-15Exact identifier
application number: M020
Lip CrackTITANIUM DIOXIDE, ZINC OXIDEBELLAGENA SKINCARE STUDIO & SPA37edc05c-82c3-90fe-e063-6294a90aa6012025-12-15Exact identifier
application number: M020
Restore And ReplenishZINC OXIDEBELLAGENA SKINCARE STUDIO & SPA37ed8525-6ae4-4e86-e063-6294a90afeb82025-12-15Exact identifier
application number: M020
Sunshade Daily Sun DefenseTITANIUM DIOXIDE, ZINC OXIDEBELLAGENA SKINCARE STUDIO & SPA37ee77dc-a96a-5efa-e063-6394a90affda2025-12-15Exact identifier
application number: M020
Sunshade Mineral SunscreenZINC OXIDEBELLAGENA SKINCARE STUDIO & SPA37df21f1-f36f-df43-e063-6294a90aea6f2025-12-15Exact identifier
application number: M020
Tinted Moisturizing Mineral SunscreenZINC OXIDEEDIT EUROSPA, LLC3751861d-3f3b-2ebd-e063-6294a90af8982025-12-15Exact identifier
application number: M020
Non Tinted Moisturizing Mineral SunscreenZINC OXIDEEDIT EUROSPA, LLC3751e278-b8b2-7bf4-e063-6394a90a42902025-12-15Exact identifier
application number: M020
Tinted Mineral Sunscreen StickTITANIUM DIOXIDE, ZINC OXIDEEDIT EUROSPA, LLC37521c60-2fee-861e-e063-6294a90ad69a2025-12-15Exact identifier
application number: M020
MATTE Non Tinted Mineral SunscreenZINC OXIDEAllure Esthetics3725d947-b1fa-3b50-e063-6394a90adf102025-12-15Exact identifier
application number: M020
GLOW Tinted Mineral SunscreenZINC OXIDEAllure Esthetics37257bb2-d91d-6ff8-e063-6294a90a01b62025-12-15Exact identifier
application number: M020
Daily RestoreZINC OXIDETYRLIN ENTERPRISES, INC.35ce7133-badb-1bc4-e063-6294a90a74782025-12-15Exact identifier
application number: M020

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
49527-752-01495270752011 BOTTLE in 1 CARTON (49527-752-01) > 30 mL in 1 BOTTLE1 bottle2016-06-010000-00-00NoNoCurrent