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 118 of 357 · 7,139 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Non Tinted Mineral Sunscreen StickTITANIUM DIOXIDE, ZINC OXIDEMILESTHETICS LLC39959db9-5ee1-a27c-e063-6394a90a1e102025-12-15Exact identifier
application number: M020
Tinted Mineral Sunscreen StickTITANIUM DIOXIDE, ZINC OXIDEMILESTHETICS LLC3995f556-20fe-3e64-e063-6294a90a5efe2025-12-15Exact identifier
application number: M020
Mineral Lip SunscreenTITANIUM DIOXIDE, ZINC OXIDEMILESTHETICS LLC3995385b-b10b-ca5c-e063-6294a90af43f2025-12-15Exact identifier
application number: M020
Tinted Mineral SunscreenTITANIUM DIOXIDE, ZINC OXIDEMILESTHETICS LLC3994aa84-30b4-3dc4-e063-6394a90a23e72025-12-15Exact identifier
application number: M020
Non Tinted Mineral SunscreenTITANIUM DIOXIDE, ZINC OXIDEMILESTHETICS LLC39947913-f1cc-25d2-e063-6294a90a42292025-12-15Exact identifier
application number: M020
Non Tinted Mineral SunscreenZINC OXIDEMicro Fibro Blast35425e24-3e2c-51db-e063-6394a90a55802025-12-15Exact identifier
application number: M020
Solar Shield TintedZINC OXIDEDENISE BELL SKIN CARE396fe2ca-eb29-5952-e063-6294a90ab2792025-12-15Exact identifier
application number: M020
Solar Shield TintedZINC OXIDEDENISE BELL SKIN CARE396f91b3-3326-3239-e063-6294a90a5df92025-12-15Exact identifier
application number: M020
Tinted Mineral SunscreenZINC OXIDEMicro Fibro Blast35422370-eb55-049c-e063-6294a90ad0a42025-12-15Exact identifier
application number: M020
Eclipse Face TintedZINC OXIDEDENISE BELL SKIN CARE396f0151-2d0d-f4da-e063-6394a90a5f7f2025-12-15Exact identifier
application number: M020
Eclipse Body Non TintedZINC OXIDEDENISE BELL SKIN CARE396f56df-d0de-1344-e063-6294a90a46ea2025-12-15Exact identifier
application number: M020
Solar Shield TintedTITANIUM DIOXIDE, ZINC OXIDEDENISE BELL SKIN CARE396eb781-5947-3665-e063-6294a90a38dd2025-12-15Exact identifier
application number: M020
Sun Veil Illuminating Sunscreen SPF30ZINC OXIDEKoco Life LLC46001097-540e-65da-e063-6294a90af2992025-12-15WarningsExact identifier
application number: M020
Mineral Primer tinted SPF40TITANIUM DIOXIDE, ZINC OXIDEOracle Esthetics, LLC3542d8d3-35a3-7d63-e063-6394a90a6fd12025-12-15Exact identifier
application number: M020
Mineral Primer non-tinted SPF40TITANIUM DIOXIDE, ZINC OXIDEOracle Esthetics, LLC354357de-1a85-3bdb-e063-6294a90aa9a22025-12-15Exact identifier
application number: M020
Mineral Primer tinted SPF40TITANIUM DIOXIDE, ZINC OXIDEOracle Esthetics, LLC35433254-1dc8-a8f3-e063-6394a90a29f02025-12-15Exact identifier
application number: M020
Sun Therapy SunscreenZINC OXIDESkin Therapy Studio LLC3544916b-3f63-3a7a-e063-6394a90ae5072025-12-15Exact identifier
application number: M020
Ultra Zinc Mineral Non TintedZINC OXIDESkin Therapy Studio LLC3545d603-3d01-c51d-e063-6394a90a15992025-12-15Exact identifier
application number: M020
Sun Therapy SunscreenZINC OXIDESkin Therapy Studio LLC357efafb-aa1c-0d69-e063-6394a90a51352025-12-15Exact identifier
application number: M020
Ultra Zinc Mineral Non TintedZINC OXIDESkin Therapy Studio LLC35806102-6919-116f-e063-6294a90ad9222025-12-15Exact 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