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 FDA2026-10-23
excluded packagepackage49527-75249527-752-01IInactivated by FDA2026-10-23

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 191 of 354 · 7,077 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Dolce and Gabbana Everlast Foundation SPF 20 34W DeepOCTISALATE, OCTOCRYLENE, TITANIUM DIOXIDE, ZINC OXIDEDolce & Gabbana Beauty S.R.L3a239897-9850-417f-8c00-e810a52540c12025-08-29WarningsExact identifier
application number: M020
Dolce and Gabbana Everlast Foundation SPF 20 36N DeepOCTISALATE, OCTOCRYLENE, TITANIUM DIOXIDE, ZINC OXIDEDolce & Gabbana Beauty S.R.Lc495afc3-6486-4652-b743-958f28eccaca2025-08-29WarningsExact identifier
application number: M020
Dolce and Gabbana Everlast Foundation SPF 20 35W DeepOCTISALATE, OCTOCRYLENE, TITANIUM DIOXIDE, ZINC OXIDEDolce & Gabbana Beauty S.R.L5440ed13-b07e-4c81-a407-d9ac68eaa4832025-08-29WarningsExact identifier
application number: M020
Dolce and Gabbana Everlast Foundation SPF 20 37W DeepOCTISALATE, OCTOCRYLENE, TITANIUM DIOXIDE, ZINC OXIDEDolce & Gabbana Beauty S.R.L9b2c4567-fde7-4b76-9988-b2cba2d3747e2025-08-29WarningsExact identifier
application number: M020
Neutrogena Hydro Boost Hyaluronic Acid Moisturizer Broad Spectrum SPF 50AVOBENZONE, HOMOSALATE, OCTISALATE, AND OCTOCRYLENEKenvue Brands LLC3abd12f4-cbe3-4dd7-e063-6394a90a50a22025-08-28WarningsExact identifier
application number: M020
Sun Bum 15 Premium Moisturizing SunscreenAVOBENZONE, HOMOSALATE, OCTISALATE, OCTOCRYLENESun Bum, LLC3d49b054-9f49-17d1-e063-6294a90a757a2025-08-28WarningsExact identifier
application number: M020
PHOFAY Matte Sunscreen Liquid Foundation SPF 30 2ENSULIZOLE,HOMOSALATE,OCTINOXATE,TITANIUM DIOXIDEHangzhou Jingshen Trading Co., Ltd.3d55291c-9d4c-85c3-e063-6394a90af3302025-08-27WarningsExact identifier
application number: M020
PHOFAY Matte Sunscreen Liquid Foundation SPF 30 3ENSULIZOLE ,HOMOSALATE,OCTINOXATE,TITANIUM DIOXIDEHangzhou Jingshen Trading Co., Ltd.3d565612-ade5-bfb3-e063-6294a90a0c652025-08-27WarningsExact identifier
application number: M020
Jack Black Double DutyAVOBENZONE OCTOCRYLENEJack Black L.L.C.36d81d6d-4f9b-692d-e063-6294a90ad5592025-08-27WarningsExact identifier
application number: M020
Sun Bum Tinted Sunscreen Lip Balm Broad Spectrum SPF 15 - SandbarHOMOSALATE, OCTISALATE, OCTOCRYLENE, ZINC OXIDESun Bum, LLC3ac57c70-9298-cbe7-e063-6394a90aefc12025-08-27WarningsExact identifier
application number: M020
Sun Bum 30 Mineral Tinted Sunscreen FaceTITANIUM DIOXIDE, ZINC OXIDESun Bum, LLC3a290aad-7f40-cb10-e063-6394a90a2e692025-08-27WarningsExact identifier
application number: M020
Broad Spectrum SPF 30 sunscreenHOMOSALATE 7.5%, OCTISALATE 5.0%, AVOBENZONE 3.0%Florida Squeezeda01f0ab9-d686-4ee1-be39-fd4c061cb0182025-08-26WarningsExact identifier
application number: M020
Sun Bum 50 Mineral Sunscreen Face StickZINC OXIDESun Bum, LLC3d48d467-4b6b-c477-e063-6294a90a5a0d2025-08-26WarningsExact identifier
application number: M020
PAPATUI Facial Moisturizer Broad Spectrum SPF 30ZINC OXIDEPAPATUI, LLC3d4ab3a5-a29b-bdd9-e063-6294a90a542c2025-08-26WarningsExact identifier
application number: M020
Broad Spectrum SPF 50 sunscreenHOMOSALATE 10%, OCTISALATE 5.0%, AVOBENZONE 3.0%Florida Squeezed34ffc25c-16e3-4c7c-9d46-9d9f279c074b2025-08-26WarningsExact identifier
application number: M020
Premium Moisturizing Sunscreen Broad Spectrum SPF 70AVOBENZONE, HOMOSALATE, OCTISALATE, OCTOCRYLENESun Bum, LLC36da7117-1c8e-7fcf-e063-6294a90aed002025-08-26WarningsExact identifier
application number: M020
Sun Bum Premium Sunscreen Face Stick Broad Spectrum SPF 30 SunscreenAVOBENZONE, HOMOSALATE, OCTISALATE, OCTOCRYLENESun Bum, LLC36dc7c13-eaf7-b415-e063-6294a90a57842025-08-26WarningsExact identifier
application number: M020
Sun Bum Face 50 Premium SunscreenAVOBENZONE, HOMOSALATE, OCTISALATE, OCTOCRYLENESun Bum, LLC3c1b7f0c-fdc2-df22-e063-6294a90aed412025-08-26WarningsExact identifier
application number: M020
Sun Bum Mist 45 Refreshing Sunscreen 3.4 OZAVOBENZONE, HOMOSALATE, OCTISALATE, OCTOCRYLENESun Bum, LLC3c1c8b83-f37d-a29d-e063-6294a90a20a82025-08-26WarningsExact identifier
application number: M020
Sun Bum 15 Premium Sunscreen Tanning OilAVOBENZONE, HOMOSALATE, OCTISALATE, OCTOCRYLENESun Bum, LLC3c468710-ca71-79be-e063-6394a90a8cfd2025-08-26WarningsExact 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