CLINIQUE SUPERBALANCED SILK MAKEUP BROAD SPECTRUM SPF 15

Product NDC
49527-052
11-digit product format
495270052
Labeler code
49527
Product ID
49527-052_f0d7103a-e61b-cbf6-e053-2995a90aae58
Type
HUMAN OTC DRUG
Nonproprietary name
OCTINOXATE, OCTISALATE, TITANIUM DIOXIDE, and ZINC OXIDE
Dosage form
LIQUID
Route
TOPICAL
Labeler
CLINIQUE LABORATORIES LLC
Application
M020
Marketing category
OTC MONOGRAPH FINAL
Marketing start
2016-07-15
Marketing end
2023-11-30
Substance
OCTINOXATE; OCTISALATE; TITANIUM DIOXIDE; ZINC OXIDE
Active strength
0 g/mL; g/mL; g/mL; g/mL
NDC exclude flag
No
Listing certified through
0000-00-00
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 productproduct49527-052DDiscontinued by firm2026-10-27
excluded packagepackage49527-05249527-052-01DDiscontinued by firm2026-10-27

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 packagepackage49527-052-01d630ba8d3edf…732f749b63fb…
2025-08-27 00:01 UTC · source 2025-08-26excluded productproductf5e01cc5f278…a2eaf40c39c3…
2025-08-27 00:01 UTC · source 2025-08-26excluded packagepackage49527-052-01f5e01cc5f278…a2eaf40c39c3…
2025-04-01 02:39 UTC · source 2025-03-31excluded productproduct2ef7874e63bc…57b86245f4fa…
2025-04-01 02:39 UTC · source 2025-03-31excluded packagepackage49527-052-012ef7874e63bc…57b86245f4fa…
2025-03-28 20:22 UTC · source 2025-03-28excluded productproducta1b67e2a42f9…c4cf2c586c0d…
2025-03-28 20:22 UTC · source 2025-03-28excluded packagepackage49527-052-01a1b67e2a42f9…c4cf2c586c0d…
2025-03-22 03:12 UTC · source 2025-03-21excluded productproductcfe11265f3b6…090c488252e2…
2025-03-22 03:12 UTC · source 2025-03-21excluded packagepackage49527-052-01cfe11265f3b6…090c488252e2…
2025-03-10 12:48 UTC · source 2025-03-10excluded productproductcdf11ea48f46…ba0047e9e063…
2025-03-10 12:48 UTC · source 2025-03-10excluded packagepackage49527-052-01cdf11ea48f46…ba0047e9e063…
2025-02-02 03:52 UTC · source 2025-01-31excluded productproduct302b2466d912…e7b80fea0513…
2025-02-02 03:52 UTC · source 2025-01-31excluded packagepackage49527-052-01302b2466d912…e7b80fea0513…
2025-01-20 13:05 UTC · source 2025-01-20excluded productproducted331223b511…672a5bd82f5f…
2025-01-20 13:05 UTC · source 2025-01-20excluded packagepackage49527-052-01ed331223b511…672a5bd82f5f…
2025-01-11 03:41 UTC · source 2025-01-10excluded productproduct0efc9e666f02…f202fb6c5f17…
2025-01-11 03:41 UTC · source 2025-01-10excluded packagepackage49527-052-010efc9e666f02…f202fb6c5f17…
2024-11-09 02:27 UTC · source 2024-11-08excluded productproductad56d346431e…cc804d4bbf1e…
2024-11-09 02:27 UTC · source 2024-11-08excluded packagepackage49527-052-01ad56d346431e…cc804d4bbf1e…
2024-10-04 04:10 UTC · source 2024-10-03excluded productproduct367a005e9d99…383a685ebd0f…
2024-10-04 04:10 UTC · source 2024-10-03excluded packagepackage49527-052-01367a005e9d99…383a685ebd0f…
2024-07-10 04:00 UTC · source 2024-07-09excluded productproduct557ba5c1ecfa…9c80585c8c6e…
2024-07-10 04:00 UTC · source 2024-07-09excluded packagepackage49527-052-01557ba5c1ecfa…9c80585c8c6e…

Reported adverse events (FAERS/openFDA)#

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

FDA-Initiated Inactive NDC Indexing#

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 179 of 353 · 7,041 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Impeccable Skin Sunscreen Foundation Broad Spectrum SPF 30 BuffZINC OXIDECosmetic Enterprises Ltd265bc5e0-0a2a-842e-e063-6394a90aae0a2025-10-13WarningsExact identifier
application number: M020
Impeccable Skin Sunscreen Foundation Broad Spectrum SPF 30 MochaZINC OXIDECosmetic Enterprises Ltd2748b6bc-e80b-ce66-e063-6394a90a400a2025-10-13WarningsExact identifier
application number: M020
Impeccable Skin Sunscreen Foundation Broad Spectrum SPF 30 BronzeZINC OXIDECosmetic Enterprises Ltd265bf123-c4c3-8414-e063-6394a90a47302025-10-13WarningsExact identifier
application number: M020
Impeccable Skin Sunscreen Foundation Broad Spectrum SPF 30 IvoryZINC OXIDECosmetic Enterprises Ltd2748c351-0a7d-6913-e063-6394a90a6ef22025-10-13WarningsExact identifier
application number: M020
Impeccable Skin Sunscreen Foundation Broad Spectrum SPF 30 NudeZINC OXIDECosmetic Enterprises Ltd265bd73f-2509-90c6-e063-6294a90a2e192025-10-13WarningsExact identifier
application number: M020
Neutrogena Beach Defense Water Plus Sun Protection Sunscreen Broad Spectrum SPF 70AVOBENZONE, HOMOSALATE, OCTISALATE, AND OCTOCRYLENEKenvue Brands LLCdad4b244-2d34-40cb-88dc-991358df83b02025-10-10WarningsExact identifier
application number: M020
Neutrogena Beach Defense Kids Sunscreen SPF 70AVOBENZONE, HOMOSALATE, OCTISALATE, OCTOCRYLENEKenvue Brands LLCeafc00ce-12e7-921f-e053-2995a90a241a2025-10-10WarningsExact identifier
application number: M020
Meijer SPF 50 Sunscreen MangoAVOBENZONE, HOMOSALATE, OCTISALATE, OCTOCRYLENEMeijer40d0294b-e937-336d-e063-6294a90a5c3c2025-10-10WarningsExact identifier
application number: M020
Vertra S Dorian Kona Gold Signature Face Stick SPF 38TITANIUM DIOXIDEEai-jr 286, Incb6c316c3-661b-6428-e053-2a95a90a1a6b2025-10-10WarningsExact identifier
application number: M020
Meijer SPF 50 Sunscreen CoconutAVOBENZONE, HOMOSALATE, OCTISALATE, OCTOCRYLENEMeijer40d15366-85b8-f5e8-e063-6294a90a5fd82025-10-10WarningsExact identifier
application number: M020
Premium Moisturizing Sunscreen Broad Spectrum SPF 70AVOBENZONE, HOMOSALATE, OCTISALATE, OCTOCRYLENEWasatch Product Development, LLCf4369f2f-fdc3-e48e-e053-2995a90a07f72025-10-10WarningsExact identifier
application number: M020
Sun Bum Face 50 Premium Sunscreen SPF 50AVOBENZONE, HOMOSALTE, OCTISALATE, OCTOCRYLENEWasatch Product Development, LLCf4ac746a-a50a-8041-e053-2a95a90a8ea62025-10-10WarningsExact identifier
application number: M020
Wonderscreen Broad Spectrum SPF 30ZINC OXIDEWasatch Product Development, LLC.e895d942-e50e-1ad6-e053-2995a90a0e022025-10-10WarningsExact identifier
application number: M020
Illuminating SPF 50 plus drops Broad Spectrum SunscreenZINC OXIDECosmetic Enterprise Ltd13f40485-b98e-e804-e063-6394a90af2af2025-10-10WarningsExact identifier
application number: M020
Impeccable Skin Moisturizing Face Sunscreen Broad Spectrum SPF 30ZINC OXIDECosmetic Enterprises LTDa84d246b-1153-85ff-e053-2995a90a270a2025-10-10WarningsExact identifier
application number: M020
MediChoice Moisturizing Lip Balm SPF15AVOBENZONE, OCTINOXATE, OCTISALATE, OCTOCRYLENEO&M HALYARD, INC.00327815-28f0-4198-bca7-c8ae768ff4162025-10-09WarningsExact identifier
application number: M020
Daybird 4-in-1 Skin Tint SerumZINC OXIDEResette, Inc.19c1a934-b0f5-1068-e063-6294a90a3b1f2025-10-09WarningsExact identifier
application number: M020
pavise Lip Defense tinted hydrating oil (hue 604)ZINC OXIDEB.A.I. Biosciences INC.f4ebbc1d-d521-1a47-e053-2a95a90a6f842025-10-09WarningsExact identifier
application number: M020
pavise Lip Defense tinted hydrating oil (hue 774)ZINC OXIDEB.A.I. Biosciences INC.f4ebd850-11a8-0d43-e053-2a95a90a2d342025-10-09WarningsExact identifier
application number: M020
pavise Lip Defense tinted hydrating oil (hue 616)ZINC OXIDEB.A.I. Biosciences INC.f4eb6b20-7c26-2942-e053-2a95a90abd312025-10-09WarningsExact identifier
application number: M020

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
49527-052-01495270052011 BOTTLE in 1 CARTON (49527-052-01) > 30 mL in 1 BOTTLE1 bottle2016-07-150000-00-00NoNoCurrent