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 FDA2026-11-13
excluded packagepackage49527-75249527-752-01IInactivated by FDA2026-11-13

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 320 of 346 · 6,912 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Alba Botanica Sport SPF 50 SunscreenAVOBENZONE, HOMOSALATE, OCTISALATE, OCTOCRYLENEHain Celestial Group, Inc.fd78fb8e-99b0-91b0-e053-6394a90a92712023-11-16WarningsExact identifier
application number: M020
Alba Botanica Kids SPF 50 Tropical FruitAVOBENZONE, HOMOSALATE, OCTISALATE, OCTOCRYLENEHain Celestial Group, Incf6941bab-1e97-1dc8-e053-2995a90a93172023-11-16WarningsExact identifier
application number: M020
Rite Aid Mineral Sunscreen Broad Spectrum SPF 50TITANIUM DIOXIDE, ZINC OXIDERite Aid0a4cea12-7e00-d201-e063-6394a90a66912023-11-16WarningsExact identifier
application number: M020
SMART CLINICAL REPAIR BROAD SPECTRUM SPF 30AVOBENZONE,HOMOSALATE,OCTINOXATE,OCTISALATECLINIQUE LABORATORIES LLCfb841fd7-0c78-01a1-e053-6394a90a43822023-11-15WarningsExact identifier
application number: M020
Banana Boat Kids Sport Sunscreen Roll-On UVA/UVB Broad Spectrum SPF 60 PlusAVOBENZONE,HOMOSALATE,OCTISALATE,OCTOCRYLENEEdgewell Personal Care Brands LLCc7563a84-f622-dad6-e053-2a95a90aa8d92023-11-15WarningsExact identifier
application number: M020
Rite Aid Ryshi Facial Mist Sunscreen Broad Spectrum SPF 30AVOBENZONE, HOMOSALATE, OCTISALATE, OCTOCRYLENERite Aid0a3808e5-3f94-0544-e063-6294a90a823b2023-11-15WarningsExact identifier
application number: M020
HEB Solutions Sunscreen Face 50 Facial Mist SunscreenAVOBENZONE, HOMOSALATE, OCTISALATE, OCTOCRYLENEH.E.Bf6cdeb2f-fc58-1780-e053-6394a90a544a2023-11-15WarningsExact identifier
application number: M020
Rite Aid Ryshi Sunscreen with Hyaluronic Acid and Collagen Broad Spectrum SPF 50AVOBENZONE, HOMOSALATE, OCTISALATE, OCTOCRYLENERite Aid0a3933b3-171f-8ce1-e063-6294a90a2d352023-11-15WarningsExact identifier
application number: M020
Rite Aid Ryshi Sunscreen Face Primer Shea Butter, Aloe, Mineral Oil, and Vitamin E Broad Spectrum SPF 30AVOBENZONE, HOMOSALATE, OCTISALATE, OCTOCRYLENERite Aid0a39957a-798d-b0a9-e063-6294a90a135d2023-11-15WarningsExact identifier
application number: M020
Rite Aid Mineral Sensitive Skin Zinc Oxide Sunscreen For Face SPF 50ZINC OXIDERite Aid0a39c146-a7a0-cde6-e063-6294a90a16a72023-11-15WarningsExact identifier
application number: M020
Beach Gypsy SPF-30OCTINOXATE, OCTOCRYLENE, OCTISALATE, AVOBENZONEMJ Products Association, LLCa518e048-5614-4b67-b6fa-e1f2e380f3522023-11-15WarningsExact identifier
application number: M020
Sea Star Sparkle SPF-50 MANGO-TANGOOCTINOXATE, OCTISALATE, OCTOCRYLENE, ZINC OXIDEMJ Products Association, LLC1f4ea582-c4d5-4c0a-8fea-4eeb2fbb63272023-11-15WarningsExact identifier
application number: M020
Max MineralTITANIUM DIOXIDE, ZINC OXIDEPeter Thomas Roth Labs, LLC0980992c-6488-2fa1-e063-6294a90a41ea2023-11-14WarningsExact identifier
application number: M020
Premium Moisturizing Sunscreen SPF 50AVOBENZONE, HOMOSALATE, OCTISALATE, OCTOCRYLENESun Bum LLCf1d46728-6933-4e6f-b7c0-3613466aa1f02023-11-14WarningsExact identifier
application number: M020
SIGNATURE CARE ACNE TREATMENTSALICYLIC ACIDSAFEWAY, INC.a60134d0-f788-90e8-e053-2a95a90acbde2023-11-14WarningsExact identifier
application number: M020
Curology the sunscreen broad spectrum SPF 30ZINC OXIDECurology Inc.e441895a-83b6-1cd5-e053-2995a90aab4b2023-11-14WarningsExact identifier
application number: M020
In Transit Skin DefenceAVOBENZONE, OCTINOXATE, OCTOCRYLENE, OXYBENZONETHIS WORKS PRODUCTS LIMITEDc3425525-df4d-403b-ac7a-84067f0301182023-11-14WarningsExact identifier
application number: M020
Perfect Legs Skin Protector SPF 30AVOBENZONE, OCTINOXATE, OCTOCRYLENETHIS WORKS PRODUCTS LIMITEDe0c54af2-9ea4-4dec-9d48-1048839508182023-11-14WarningsExact identifier
application number: M020
Suzanne Organics Tinted Mineral Sunscreen Broad Spectrum SPF 25 - SandZINC OXIDESLC Skincare935d0f47-048d-4823-bf08-8ece23e697362023-11-14WarningsExact identifier
application number: M020
Suzanne Organics Tinted Mineral Sunscreen Broad Spectrum SPF 25 - BronzeZINC OXIDESLC Skincaredefbb664-0a94-4ea6-b036-71782880151e2023-11-14WarningsExact 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