HUTTON KLEIN HK DERMATOLOGISTS SPF 40 Mineral Based Facial Sunscreen Tinted

Product NDC
81679-203
11-digit product format
816790203
Labeler code
81679
Product ID
81679-203_296f0692-e2e0-4e97-872f-9ae03bebca27
Type
HUMAN OTC DRUG
Nonproprietary name
Titanium Dioxide, Zinc Oxide
Dosage form
CREAM
Route
TOPICAL
Labeler
Hutton, Kathleen MD
Application
M020
Marketing category
OTC MONOGRAPH DRUG
Marketing start
2017-02-17
Substance
TITANIUM DIOXIDE; ZINC OXIDE
Active strength
80; 38 mg/g; mg/g
NDC exclude flag
No
Listing certified through
2027-12-31
Current FDA listing
Yes

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 · 2 matching rows.

View current auxiliary records. · View the auxiliary file history.

Captured / source date, Dataset, Scope table
Captured / source dateDatasetScopeProduct NDCPackage NDCCodeStatusReporting periodArchiveSnapshotSource SHA-256
2025-01-11 03:41 UTC · source 2025-01-10excluded productproduct81679-203UExcluded because listing certification expiredexcluded / ndc_excluded.zip0efc9e666f02…f202fb6c5f17…
2025-01-11 03:41 UTC · source 2025-01-10excluded packagepackage81679-20381679-203-50UExcluded because listing certification expiredexcluded / ndc_excluded.zip0efc9e666f02…f202fb6c5f17…

Reported adverse events (FAERS/openFDA)#

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

Additional Listing Data#

Finished product
Yes
Brand name base
HUTTON KLEIN HK DERMATOLOGISTS SPF 40 Mineral Based Facial Sunscreen Tinted
Listing expiration
2027-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
TITANIUM DIOXIDE80 mg/g
ZINC OXIDE38 mg/g

Harmonized UNII identifiers#

UNII identifiers page 1 of 1 · 2 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
15FIX9V2JPInternal UNII lookup
SOI2LOH54ZInternal UNII lookup

Harmonized SPL set identifiers#

SPL set identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
293a6a6c-adf3-452d-92f5-3baceb619e39Available on FDA.report

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
81679-203-50HUTTON KLEIN HK DERMATOLOGISTS SPF 40 Mineral Based Facial Sunscreen Tinted53 g in 1 BOTTLE, PUMPCREAM532

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
81679-203HUTTON KLEIN HK DERMATOLOGISTS SPF 40 MINERAL BASED FACIAL SUNSCREEN TINTED (TITANIUM DIOXIDE, ZINC OXIDE) CREAM [HUTTON, KATHLEEN MD]2Current NDC, 1 package rows20250119_293a6a6c-adf3-452d-92f5-3baceb619e39.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 259 of 346 · 6,912 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Zoey naturals Broad Spectrum SPF 50 Fragrance Free SunscreenZINC OXIDEAbsolutely Natural6e05e060-a531-4c4a-b273-889407ec57042024-12-11WarningsExact identifier
application number: M020
Peptide Lip Shine SPF30 SunscreenZINC OXIDEColorescience, Inc.98cdf19d-8b8a-4051-88bb-79160b2af39e2024-12-11WarningsExact identifier
application number: M020
Zoey naturals Broad Spectrum SPF 50Plus Fragrance Free SunscreenZINC OXIDEAbsolutely Natural082983a4-7b98-489d-8ac2-a185923b86ba2024-12-11WarningsExact identifier
application number: M020
Absolutely Natural Broad Spectrum SPF 50 SunscreenZINC OXIDEAbsolutely Natural89657538-904d-4908-ba7b-6f84706a80012024-12-11WarningsExact identifier
application number: M020
SISLEYA Global Anti-Age Hand care SPF 15AVOBENZONE, OCTINOXATE, OCTISALATEC.F.E.B. Sisleycddf11b1-a89b-4b54-b228-55ba8147f0222024-12-10WarningsExact identifier
application number: M020
SUNLEYA Age minimizing sun care SPF 15AVOBENZONE, OCTINOXATE, OCTISALATE, OXYBENZONEC.F.E.B. Sisley67498d45-0871-4806-8854-81d3e50c4b902024-12-10WarningsExact identifier
application number: M020
SUPER CREME SOLAIRE CORPS Body sun care SPF 15AVOBENZONE, OCTINOXATE, OCTISALATE, OXYBENZONEC.F.E.B. Sisley1c774aa7-8963-4221-b4b0-b894bd1b941f2024-12-10WarningsExact identifier
application number: M020
Tinted Sunscreen Cream SPF 30 4-Deep AmberTITANIUM DIOXIDE, ZINC OXIDEC.F.E.B. - Sisley5599922a-b020-477c-a44c-1db42ec5756a2024-12-10WarningsExact identifier
application number: M020
SUNLEYA Age minimizing sun care SPF 50 plusAVOBENZONE, HOMOSALTE, OCTISALATE, OCTOCRYLENEC.F.E.B. Sisley7c9fadaf-b961-4df0-89ae-87141b50b2c12024-12-10WarningsExact identifier
application number: M020
Tinted Sunscreen SPF 30 1-NaturalTITANIUM DIOXIDE, ZINC OXIDEC.F.E.B. - Sisleyb3d53a10-2647-492a-a05f-b97c3f716aa82024-12-10WarningsExact identifier
application number: M020
Tinted Sunscreen SPF 30 2-GoldenTITANIUM DIOXIDE, ZINC OXIDEC.F.E.B. - Sisley389cbce6-552c-4633-babd-7b672632f0b92024-12-10WarningsExact identifier
application number: M020
BANANA BOATAVOBENZONE,OCTISALATE,OCTOCRYLENEEdgewell Personal Care Brands LLC28f08236-1f01-d759-e063-6294a90adcfa2024-12-10WarningsExact identifier
application number: M020
Blistex Five Star Lip Protection Broad SpectrumHOMOSALATE, OCTISALATE, AVOBENZONE, AND DIMETHICONEBlistex Inc.47b57317-7df5-442e-a3a4-1d44fe278ac62024-12-10WarningsExact identifier
application number: M020
AHAVA Brightening Broad Spectrum SPF 20AVOBENZONE, HOMOSALATE, OCTISALATE, AND OCTOCRYLENEAHAVA - Dead Sea Laboratories Ltd724bbb91-e273-4926-9ad6-a1657ffe4cd82024-12-10WarningsExact identifier
application number: M020
ATTITUDE Sunly Mineral Sunscreen Stick Unscented SPF 30ZINC OXIDE9055-7588 Quebec Inc. DBA Attitude0d83c576-5dfb-583a-e063-6294a90a2a282024-12-09WarningsExact identifier
application number: M020
ATTITUDE Sunly Kids Mineral Sunscreen Face Stick Unscented SPF 30ZINC OXIDE9055-7588 Quebec Inc. DBA Attitude0d833e3b-5330-3c5b-e063-6394a90a2ed22024-12-09WarningsExact identifier
application number: M020
ATTITUDE Oatmeal Sensitive Natural Mineral Sunscreen Stick Unscented SPF 30ZINC OXIDE9055-7588 Quebec Inc. DBA Attitude0d9533ba-5606-4116-e063-6294a90ad3b12024-12-09WarningsExact identifier
application number: M020
ATTITUDE Sunly Kids Mineral Sunscreen Stick Unscented SPF 30ZINC OXIDE9055-7588 Quebec Inc. DBA Attitude0d82121d-1dc2-cd99-e063-6394a90aa7662024-12-09WarningsExact identifier
application number: M020
Attitude Kids Oatmeal sensitive mineral sunscreen unscented SPF 30ZINC OXIDE9055-7588 Quebec Inc. DBA Attitude310e66a2-8714-4016-87f4-81c1fef19ec92024-12-09WarningsExact identifier
application number: M020
Attitude Oatmeal sensitive mineral sunscreen unscented SPF 30ZINC OXIDE9055-7588 Quebec Inc. DBA Attitudeb6b8733d-6431-4ed2-9350-c63bb901c8042024-12-09WarningsExact identifier
application number: M020

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startSampleExclude flagStatus
81679-203-508167902035053 g in 1 BOTTLE, PUMP (81679-203-50) 53 g2023-12-01NoNoCurrent