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 137 of 354 · 7,077 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
ProtectME Tinted Mineral SPF 40TITANIUM DIOXIDE, ZINC OXIDEPUREFECTION LA, INC.33dccd5d-8db1-f699-e063-6394a90a59a22025-12-10Exact identifier
application number: M020
Protect ME Non Tinted Mineral SPF 40ZINC OXIDEPUREFECTION LA, INC.34a2d716-b853-752e-e063-6394a90a52e22025-12-10Exact identifier
application number: M020
Tinted Mineral Moisturizing SunscreenTITANIUM DIOXIDE, ZINC OXIDEABOUT FACE AESTHETICS, INC.364728b4-e0ff-8466-e063-6394a90a00892025-12-10Exact identifier
application number: M020
tinted mineral sunscreenTITANIUM DIOXIDE, ZINC OXIDESkin & Bare It LLC35d42661-e511-1dfc-e063-6294a90a9ed72025-12-10Exact identifier
application number: M020
non-tinted mineral sunscreenTITANIUM DIOXIDE, ZINC OXIDESkin & Bare It LLC35d3ef95-621c-f193-e063-6294a90ac3ee2025-12-10Exact identifier
application number: M020
face Plus body sunscreen tintedZINC OXIDESkin & Bare It LLC35d45df5-e9bf-1a08-e063-6294a90ae04f2025-12-10Exact identifier
application number: M020
face Plus body sunscreen non-tintedZINC OXIDESkin & Bare It LLC361ef750-0f0e-bd01-e063-6294a90a00202025-12-10Exact identifier
application number: M020
bare skin smooth mineral tintZINC OXIDESkin & Bare It LLC361f2933-73d5-a9d7-e063-6394a90abb3c2025-12-10Exact identifier
application number: M020
Smoothing Mineral Sunscreen Non-TintedTITANIUM DIOXIDE, ZINC OXIDEDANIEL BEHROOZAN MD A MEDICAL CORPORATION32721b87-aef1-d759-e063-6394a90a40d32025-12-10Exact identifier
application number: M020
Non-Tinted Mineral StickTITANIUM DIOXIDE, ZINC OXIDEShelley Bennett Skincare326e9a14-5fb6-6a6e-e063-6294a90adece2025-12-10Exact identifier
application number: M020
3-in-1 Daily Vanishing Tinted Sunscreen CreamZINC OXIDEShelley Bennett Skincare325dae60-01cc-a120-e063-6294a90a2ef22025-12-10Exact identifier
application number: M020
Daily Moisturizing Glow Sunscreen CreamZINC OXIDEShelley Bennett Skincare326e49b8-e21c-0df0-e063-6394a90a2ebc2025-12-10Exact identifier
application number: M020
Daily Moisturizing Glow Sunscreen CreamZINC OXIDESHELLEY BENNET SKINCARE325df1f8-1678-c07c-e063-6294a90a96fb2025-12-10Exact identifier
application number: M020
Tinted Mineral SunscreenTITANIUM DIOXIDE, ZINC OXIDEHirschman, Kristina35bafa0b-d253-c263-e063-6394a90ad1e42025-12-10Exact identifier
application number: M020
Tinted Mineral SunscreenTITANIUM DIOXIDE, ZINC OXIDEHirschman, Kristina35ba578f-a842-7eec-e063-6394a90a11652025-12-10Exact identifier
application number: M020
Tinted Mineral Sunscreen Zinc OxideZINC OXIDEHirschman, Kristina35bb3b36-3886-ea8e-e063-6394a90a52572025-12-10Exact identifier
application number: M020
Non Tinted Mineral Sunscreen StickTITANIUM DIOXIDE, ZINC OXIDEHirschman, Kristina35bc3994-1f72-2bbf-e063-6294a90ac2f12025-12-10Exact identifier
application number: M020
Tinted Mineral Sunscreen StickTITANIUM DIOXIDE, ZINC OXIDEHirschman, Kristina35bccadf-6fc8-abd0-e063-6294a90aaa2e2025-12-10Exact identifier
application number: M020
Mineral Sunscreen Zinc OxideZINC OXIDEHirschman, Kristina35bb9341-355f-4910-e063-6294a90a8c152025-12-10Exact identifier
application number: M020
Tinted Mineral SunscreenTITANIUM DIOXIDE, ZINC OXIDEHirschman, Kristina35bd61ff-0d66-a9b3-e063-6394a90ad9402025-12-10Exact 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