Home NDC 81679-203 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 date Dataset Scope Product NDC Package NDC Code Status Reporting period Archive Snapshot Source SHA-256 2025-01-11 03:41 UTC · source 2025-01-10 excluded product product 81679-203 U Excluded because listing certification expired excluded / ndc_excluded.zip 0efc9e666f02…f202fb6c5f17…2025-01-11 03:41 UTC · source 2025-01-10 excluded package package 81679-203 81679-203-50 U Excluded because listing certification expired excluded / ndc_excluded.zip 0efc9e666f02…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 Ingredient Strength TITANIUM DIOXIDE 80 mg/g ZINC OXIDE 38 mg/g
Harmonized UNII identifiers# UNII identifiers page 1 of 1 · 2 matching rows.
Identifier, FDA.report destination table Identifier FDA.report destination 15FIX9V2JP Internal UNII lookup SOI2LOH54Z Internal UNII lookup
Harmonized SPL set identifiers# SPL set identifiers page 1 of 1 · 1 matching rows.
DailyMed Package Descriptions# Package NDC, Product, Description table Package NDC Product Description Form Quantity Strength SPL version 81679-203-50 HUTTON KLEIN HK DERMATOLOGISTS SPF 40 Mineral Based Facial Sunscreen Tinted 53 g in 1 BOTTLE, PUMP CREAM 53 2
DailyMed Dashboard NDC Coverage# NDC, Dashboard title, SPL version table NDC Dashboard title SPL version Validation Dashboard ZIP 81679-203 HUTTON KLEIN HK DERMATOLOGISTS SPF 40 MINERAL BASED FACIAL SUNSCREEN TINTED (TITANIUM DIOXIDE, ZINC OXIDE) CREAM [HUTTON, KATHLEEN MD] 2 Current NDC, 1 package rows 20250119_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 143 of 354 · 7,077 matching rows.
Brand, Generic, Manufacturer table Brand Generic Manufacturer SPL set ID Effective date Available safety fields Join Tinted Mineral Sunscreen TITANIUM DIOXIDE, ZINC OXIDE Maloney Plastic Surgery Skin Care, PLLC 316b46ac-6dde-72d1-e063-6294a90a03da 2025-12-09 Exact identifier application number: M020 Replenish ZINC OXIDE Maloney Plastic Surgery Skin Care, PLLC 316c43fb-0c15-87d4-e063-6294a90a0a63 2025-12-09 Exact identifier application number: M020 BIOJUVE Microbiome-Safe Sheer Finish SPF 50 Sunscreen TITANIUM DIOXIDE AND ZINC OXIDE Crown Laboratories ece7565b-f3e5-3386-e053-2a95a90a5802 2025-12-09 Warnings Exact identifier application number: M020 Hydraboost Lip Treatment AVOBENZONE, HOMOSALATE, OCTISALATE, OCTOCRYLENE Bluemercury 2cf30083-8723-23f6-e063-6394a90a55de 2025-12-09 Warnings Exact identifier application number: M020 Florida Babe Sport Non-Tinted Mineral Sunscreen TITANIUM DIOXIDE, ZINC OXIDE Tichy Anesthesia PA 31e4756d-8604-6e75-e063-6294a90aebe1 2025-12-09 Exact identifier application number: M020 Florida Babe Sport Tinted Mineral Sunscreen TITANIUM DIOXIDE, ZINC OXIDE Tichy Anesthesia PA 31e4d9ae-f532-f9f5-e063-6294a90a8d39 2025-12-09 Exact identifier application number: M020 Arbonne FunSun Mineral Sunscreen Broad Spectrum SPF 30 ZINC OXIDE Arbonne International, LLC 91bcd120-28e5-4f44-9522-550c1dbcd82c 2025-12-09 Warnings Exact identifier application number: M020 Florida Babe Active Tinted 20percent Zinc Oxide Mineral Sunscreen ZINC OXIDE Tichy Anesthesia PA 31e509f2-dcb6-5ae0-e063-6394a90a70c1 2025-12-09 Exact identifier application number: M020 Florida Babe Active Non-Tinted 20percent Zinc Oxide Mineral Sunscreen ZINC OXIDE Tichy Anesthesia PA 31e57817-b8c4-8178-e063-6294a90a0149 2025-12-09 Exact identifier application number: M020 Florida Babe Everyday Tinted Replenishing Daily Protection ZINC OXIDE Tichy Anesthesia PA 3231f1fe-51b3-b2e7-e063-6394a90a2758 2025-12-09 Exact identifier application number: M020 Florida Babe Everyday Tinted Replenishing Daily Protection ZINC OXIDE Tichy Anesthesia PA 31e63876-3e39-adc6-e063-6394a90ab146 2025-12-09 Exact identifier application number: M020 Florida Babe SPORT Mineral Sunscreen Stick Tinted TITANIUM DIOXIDE, ZINC OXIDE Tichy Anesthesia PA 31f5bbe4-5f6e-3bef-e063-6294a90a2646 2025-12-09 Exact identifier application number: M020 Florida Babe SPORT Mineral Sunscreen Stick Non-Tinted TITANIUM DIOXIDE, ZINC OXIDE Tichy Anesthesia PA 31f54a79-70b7-def5-e063-6294a90a709b 2025-12-09 Exact identifier application number: M020 Florida Babe Sport Tinted Mineral Sunscreen TITANIUM DIOXIDE, ZINC OXIDE Tichy Anesthesia PA 3231b71c-4d27-e5e2-e063-6294a90a031b 2025-12-09 Exact identifier application number: M020 Arbonne Soft Focus Veil Broad Spectrum SPF 30 Sunscreen TITANIUM DIOXIDE AND ZINC OXIDE Arbonne International, LLC 3c9b605b-5a16-4f89-a956-8c4c62de72d3 2025-12-09 Warnings Exact identifier application number: M020 Tinted Mineral Sunscreen TITANIUM DIOXIDE, ZINC OXIDE THE AESTHETICS ACADEMY, LLC 364b9560-f7a1-ed8f-e063-6294a90a2c41 2025-12-09 Exact identifier application number: M020 Sunshield Moisturizing Sunscreen and Antioxidant ZINC OXIDE Oculofacial Surgery andCosmetic Laser Institute, LLC. 32c247fc-d4da-e03d-e063-6394a90a72b0 2025-12-09 Exact identifier application number: M020 SCALP SUNSCREEN TITANIUM DIOXIDE, ZINC OXIDE FOLICULE LLC 387b10e1-5443-7b7a-e063-6394a90a2c7a 2025-12-09 Exact identifier application number: M020 Sunshield Moisturizing Sunscreen and Antioxidant ZINC OXIDE Oculofacial Surgery andCosmetic Laser Institute, LLC. 32c3936e-4089-edd0-e063-6294a90ad3f8 2025-12-09 Exact identifier application number: M020 Tinted Replenishing Daily Protection ZINC OXIDE THE AESTHETICS ACADEMY, LLC 364cf1f7-1f87-51f7-e063-6294a90a789c 2025-12-09 Exact identifier application number: M020
Packages# Package NDC, 11-digit format, Description table Package NDC 11-digit format Description Units Marketing start Sample Exclude flag Status 81679-203-50 81679020350 53 g in 1 BOTTLE, PUMP (81679-203-50) 53 g 2023-12-01 No No Current