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 132 of 354 · 7,077 matching rows.
Brand, Generic, Manufacturer table Brand Generic Manufacturer SPL set ID Effective date Available safety fields Join Nourish And Defend ZINC OXIDE ANASTASIA FOX-TOMYLOVYCH 3726f463-7e55-c2a2-e063-6394a90a3c51 2025-12-11 Exact identifier application number: M020 Mattify Total Protection Sunscreen TITANIUM DIOXIDE, ZINC OXIDE CLEAN SLATE SKIN & BODY, INC. 37617bd5-c275-aeee-e063-6394a90a214d 2025-12-11 Exact identifier application number: M020 Not YO 80s Zinc Sunscreen ZINC OXIDE CLEAN SLATE SKIN & BODY, INC. 37644dfd-e96d-a783-e063-6294a90a9796 2025-12-11 Exact identifier application number: M020 Not YO 80s Zinc Sunscreen ZINC OXIDE CLEAN SLATE SKIN & BODY, INC. 3762f132-4ab0-74ad-e063-6394a90a436c 2025-12-11 Exact identifier application number: M020 GLOW UP Ageless Daily Protection Sunscreen ZINC OXIDE CLEAN SLATE SKIN & BODY, INC. 37637e45-c6ed-12ca-e063-6294a90aeb02 2025-12-11 Exact identifier application number: M020 Face and Body Sunscreen ZINC OXIDE SCIENCE CEUTICALS, LLC 369b42f3-5203-87c4-e063-6394a90a6284 2025-12-11 Exact identifier application number: M020 Nourish Non-Tinted Mineral Sunscreen ZINC OXIDE Fern Burg 34a32097-de93-9b1d-e063-6394a90a41df 2025-12-11 Exact identifier application number: M020 Mattify Total Protection Sunscreen TITANIUM DIOXIDE, ZINC OXIDE CLEAN SLATE SKIN & BODY, INC. 37641f8b-0133-8bfc-e063-6294a90aac5c 2025-12-11 Exact identifier application number: M020 GLOW UP Ageless Daily Protection Sunscreen ZINC OXIDE CLEAN SLATE SKIN & BODY, INC. 3764856a-98c5-334e-e063-6394a90a629d 2025-12-11 Exact identifier application number: M020 Essential Mineral Sun Protection TITANIUM DIOXIDE, ZINC OXIDE Fern Burg 34a360b2-6798-c7e8-e063-6294a90a5cbb 2025-12-11 Exact identifier application number: M020 Nourish Non-Tinted Mineral Sunscreen ZINC OXIDE Fern Burg 34a3e268-e376-11a0-e063-6294a90a46af 2025-12-11 Exact identifier application number: M020 Tinted Mineral Matte CE Sunscreen TITANIUM DIOXIDE, ZINC OXIDE The Maui Medical Group, Inc 34b72d14-b69b-e9dd-e063-6394a90a748e 2025-12-11 Exact identifier application number: M020 Tinted Mineral Sunscreen TITANIUM DIOXIDE, ZINC OXIDE SCIENCE CEUTICALS, LLC 369b20e2-2cad-e047-e063-6294a90a1bba 2025-12-11 Exact identifier application number: M020 Tinted Mineral Matte CE Sunscreen TITANIUM DIOXIDE, ZINC OXIDE The Maui Medical Group, Inc 34b60880-5fe1-b78f-e063-6294a90a748d 2025-12-11 Exact identifier application number: M020 Sheer Mineral Sunscreen TITANIUM DIOXIDE, ZINC OXIDE The Maui Medical Group, Inc 34b51190-6a6d-c5e0-e063-6394a90ae875 2025-12-11 Exact identifier application number: M020 Tinted Ultra Zinc Face and Body ZINC OXIDE LIV BODY AND BEAUTY LLC 374fae34-41b9-4cab-e063-6394a90a9b1d 2025-12-11 Exact identifier application number: M020 Z Bloc ZINC OXIDE The Maui Medical Group, Inc 34b64eb5-a91f-de43-e063-6294a90a8043 2025-12-11 Exact identifier application number: M020 Sheer Tinted Sunscreen Stick TITANIUM DIOXIDE, ZINC OXIDE The Maui Medical Group, Inc 34b6e8d0-6235-dac2-e063-6394a90afefd 2025-12-11 Exact identifier application number: M020 Tinted Sunscreen Face Primer TITANIUM DIOXIDE, ZINC OXIDE LIV BODY AND BEAUTY 374f6b79-2ac4-61cf-e063-6394a90a699b 2025-12-11 Exact identifier application number: M020 Non Tinted Ultra Zinc Face and Body ZINC OXIDE LIV BODY AND BEAUTY LLC 375008f2-8dd4-aa31-e063-6394a90a5be8 2025-12-11 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