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 286 of 346 · 6,912 matching rows.
Brand, Generic, Manufacturer table Brand Generic Manufacturer SPL set ID Effective date Available safety fields Join Bright as Day Mineral SPF50 ZINC OXIDE Koco Life LLC 1c245a53-4098-62e6-e063-6294a90abf12 2024-09-23 Warnings Exact identifier application number: M020 Pure Protect Mineral Sunscreen Stick SPF50 ZINC OXIDE Koco Life LLC 22cd5999-9b9a-91a3-e063-6394a90a0da5 2024-09-23 Warnings Exact identifier application number: M020 ABSOLUTELY natural Lip Balm Broad Spectrum SPF 15 Sunscreen ZINC OXIDE Absolutely Natural eb914dd8-9b11-44dd-8c4f-4d4c0c3bf1ea 2024-09-23 Warnings Exact identifier application number: M020 SUNSCREEN 01 AVOBENZONE,HOMOSALATE,OCTOCRYLENE,OCTISALATE Cosmuses Cosmetics (Ningbo) Co., Ltd. 229dabbc-9043-3c9d-e063-6394a90a5692 2024-09-21 Warnings Exact identifier application number: M020 GLC OG Natural Tinted SPF 30 Sunscreen ZINC OXIDE GUD LIFE CO. LLC 25e1e8ec-e19d-45f7-b339-5d12c2b511d6 2024-09-18 Warnings Exact identifier application number: M020 Target Up and Up Sunscreen SPF 30 SPORT Broad Spectrum AVOBENZONE, HOMOSALATE,OCTISALATE,OCTOCRYLENE TARGET CORPORATION bad7d56e-662e-0776-e053-2a95a90a0af0 2024-09-18 Warnings Exact identifier application number: M020 Target Up and Up Kids SPF 50 AVOBENZONE, HOMOSALATE, OCTISALATE, OCTOCRYLENE TARGET CORPORATION b82b6d0d-616d-f041-e053-2995a90ae6a3 2024-09-18 Warnings Exact identifier application number: M020 COOLA Dew Good Illuminating Body Melt SPF 40 AVOBENZONE, OCTISALATE, OCTOCRYLENE COOLA LLC 43d293f6-e13c-4ee9-89df-2a3ef0034e31 2024-09-16 Warnings Exact identifier application number: M020 Proceuticals Private Label by TiZO non-tinted replenishing daily protection ZINC OXIDE Fallien Cosmeceuticals, Ltd 2203ea22-d12a-99fe-e063-6394a90aca9f 2024-09-13 Warnings Exact identifier application number: M020 OS-01 Face SPF BS SPF30 Tinted ZINC OXIDE Allure Labs 22042031-ac8e-1ab2-e063-6394a90a6ed4 2024-09-13 Warnings Exact identifier application number: M020 OS-01 Face SPF BS SPF30 Tinted ZINC OXIDE ONESKIN INC. 2204e776-b1a1-be15-e063-6294a90af5de 2024-09-13 Warnings Exact identifier application number: M020 OS-01 Face SPF BS SPF30 Untinted ZINC OXIDE Allure Labs 2205345b-5e92-37eb-e063-6294a90a6b6c 2024-09-13 Warnings Exact identifier application number: M020 OS-01 Face SPF BS SPF30 Untinted ZINC OXIDE ONESKIN INC. 2205ec0e-ac3f-299f-e063-6294a90a2174 2024-09-13 Warnings Exact identifier application number: M020 H-E-B SOLUTIONS SUNSCREEN COCONUT SPF 50 CONTINUOUS AVOBENZONE, HOMOSALATE, OCTISALATE, OCTOCRYLENE H.E.B f4130277-ea9b-6b25-e053-2a95a90a59be 2024-09-13 Warnings Exact identifier application number: M020 HEB SPF 50 Tattoo Continuous Sunscreen AVOBENZONE, HOMOSALATE, OCTISALATE, OCTOCRYLENE H.E.B f6df491d-1fa9-a4c8-e053-6394a90a3866 2024-09-13 Warnings Exact identifier application number: M020 YOUR Day Cream Sunscreen Broad Spectrum SPF 30 OCTISALATE, OXYBENZONE, AVOBENZONE, OCTOCRYLENE Skin Ai, LLC 21cbd5ac-5307-939b-e063-6294a90ac791 2024-09-10 Warnings Exact identifier application number: M020 Mario Badescu SPF 17 AVOBENZONE, OCTINOXATE, OCTOCRYLENE Bentley Laboratories LLC 0fd51f8d-ee67-48fd-ab98-1fedb0339462 2024-09-10 Warnings Exact identifier application number: M020 Mario Badescu Collagen SPF 15 AVOBENZONE, OCTINOXATE, OXYBENZONE Bentley Laboratories LLC 0246b11b-f1ba-4f47-91ab-52a6554b9467 2024-09-10 Warnings Exact identifier application number: M020 Mario Badescu The Moisture Magnet SPF 15 AVOBENZONE, OCTINOXATE, OXYBENZONE Bentley Laboratories LLC f6d653f5-52a0-42ad-8308-b8d6f57050cc 2024-09-10 Warnings Exact identifier application number: M020 MARIO BADESCU SPF 30 AVOBENZONE, OCTINOXATE, OCTISALATE, OCTOCRYLENE Bentley Laboratories LLC fe485d4c-0ded-4061-ac34-77b72d535090 2024-09-10 Warnings 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