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 305 of 346 · 6,912 matching rows.
Brand, Generic, Manufacturer table Brand Generic Manufacturer SPL set ID Effective date Available safety fields Join Hydrator Plus SPF 30 BROAD SPECTRUM CP Skin Health Group, Inc. b6c0db82-9fba-6216-e053-2a95a90a7560 2024-02-14 Warnings Exact identifier application number: M020 REPAIRWEAR LASER FOCUS SPF 15 LINE SMOOTHING CO/O OCTINOXATE, TITANIUM DIOXIDE CLINIQUE LABORATORIES LLC 10f7ec01-541b-a15a-e063-6294a90aa9df 2024-02-09 Warnings Exact identifier application number: M020 Sunscreen HOMOSALATE, OCTINOXATE, OCTISALATE, OXYBENZONE Safetec of America, Inc. 754186c8-3c88-40a0-a4e3-35e3ea9d1b4c 2024-02-08 Warnings Exact identifier application number: M020 MIAMI BEACH BUM SPF-50 Blocked Sunscreen ZINC OXIDE MIAMI BEACH BUM 2cf40d87-626b-4309-8f13-fd980161c62f 2024-02-07 Warnings Exact identifier application number: M020 Equate Sunscreen for All Skin Tones SPF 50 AVOBENZONE, HOMOSALATE, OCTISALATE, OCTOCRYLENE WAL-MART INC. 1062060a-a5c7-1805-e063-6294a90ab802 2024-02-02 Warnings Exact identifier application number: M020 Equate Kids Sunscreen Broad Spectrum SPF 50 Equate AVOBENZONE, HOMOSALATE, OCTISALATE, OCTOCRYLENE WAL-MART INC. 10631036-0fa6-b3ee-e063-6294a90af7aa 2024-02-02 Warnings Exact identifier application number: M020 Death Tan SPF 50 Sport Sunscreen AVOBENZONE, HOMOSALATE, OCTOCRYLENE Derma Care Research Labs, LLC 106ab5e2-e134-b81d-e063-6294a90a5bca 2024-02-02 Warnings Exact identifier application number: M020 COOLA Rosilliance Mineral Tinted Face Moisturizer SPF 30 Golden Hour TITANIUM DIOXIDE COOLA, LLC edfda0f5-0f72-5cc7-e053-2a95a90ae38d 2024-02-02 Warnings Exact identifier application number: M020 COOLA Mineral Liplux Lip Balm SPF 30 Summer Crush ZINC OXIDE COOLA, LLC edc6754e-dabb-5bff-e053-2a95a90a7390 2024-02-02 Warnings Exact identifier application number: M020 COOLA Mineral Liplux Lip Balm SPF 30 Skinny Dip ZINC OXIDE COOLA, LLC ee01f936-81a9-a54d-e053-2a95a90a5227 2024-02-02 Warnings Exact identifier application number: M020 toty Solaria Mineral TITANIUM DIOXIDE, ZINC OXIDE Chipican LLC e9d590d8-e71a-0715-e053-2a95a90a5acf 2024-02-01 Warnings Exact identifier application number: M020 THE FACE SHOP EVERYDAY MINERAL FACE PROTECTION SPF 50 ZINC OXIDE LG H&H Co., Ltd. 10d343c8-f0c1-6b90-e063-6294a90a24ba 2024-02-01 Warnings Exact identifier application number: M020 THE FACE SHOP EVERYDAY MINERAL FACE PROTECTION SPF 50 ZINC OXIDE fmg Co.Ltd 10d401af-fd92-d82a-e063-6294a90a9f7f 2024-02-01 Warnings Exact identifier application number: M020 La Roche Posay Laboratoire Dermatologique Anthelios 60 Face Light Fluid Sunscreen Broad Spectrum SPF 60 Water Resistant 80 Minutes AVOBENZONE, HOMOSALATE, OCTISALATE AND OCTOCRYLENE L'Oreal USA Products Inc 18f05adb-43a8-47e5-bc5a-fbf3209d0a44 2024-01-31 Warnings Exact identifier application number: M020 La Roche Posay Laboratoire Dermatologique Anthelios 60 Face Light Fluid Sunscreen Broad Spectrum SPF 60 Water Resistant 80 Minutes AVOBENZONE, HOMOSALATE, OCTISALATE AND OCTOCRYLENE Cosmetique Active Production 03593e3c-c98a-43af-82bc-10331e23342c 2024-01-31 Warnings Exact identifier application number: M020 ATOMY SUN HOMOSALATE, OCTOCRYLENE, ETHYLHEXYL SALICYLATE, BUTYL METHOXYDIBENZOYLMETHANE ATOMY CO., LTD. bdf0a11d-3563-4b09-a430-f031709cb3f3 2024-01-30 Warnings Exact identifier application number: M020 ATOMY DERMA CALMING SUN TITANIUM DIOXIDE ATOMY CO., LTD. fd5fc3ba-6e7c-4e48-8e65-47c03141df45 2024-01-30 Warnings Exact identifier application number: M020 EltaMD UV Lip Balm SPF31 ZINC OXIDE AND OCTINOXATE SUNSCREEN CP Skin Health, Inc 0ec70f0a-cda4-4953-b056-e1e6e9921e5b 2024-01-25 Warnings Exact identifier application number: M020 BBW SPF 35 Natural Lip Balm BBW SPF 35 NATURAL LIP BALM Autumn Harp 0f8b024c-c481-951b-e063-6394a90ac63c 2024-01-22 Warnings Exact identifier application number: M020 Bath and Body Works SPF 35 Natural Lip Balm BATH AND BODY WORKS SPF 35 NATURAL LIP BALM Bath and Body Works, Inc. 0f8dab80-c84f-ffbd-e063-6294a90a317e 2024-01-22 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