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.
| 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 |
|---|---|
| TITANIUM DIOXIDE | 80 mg/g |
| ZINC OXIDE | 38 mg/g |
Harmonized UNII identifiers#
| Identifier | FDA.report destination |
|---|---|
| 15FIX9V2JP | Internal UNII lookup |
| SOI2LOH54Z | Internal UNII lookup |
Harmonized SPL set identifiers#
| Identifier | FDA.report destination |
|---|---|
| 293a6a6c-adf3-452d-92f5-3baceb619e39 | Available on FDA.report |
DailyMed Package Descriptions#
| 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 | 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.
| Brand | Generic | Manufacturer | SPL set ID | Effective date | Available safety fields | Join |
|---|---|---|---|---|---|---|
| Vertra Pearl White Face Stick SPF 50 | PADIMATE O, TITANIUM DIOXIDE | Toshiki Pigment Co., ltd. | b7163861-7084-5adf-e053-2995a90ae199 | 2025-11-04 | Warnings | M020 |
| Land Shark SPF 8 | OCTINOXATE AND OXYBENZONE | Tropical Seas, Inc. | b5fa2883-998f-2128-e053-2995a90a5c84 | 2025-11-04 | Warnings | M020 |
| Land Shark SPF 15 | OCTOCRYLENE, OCTISALATE, AND AVOBENZONE | Tropical Seas, Inc. | b557c9c5-6ea8-1d59-e053-2995a90aff68 | 2025-11-04 | Warnings | M020 |
| Vertra Ehukai Beige Face Stick SPF 38 | TITANIUM DIOXIDE | Toshiki Pigment Co., ltd. | b71619c4-a8ef-1dda-e053-2995a90aba50 | 2025-11-04 | Warnings | M020 |
| Land Shark SPF 45 | OCTOCRYLENE, OCTINOXATE, OXYBENZONE, HOMOSALATE AND OCTISALATE | Tropical Seas, Inc. | b4cafdf1-44e1-10c0-e053-2995a90ab3dc | 2025-11-04 | Warnings | M020 |
| Reef Kids SPF 30 Oxybenzone Free | OCTOCRYLENE, OCTISALATE, AND AVOBENZONE | Tropical Seas, Inc. | e226b07a-9f44-4b17-8f26-c86dcfa5dcda | 2025-11-04 | Warnings | M020 |
| Land Shark SPF 50 | OCTOCRYLENE, OCTISALATE, AND AVOBENZONE | Tropical Seas, Inc. | b4cc95f0-d684-5331-e053-2995a90a3295 | 2025-11-04 | Warnings | M020 |
| Land Shark SPF 20 | OCTOCRYLENE, OCTISALATE, AND AVOBENZONE | Tropical Seas, Inc. | b55792e6-2ead-1fb1-e053-2995a90ac915 | 2025-11-04 | Warnings | M020 |
| Land Shark SPF 8 | OCTINOXATE AND OXYBENZONE | Tropical Seas, Inc. | b5e68448-4131-1c6c-e053-2a95a90a014a | 2025-11-04 | Warnings | M020 |
| Land Shark SPF 40 | ZINC OXIDE AND TITANIUM DIOXIDE | Tropical Seas, Inc. | d204c38c-b5d1-3511-e053-2a95a90a9dc8 | 2025-11-04 | Warnings | M020 |
| Expedition BackCountry SPF 30 | OCTOCRYLENE, OCTISALATE, AND AVOBENZONE | Tropical Seas, Inc. | b5e4e63c-3e51-0a78-e053-2a95a90abd87 | 2025-11-04 | Warnings | M020 |
| Reef Babies SPF 50 Oxybenzone Free | OCTOCRYLENE, OCTISALATE, AND AVOBENZONE | Tropical Seas, Inc. | 8cd68b09-2578-4519-b00e-e83e0e440815 | 2025-11-04 | Warnings | M020 |
| Land Shark SPF 30 | OCTOCRYLENE, OCTISALATE, AND AVOBENZONE | Tropical Seas, Inc. | b5e44be7-3a46-34e2-e053-2a95a90a9660 | 2025-11-04 | Warnings | M020 |
| Reef Kids SPF 30 Oxybenzone Free | OCTOCRYLENE, OCTISALATE, AND AVOBENZONE | Tropical Seas, Inc. | 005a9e7c-e392-4b9a-911f-d7586f7ae94e | 2025-11-04 | Warnings | M020 |
| Land Shark SPF 30 | OCTOCRYLENE, OCTISALATE, AVOBENZONE | Tropical Seas, Inc. | b559d349-2ffd-492c-e053-2995a90aab06 | 2025-11-04 | Warnings | M020 |
| Land Shark Zinky SPF 36 Pink Beach | ZINC OXIDE | Tropical Seas, Inc. | d240e6c9-d053-9924-e053-2a95a90a855a | 2025-11-04 | Warnings | M020 |
| Land Shark SPF 15 | OCTOCRYLENE, OCTISALATE, AND AVOBENZONE | Tropical Seas, Inc. | b5e49c6f-477b-aafc-e053-2a95a90a982a | 2025-11-04 | Warnings | M020 |
| Land Shark SPF 30 | OCTOCRYLENE, OCTISALATE, AVOBENZONE | Tropical Seas, Inc. | b559e03b-f5d3-bd72-e053-2995a90a31ca | 2025-11-04 | Warnings | M020 |
| Land Shark SPF 30 Clear Zinc | ZINC OXIDE AND TITANIUM DIOXIDE | Tropical Seas, Inc. | d128269b-73fa-e5f3-e053-2995a90af1ed | 2025-11-04 | Warnings | M020 |
| Land Shark SPF 50 Sport | OCTOCRYLENE, OCTISALATE, AND AVOBENZONE | Tropical Seas, Inc. | b5e40a7c-b49d-cfc3-e053-2995a90ac27e | 2025-11-04 | Warnings | M020 |
Packages#
| 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 |