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 |
|---|---|---|---|---|---|---|
| Brightening Primer SPF 20 | TITANIUM DIOXIDE AND ZINC OXIDE | Colorescience | a42d6761-47cd-4c9b-9656-64e37e065639 | 2025-12-17 | Warnings | M020 |
| Avail Body with Sunscreen | HOMOSALATE, OCTOCRYLENE, OCTISALATE, AND AVOBENZONE | Emeis Cosmetics Pty Ltd | 4bb39ea1-f948-4357-b425-0cafd454ce30 | 2025-12-17 | Warnings | M020 |
| Bronzing Primer SPF 20 | TITANIUM DIOXIDE AND ZINC OXIDE | Colorescience | f749af07-0fcd-4376-be62-7c078b3e7eb6 | 2025-12-17 | Warnings | M020 |
| Miffy Tone Perfecting SPF Cushion | HOMOSALATE, OCTISALATE, OCTOCRYLENE, ZINC OXIDE | RBGROUP Co., Ltd | 98a2906d-61e2-4627-a695-a20f10872f9a | 2025-12-16 | Warnings | M020 |
| Dear Sun Tone Perfecting SPF Cushion | HOMOSALATE, OCTISALATE, OCTOCRYLENE, ZINC OXIDE | RBGROUP Co., Ltd | 80748647-e0ea-46dc-8ee2-a0ad77c4b19d | 2025-12-16 | Warnings | M020 |
| SUNSCREEN Stick | ZINC OXIDE 15%, TITANIUM DIOXIDE 8%, HOMOSALATE 6% | Foshan Sugar Max Cosmetics CO.,Ltd | 460e1038-30f0-a6e4-e063-6394a90ad534 | 2025-12-16 | Warnings | M020 |
| SUNSCREEN SPRAY150ml | ZINC OXIDE 15%, TITANIUM DIOXIDE 6%, HOMOSALATE 5%, OCTISALATE 4% | Foshan Sugar Max Cosmetics CO.,Ltd | 460ead6c-dd44-e320-e063-6294a90a2b64 | 2025-12-16 | Warnings | M020 |
| Sunscreen Cream | ZINC OXIDE 12%,TITANIUM DIOXIDE 8%, HOMOSALATE 12%, OCTISALATE4.5%,PHENYLBENZIMIDAZOLE SULFONIC ACID 3.5% | Foshan Sugar Max Cosmetics CO.,Ltd | 460f0ca0-9440-9a6e-e063-6394a90a33b3 | 2025-12-16 | Warnings | M020 |
| Unseen Sunscreen Lip Protector SPF 30 | OCTOCRYLENE, AVOBENZONE, HOMOSALATE, OCTISALATE | Supergoop LLC | db12a89f-5fef-1b2a-e053-2a95a90a56f9 | 2025-12-16 | Warnings | M020 |
| Tinted Mineral Sunscreen | ZINC OXIDE | Natur LLC | 365f3c48-15a6-2d32-e063-6394a90aad78 | 2025-12-16 | M020 | |
| Non Tinted Mineral Sunscreen | ZINC OXIDE | Natur LLC | 365fffa2-b846-7dd3-e063-6394a90a47cb | 2025-12-16 | M020 | |
| Tinted Replenishing Daily Protection | ZINC OXIDE | Natur LLC | 36603550-9c3d-5e33-e063-6394a90adfc9 | 2025-12-16 | M020 | |
| Shield And Protect Tinted | ZINC OXIDE | TRILOGY LABORATORIES, LLC | 37f00e51-1123-c04c-e063-6294a90abed8 | 2025-12-16 | M020 | |
| Shield And Protect | ZINC OXIDE | TRILOGY LABORATORIES, LLC | 37f09dd5-084f-3c80-e063-6394a90a7a53 | 2025-12-16 | M020 | |
| Non Tinted Facial Mineral Protectant | TITANIUM DIOXIDE, ZINC OXIDE | EUROPEAN SKIN AND MASSAGE STUDIO | 3766496f-231c-f98c-e063-6294a90aae08 | 2025-12-16 | M020 | |
| Tinted Facial Mineral Protectant | TITANIUM DIOXIDE, ZINC OXIDE | EUROPEAN SKIN AND MASSAGE STUDIO | 3766b0d8-20e6-a227-e063-6294a90af4da | 2025-12-16 | M020 | |
| Non-Tinted Mineral Sunscreen | ZINC OXIDE | WECARE FRISCO PLLC | 37515807-e29a-3916-e063-6394a90a1ffd | 2025-12-16 | M020 | |
| Tinted Mineral Sunscreen Broad Spectrum SPF 40 | TITANIUM DIOXIDE, ZINC OXIDE | WECARE FRISCO PLLC | 374f866d-eb52-61e3-e063-6394a90a77c7 | 2025-12-16 | M020 | |
| Tinted Lip Protection | TITANIUM DIOXIDE, ZINC OXIDE | WECARE FRISCO PLLC | 3750c23d-c3f8-fac3-e063-6394a90a135e | 2025-12-16 | M020 | |
| Non-Tinted Mineral Sunscreen Broad Spectrum SPF 40 | ZINC OXIDE | WECARE FRISCO PLLC | 374fe86e-cbe8-f911-e063-6294a90a9600 | 2025-12-16 | 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 |