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 |
|---|---|---|---|---|---|---|
| Tenacious Ergodyne | SPF 50 SUNSCREEN LOTION | Tenacious Holdings, Inc. | aaaa1f54-1136-4062-85ba-0926351580bb | 2024-10-23 | Warnings | M020 |
| Bull Frog SPF 50 Quik with Water Armor Tech | AVOBENZONE, HOMOSALATE, OCTISALATE, OCTOCRYLENE | BULLFROG BRANDS, LLC. | f706f90c-eb79-2201-e053-6394a90a2ce4 | 2024-10-23 | Warnings | M020 |
| Bull Frog SPF 50 Quik with Water Armor Tech | AVOBENZONE, HOMOSALATE, OCTISALATE, OCTOCRYLENE | BULLFROG BRANDS, LLC. | f70816a3-cc04-b000-e053-6294a90a0fae | 2024-10-23 | Warnings | M020 |
| Alumier MD Post Procedure Kit | TITANIUM DIOXIDE, ZINC OXIDE | Alumier Labs | 252859de-6676-5e07-e063-6394a90a64a1 | 2024-10-23 | Warnings | M020 |
| Equate Sunscreen Tanning Oil With Coconut Oil SPF 6 | AVOBENZONE, HOMOSALATE | WAL-MART STORES INC. | f44d83d3-ffca-7a93-e053-2a95a90a7715 | 2024-10-23 | Warnings | M020 |
| Tanning Sunscreen UVB Protection Dry Oil Equate | AVOBENZONE, HOMOSALATE, OCTISALATE | WAL-MART STORES INC. | acdf62f2-742e-5df9-e053-2a95a90a96c5 | 2024-10-23 | Warnings | M020 |
| WALMART EQUATE BEAUTY ULTRA LIGHT SUNSCREEN SPF 100 | AVOBENZONE, HOMOSALATE, OCTISALATE, OCTOCRYLENE, OXYBENZONE | WAL-MART STORES INC. | c8d4feca-7bee-2413-e053-2a95a90a739c | 2024-10-23 | Warnings | M020 |
| Equate Sunscreen for All Skin Tones SPF 50 | AVOBENZONE, HOMOSALATE, OCTISALATE, OCTOCRYLENE | Wal-Mart Stores Inc | f410ffcc-ef0e-13c4-e053-2a95a90a568a | 2024-10-23 | Warnings | M020 |
| Positive Light Tinted Moisturizer Broad Spectrum SPF 20 Sunscreen 44N | HOMOSALATE, TITANIUM DIOXIDE, ZINC OXIDE | Rare Beauty, LLC | cffbb6af-5a04-f58a-e053-2995a90a1ae2 | 2024-10-23 | Warnings | M020 |
| Banana Boat | TITANIUM DIOXIDE, ZINC OXIDE | Edgewell Personal Care Brands, LLC | 441a46f0-ecda-4448-e054-00144ff88e88 | 2024-10-23 | Warnings | M020 |
| Positive Light Tinted Moisturizer Broad Spectrum SPF 20 Sunscreen 28C | HOMOSALATE, TITANIUM DIOXIDE, ZINC OXIDE | Rare Beauty, LLC | cffb8219-7076-de64-e053-2a95a90a6036 | 2024-10-23 | Warnings | M020 |
| Positive Light Tinted Moisturizer Broad Spectrum SPF 20 Sunscreen 10N | HOMOSALATE, TITANIUM DIOXIDE, ZINC OXIDE | Rare Beauty, LLC | cfee02eb-92f9-be12-e053-2a95a90a4337 | 2024-10-23 | Warnings | M020 |
| CVS Pharmacy Kids SPF 70 Clear | AVOBENZONE, HOMOSALATE, OCTISALATE, OCTOCRYLENE, OXYBENZONE | CVS Pharmacy | 4eb824a6-66ac-01f8-e054-00144ff8d46c | 2024-10-22 | Warnings | M020 |
| CVS Health 60 Plus Sensitive Skin Sun | TITANIUM DIOXIDE, ZINC OXIDE | CVS Pharmacy | 477c25ec-33db-04a6-e054-00144ff8d46c | 2024-10-22 | Warnings | M020 |
| CVS Health SPF 70 Clear | AVOBENZONE, HOMOSALATE, OCTISALATE, OCTOCRYLENE, OXYBENZONE | CVS Pharmacy | 4eb75945-9d65-55b4-e054-00144ff88e88 | 2024-10-22 | Warnings | M020 |
| CVS Health Sport SPF 50 Clear | AVOBENZONE, HOMOSALATE, OCTISALATE, OCTOCRYLENE, | CVS Pharmacy | 4ec6384a-8faf-5712-e054-00144ff8d46c | 2024-10-22 | Warnings | M020 |
| CVS Health Sport SPF 30 Clear | AVOBENZONE, HOMOSALATE, OCTOCRYLENE, | CVS Pharmacy | 4ec6b50b-5236-6f5b-e054-00144ff8d46c | 2024-10-22 | Warnings | M020 |
| CVS Pharmacy SPF 70 Beach Guard Clear | AVOBENZONE, HOMOSALATE, OCTISALATE, OCTOCRYLENE, OXYBENZONE | CVS Pharmacy | 4ec75d23-a33b-6c52-e054-00144ff88e88 | 2024-10-22 | Warnings | M020 |
| CVS Health SPF 70 Beach Guard Sun | AVOBENZONE, HOMOSALATE, OCTISALATE, OCTOCRYLENE, OXYBENZONE | CVS Pharmacy | 4adbd66a-6b38-046d-e054-00144ff8d46c | 2024-10-22 | Warnings | M020 |
| CVS Health Sport SPF 100 Clear | AVOBENZONE, HOMOSALATE, OCTISALATE, OCTOCRYLENE, OXYBENZONE | CVS Pharmacy | 651c245c-2d3a-0019-e053-2991aa0a4637 | 2024-10-22 | 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 |