Spa Niacinamide And Vitamin E Hand Cream Broad Spectrum SPF 15
- Product NDC
- 68828-003
- 11-digit product format
- 688280003
- Labeler code
- 68828
- Product ID
- 68828-003_42d81048-d0fd-6bb2-e063-6294a90aacb6
- Type
- HUMAN OTC DRUG
- Nonproprietary name
- avobenzone, homosalate, octisalate, octocrylene
- Dosage form
- CREAM
- Route
- TOPICAL
- Labeler
- Distribuidora Comercial Jafra, S.A. de C.V.
- Application
- M020
- Marketing category
- OTC MONOGRAPH DRUG
- Marketing start
- 2022-06-01
- Substance
- AVOBENZONE; HOMOSALATE; OCTISALATE; OCTOCRYLENE
- Active strength
- 3; 5; 5; 7 g/100mL; g/100mL; g/100mL; g/100mL
- NDC exclude flag
- No
- Listing certified through
- 2026-12-31
- Current FDA listing
- Yes
NDC auxiliary status#
These records are reproduced from FDA’s unfinished, excluded, and compounder listings. They describe what appeared in the source files; a missing record does not establish a regulatory status. View all current auxiliary records, including entries without an NDC. · View the auxiliary file history.
| Dataset | Scope | Product NDC | Package NDC | Code | Status | Reporting period | Source date |
|---|---|---|---|---|---|---|---|
| excluded package | package | 68828-003 | 68828-003-02 | D | Discontinued by firm | 2026-10-27 |
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 |
|---|---|---|---|---|---|---|---|---|---|---|
| 2025-12-14 17:58 UTC · source 2025-12-05 | excluded package | package | 68828-003 | 68828-003-02 | D | Discontinued by firm | excluded / ndc_excluded.zip | d630ba8d3edf… | 732f749b63fb… | |
| 2025-08-27 00:01 UTC · source 2025-08-26 | excluded package | package | 68828-003 | 68828-003-02 | D | Discontinued by firm | excluded / ndc_excluded.zip | f5e01cc5f278… | a2eaf40c39c3… |
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
- Spa Niacinamide And Vitamin E Hand Cream Broad Spectrum SPF 15
- Listing expiration
- 2026-12-31
Active Ingredients#
| Ingredient | Strength |
|---|---|
| AVOBENZONE | 3 g/100mL |
| HOMOSALATE | 5 g/100mL |
| OCTISALATE | 5 g/100mL |
| OCTOCRYLENE | 7 g/100mL |
Harmonized UNII identifiers#
| Identifier | FDA.report destination |
|---|---|
| G63QQF2NOX | Internal UNII lookup |
| V06SV4M95S | Internal UNII lookup |
| 4X49Y0596W | Internal UNII lookup |
| 5A68WGF6WM | Internal UNII lookup |
Harmonized SPL set identifiers#
| Identifier | FDA.report destination |
|---|---|
| 865057ce-f617-4232-a60e-e23c120b0a73 | Available on FDA.report |
DailyMed Product Concepts#
| Product concept | Relation | Version | Effective |
|---|---|---|---|
| ebc62596-fc97-4d03-9483-7ba095d25db7 | Product name | 1 | 20151210 |
| 0ca1d589-929b-4b33-bc5b-1d84abdafa6a | Product name | 1 | 20150324 |
| fc363c46-397b-4476-ac0f-70e43e8e4592 | Product name | 1 | 20150324 |
| 1681bc73-b05f-12c3-1075-382ae39f449c | Product name | 1 | 20140508 |
DailyMed Package Descriptions#
| Package NDC | Product | Description | Form | Quantity | Strength | SPL version |
|---|---|---|---|---|---|---|
| 68828-003-01 | Spa Niacinamide And Vitamin E Hand Cream Broad Spectrum SPF 15 | 75 mL in 1 TUBE | CREAM | 75 | 7 | |
| 68828-003-01 | Spa Niacinamide And Vitamin E Hand Cream Broad Spectrum SPF 15 | 1 in 1 CARTON | CREAM | 1 | 7 | |
| 68828-003-02 | Spa Niacinamide And Vitamin E Hand Cream Broad Spectrum SPF 15 | 1 in 1 CARTON | CREAM | 1 | 7 | |
| 68828-003-02 | Spa Niacinamide And Vitamin E Hand Cream Broad Spectrum SPF 15 | 7 mL in 1 TUBE | CREAM | 7 | 7 |
DailyMed Dashboard NDC Coverage#
| NDC | Dashboard title | SPL version | Validation | Dashboard ZIP |
|---|---|---|---|---|
| 68828-003 | SPA NIACINAMIDE AND VITAMIN E HAND CREAM BROAD SPECTRUM SPF 15 (AVOBENZONE, HOMOSALATE, OCTISALATE, OCTOCRYLENE) CREAM [DISTRIBUIDORA COMERCIAL JAFRA, S.A. DE C.V.] | 5 | Current NDC, Legacy NDC, 4 package rows | 20250104_865057ce-f617-4232-a60e-e23c120b0a73.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 |
|---|---|---|---|---|---|---|
| PHYSICAL TINTED MOISTURIZER SPF44 | ZINC OXIDE, TITANIUM DIOXIDE | Drmtlgy, LLC | 483d0d28-56f3-4b37-af03-0331e1653d73 | 2025-11-06 | Warnings | M020 |
| Neutrogena Rapid Wrinkle Repair Retinol Moisturizer Sunscreen Broad Spectrum SPF 30 Day | AVOBENZONE, HOMOSALATE, OCTISALATE, AND OCTOCRYLENE | Kenvue Brands LLC | d3ebe2a9-434e-497c-8fed-b5c73c70a58b | 2025-11-05 | Warnings | M020 |
| Clear Smart Shine Control Sunscreen Broad Spectrum SPF 25 | AVOBENZONE,HOMOSALATE,OCTISALATE,OCTOCRYLENE | Distribuidora Comercial Jafra, S.A. de C.V. | a57bcf44-580d-520e-e053-2a95a90a6923 | 2025-11-05 | Warnings | M020 |
| Spa Niacinamide And Vitamin E Hand Cream Broad Spectrum SPF 15 | AVOBENZONE, HOMOSALATE, OCTISALATE, OCTOCRYLENE | Distribuidora Comercial Jafra, S.A. de C.V. | 865057ce-f617-4232-a60e-e23c120b0a73 | 2025-11-05 | Warnings | M020 68828-003 |
| Revitalize Solar Protection Fluid Broad Spectrum SPF 50 | AVOBENZONE, HOMOSALATE, OCTISALATE, OCTOCRYLENE | Distribuidora Comercial Jafra, S.A. de C.V. | 29b3ee35-e849-4427-a455-37d92c4b995c | 2025-11-05 | Warnings | M020 |
| Sarah Creal Brilliant Repair Shield | ZINC OXIDE | Sarah Creal LLC | 258ab6f2-f1a7-2d0d-e063-6294a90af34a | 2025-11-05 | Warnings | M020 |
| Perricone MD Cold Plasma Plus Neck and Chest Broad Spectrum SPF 25 | TITANIUM DIOXIDE | THG Beauty USA LLC | 23a55301-2277-6e4f-e063-6394a90af171 | 2025-11-05 | Warnings | M020 |
| Sun Bum Face and Body Stick 40 | AVOBENZONE, HOMOSALATE, OCTISALATE, OCTOCRYLENE | Sun Bum, LLC | 20d9d60d-e0ce-a177-e063-6394a90a162e | 2025-11-05 | Warnings | M020 |
| Obagi Nu-Derm Fx System Normal-Dry Skin Transformation Complexion Brightening System | TITANIUM DIOXIDE, ZINC OXIDE | Obagi Cosmeceuticals LLC | 4cbf1dc6-78b3-4e51-a53f-2018ac88136a | 2025-11-04 | Warnings | M020 |
| SUNBEAT PROCARE FPS 50 KIDS | HOMOSALATE, OCTOCRYLENE, OCTISALATE, AVOBENZONE, ENSULIZOLE | Tecnoglobal, PH7 S.A. DE C.V. | 42c74ddf-70a3-f2b1-e063-6294a90a91a9 | 2025-11-04 | Warnings | M020 |
| 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 |
Packages#
| Package NDC | 11-digit format | Description | Units | Marketing start | Marketing end | Sample | Exclude flag | Status |
|---|---|---|---|---|---|---|---|---|
| 68828-003-01 | 68828000301 | 1 TUBE in 1 CARTON (68828-003-01) / 75 mL in 1 TUBE | 1 tube | 2022-06-01 | 0000-00-00 | No | No | Current |
| 68828-003-02 | 68828000302 | 1 TUBE in 1 CARTON (68828-003-02) > 7 mL in 1 TUBE | 1 tube | 2022-06-01 | 0000-00-00 | No | No | Current |