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 | 2026-11-13 |
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 |
|---|---|---|---|---|---|---|
| Zinc Oxide | PACIFICA ULTRA CC CREAM RADIANT FOUNDATION SPF 30 COOL/DEEP | Pacifica Beauty, LLC | 373901f7-0e32-0f32-e063-6394a90abe25 | 2025-06-10 | Warnings | M020 |
| Zinc Oxide | PACIFICA ULTRA CC CREAM RADIANT FOUNDATION SPF 30 WARM/TAN | Pacifica Beauty, LLC | 37397b96-ef14-9098-e063-6294a90aafc9 | 2025-06-10 | Warnings | M020 |
| Zinc Oxide | PACIFICA ULTRA CC CREAM RADIANT FOUNDATION SPF 30 WARM/LIGHT | Pacifica Beauty, LLC | 373aba7c-2ae1-8726-e063-6294a90ae3d8 | 2025-06-10 | Warnings | M020 |
| Zinc Oxide | PACIFICA ULTRA CC CREAM RADIANT FOUNDATION SPF 30 NATURAL/MEDIUM | Pacifica Beauty, LLC | 373c29b9-2f75-9777-e063-6394a90a68a6 | 2025-06-10 | Warnings | M020 |
| Hydrating Sheer Lip Balm Trio The Neutrals Broad Spectrum SPF 30 | AVOBENZONE, OCTISALATE, AND HOMOSALATE | MDSolarSciences | 374395ea-ab91-de70-e063-6394a90aec56 | 2025-06-10 | Warnings | M020 |
| ANDALOU NATURALS DEEP HYDRATION DAILY SHADE BLUE LIGHT DEFENSE FACIAL SPF 30 | ZINC OXIDE | Andalou naturals | aa689e82-6512-46d8-aec9-269f9348d3f8 | 2025-06-09 | Warnings | M020 |
| ALLIES OF SKIN The One SPF-50 Invisible Sunscreen | AVOBENZONE, HOMOSALATE, OCTOCRYLENE, OCTISALATE | ALLIES GROUP PTE. LTD. | 36e1c61c-33ab-4a5d-853d-119c29632b08 | 2025-06-09 | Warnings | M020 |
| SHISEIDO ULTIMATE SUN PROTECTION S | TITANIUM DIOXIDE AND ZINC OXIDE | Shiseido Americas Corporation | b2fae1ba-67fe-48ef-b31f-62db34349961 | 2025-06-09 | Warnings | M020 |
| Olay Super Cream with Sunscreen Broad Spectrum SPF 30 | AVOBENZONE, HOMOSALATE, OCTISALATE, AND OCTOCRYLENE | The Procter & Gamble Manufacturing Company | 372819f1-0813-2cd5-e063-6294a90ac5bf | 2025-06-09 | Warnings | M020 |
| Naturium Phyto-Glow Lip Balm SPF 45-Clear | AVOBENZONE, HOMOSALATE, OCTISALATE | e.l.f. Cosmetics, Inc. | 3806e2f2-ffd1-6d69-e063-6394a90acb44 | 2025-06-09 | Warnings | M020 |
| Naturium Phyto-Glow Lip Balm SPF 45-Getaway | AVOBENZONE, HOMOSALATE, OCTISALATE | e.l.f. Cosmetics, Inc. | 3808613f-88d6-6c1a-e063-6294a90a5bb2 | 2025-06-09 | Warnings | M020 |
| 1000 Roses Daily Shade Facial SPF 18 | OCTISALATE, OCTOCRYLENE, AND AVOBENZONE | Andalou naturals | 0923e090-6834-4373-80fe-21f00b8c1c17 | 2025-06-09 | Warnings | M020 |
| dAlba Vegan Fresh Sun Cushion | ZINC OXIDE, HOMOSALATE, OCTOCRYLENE | ADMTMAX LLC | 20afcbab-a2f4-7965-e063-6294a90a83d1 | 2025-06-08 | Warnings | M020 |
| dAlba Vegan Mild Sunscreen | ZINC OXIDE | ADMTMAX LLC | 20ab5698-cd9f-0821-e063-6394a90a60d7 | 2025-06-08 | Warnings | M020 |
| dAlba Vegan Fresh Sun Stick | HOMOSALATE, ETHYLHEXYL METHOXYCINNAMATE, ETHYLHEXYL SALICYLATE | ADMTMAX LLC | 20ae82ae-bc8f-89d1-e063-6394a90afff2 | 2025-06-08 | Warnings | M020 |
| dAlba Vegan Essence Sunscreen | HOMOSALATE, OCTOCRYLENE, ETHYLHEXYL METHOXYCINNAMATE, ETHYLHEXYL SALICYLATE | ADMTMAX LLC | 1ccfa213-2f83-ad50-e063-6294a90a38bf | 2025-06-08 | Warnings | M020 |
| Pacifica Ultra CC Cream Radiant Foundation SPF 30 Warm/Medium | ZINC OXIDE | Pacifica Beauty, LLC | 36ec6c9d-f7dc-0419-e063-6294a90a55e6 | 2025-06-06 | Warnings | M020 |
| Pacifica Ultra CC Cream Radiant Foundation SPF 30 Neutral/Fair | ZINC OXIDE | Pacifica Beauty, LLC | 36ed9101-249a-922c-e063-6394a90a2608 | 2025-06-06 | Warnings | M020 |
| Rodan and Fields Reverse Brightening Defense Broad Spectrum SPF 50 Mineral Sunscreen | TITANIUM DIOXIDE, ZINC OXIDE | Rodan & Fields Beauty, LLC | afa2d42e-b54d-4843-b313-0c44fe5c5d52 | 2025-06-06 | Warnings | M020 |
| 1000 Roses CC Color Plus Correct Sheer Tan SPF 30 | ZINC OXIDE | Andalou naturals | 9314e4fc-ba3e-480e-a005-b8928130ed70 | 2025-06-06 | 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 |