celazome
- Product NDC
- 58466-108
- 11-digit product format
- 584660108
- Labeler code
- 58466
- Product ID
- 58466-108_f1bea67c-e6e1-44cf-b088-53a00d157b70
- Type
- HUMAN OTC DRUG
- Nonproprietary name
- OXYBENZONE, OCTINOXATE, OCTISALATE, and HOMOSALATE
- Dosage form
- CREAM
- Route
- TOPICAL
- Labeler
- Dermazone LLC
- Application
- M020
- Marketing category
- OTC MONOGRAPH DRUG
- Marketing start
- 2015-10-01
- Substance
- OXYBENZONE; OCTINOXATE; OCTISALATE; HOMOSALATE
- Active strength
- 60; 75; 50; 50 mg/g; mg/g; mg/g; mg/g
- NDC exclude flag
- No
- Listing certified through
- 2026-12-31
- 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 | Package NDC | Code | Status | Snapshot | Source SHA-256 |
|---|---|---|---|---|---|---|---|
| 2025-04-01 02:39 UTC · source 2025-03-31 | excluded product | product | I | Inactivated by FDA | 2ef7874e63bc… | 57b86245f4fa… | |
| 2025-04-01 02:39 UTC · source 2025-03-31 | excluded package | package | 58466-108-04 | I | Inactivated by FDA | 2ef7874e63bc… | 57b86245f4fa… |
| 2025-03-28 20:22 UTC · source 2025-03-28 | excluded product | product | I | Inactivated by FDA | a1b67e2a42f9… | c4cf2c586c0d… | |
| 2025-03-28 20:22 UTC · source 2025-03-28 | excluded package | package | 58466-108-04 | I | Inactivated by FDA | a1b67e2a42f9… | c4cf2c586c0d… |
| 2025-03-22 03:12 UTC · source 2025-03-21 | excluded product | product | I | Inactivated by FDA | cfe11265f3b6… | 090c488252e2… | |
| 2025-03-22 03:12 UTC · source 2025-03-21 | excluded package | package | 58466-108-04 | I | Inactivated by FDA | cfe11265f3b6… | 090c488252e2… |
| 2025-03-10 12:48 UTC · source 2025-03-10 | excluded product | product | I | Inactivated by FDA | cdf11ea48f46… | ba0047e9e063… | |
| 2025-03-10 12:48 UTC · source 2025-03-10 | excluded package | package | 58466-108-04 | I | Inactivated by FDA | cdf11ea48f46… | ba0047e9e063… |
| 2025-02-02 03:52 UTC · source 2025-01-31 | excluded product | product | U | Excluded because listing certification expired | 302b2466d912… | e7b80fea0513… | |
| 2025-02-02 03:52 UTC · source 2025-01-31 | excluded package | package | 58466-108-04 | U | Excluded because listing certification expired | 302b2466d912… | e7b80fea0513… |
| 2025-01-20 13:05 UTC · source 2025-01-20 | excluded product | product | U | Excluded because listing certification expired | ed331223b511… | 672a5bd82f5f… | |
| 2025-01-20 13:05 UTC · source 2025-01-20 | excluded package | package | 58466-108-04 | U | Excluded because listing certification expired | ed331223b511… | 672a5bd82f5f… |
| 2025-01-11 03:41 UTC · source 2025-01-10 | excluded product | product | U | Excluded because listing certification expired | 0efc9e666f02… | f202fb6c5f17… | |
| 2025-01-11 03:41 UTC · source 2025-01-10 | excluded package | package | 58466-108-04 | U | Excluded because listing certification expired | 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
- celazome
- Brand name suffix
- Moisturizing SPF 29 Active with DNArescue
- Listing expiration
- 2026-12-31
Active Ingredients#
| Ingredient | Strength |
|---|---|
| OXYBENZONE | 60 mg/g |
| OCTINOXATE | 75 mg/g |
| OCTISALATE | 50 mg/g |
| HOMOSALATE | 50 mg/g |
Harmonized UNII identifiers#
| Identifier | FDA.report destination |
|---|---|
| 95OOS7VE0Y | Internal UNII lookup |
| 4Y5P7MUD51 | Internal UNII lookup |
| 4X49Y0596W | Internal UNII lookup |
| V06SV4M95S | Internal UNII lookup |
Harmonized SPL set identifiers#
| Identifier | FDA.report destination |
|---|---|
| 99fb90ca-6527-459b-8af2-627ea9abe11b | Available on FDA.report |
FDA-Initiated Inactive NDC Indexing#
| NDC | Effective | Action | Document | Indexing SPL | Related label |
|---|---|---|---|---|---|
| 58466-108-04 | 2025-07-25 | C162847 | 48780-1 | 2cef2736-636a-d83d-e063-dadaa90ab31f | celazome ® Moisturizing SPF 29 Active with DNArescue™ |
| 58466-108-04 | 2025-01-30 | C162847 | 48780-1 | 2cef2736-636a-d83d-e063-dadaa90ab31f | celazome ® Moisturizing SPF 29 Active with DNArescue™ |
DailyMed Package Descriptions#
| Package NDC | Product | Description | Form | Quantity | Strength | SPL version |
|---|---|---|---|---|---|---|
| 58466-108-04 | celazomeMoisturizing SPF 29 Active with DNArescue | 113 g in 1 BOTTLE, DISPENSING | CREAM | 113 | 3 | |
| 58466-108-04 | celazomeMoisturizing SPF 29 Active with DNArescue | 1 in 1 CARTON | CREAM | 1 | 3 |
DailyMed Socrata Ingredients#
DailyMed Dashboard NDC Coverage#
| NDC | Dashboard title | SPL version | Validation | Dashboard ZIP |
|---|---|---|---|---|
| 58466-108 | CELAZOME MOISTURIZING SPF 29 ACTIVE WITH DNARESCUE (OXYBENZONE, OCTINOXATE, OCTISALATE, AND HOMOSALATE) CREAM [DERMAZONE SOLUTIONS, INC.] | 2 | Current NDC, Legacy NDC, 2 package rows | 20181117_99fb90ca-6527-459b-8af2-627ea9abe11b.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 |
|---|---|---|---|---|---|---|
| 2000DL-CL30T | SPF30 BS TROPICAL | Epic Laboratories, LLC | 0286f94e-a2e8-b529-e063-6294a90ac08d | 2026-03-02 | Warnings | M020 |
| 2000DL-CL30V | SPF30 BS ORIGINAL | Epic Laboratories, LLC | 1872eefd-d702-ac9f-e063-6294a90a24ef | 2026-03-02 | Warnings | M020 |
| JAYSUING White Birch Moisturizing Sunscreen Cream | TITANIUM DIOXIDE | Shantou Jaysuing Cleaning and Environmental Protection Technology Co., Ltd. | 4c174691-cc32-b2e4-e063-6294a90a0f73 | 2026-03-02 | Warnings | M020 |
| Kypris Pot of Shade Heliotropic Broad Spectrum SPF 30 Sunscreen And Primer | ZINC OXIDE | Kypris Beauty LLC | a5d5f7bd-d7bf-4a5c-8530-b9d5d74754c3 | 2026-02-27 | Warnings | M020 |
| Avobenzone, Homosalate, Octisalate | AVOBENZONE, HOMOSALATE, OCTISALATE | Chain Drug Marketing Association | 6307627a-94e2-47ea-8519-68975716dd6e | 2026-02-27 | Warnings, Adverse reactions | M020 |
| Sport Sunscreen SPF 30 | AVEBONZONE, HOMOSALATE, OCTISALATE | Chain Drug Marketing Association | a38e150e-2e50-4936-ae46-408f9cf82d15 | 2026-02-27 | Warnings, Adverse reactions | M020 |
| Sport Sunscreen SPF 70 | AVOBENZONE, HOMOSALATE, OCTISALATE | Chain Drug Marketing Association | 87811c86-19d2-4179-8d22-2aeb4680ff57 | 2026-02-27 | Warnings, Adverse reactions | M020 |
| Sunscreen for Kids SPF 50 | AVEBONZONE, HOMOSALATE, OCTISALATE | Chain Drug Marketing Association | d7215a32-00a9-4b70-8597-8ea91f546c1e | 2026-02-27 | Warnings, Adverse reactions | M020 |
| Sport Sunscreen SPF 50 | AVEBONZONE, HOMOSALATE, OCTISALATE | Chain Drug Marketing Association | 9fccccd4-2d2e-4812-85b1-bbeb44ff04ea | 2026-02-27 | Warnings, Adverse reactions | M020 |
| Avobenzone, Homosalate, Octisalate | AVOBENZONE, HOMOSALATE, OCTISALATE | The Kroger Co. | be702a3b-1652-4468-803d-295100d3e3e2 | 2026-02-27 | Warnings, Adverse reactions | M020 |
| Avobenzone, Homosalate, Octisalate | AVOBENZONE, HOMOSALATE, OCTISALATE | The Kroger Co. | 644ec129-15c9-4ac1-8362-5b4c2e58ab9a | 2026-02-27 | Warnings, Adverse reactions | M020 |
| SPF Beauty | SPF BEAUTY | Walmart Inc. | f06f26af-81d6-4603-b377-fd12430ec952 | 2026-02-27 | Warnings, Adverse reactions | M020 |
| SPF Moisturizer | SPF MOISTURIZER | Walmart Inc. | 41de3171-9ed3-45da-96fb-dfcf41912229 | 2026-02-27 | Warnings, Adverse reactions | M020 |
| Facial Moisturizer | DAILY FACIAL MOISTURIZER SPF 15 | Walmart Inc. | 2cec9c90-2e64-f005-e063-6294a90a8753 | 2026-02-27 | Warnings, Adverse reactions | M020 |
| Avobenzone, Homosalate, Octisalate | AVOBENZONE, HOMOSALATE, OCTISALATE | Walmart Inc. | 309d881d-40e0-37bc-e063-6294a90a3769 | 2026-02-27 | Warnings, Adverse reactions | M020 |
| Avbenzone, Homosalate, Octisalate | AVBENZONE, HOMOSALATE, OCTISALATE | Walmart Inc. | d3d7a5d3-5c78-45c3-ba4b-7ac1a3b4526a | 2026-02-27 | Warnings | M020 |
| MELAO Sunscreen Stick | ETHYLHEXYL METHOXYCINNAMATE, HOMOSALATE, OCTOCRYLENE, AVOBENZONE | Guangdong Aimu Biological Technology Co., Ltd | 4ba15c03-0409-918b-e063-6294a90ac6ee | 2026-02-26 | Warnings | M020 |
| TIBENA EVERY DAY REAL SUN BLOCK | TITANIUM DIOXIDE, ZINC OXIDE | KONAD CO LTD | 211c9930-4f91-cf8f-e063-6394a90a97b3 | 2026-02-26 | Warnings | M020 |
| Olay Regenerist Whip Lightweight Moisturizer with Sunscreen Broad Spectrum SPF 25 | AVOBENZONE, HOMOSALATE, OCTISALATE, AND OCTOCRYLENE | The Procter & Gamble Manufacturing Company | 4bbc0639-3a80-1c28-e063-6394a90a3c00 | 2026-02-26 | Warnings | M020 |
| CLE DE PEAU BEAUTE RADIANT FLUID FOUNDATION MATTE M B10 | TITANIUM DIOXIDE | Shiseido Americas Corporation | 54f8210f-4934-4ada-89c3-aa89e7a09260 | 2026-02-26 | Warnings | M020 |
Packages#
| Package NDC | 11-digit format | Description | Marketing start | Marketing end | Sample | Exclude flag | Status |
|---|---|---|---|---|---|---|---|
| 58466-108-04 | 58466010804 | 1 BOTTLE, DISPENSING in 1 CARTON (58466-108-04) / 113 g in 1 BOTTLE, DISPENSING | 2015-10-01 | 0000-00-00 | No | No | Current |