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 |
|---|---|---|---|---|---|---|
| Sport Sunscreen SPF 50 | AVOBENZONE, HOMOSALATE, OCTISALATE | The Kroger Co. | 22aa46af-5d0f-4256-8f45-be06f6627561 | 2026-08-10 | Warnings | M020 |
| Colorescience Total Protection No Show Mineral Body Shield | ZINC OXIDE | Colorescience | 52e1f59e-63cb-7480-e063-6394a90ad7c5 | 2026-08-10 | Warnings | M020 |
| Eucerin Radiant Tone Tinted Sunscreen SPF 50 | AVOBENZENE 3%, HOMOSALATE 10%, OCTISALATE 5%, OCTOCRYLENE 10% | Beiersdorf Inc | 596a4204-3d29-9023-e063-6294a90ad99e | 2026-08-10 | Warnings | M020 |
| Journee Firm Riche Broad Spectrum Sunscreen SPF 30 | TITANIUM DIOXIDE AND ZINC OXIDE | Merz North America, Inc. | d4d4bfcf-3674-4847-8ad8-1716a8e821ae | 2026-08-10 | Warnings | M020 |
| ULTRA VIOLETTE Unblock Screen SPF 50 Sunscreen | BEMOTRIZINOL, OCTOCRYLENE, ZINC OXIDE | Grace and Fire USA Inc. | 56ad0dce-410e-9d78-e063-6294a90a1c3e | 2026-08-09 | Warnings | M020 |
| ORLASKIN SPF50 Antioxidant SoothingComplex Sunscreen | ETHYLHEXYL METHOXYCINNAMATE ETHYLHEXYL SALICYLATE BUTYL METHOXYDIBENZOYLMETHANE ZINC OXIDE BIS-ETHYLHEXYLOXYPHENOL METHOXYPHENYL TRIAZINE | Guangzhou Yapheon Health Industry Co., Ltd. | 552a36ed-7a66-4048-e063-6394a90a09bc | 2026-08-08 | Warnings | M020 |
| lip balm SPF15( 2533) 01 | AVOBENZONE,HOMOSALATE,OCTOCRYLENE,OCTISALATE | Cosmuses Cosmetics (Ningbo) Co., Ltd. | 5870aa44-1375-cdc5-e063-6394a90af4a5 | 2026-08-07 | Warnings | M020 |
| lip balm SPF15( Zinc oxide) 01 | ZINC OXIDE | Cosmuses Cosmetics (Ningbo) Co., Ltd. | 5871ab1d-cf07-d737-e063-6394a90a58fe | 2026-08-07 | Warnings | M020 |
| VEIRFOO Brightening Hydrating Antiwrinkle Sunscreen | TITANIUM DIOXIDE, OCTINOXATE | LCM TECHNOLOGY Co., Ltd | 4cbbf8aa-8910-b7e7-e063-6294a90a4f07 | 2026-08-07 | Warnings | M020 |
| AVOBENZONE, HOMOSALATE, OCTISALATE | AVOBENZONE, HOMOSALATE, OCTISALATE | Topco Associates LLC | 58636012-7e29-7206-e063-6394a90a83e9 | 2026-08-06 | Warnings, Adverse reactions | M020 |
| AVOBENZONE, HOMOSALATE, OCTISALATE | AVOBENZONE, HOMOSALATE, OCTISALATE | Topco Associates LLC | 5864275d-a480-06f8-e063-6394a90aecab | 2026-08-06 | Warnings, Adverse reactions | M020 |
| Avebonzone, Homosalate, Octisalate | AVEBONZONE, HOMOSALATE, OCTISALATE | Topco Associates LLC | 5864881c-c495-1f32-e063-6294a90a1304 | 2026-08-06 | Warnings, Adverse reactions | M020 |
| Elta MD UV Daily Peptide Lip Balm SPF 40 | ZINC OXIDE | CP Skin Health Group, Inc | 945538b5-5745-42cf-b610-0018ca2ec254 | 2026-08-06 | Warnings | M020 |
| Avebonzone, Homosalate, Octisalate | AVEBONZONE, HOMOSALATE, OCTISALATE | Topco Associates LLC | 58653d79-8fff-f319-e063-6294a90af7a3 | 2026-08-06 | Warnings, Adverse reactions | M020 |
| Avebonzone, Homosalate, Octisalate | AVEBONZONE, HOMOSALATE, OCTISALATE | Topco Associates LLC | 5865f0e5-14b2-c4bf-e063-6294a90a4710 | 2026-08-06 | Warnings, Adverse reactions | M020 |
| Stream2Sea Ecostock SPF 40 Sunscreen | ZINC OXIDE | Stream2Sea, LLC | 5866e026-a652-3300-e063-6394a90acff0 | 2026-08-06 | Warnings | M020 |
| NHLMA Skin Defense Sunscreen | BROAD SPECTRUM SPF 30 | NATIONAL HAIR LOSS LLC | 56326ae0-387f-ad08-e063-6294a90acc4f | 2026-08-06 | Warnings | M020 |
| EltaMD UV Restore | TITANIUM DIOXIDE, ZINC OXIDE SUNSCREEN | CP Skin Health Group, Inc | 37fee381-ce6b-4949-9a4a-778aa839fb84 | 2026-08-06 | Warnings | M020 |
| Neutrogena MoistureShine Lip Soother with Sunscreen SPF 20, Shine 30 | AVOBENZONE, HOMOSALATE, OCTOCRYLENE | Kenvue Brands LLC | 129ae274-0094-be5e-e063-6394a90a9801 | 2026-08-05 | Warnings | M020 |
| Leader Kids Sport Sunscreen SPF 50 | AVOBENZONE, HOMOSALATE, OCTISALATE, OCTOCRYLENE | CARDINAL HEALTH 110, LLC. DBA LEADER | 3636693a-ba81-5d49-e063-6394a90a3006 | 2026-08-05 | 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 |