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 |
|---|---|---|---|---|---|---|
| SP-FFC3-L0TN Barrier Protection Hydrating Mineral Face Sunscreen | BARRIER PROTECTION HYDRATING MINERAL FACE SUNSCREEN | Epic Etailers, LLC (DBA: Beauty by Earth) | 5078479e-a196-7e4d-e063-6394a90ab266 | 2026-05-19 | Warnings | M020 |
| InvisibleMatteBarrierDefenseCeramideSunscreenSerumSPF30SP-FSRM-N0TT | INVISIBLE MATTE BARRIER DEFENSE CERAMIDE SUNSCREEN SERUM SPF 30 | Epic Etailers, LLC (DBA: Beauty by Earth) | 50790945-f359-07c8-e063-6294a90a5af9 | 2026-05-19 | Warnings | M020 |
| Sun Bum Amazon 8 OZ SPF 15 | AVOBENZONE, HOMOSALATE, OCTISALATE, OCTOCRYLENE | Sun Bum | 522fc8a4-ce9f-8be8-e063-6294a90aebf0 | 2026-05-19 | Warnings | M020 |
| Timesavvy Hybrid Sheer Sun Serum Broad Spectrum SPF 50 | HOMOSALATE, OCTISALATE, OCTOCRYLENE, ZINC OXIDE | PROBETTER USA INC. | 66624df4-cb6c-4cfb-bbbe-9f885f2ad778 | 2026-05-18 | Warnings | M020 |
| Hampton Sun SPF 50 | AVOBENZONE 3.00 % OCTISALATE 5.00 % HOMOSALATE 10.00 % | S&C Hampton Sun LLC | 4df050f9-1185-4ee4-a0cd-84ba9d254e58 | 2026-05-18 | M020 | |
| Hampton Sun SPF 70 Kids | AVOBENZONE, HUMOSALATE, OCTISALATE, OCTOCRYLENE | S&C Hampton Sun LLC | 7c976082-3265-4c0b-9985-277d27988895 | 2026-05-18 | Warnings | M020 |
| Evereden Kids Cooling Mineral Sunstick SPF30 | ZINC OXIDE | Eden Brands Inc. | 521afa81-737f-81d4-e063-6394a90ad307 | 2026-05-18 | Warnings | M020 |
| cle de peau BEAUTE RESTORATIVE DAY SUPREME | AVOBENZONE, HOMOSALATE, OCTISALATE, AND OCTOCRYLENE | Shiseido Americas Corporation | 157e52c5-f6fa-430b-bbb8-86b7c0868ad3 | 2026-05-18 | Warnings | M020 |
| cle de peau BEAUTE SKIN BEAUTY ENHANCER | AVOBENZONE, OCTISALATE, AND OCTOCRYLENE | Shiseido Americas Corporation | bc6230f1-dba2-4418-b48c-c5e67aebd1bd | 2026-05-18 | Warnings | M020 |
| Hampton Sun SPF 30 SILK BODY | AVOBENZONE, HUMOSALATE, OCTISALATE, OCTOCRYLENE | S&C Hampton Sun LLC | ed0c184d-473a-4c4c-b6ec-e1d79ad58460 | 2026-05-18 | Warnings | M020 |
| Sheer Defense Tinted SPF 46 | ZINC OXIDE, OCTINOXATE | Private Label Skin Care | 017265e9-31e6-43ce-9432-cb88f471c496 | 2026-05-18 | Warnings | M020 |
| Aveeno Daily Moisturizing Face Sunscreen Broad Spectrum SPF30 | AVOBENZONE, HOMOSALATE, OCTISALATE, OCTOCRYLENE | Kenvue Brands LLC | 51d59378-df72-e438-e063-6294a90a97f1 | 2026-05-15 | Warnings | M020 |
| Natural Sense SPF 50 Sunscreen | SUNSCREEN | Dr. Natural LLC | 49a2430e-c15b-4610-e063-6294a90ac520 | 2026-05-15 | Warnings | M020 |
| LANCOME PARIS UV EXPERT SUPRA SCREEN MINERAL INVISIBLE SUNSCREEN SPF 50 SERUM | TITANIUM DIOXIDE AND ZINC OXIDE | LOreal USA Products Inc. | 23cc5ff4-f842-4e3e-ac5c-23dbaf7d3914 | 2026-05-15 | Warnings | M020 |
| LANCOME PARIS UV EXPERT SUPRA SCREEN MINERAL INVISIBLE SUNSCREEN SPF 50 SERUM | TITANIUM DIOXIDE AND ZINC OXIDE | SICOS ET CIE | c688f8e6-2cd2-40db-b03f-90fd74c2d89c | 2026-05-15 | Warnings | M020 |
| Lancome Paris Teint Idole Ultra Wear Breathable Coverage Foundation Broad Spectrum SPF 25 Sunscreen | OCTINOXATE AND TITANIUM DIOXIDE | L'Oreal USA Products Inc | 7df9dbd2-7db9-4961-819d-e93d14a065c3 | 2026-05-15 | Warnings | M020 |
| Lancome Paris Teint Idole Ultra Wear Breathable Coverage Foundation Broad Spectrum SPF 25 Sunscreen | OCTINOXATE AND TITANIUM DIOXIDE | SICOS ET CIE | 20efd5fa-3077-4fd4-82d0-ddca946e4528 | 2026-05-15 | Warnings | M020 |
| Target Up and Up Ultra Light Dry-Touch SPF 70 Sunscreen | AVOBENZONE, HOMOSALATE, OCTISALATE, OCTOCRYLENE | TARGET CORPORATION | 51de3d0b-2721-92d3-e063-6394a90a18bb | 2026-05-15 | Warnings | M020 |
| MELAO Hydrating Lightweight Sunscreen | OCTOCRYLENE,HOMOSALATE,ETHYLHEXYL SALICYLATE,PHENYLBENZIMIDAZOLE SULFONIC ACID,BUTYL METHOXYDIBENZOYLMETHANE,TITANIUM DIOXIDE | Guangdong Aimu Biological Technology Co., Ltd | 51c353cb-94c4-e110-e063-6394a90a497e | 2026-05-14 | Warnings | M020 |
| Hampton Sun SPF 8 Bronze Sunscreen | HOMOSALATE 7.5%, OCTISALATE 5.00%, AVOBENZONE 3.00% | S&C Hampton Sun LLC | 7cf4d943-be6e-4e38-8891-1e0b22af5536 | 2026-05-14 | 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 |