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 |
|---|---|---|---|---|---|---|
| PRO-TECT SUNSCREEN FOR PROFESSIONALS | MERADIMATE, OCTINOXATE, OCTISALATE, OXYBENZONE | Bio-Medical & Pharmaceutical Manufacturing Corporation | 374e172b-90e8-4fca-8934-dee3ed7b599d | 2025-12-03 | Warnings | M020 |
| LBEL SOLUTIONS PRO HIALURON BALM BALSAMO LABIAL HIDRATANTE 72H FPS 20 HYDRATING LIP BALM 72H SPF 20 BERRY UNIVERSEL | OCTINOXATE, ZINC OXIDE | BEL STAR S A | 25b6cb46-6516-376a-e063-6394a90a44f6 | 2025-12-03 | Warnings | M020 |
| LBEL LUMI AGE ANTI AGING NOURISHING FACIAL WITH SPF 30 | AVOBENZONE, OCTISALATE, OCTOCRYLENE | BEL STAR SA | 4510cd0d-40b8-f452-e063-6394a90a44e5 | 2025-12-03 | Warnings | M020 |
| BANANA BOAT | AVOBENZONE,HOMOSALATE,OCTISALATE,OCTOCRYLENE | Edgewell Personal Care Brands LLC | 45117885-c674-b58a-e063-6394a90af5f4 | 2025-12-03 | Warnings | M020 |
| CANNON BALM | OCTINOXATE, OCTISALATE, OCTOCRYLENE, AVOBENZONE | DUKE CANNON SUPPLY CO. | f70a0173-c8ba-da7c-e053-6294a90a67db | 2025-12-03 | Warnings | M020 |
| CANNON BALM 140 | AVOBENZONE, OCTINOXATE, OCTISALATE, OCTOCRYLENE, OXYBENZONE | DUKE CANNON SUPPLY CO. | f70c8632-ed11-0cc3-e053-6394a90a77db | 2025-12-03 | Warnings | M020 |
| Omega-Boost Sheer Mineral Sunscreen | MINERAL SUNSCREEN | Trilogy Natural Products Limited | 0405b7a6-6885-ed93-e063-6294a90a9386 | 2025-12-03 | Warnings | M020 |
| Poolside Hot Head SPF 30 hair scalp sunscreen mist | HOMOSALATE , OCTOCRYLENE , OCTISALATE , AVOBENZONE | Longway Technology(Guangzhou)Co.,Ltd. | 4517da75-c91a-1f93-e063-6394a90a65ac | 2025-12-03 | Warnings | M020 |
| Poolside Tropic Touch SPF 30 Sunscreen Body spray. | HOMOSALATE , OCTOCRYLENE , OCTISALATE , AVOBENZONE | Longway Technology(Guangzhou)Co.,Ltd. | 4517ef95-8ea1-3de6-e063-6394a90a2c79 | 2025-12-03 | Warnings | M020 |
| Poolside Orange Creme SPF 30 Sunscreen oil mist | HOMOSALATE 15%, OCTOCRYLENE 10%, OCTISALATE 5%, AVOBENZONE 3% | Longway Technology(Guangzhou)Co.,Ltd. | 4517fd05-ea60-0492-e063-6294a90a28e9 | 2025-12-03 | Warnings | M020 |
| e.l.f. All Set For Sun SPF 45 Sunscreen | AVOBENZONE, OCTISALATE, OCTOCRYLENE | e.l.f. Cosmetics, Inc. | 26f43446-e5ee-57a5-e063-6394a90a8661 | 2025-12-03 | Warnings | M020 |
| Banana Boat | AVOBENZONE, HOMOSALATE, OCTOCRYLENE | Edgewell Personal Care Brands LLC | 7678467a-9da3-1b51-e053-2991aa0a568f | 2025-12-02 | Warnings | M020 |
| Cardinal Health Leader General Protection SPF 70 Sunscreen | AVOBENZONE, HOMOSALATE, OCTISALATE, OCTCRYLENE | CARDINAL HEALTH, INC. | b60cf360-7c8d-5da4-e053-2995a90a24c2 | 2025-12-02 | Warnings | M020 |
| Cardinal Health Leader General Protection Sunscreen SPF 30 | AVOBENZONE, HOMOSALATE, OCTISALATE, OCTOCRYLENE | CARDINAL HEALTH, INC. | b6107d22-a992-eaa1-e053-2995a90a29c2 | 2025-12-02 | Warnings | M020 |
| Cardinal Health Leader General Protection Sunscreen SPF 50 | AVOBENZONE, HOMOSALATE, OCTISALATE, OCTOCRYLENE | CARDINAL HEALTH, INC. | b623defb-4a9d-6fc5-e053-2995a90ae846 | 2025-12-02 | Warnings | M020 |
| Cardinal Health Leader Sport Sunscreen SPF 30 | AVOBENZONE, HOMOSALATE, OCTISALATE, OCTOCRYLENE | CARDINAL HEALTH, INC. | b62329d7-29e9-d111-e053-2a95a90aab06 | 2025-12-02 | Warnings | M020 |
| Leader Ultra Sheer SPF 100 Sunscreen | AVOBENZONE, HOMOSALATE, OCTISALATE, OCTOCRYLENE, OXYBENZONE | CARDINAL HEALTH, INC. | b5a467e0-a6ab-4136-8101-f22cc319de58 | 2025-12-02 | Warnings | M020 |
| Leader General Protection SPF 30 Sunscreen | AVOBENZONE, HOMOSALATE, OCTISALATE, OCTOCRYLENE | CARDINAL HEALTH, INC. | 9544b046-055e-5886-e053-2a95a90ad09e | 2025-12-02 | Warnings | M020 |
| BANANA BOAT | AVOBENZONE,HOMOSALATE,OCTISALATE,OCTOCRYLENE | Edgewell Personal Care Brands LLC | 44fe0844-cb74-7a04-e063-6294a90aca15 | 2025-12-02 | Warnings | M020 |
| CLINIQUE FOR MEN DAILY HYDRATOR BROAD SPECTRUM SPF 35 | AVOBENZONE,HOMOSALATE,OCTISALATE, AND OCTOCRYLENE | CLINIQUE LABORATORIES LLC | 44fe7468-001c-f2ee-e063-6394a90ae3b4 | 2025-12-02 | 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 |