Dermatone SPF 30
- Product NDC
- 54414-048
- 11-digit product format
- 544140048
- Labeler code
- 54414
- Product ID
- 54414-048_32e594c6-6baf-91c3-e063-6394a90ae2a1
- Type
- HUMAN OTC DRUG
- Nonproprietary name
- Avobenzone, Homosalate, Octisalate, Octocrylene
- Dosage form
- LOTION
- Route
- TOPICAL
- Labeler
- Dermatone Labs LLC
- Application
- M020
- Marketing category
- OTC MONOGRAPH DRUG
- Marketing start
- 2022-06-26
- Substance
- HOMOSALATE; OCTOCRYLENE; AVOBENZONE
- Active strength
- 7; 5; 1.8 g/100mL; g/100mL; g/100mL
- NDC exclude flag
- No
- Listing certified through
- 2026-12-31
- Current FDA listing
- Yes
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
- Dermatone SPF 30
- Listing expiration
- 2026-12-31
Active Ingredients#
| Ingredient | Strength |
|---|---|
| HOMOSALATE | 7 g/100mL |
| OCTOCRYLENE | 5 g/100mL |
| AVOBENZONE | 1.8 g/100mL |
Harmonized UNII identifiers#
| Identifier | FDA.report destination |
|---|---|
| V06SV4M95S | Internal UNII lookup |
| 5A68WGF6WM | Internal UNII lookup |
| G63QQF2NOX | Internal UNII lookup |
Harmonized SPL set identifiers#
| Identifier | FDA.report destination |
|---|---|
| 32e5bddf-a0b5-c511-e063-6294a90aaf66 | Available on FDA.report |
DailyMed Product Concepts#
| Product concept | Relation | Version | Effective |
|---|---|---|---|
| 6084a4f4-5437-c9a5-caec-5361ee075a59 | Product name | 1 | 20140508 |
| 90c5639a-61b0-88d6-ddcf-21888e94869a | Product name | 1 | 20140508 |
| 9514609b-a2a9-f8ec-6ba6-3f8e5ee89877 | Product name | 1 | 20140508 |
| 9869efd7-d6dd-0665-5b67-53adbe6ef15e | Product name | 1 | 20140508 |
DailyMed Package Descriptions#
| Package NDC | Product | Description | Form | Quantity | Strength | SPL version |
|---|---|---|---|---|---|---|
| 54414-048-01 | Dermatone SPF 30 | 89 mL in 1 TUBE | LOTION | 89 | 9 |
DailyMed Dashboard NDC Coverage#
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 |
|---|---|---|---|---|---|---|
| Avebonzone, Homosalate, Octisalate | AVEBONZONE, HOMOSALATE, OCTISALATE | Amazon.com Services LLC | 4ab6773f-00e1-897a-e063-6294a90ab0b8 | 2026-04-06 | Warnings, Adverse reactions | M020 |
| Principal Secret Revolutionary Anti-Aging Broad Spectrum SPF 15 | AVOBENZONE, OCTINOXATE, OCTISALATE, AND OCTOCRYLENE | Guthy-Renker LLC | eb1a9b67-b9e2-41f8-bc6d-df94b6a33ab8 | 2026-04-06 | Warnings | M020 |
| TIRTIR HYDRO UV SHIELD SUNSCREEN SPF50 BROAD SPECTRUM | HOMOSALATE, AVOBENZONE, OCTISALATE, OCTOCRYLENE | TIRTIR USA Inc. | 4ec04105-e54f-a82e-e063-6394a90a6c5a | 2026-04-05 | Warnings | M020 |
| PRVWORA Ultra Defense Sunscreen | AVOBENZONE, OCTINOXATE, OCTISALATE, OCTOCRYLENE | Cellarkbio Inc. | 50cf1d88-3e7e-47b7-816a-3d579bde0a6a | 2026-04-04 | Warnings | M020 |
| EltaMD UV Shield SPF45 | ZINC OXIDE AND OCTINOXATE SUNSCREEN | CP Skin Health Group, Inc. | 7c49f971-d425-4be9-a665-5cd218b7f945 | 2026-04-03 | Warnings | M020 |
| Jack Black | AVOBENZONE/HOMOSALATE/OCTISALATE/PETROLATUM | Jack Black L.L.C. | 4baade5c-e759-d98f-e063-6394a90aa056 | 2026-04-03 | Warnings | M020 |
| Vacation SPF 30 ClassicSpray | AVOBENZONE, OCTISALATE, OCTOCRYLENE | Vacation Inc. | da43d71d-733b-5700-e053-2a95a90a5dca | 2026-04-03 | Warnings | M020 |
| Warriors Crown Sentinel Zinc Defense Sunscreen SPF 30 | ZINC OXIDE | Allure Labs | 4e93e64a-97ab-e0a5-e063-6294a90ad950 | 2026-04-03 | Warnings | M020 |
| Pro-Collagen Marine Broad Spectrum SPF 30 | AVOBENZONE, OCTINOXATE, AND OCTOCRYLENE | ELEMIS Limited | 3321281e-612b-4305-bf6d-bfab02c65ffb | 2026-04-03 | Warnings | M020 |
| EltaMD Skincare UV AOX Elements SPF50 Tinted | TITANIUM DIOXIDE, ZINC OXIDE SUNSCREEN | CP Skin Health Group, Inc | 2c74209d-9b88-4c32-ad42-cd6de16c1fef | 2026-04-03 | Warnings | M020 |
| EltaMD UV Restore Tinted | TITANIUM DIOXIDE AND ZINC OXIDE SUNSCREEN | CP Skin Health Group, Inc | 4fc18856-01b3-43ed-9e1b-b4394e31aa3c | 2026-04-03 | Warnings | M020 |
| Sunscreen for baby SPF50plus | OCTOCRYLENE,ETHYLHEXYL METHOXYCINNAMATE,TITANIUM DIOXIDE,ETHYLHEXYL SALICYLATE | Guangzhou Senmai Biotechnology Co., Ltd. | 1cb7fbca-0874-ae53-e063-6294a90ab42a | 2026-04-02 | Warnings | M020 |
| TiZO3 | TITANIUM DIOXIDE, ZINC OXIDE | Fallien Cosmeceuticals, LTD | 4e7bdec2-abcc-0267-e063-6394a90ae47a | 2026-04-02 | Warnings | M020 |
| TIZO PHOTOCEUTICAL AM REPLENISH - TINTED | ZINC OXIDE | Fallien Cosmeceuticals, LTD | 4e7c4702-5707-6c3e-e063-6394a90a05fd | 2026-04-02 | Warnings | M020 |
| Ilia Sun Serum Mineral Sunscreen SPF 50 Light Medium | ZINC OXIDE | Ilia, Inc. | 4e7cc73c-d6c9-ecb0-e063-6394a90a922c | 2026-04-02 | Warnings | M020 |
| EltaMD UV Restore | TITANIUM DIOXIDE, ZINC OXIDE SUNSCREEN | CP Skin Health Group, Inc | 17b47994-82d6-4f9d-8249-bdb55106c9b3 | 2026-04-02 | Warnings | M020 |
| Hand Sunscreen Cream | AVOBENZONE, OCTISALATE, OCTOCRYLENE | Jiangsu Senwo Medical Technology Co., Ltd. | 4e615757-76b1-8f34-e063-6394a90a280a | 2026-04-01 | Warnings | M020 |
| All Good Mineral Sport Sunscreen Sunstick SPF 30 | ZINC OXIDE | Elemental Herbs, Inc. | 4e67b76e-b791-4e26-e063-6294a90aa991 | 2026-04-01 | Warnings | M020 |
| All Good Coconut Mineral Sunscreen Sunstick SPF 30 | ZINC OXIDE | Elemental Herbs, Inc. | 4e67e89b-a7be-a540-e063-6294a90a6d8f | 2026-04-01 | Warnings | M020 |
| SHISEIDO BENEFIANCE WRINKLE SMOOTHING DAY | AVOBENZONE, HOMOSALATE, OCTISALATE, AND OCTOCRYLENE | Shiseido Americas Corporation | cad3a446-36a8-4146-81b5-1cc8d65abf14 | 2026-04-01 | Warnings | M020 |
Packages#
| Package NDC | 11-digit format | Description | Units | Marketing start | Sample | Exclude flag | Status |
|---|---|---|---|---|---|---|---|
| 54414-048-01 | 54414004801 | 89 mL in 1 TUBE (54414-048-01) | 89 ml | 2022-06-26 | No | No | Current |