Sunscreen
- Product NDC
- 55550-102
- 11-digit product format
- 555500102
- Labeler code
- 55550
- Product ID
- 55550-102_1a647efd-f17c-44f1-ab72-974603f42bf7
- Type
- HUMAN OTC DRUG
- Nonproprietary name
- Homosalate, Octinoxate, Octisalate, Oxybenzone
- Dosage form
- LOTION
- Route
- TOPICAL
- Labeler
- Total Resources International
- Application
- M020
- Marketing category
- OTC MONOGRAPH DRUG
- Marketing start
- 2023-01-20
- Substance
- HOMOSALATE; OCTINOXATE; OCTISALATE; OXYBENZONE
- Active strength
- 6; 7.5; 5; 5 mg/g; mg/g; mg/g; mg/g
- NDC exclude flag
- No
- Listing certified through
- 2027-12-31
- 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 | Snapshot | Source SHA-256 |
|---|---|---|---|---|---|
| 2022-08-30 03:57 UTC · source 2022-08-29 | excluded product | product | fb8cb913e6d1… | eb8c232b6be0… | |
| 2022-08-30 03:57 UTC · source 2022-08-29 | excluded package | package | 55550-102-01 | fb8cb913e6d1… | eb8c232b6be0… |
| 2022-04-09 23:13 UTC · source 2022-04-08 | excluded product | product | 86f5da6cb304… | a595104c45d7… | |
| 2022-04-09 23:13 UTC · source 2022-04-08 | excluded package | package | 55550-102-01 | 86f5da6cb304… | a595104c45d7… |
| 2022-04-04 05:40 UTC · source 2022-04-01 | excluded product | product | bd6a592717d7… | 303034d00443… | |
| 2022-04-04 05:40 UTC · source 2022-04-01 | excluded package | package | 55550-102-01 | bd6a592717d7… | 303034d00443… |
| 2021-12-27 23:28 UTC · source 2021-12-27 | excluded product | product | 8dfbde2a14a4… | c9ff85d89658… | |
| 2021-12-27 23:28 UTC · source 2021-12-27 | excluded package | package | 55550-102-01 | 8dfbde2a14a4… | c9ff85d89658… |
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
- Sunscreen
- Listing expiration
- 2026-12-31
Active Ingredients#
| Ingredient | Strength |
|---|---|
| HOMOSALATE | 6 mg/g |
| OCTINOXATE | 7.5 mg/g |
| OCTISALATE | 5 mg/g |
| OXYBENZONE | 5 mg/g |
Harmonized UNII identifiers#
| Identifier | FDA.report destination |
|---|---|
| V06SV4M95S | Internal UNII lookup |
| 4Y5P7MUD51 | Internal UNII lookup |
| 4X49Y0596W | Internal UNII lookup |
| 95OOS7VE0Y | Internal UNII lookup |
Harmonized SPL set identifiers#
| Identifier | FDA.report destination |
|---|---|
| 7d4f820d-e154-428e-89c2-2e26e088ceef | Available on FDA.report |
FDA-Initiated Inactive NDC Indexing#
| NDC | Effective | Action | Document | Indexing SPL | Related label |
|---|---|---|---|---|---|
| 55550-102-01 | 2023-01-26 | C162847 | 48780-1 | ba0f9c33-2171-a910-e053-dadaa90a0b85 | Sunscreen |
| 55550-102-01 | 2021-01-29 | C162847 | 48780-1 | ba0f9c33-2171-a910-e053-dadaa90a0b85 | Sunscreen |
DailyMed Package Descriptions#
| Package NDC | Product | Description | Form | Quantity | Strength | SPL version |
|---|---|---|---|---|---|---|
| 55550-102-01 | Sunscreen | 1.5 g in 1 PACKET | LOTION | 1.5 | 4 |
DailyMed Socrata Ingredients#
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 |
|---|---|---|---|---|---|---|
| MEDICUBE PDRN SILKY SUNSCREEN | HOMOSALATE, OCTOCRYLENE, OCTISALATE, AVOBENZONE | APR US INC | 57154bec-6714-0314-e063-6294a90a4bd0 | 2026-07-20 | Warnings | M020 |
| TOCOBO Double UV Defense Set | AVOBENZONE, HOMOSALATE, OCTISALATE, OCTOCRYLENE | PICTON Co., Ltd. | 56aff65a-aa08-dc3f-e063-6294a90acac3 | 2026-07-19 | Warnings | M020 |
| THE SPORTO Invisible Sport for Body | AVOBENZONE, OCTISALATE, AND OCTOCRYLENE | Dune Suncare, Inc. | 46564a09-909d-bcc7-e063-6294a90a627b | 2026-07-17 | Warnings | M020 |
| RR Sun Creme | HOMOSALATE, OCTOCRYLENE, OCTISALATE, AND AVOBENZONE | Undefined Inc | dc60b685-a7fc-47bb-ade9-44a8e3b54812 | 2026-07-17 | Warnings | M020 |
| Cetaphil Tinted Daily Facial Moisturizer SPF 50 | HOMOSALATE, OCTOCRYLENE, OCTISALATE, AVOBENZONE | Galderma Laboratories, L.P. | 0ef2ebae-7198-47f4-8891-d1ca3cf54d4b | 2026-07-16 | Warnings | M020 |
| Mederma Scar Cream | AVOBENZONE, OCTOCRYLENE, AND OXYBENZONE | PMI Branded Pharmaceuticals, Inc. | f9be5adb-dce3-4b17-939f-d80d486f2cb0 | 2026-07-16 | Warnings | M020 |
| BaseLife Pure Mineral Shield Sunscreen | ZINC OXIDE | Wintech America, Inc. | 7f741a91-6ed8-4d08-9196-d15527d044d5 | 2026-07-15 | Warnings | M020 |
| BaseLife Clear UV Defense Sunscreen | AVOBENZONE, HOMOSALATE, OCTISALATE, OCTOCRYLENE | Wintech America, Inc. | 128db446-93ba-4347-bd39-66177572c659 | 2026-07-15 | Warnings | M020 |
| Biore Aqua Rich Facial Mist SPF 50 | OCTOCRYLENE, OCTISALATE, AVOBENZENE, HOMOSALATE | Kao USA Inc. | 56a80a0d-b0b5-1098-e063-6294a90a5270 | 2026-07-15 | Warnings | M020 |
| Anti Aging Lip Balm Pot SPF 15 | LIP BALM | Epicuren Disocovery | 4097e28a-ed11-e16a-e063-6294a90a5e9b | 2026-07-14 | Warnings | M020 |
| HolyCow Mineral Tallow Sunscreen Face and Body SPF 50 | ZINC OXIDE | CALM ENTERPRISE LLC | 722462d8-d2ab-44ce-9065-673ab2076269 | 2026-07-14 | Warnings | M020 |
| X-Treme Cream Propolis Sunscreen SPF 45 | X-TREME CREAM | Epicuren Discovery | 3b29976e-eee0-b978-e063-6294a90accd6 | 2026-07-14 | Warnings | M020 |
| Anti-Aging Lip Balm SPF 15 | LIP BALM | Epicuren Discovery | 3cbd0550-b6e5-3e86-e063-6394a90ac07f | 2026-07-14 | Warnings | M020 |
| Zinc Oxide Perfecting Sunscreen | ZINC OXIDE | Epicuren Discovery | 1a0228f9-bf3f-a1fe-e063-6294a90a3fb5 | 2026-07-14 | Warnings | M020 |
| Vacation Face | AVOBENZONE, HOMOSALATE, OCTISALATE, AND OCTOCRYLENE | Vacation INC. | 14b8a3cf-031c-4c52-ba81-e683e69d0f37 | 2026-07-14 | Warnings | M020 |
| Mederma Scar Cream | AVOBENZONE, OCTOCRYLENE, AND OXYBENZONE | L. Perrigo Company | bd5c9df7-8dfb-4d20-9966-e148c5667b22 | 2026-07-14 | Warnings | M020 |
| Sun Juice Body Mist Sunscreen SPF30 - Watermelon Sugar PARADISO | AVOBENZONE, HOMOSALATE, OCTISALATE | Koco Life LLC | 4081a4ad-b738-5fb6-e063-6394a90a9171 | 2026-07-13 | Warnings | M020 |
| Sun Juice Body Mist Sunscreen SPF30 - Coconut Cream PARADISO | AVOBENZONE, HOMOSALATE, OCTISALATE | Koco Life LLC | 3cc5c1d8-91f8-8ad2-e063-6294a90a9229 | 2026-07-13 | Warnings | M020 |
| Olay Super Serum Body Broad Spectrum SPF 30 | AVOBENZONE, HOMOSALATE, OCTISALATE, AND OCTOCRYLENE | The Procter & Gamble Manufacturing Company | 5513c5e2-3baf-2f09-e063-6394a90a495a | 2026-07-13 | Warnings | M020 |
| Sun Juice Body Mist Sunscreen SPF30 - Peach Sky PARADISO | AVOBENZONE, HOMOSALATE, OCTISALATE | Koco Life LLC | 3cc48592-f70d-664e-e063-6294a90ac6e8 | 2026-07-13 | Warnings | M020 |
Packages#
| Package NDC | 11-digit format | Description | Units | Marketing start | Sample | Exclude flag | Status |
|---|---|---|---|---|---|---|---|
| 55550-102-01 | 55550010201 | 1.5 g in 1 PACKET (55550-102-01) | 1.5 g | 2023-01-20 | No | No | Current |