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
- 2027-12-31
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 |
|---|---|---|---|---|---|---|
| SHISEIDO BENEFIANCE WRINKLERESIST24 DAY | AVOBENZONE, OCTINOXATE, AND OCTOCRYLENE | SHISEIDO AMERICAS CORPORATION | 7d9c0f81-005f-4223-940e-a64143db5275 | 2026-01-06 | Warnings | M020 |
| SHISEIDO FUTURE Solution LX INFINITE TREATMENT PRIMER | TITANIUM DIOXIDE, OCTINOXATE, AND ENSULIZOLE | SHISEIDO AMERICAS CORPORATION | ff088b0c-27c9-4ea8-bf94-6261378c7190 | 2026-01-06 | Warnings | M020 |
| Drs. pharmacy sunscreen SPF 50 (physical filters) | SUNSCREEN SPF 50 | OL PHARMA TECH LLC. (Drs. Pharmacy) | 31e976a2-0623-0dca-e063-6394a90a08da | 2026-01-06 | Warnings | M020 |
| SHISEIDO SYNCHRO SKIN SELF-REFRESHING TINT 115 Fair Shirakaba | OCTINOXATE, OCTOCRYLENE, AND TITANIUM DIOXIDE | SHISEIDO AMERICAS CORPORATION | 26151cf4-0fee-4a42-92fd-4d7b9cef8381 | 2026-01-06 | Warnings | M020 |
| Drs. pharmacy sunscreen SPF 50 (physical filters) | SUNSCREEN SPF 50 | OL PHARMA TECH LLC. (Drs. Pharmacy) | 315a5ca4-4536-d585-e063-6294a90a1c50 | 2026-01-06 | Warnings | M020 |
| Drs. pharmacy sunscreen SPF 30 (Physical Filters) | SUNSCREEN SPF 30 | OL PHARMA TECH LLC. (Drs. Pharmacy) | 315a5b1f-9dc2-a243-e063-6394a90a5e08 | 2026-01-06 | Warnings | M020 |
| SHISEIDO ULTIMATE SUN PROTECTOR | AVOBENZONE, HOMOSALATE, OCTISALATE, AND OCTOCRYLENE | SHISEIDO AMERICAS CORPORATION | 51f759b7-8c49-41d4-aaa3-f901d599cac5 | 2026-01-06 | Warnings | M020 |
| cle de peau BEAUTE SYNACTIF DAYTIME MOISTURIZER ENRICHED n (Refill) | AVOBENZONE, OCTINOXATE, AND OCTOCRYLENE | SHISEIDO AMERICAS CORPORATION | 463dc557-9743-4a38-969e-2c78fc10ee2a | 2026-01-06 | Warnings | M020 |
| CLE DE PEAU BEAUTE PROTECTIVE FORTIFYING n | AVOBENZONE, OCTINOXATE, OCTOCRYLENE, AND OXYBENZONE | SHISEIDO AMERICAS CORPORATION | 23bb4225-bfb5-47e2-80fe-733761ba4069 | 2026-01-06 | Warnings | M020 |
| SHISEIDO WHITE LUCENT DAY | AVOBENZONE, OCTINOXATE, AND OCTOCRYLENE | SHISEIDO AMERICAS CORPORATION | e881e637-e0f0-4c90-8343-2be6e74020b8 | 2026-01-06 | Warnings | M020 |
| Hawaiian Tropic Lip Balm Sunscreen SPF 30 | AVOBENZONE,OCTISALATE,OCTOCRYLENE | Edgewell Personal Care Brands LLC | c7b71be3-f906-bd09-e053-2995a90adc61 | 2026-01-06 | Warnings | M020 |
| SHISEIDO BENEFIANCE WRINKLERESIST24 DAY | AVOBENZONE, OCTINOXATE, AND OCTOCRYLENE | SHISEIDO AMERICAS CORPORATION | d308d578-c881-4c10-8c79-9e3cd58b694c | 2026-01-06 | Warnings | M020 |
| HAWAIIAN TROPIC | AVOBENZONE,HOMOSALATE,OCTOCRYLENE | Edgewell Personal Care Brands LLC | 051b7413-8f1b-7135-e063-6294a90a9364 | 2026-01-06 | Warnings | M020 |
| Coppertone Sport Sunscreen Lip Balm SPF 30 | AVOBENZONE, HOMOSALATE, OCTISALATE, OCTOCRYLENE, | Beiersdorf Inc | 47bc6776-1130-0162-e063-6294a90a2adc | 2026-01-06 | Warnings | M020 |
| HAWAIIAN TROPIC | AVOBENZONE,HOMOSALATE,OCTISALATE,OCTOCRYLENE | Edgewell Personal Care Brands LLC | 088fa3cd-b9b8-d10b-e063-6394a90a7fd6 | 2026-01-06 | Warnings | M020 |
| SPF 50 Florida Sun Defense Broad Spectrum SPF 50 Sunscreen Body Oil | HOMOSALATE, OCTISALATE, OCTOCRYLENE | Naples Soap Company, Inc. | 47c147a9-c4f4-ab82-e063-6394a90aaa5c | 2026-01-06 | Warnings | M020 |
| PoutScreen Lip Treatment Love Letter | AVOBENZONE, OCTINOXATE, OCTOCRYLENE | NAKED SUNDAYS PTY LTD | 47d22c6d-49fd-f97c-e063-6294a90a6ba1 | 2026-01-06 | Warnings | M020 |
| HAWAIIAN TROPIC | AVOBENZONE,HOMOSALATE,OCTISALATE,OCTOCRYLENE | Edgewell Personal Care Brands, LLC | 56ab90db-51bd-ffb3-e063-6294a90a852b | 2026-01-06 | Warnings | M020 |
| HAWAIIAN TROPIC | AVOBENZONE,HOMOSALATE,OCTISALATE,OCTOCRYLENE | Edgewell Personal Care Brands, LLC | 56ac28e7-41f1-bd4e-e063-6294a90a0e7b | 2026-01-06 | Warnings | M020 |
| Moisturizing Antioxidant SPF 50 | OCTINOXATE, OCTISALATE, HOMOSALATE, OXYBENZONE, ZINC OXIDE | Topiderm, Inc. | 727c14d3-ad26-4e8b-91f6-b7a5f07e4e2f | 2026-01-05 | 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 |