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 |
|---|---|---|---|---|---|---|
| DAY DEFENSE TINTED | TITANIUM DIOXIDE, ZINC OXIDE | THE SKIN CARE SOURCE, INC. | 36ad4442-e45f-90e2-e063-6294a90aeef5 | 2025-12-17 | M020 | |
| Tinted Mineral Sunscreen | TITANIUM DIOXIDE, ZINC OXIDE | HSC MIAMI, INC | 36d8b849-cf73-e008-e063-6394a90a410a | 2025-12-17 | M020 | |
| TINTED RESTORATIVE MOISTURIZER | ZINC OXIDE | SKINERGIX LLC | 3636adf0-c3bd-7422-e063-6394a90aaccc | 2025-12-17 | M020 | |
| Premier Zinc | ZINC OXIDE | ENSO SKINCARE & WELLNESS LLC | 3bb378c8-14b0-aa13-e063-6294a90a4db3 | 2025-12-17 | Warnings | M020 |
| Protect and Renew | ZINC OXIDE | ENSO SKINCARE & WELLNESS LLC | 3bb479ed-1153-8e80-e063-6294a90a2937 | 2025-12-17 | Warnings | M020 |
| Flawless Finish | TITANIUM DIOXIDE, ZINC OXIDE | ENSO SKINCARE & WELLNESS LLC | 3b8df7ce-e5ce-aaf8-e063-6394a90afdae | 2025-12-17 | Warnings | M020 |
| Shield Mineral Sunscreen Tinted | ZINC OXIDE | SMOOTHE LLC | 369b9d76-f6c3-e25f-e063-6294a90adaf3 | 2025-12-17 | M020 | |
| Shield Mineral Sunscreen Non Tinted | ZINC OXIDE | SMOOTHE LLC | 369bc20d-7192-7c0a-e063-6294a90a3dfe | 2025-12-17 | M020 | |
| Lip Balm | TITANIUM DIOXIDE, ZINC OXIDE | PATRICIA SOLIS MAKEUP ARTIST, LLC | 369d63a9-b9a9-9530-e063-6394a90ac8ef | 2025-12-17 | M020 | |
| Matte Tint | TITANIUM DIOXIDE, ZINC OXIDE | PATRICIA SOLIS MAKEUP ARTIST, LLC | 369ced69-59b4-0f3c-e063-6294a90a582f | 2025-12-17 | M020 | |
| Hydra Tint | ZINC OXIDE | PATRICIA SOLIS MAKEUP ARTIST, LLC | 369d4e7a-8356-8f15-e063-6394a90acca8 | 2025-12-17 | M020 | |
| Mineral Sunscreen Tinted | TITANIUM DIOXIDE, ZINC OXIDE | LOTUS SKINCARE AND MAKE-UP STUDIO | 36b0ac77-13d8-4259-e063-6394a90a893b | 2025-12-17 | M020 | |
| Mineral Sunscreen Non-Tinted | TITANIUM DIOXIDE, ZINC OXIDE | LOTUS SKINCARE AND MAKE-UP STUDIO | 36b000e3-2516-932c-e063-6294a90a0e41 | 2025-12-17 | M020 | |
| Moisturizing Mineral Sunscreen Tinted | ZINC OXIDE | LOTUS SKINCARE AND MAKE-UP STUDIO | 36b12dbc-5edc-aad1-e063-6394a90a42ea | 2025-12-17 | M020 | |
| Mineral Lip Sunscreen | TITANIUM DIOXIDE, ZINC OXIDE | LOTUS SKINCARE AND MAKE-UP STUDIO | 36b1a6c8-b4ff-089a-e063-6394a90a2469 | 2025-12-17 | M020 | |
| Badger SPF 40 Tinted Mineral Face | ZINC OXIDE | W.S. Badger Company, Inc. | 4628c04f-b7a6-b3fe-e063-6294a90a1675 | 2025-12-17 | Warnings | M020 |
| Coppertone Kids Sunscreen SPF 50 | (TO DELIVER) AVOBENZONE 3%, HOMOSALATE 10%, OCTISALATE 5%, OCTOCRYLENE 5% | Beiersdorf Inc | 0a5a4d0e-8ab2-3d79-e063-6394a90a7006 | 2025-12-17 | Warnings | M020 |
| Coppertone Kids Sunscreen SPF 50 | (TO DELIVER) AVOBENZONE 3%, HOMOSALATE 5%, OCTISALATE 10%, OCTOCRYLENE 5% | Beiersdorf Inc | 0a5a42a3-6fe4-2980-e063-6394a90a54fe | 2025-12-17 | Warnings | M020 |
| Coppertone Glow Suncreen SPF 30 | AVOBENZONE, HOMOSALATE, OCTISALATE, OCTOCRYLENE | Beiersdord Inc | b65c117d-f200-bb22-e053-2995a90ab71d | 2025-12-17 | Warnings | M020 |
| Covergirl Clean Fresh Tinted Lip Balm Glowing Protection SPF 15 Mineral Sunscreen - All shades | ZINC OXIDE AND TITANIUM DIOXIDE | Noxell | 2cdbeb73-b805-f144-e063-6294a90a088d | 2025-12-17 | 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 |