Hello Sunday The One For Your Lips Clear Lip Balm SPF 50
- Product NDC
- 10596-806
- 11-digit product format
- 105960806
- Labeler code
- 10596
- Product ID
- 10596-806_43d0f364-238d-9fae-e063-6394a90a4777
- Type
- HUMAN OTC DRUG
- Nonproprietary name
- Avobenzone, Homosalate, Octisalate, Octocrylene
- Dosage form
- STICK
- Route
- TOPICAL
- Labeler
- Kao USA Inc.
- Application
- M020
- Marketing category
- OTC MONOGRAPH DRUG
- Marketing start
- 2024-02-01
- Substance
- OCTISALATE; AVOBENZONE; OCTOCRYLENE; HOMOSALATE
- Active strength
- 50; 30; 90; 73 mg/mL; mg/mL; mg/mL; mg/mL
- 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 |
|---|---|---|---|---|---|---|---|
| 2025-08-27 00:01 UTC · source 2025-08-26 | excluded product | product | I | Inactivated by FDA | f5e01cc5f278… | a2eaf40c39c3… | |
| 2025-08-27 00:01 UTC · source 2025-08-26 | excluded package | package | 10596-806-01 | I | Inactivated by FDA | f5e01cc5f278… | a2eaf40c39c3… |
| 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 | 10596-806-01 | 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 | 10596-806-01 | 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 | 10596-806-01 | 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 | 10596-806-01 | 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 | 10596-806-01 | 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 | 10596-806-01 | 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 | 10596-806-01 | 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
- Hello Sunday The One For Your Lips Clear Lip Balm SPF 50
- Listing expiration
- 2026-12-31
Active Ingredients#
| Ingredient | Strength |
|---|---|
| OCTISALATE | 50 mg/mL |
| AVOBENZONE | 30 mg/mL |
| OCTOCRYLENE | 90 mg/mL |
| HOMOSALATE | 73 mg/mL |
Harmonized UNII identifiers#
| Identifier | FDA.report destination |
|---|---|
| 4X49Y0596W | Internal UNII lookup |
| G63QQF2NOX | Internal UNII lookup |
| 5A68WGF6WM | Internal UNII lookup |
| V06SV4M95S | Internal UNII lookup |
Harmonized SPL set identifiers#
| Identifier | FDA.report destination |
|---|---|
| 0c92dfc3-782d-e11f-e063-6394a90a2f8a | Available on FDA.report |
DailyMed Product Concepts#
| Product concept | Relation | Version | Effective |
|---|---|---|---|
| baf7f49c-75b6-496b-a00e-8e766a8e4f03 | Product name | 1 | 20210127 |
| ebc62596-fc97-4d03-9483-7ba095d25db7 | Product name | 1 | 20151210 |
| 0ca1d589-929b-4b33-bc5b-1d84abdafa6a | Product name | 1 | 20150324 |
| fc363c46-397b-4476-ac0f-70e43e8e4592 | Product name | 1 | 20150324 |
FDA-Initiated Inactive NDC Indexing#
| NDC | Effective | Action | Document | Indexing SPL | Related label |
|---|---|---|---|---|---|
| 10596-806-01 | 2025-11-17 | C162847 | 48780-1 | 2cef2736-8679-d83d-e063-dadaa90ab31f | Hello Sunday The One For Your Lips Clear Lip Balm SPF 50 |
| 10596-806-01 | 2025-01-30 | C162847 | 48780-1 | 2cef2736-8679-d83d-e063-dadaa90ab31f | Hello Sunday The One For Your Lips Clear Lip Balm SPF 50 |
DailyMed Package Descriptions#
| Package NDC | Product | Description | Form | Quantity | Strength | SPL version |
|---|---|---|---|---|---|---|
| 10596-806-01 | Hello Sunday The One For Your Lips Clear Lip Balm SPF 50 | 15 mL in 1 TUBE | STICK | 15 | 2 | |
| 10596-806-01 | Hello Sunday The One For Your Lips Clear Lip Balm SPF 50 | 1 in 1 CARTON | STICK | 1 | 2 |
DailyMed Dashboard NDC Coverage#
| NDC | Dashboard title | SPL version | Validation | Dashboard ZIP |
|---|---|---|---|---|
| 10596-806 | HELLO SUNDAY THE ONE FOR YOUR LIPS CLEAR LIP BALM SPF 50 (AVOBENZONE, HOMOSALATE, OCTISALATE, OCTOCRYLENE) STICK [KAO USA INC.] | 1 | Current NDC, 2 package rows | 20240201_0c92dfc3-782d-e11f-e063-6394a90a2f8a.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 |
|---|---|---|---|---|---|---|
| SHADED | TITANIUM DIOXIDE, ZINC OXIDE | Potency No. 710 LLC | 31177bbd-68b0-8b24-e063-6294a90aa8d8 | 2025-12-10 | Warnings | M020 |
| SHADED | TITANIUM DIOXIDE, ZINC OXIDE | Potency No. 710 LLC | 3117e138-83a1-0931-e063-6394a90abe43 | 2025-12-10 | Warnings | M020 |
| SHADED | TITANIUM DIOXIDE, ZINC OXIDE | Potency No. 710 LLC | 31188175-a4ca-449f-e063-6394a90a3c05 | 2025-12-10 | Warnings | M020 |
| COVERED | ZINC OXIDE | Potency No. 710 LLC | 3118c3ed-f0f0-f997-e063-6294a90a53a9 | 2025-12-10 | Warnings | M020 |
| COVERED | ZINC OXIDE | Potency No. 710 LLC | 3117faeb-1792-1b2e-e063-6294a90a92df | 2025-12-10 | Warnings | M020 |
| Non-Tinted Mineral Foaming Sunscreen | TITANIUM DIOXIDE, ZINC OXIDE | Restore Skin Therapy, LLC | 364b6af2-a0ed-4a17-e063-6394a90a3a17 | 2025-12-10 | M020 | |
| Morning Replenish | ZINC OXIDE | Restore Skin Therapy, LLC | 364b26c2-a1bb-9660-e063-6294a90a14d1 | 2025-12-10 | M020 | |
| Glass Skin Sunscreen Tinted | ZINC OXIDE | Fleur de Lune, LLC | 34288989-35b8-3aa3-e063-6394a90ac2c4 | 2025-12-10 | M020 | |
| Glass Skin Sunscreen Tinted | ZINC OXIDE | Fleur de Lune, LLC | 3418394b-fede-65ce-e063-6394a90ad5f9 | 2025-12-10 | M020 | |
| Glass Skin Sunscreen Non-Tinted | ZINC OXIDE | Fleur de Lune, LLC | 341871e5-c170-7560-e063-6394a90a8eee | 2025-12-10 | M020 | |
| Glass Skin Sunscreen Non-Tinted | ZINC OXIDE | Fleur de Lune, LLC | 3428bdbb-1f18-a29b-e063-6294a90addbc | 2025-12-10 | M020 | |
| Sheer Facial Mineral Sunscreen | TITANIUM DIOXIDE, ZINC OXIDE | BB MEDICAL & DERMATOLOGY INC | 342b2403-4f4a-3e77-e063-6294a90a4f0a | 2025-12-10 | M020 | |
| Sheer Mineral Sunscreen Bar | TITANIUM DIOXIDE, ZINC OXIDE | BB MEDICAL & DERMATOLOGY INC | 342b69d5-f0e1-99cd-e063-6294a90abb6e | 2025-12-10 | M020 | |
| Sheer Facial Mineral Sunscreen | TITANIUM DIOXIDE, ZINC OXIDE | BB MEDICAL & DERMATOLOGY INC | 342c3f42-c17f-f777-e063-6394a90a8058 | 2025-12-10 | M020 | |
| Lip SPF | TITANIUM DIOXIDE, ZINC OXIDE | FRANCISCO FLORES, M.D., P.A. | 396d3fdd-99d8-77e8-e063-6294a90aec2f | 2025-12-10 | M020 | |
| Non-Tinted Mineral Sunscreen | TITANIUM DIOXIDE, ZINC OXIDE | FRANCISCO FLORES, M.D., P.A. | 396cae82-7641-e1b2-e063-6394a90a7c07 | 2025-12-10 | M020 | |
| Solar Knight SPF 40 Broad Spectrum | TITANIUM DIOXIDE, ZINC OXIDE | MASCARENAS ENTERPRISES, INC. | 36c27c91-22ac-205c-e063-6294a90ab379 | 2025-12-10 | M020 | |
| Tinted Mineral Sunscreen | TITANIUM DIOXIDE, ZINC OXIDE | FRANCISCO FLORES, M.D., P.A. | 396ce15a-06ad-4055-e063-6294a90a27fb | 2025-12-10 | M020 | |
| Dermablue Daily Replenishing | ZINC OXIDE | Dermablue, P.C. | 308da9c9-544e-d5d1-e063-6294a90aa49b | 2025-12-10 | Warnings | M020 |
| Recoverie Mineral Matte | ZINC OXIDE | Clear Day Acne Clinic | 308f41de-fb14-40f9-e063-6394a90a008f | 2025-12-10 | Warnings | M020 |
Packages#
| Package NDC | 11-digit format | Description | Units | Marketing start | Sample | Exclude flag | Status |
|---|---|---|---|---|---|---|---|
| 10596-806-01 | 10596080601 | 1 TUBE in 1 CARTON (10596-806-01) / 15 mL in 1 TUBE | 1 tube | 2024-02-01 | No | No | Current |