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 |
|---|---|---|---|---|---|---|
| Pelotan Sunscreen Broad Spectrum SPF 30 | AVOBENZONE, OCTINOXATE, OCTOCRYLENE | Pelotan LLC | 3a9f94eb-98b7-5a20-e063-6394a90a173b | 2025-07-23 | Warnings | M020 |
| Basin Frosted Orange Cream SPF 15 Broad Spectrum Sunscreen Lip Balm | AVOBENZONE, OCTINOXATE, OCTISALATE, OCTOCRYLENE | Retail Concepts of Minnesota, Inc. | 3a9fc050-f74f-a431-e063-6294a90ad4c2 | 2025-07-23 | Warnings | M020 |
| Pelotan Sunscreen Broad Spectrum SPF 30 | AVOBENZONE, OCTINOXATE, OCTOCRYLENE | Pelotan LLC | 3aa0799b-0790-2476-e063-6294a90a8bcc | 2025-07-23 | Warnings | M020 |
| The Men Pen TALLOW GUARD SPF 30 PREMIUM ZINC SUNSCREEN | ZINC OXIDE | Guangzhou Haishi Biological Technology Co., Ltd. | 3aa3c442-26a6-0ab0-e063-6294a90a93a5 | 2025-07-23 | Warnings | M020 |
| Basin Italian Gelato SPF 15 Broad Spectrum Sunscreen Lip Balm | AVOBENZONE, OCTINOXATE, OCTISALATE, OCTOCRYLENE | Retail Concepts of Minnesota, Inc. | 3a89106d-dbf0-e6ea-e063-6294a90a60f3 | 2025-07-22 | Warnings | M020 |
| Basin American Mint Julep SPF 15 Broad Spectrum Sunscreen Lip Balm | AVOBENZONE, OCTINOXATE, OCTISALATE, OCTOCRYLENE | Retail Concepts of Minnesota, Inc. | 3a898964-b4aa-e86d-e063-6394a90a34c6 | 2025-07-22 | Warnings | M020 |
| No7 Future Renew Damage Reversal System Kit | AVOBENZONE, OCTINOXATE, OCTISALATE, OCTOCRYLENE | BCM Cosmetique SAS | 3512c120-b8ba-ba59-e063-6394a90ac1e2 | 2025-07-22 | Warnings | M020 |
| Basin Lime Sugar SPF 15 Broad Spectrum Sunscreen Lip Balm | AVOBENZONE, OCTINOXATE, OCTISALATE, OCTOCRYLENE | Retail Concepts of Minnesota, Inc. | 3a89d736-efef-088e-e063-6394a90a5e62 | 2025-07-22 | Warnings | M020 |
| Basin Juicy Watermelon SPF 15 Broad Spectrum Sunscreen Lip Balm | AVOBENZONE, OCTINOXATE, OCTISALATE, OCTOCRYLENE | Retail Concepts of Minnesota, Inc. | 3a8a093b-cc9c-26fc-e063-6394a90a2028 | 2025-07-22 | Warnings | M020 |
| Basin Coconut SPF 15 Broad Spectrum Sunscreen Lip Balm | AVOBENZONE, OCTINOXATE, OCTISALATE, OCTOCRYLENE | Retail Concepts of Minnesota, Inc. | 3a8a87d6-ef86-60c2-e063-6394a90a0706 | 2025-07-22 | Warnings | M020 |
| Basin Eucalyptus Mint SPF 15 Broad Spectrum Sunscreen Lip Balm | AVOBENZONE, OCTINOXATE, OCTISALATE, OCTOCRYLENE | Retail Concepts of Minnesota, Inc. | 3a8b773c-f456-836a-e063-6294a90a0d46 | 2025-07-22 | Warnings | M020 |
| Basin Strawberry SPF 15 Broad Spectrum Sunscreen Lip Balm | AVOBENZONE, OCTINOXATE, OCTISALATE, OCTOCRYLENE | Retail Concepts of Minnesota, Inc. | 3a8bc90d-350f-98c8-e063-6294a90abd9c | 2025-07-22 | Warnings | M020 |
| Basin Peach Apricot SPF 15 Broad Spectrum Sunscreen Lip Balm | AVOBENZONE, OCTINOXATE, OCTISALATE, OCTOCRYLENE | Retail Concepts of Minnesota, Inc. | 3a8bd5d8-1c4c-0407-e063-6394a90a138f | 2025-07-22 | Warnings | M020 |
| CLEAR GLOW RADIANT SUN SERUM SPF50 | AVOBENZONE 15MG/G, HOMOSALATE 5MG/G, OCTOCRYLENE 25MG/G, (SUNSCREEN) | NAKED SUNDAYS PTY LTD | d748e291-3a29-663c-e053-2995a90a8d92 | 2025-07-22 | Warnings | M020 |
| La Defense Broad Spectrum SPF 30 Mineral Sunscreen | ZINC OXIDE, TITANIUM DIOXIDE | Luzern Laboratories, Inc | 3f00befa-415d-415d-89e1-6ba8770ba51e | 2025-07-21 | Warnings | M020 |
| PREDIRE PARIS skin shield protector mineral defense cream | PREDIRE PARIS SKIN SHIELD PROTECTOR MINERAL DEFENSE CREAM | Guangzhou Fantesy Biotechnology Co.,Ltd | 3a7c1345-532f-b38f-e063-6394a90a5245 | 2025-07-21 | Warnings | M020 |
| Medicated Peppermint Lip Balm | DIMETHICONE, UNSPECIFIED, OCTINOXATE, AND OCTISALATE | Blistex Inc | 5d48a6fa-ddce-47c3-9b09-1f3abb695017 | 2025-07-18 | Warnings | M020 |
| ICD Moisture Layer Sunscreen | HOMOSALATE, OCTISALATE, OCTOCRYLENE, AVOBENZONE | ICD Moisture Layer Sunscreen | 3a2a74f2-9fed-808f-e063-6294a90a410c | 2025-07-18 | Warnings | M020 |
| Counter Beauty Dew Skin Tinted Moisturizer No. 2 | ZINC OXIDE | G2G Ventures, PBC | 3a35c95b-10eb-689f-e063-6394a90ae1d4 | 2025-07-18 | Warnings | M020 |
| Counter Beauty Dew Skin Tinted Moisturizer No. 3 | ZINC OXIDE | G2G Ventures, PBC | 3a35bbb2-a1eb-346b-e063-6294a90a9078 | 2025-07-18 | 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 |