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 |
|---|---|---|---|---|---|---|
| SPF Lip Colour | ZINC OXIDE | Lauren Brooke Cosmetiques, LLC | 50b344b5-e39d-48ef-e063-6394a90ae41c | 2026-04-30 | Warnings | M020 |
| No 7 Prime Forever SPF 50 Primer | NO 7 PRIME FOREVER BROAD SPECTRUM SUNSCREEN SPF50 PRIMER | Boots Retail USA | 50b3e9fa-faf8-0026-e063-6294a90a0823 | 2026-04-30 | Warnings | M020 |
| Tru Skin Rituals SPF 25 | TITANIUM DIOXIDE, ZINC OXIDE | Spa de Soleil | f725cd5c-999e-2393-e053-6394a90a09dc | 2026-04-30 | Warnings | M020 |
| Moisture Sunscreen SPF 50 | TITANIUM DIOXIDE, ZINC OXIDE | Spa de Soleil | cb95975f-060d-23c2-e053-2a95a90adf1b | 2026-04-30 | Warnings | M020 |
| Day Cream SPF 30 | OCTOCRYLENE, OCTINOXATE, AVOBENZONE | Anthony Skin LLC | 5070e8cc-12c0-c2c4-e063-6294a90a1422 | 2026-04-29 | Warnings | M020 |
| Steak n Shake Beef Tallow Sunscreen SPF 30 | ZINC OXIDE | HRR Enterprises, Inc | 0eb122d8-6826-4843-bed1-9e0cb8316e6d | 2026-04-29 | Warnings | M020 |
| EQUATE SUNSCREEN SPF 50 SPORT BROAD SPECTRUM | AVOBENZONE, HOMOSALATE, OCTISALATE, OCTOCRYLENE | Walmart | 509b6c7d-8a28-2d3a-e063-6394a90af068 | 2026-04-29 | Warnings | M020 |
| Freaks of Nature Solar Shield Broad Spectrum SPF 30 | FREAKS OF NATURE SOLAR SHIELD BROAD SPECTRUM SPF 30 | THE FREAKS OF NATURE, INC. | 509b8610-6dbe-611f-e063-6394a90a9fd1 | 2026-04-29 | Warnings | M020 |
| TiZO2 | TITANIUM DIOXIDE, ZINC OXIDE | Fallien Cosmeceuticals Ltd. | 509cad98-0321-2a0a-e063-6294a90a6ea9 | 2026-04-29 | Warnings | M020 |
| TiZO2 | TITANIUM DIOXIDE, ZINC OXIDE | Fallien Cosmeceuticals Ltd. | 509d7206-0cc1-c997-e063-6294a90a89e0 | 2026-04-29 | Warnings | M020 |
| COTZ FACE MOISTURE | ZINC OXIDE | Fallien Cosmeceuticals Ltd. | 509d9a74-bc8d-c9c1-e063-6394a90a403d | 2026-04-29 | Warnings | M020 |
| JMSOLUTION MARINE LUMINOUS PEARL SUNSCREEN | AVOBENZONE, HOMOSALATE, OCTISALATE, OCTOCRYLENE | GPNY CORP | 212d4563-2fad-31a5-e063-6394a90aff71 | 2026-04-29 | Warnings | M020 |
| JMSOLUTION SKIN BOOST NIACINAMIDE SUNSCREEN | HOMOSALATE, OCTISALATE, OCTOCRYLENE, TITANIUM DIOXIDE | GPNY CORP | 211dea04-faad-8ffc-e063-6294a90a8d68 | 2026-04-29 | Warnings | M020 |
| La Roche Posay Laboratoire Dermatologique Anthelios Glow Daily Glow Sunscreen Bronze Cell OX Shield Broad Spectrum SPF 35 | AVOBENZONE, HOMOSALATE, OCTISALATE AND OCTOCRYLENE | L'Oreal USA Products Inc | 5e19577b-9911-4fa1-a2b7-7ca2e02d1fd8 | 2026-04-28 | Warnings | M020 |
| Daily Defence Moisturising Sunscreen Broad Spectrum SPF 50 | AVOBENZONE, HOMOSALATE, OCTISALATE, OCTOCRYLENE | Ultraceuticals Pty Ltd | 50888d3f-46ae-e2c2-e063-6394a90ad6af | 2026-04-28 | Warnings | M020 |
| Anything SPF | OCTINOXATE, OCTISALATE, ZINC OXIDE, AVOBENZONE, HOMOSALATE, TITANIUM DIOXIDE | Anything SPF LLC | 508b8dcb-6600-6dad-e063-6294a90a565a | 2026-04-28 | Warnings | M020 |
| Fusion Water Magic | OCTOCRYLENE, HOMOSALATE, OCTISALATE, AND AVOBENZONE | ISDIN Corp. | d4f91d5a-600a-4255-a6e1-e7e7197848c7 | 2026-04-28 | Warnings | M020 |
| La Roche Posay Laboratoire Dermatologique Anthelios Glow Daily Glow Sunscreen Pearl Cell OX Shield Broad Spectrum SPF 35 | AVOBENZONE, HOMOSALATE, OCTISALATE AND OCTOCRYLENE | L'Oreal USA Products Inc | c6a1b995-1898-4a92-b128-7d5ebd6d8d3d | 2026-04-28 | Warnings | M020 |
| Obagi Skintrinsiq Antioxidant Protocol | AVOBENZONE, HOMOSALATE, OCTISALATE. OCTOCRYLENE, AND OXYBENZONE | Obagi Cosmeceuticals LLC | 53023b16-8d64-4dfc-bc75-b4f248425c4d | 2026-04-27 | Warnings | M020 |
| TONEfitSUN Sebum Control Vegan Sunscreen | AVOBENZONE, HOMOSALATE, OCTISALATE, OCTOCRYLENE | Hankook Cosmetics Manufacturing Co.,Ltd_Eumseong Factory | 506b96ae-eb2a-edad-e063-6294a90a470e | 2026-04-27 | 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 |