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_5fdbf3c5-acab-1bd8-e063-6294a90a40b4
- 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
- Marketing end
- 2027-06-30
- Substance
- OCTISALATE; AVOBENZONE; OCTOCRYLENE; HOMOSALATE
- Active strength
- 50; 30; 90; 73 mg/mL; mg/mL; mg/mL; mg/mL
- NDC exclude flag
- No
- 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
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#
| Effective | Related label |
|---|---|
| 2025-11-17 | Hello Sunday The One For Your Lips Clear Lip Balm SPF 50 |
| 2025-11-17 | Hello Sunday The One For Your Lips Clear Lip Balm SPF 50 |
| 2025-01-30 | Hello Sunday The One For Your Lips Clear Lip Balm SPF 50 |
| 2025-01-30 | 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 |
|---|---|---|---|---|---|---|
| Mary Kay Foundation Primer | AVOBENZONE, HOMOSALATE, OCTISALATE, OCTOCRYLENE | Mary Kay Inc. | 59d25b44-1adb-4790-8ce6-2d847a06b8b3 | 2024-12-17 | Warnings | M020 |
| Mary Kay TimeWise Repair Volu-Firm The Go Set | AVOBENZONE, HOMOSALATE, OCTISALATE, OCTOCRYLENE, AND OXYBENZONE | Mary Kay Inc. | cf7fb8f0-483d-443b-b381-086a255f0783 | 2024-12-17 | Warnings | M020 |
| Mary Kay TimeWise Repair Volu-Firm Sampler Set | AVOBENZONE, HOMOSALATE, OCTISALATE, OCTOCRYLENE, AND OXYBENZONE | Mary Kay Inc. | 0a9ee359-19c1-4266-8a51-a68f655de151 | 2024-12-17 | Warnings | M020 |
| Mary Kay TimeWise Repair Volu-Firm Set | AVOBENZONE, HOMOSALATE, OCTISALATE, OCTOCRYLENE, AND OXYBENZONE | Mary Kay Inc. | d459e2f7-dc78-4519-9733-01495fc447a2 | 2024-12-17 | Warnings | M020 |
| Babo Botanicals Daily Sheer Tinted Mineral Sunscreen SPF 50 | ZINC OXIDE | Babo Botanicals, Inc. | 2982ce67-f136-b93b-e063-6394a90a81ac | 2024-12-17 | Warnings | M020 |
| AHAVA Protecting Body Broad Spectrum SPF 30 | AVOBENZONE, ENSULIZOLE, OCTISALATE, AND OCTOCRYLENE | AHAVA - Dead Sea Laboratories Ltd | e188c328-3617-4f02-8bc9-47976acf3711 | 2024-12-17 | Warnings | M020 |
| Cerave Hydrating Mineral Sunscreen Broad Spectrum SPF 30 Deep Sheer Tint | TITANIUM DIOXIDE AND ZINC OXIDE | L'Oreal USA Products Inc | a1cab79d-0151-49ee-86dc-c2739842e62e | 2024-12-17 | Warnings | M020 |
| SPF 50 plus Sunscreen | TITANIUM DIOXIDE, OCTISALATE, AND ZINC OXIDE | KAS Direct LLC dba BabyGanics | 5a4c71fc-aa6f-47f7-8d1d-2af2e726cf9b | 2024-12-17 | Warnings | M020 |
| Even Up Sunscreen SPF 50 | TITANIUM DIOXIDE AND ZINC OXIDE | Colorescience | f9d375af-3c8b-4462-b729-fdd4be929284 | 2024-12-17 | Warnings | M020 |
| ATTITUDE Sunly Mineral Sunscreen Stick Tropical SPF 30 | ZINC OXIDE | 9055-7588 Quebec Inc. DBA Attitude | 0d842103-7157-793a-e063-6394a90a6feb | 2024-12-16 | Warnings | M020 |
| SPF15 natural lip balm 01 | AVOBENZONE,HOMOSALATE,OCTOCRYLENE,OCTISALATE | Cosmuses Cosmetics (Ningbo) Co., Ltd. | 295f2a15-19fa-011f-e063-6394a90aea7b | 2024-12-16 | Warnings | M020 |
| BOBBI BROWN LIP BALM BROAD SPECTRUM SPF 15 | AVOBENZONE, OCTINOXATE, AND OCTISALATE | Bobbi Brown Professional Cosmetics Inc. | 4bfbfac7-6738-4996-a152-95dfbd759154 | 2024-12-16 | Warnings | M020 |
| BOBBI BROWN INTENSIVE SERUM FOUNDATION BROAD SPECTRUM SPF 40 | OCTINOXATE, TITANIUM DIOXIDE, AND ZINC OXIDE | Bobbi Brown Professional Cosmetics Inc. | dc6b28ca-b922-460a-8028-fb3f5afdbe9d | 2024-12-16 | Warnings | M020 |
| BOBBI BROWN INTENSIVE SERUM FOUNDATION BROAD SPECTRUM SPF 30 | OCTINOXATE, TITANIUM DIOXIDE AND ZINC OXIDE | Bobbi Brown Professional Cosmetics Inc. | 1f9a4b71-45aa-4156-9fe6-ffa81f808a85 | 2024-12-16 | Warnings | M020 |
| AHAVA Protecting Moisturizing SPF50 | AVOBENZONE, ENSULIZOLE, HOMOSALATE, OCTISALATE, AND OCTOCRYLENE | AHAVA - Dead Sea Laboratories Ltd | 7502e06d-754b-4cb8-ba4c-91eee0453932 | 2024-12-16 | Warnings | M020 |
| Natural Finish Pressed Foundation SPF 20 Sunscreen | TITANIUM DIOXIDE AND ZINC OXIDE | Colorescience | c389e183-bfad-4813-af09-fae3aa05e82a | 2024-12-16 | Warnings | M020 |
| Sunforgettable Total Protection Brush-On Shield SPF 50 | TITANIUM DIOXIDE AND ZINC OXIDE | Colorescience | c77357f1-7ada-4325-86f7-5ee801610f42 | 2024-12-16 | Warnings | M020 |
| Sunforgettable Total Protection Sheet Matte Sunscreen SPF 30 | ZINC OXIDE | Colorescience | 5b6f906e-6620-48b0-9c39-0eb1c8dc1c63 | 2024-12-16 | Warnings | M020 |
| Ryshi SPF 50 Sunscreen | AVOBENZONE 3%, HOMOSALATE 15%, OCTISALATE 5%, OCTOCRYLENE 10% | Rite Aid | e313350f-74d9-370b-e053-2995a90aeeaf | 2024-12-15 | Warnings | M020 |
| Annmarie SPF 20 Sunscreen | ZINC OXIDE 15% | Annmarie Gianni Skin Care LLC | cc722ce1-0ded-19d5-e053-2995a90a7d03 | 2024-12-15 | Warnings | M020 |
Packages#
| Package NDC | 11-digit format | Description | Units | Marketing start | Marketing end | 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 | 2027-06-30 | No | No | Historical |