Hydrating Sheer Lip Balm SPF 30 - BARE
- Product NDC
- 49358-601
- 11-digit product format
- 493580601
- Labeler code
- 49358
- Product ID
- 49358-601_36d8ea31-6d00-0d8f-e063-6394a90ae824
- Type
- HUMAN OTC DRUG
- Nonproprietary name
- Avobenzone, Octisalate, and Homosalate
- Dosage form
- LIPSTICK
- Route
- TOPICAL
- Labeler
- MDSolarSciences
- Application
- M020
- Marketing category
- OTC MONOGRAPH DRUG
- Marketing start
- 2023-07-01
- Substance
- AVOBENZONE; OCTISALATE; HOMOSALATE
- Active strength
- 30; 50; 100 mg/g; mg/g; mg/g
- 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 |
|---|---|---|---|---|---|---|---|
| 2025-04-01 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 | 49358-601-01 | 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 | 49358-601-01 | 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 | 49358-601-01 | 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 | 49358-601-01 | 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 | 49358-601-01 | 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 | 49358-601-01 | 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 | 49358-601-01 | 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
- Hydrating Sheer Lip Balm SPF 30 - BARE
- Brand name suffix
- Broad Spectrum SPF 30 UVA-UVB Sunscreen
- Listing expiration
- 2026-12-31
Active Ingredients#
| Ingredient | Strength |
|---|---|
| AVOBENZONE | 30 mg/g |
| OCTISALATE | 50 mg/g |
| HOMOSALATE | 100 mg/g |
Harmonized UNII identifiers#
| Identifier | FDA.report destination |
|---|---|
| 4X49Y0596W | Internal UNII lookup |
| G63QQF2NOX | Internal UNII lookup |
| V06SV4M95S | Internal UNII lookup |
Harmonized SPL set identifiers#
| Identifier | FDA.report destination |
|---|---|
| 0f23441c-2399-4a72-9f0a-420d25db78af | Available on FDA.report |
DailyMed Product Concepts#
| Product concept | Relation | Version | Effective |
|---|---|---|---|
| ebc62596-fc97-4d03-9483-7ba095d25db7 | Product name | 1 | 20151210 |
FDA-Initiated Inactive NDC Indexing#
| NDC | Effective | Action | Document | Indexing SPL | Related label |
|---|---|---|---|---|---|
| 49358-601-01 | 2025-06-05 | C162847 | 48780-1 | 2cef2736-5aef-d83d-e063-dadaa90ab31f | Hydrating Sheer Lip Balm SPF 30 Broad Spectrum SPF 30 UVA-UVB Sunscreen |
| 49358-601-01 | 2025-01-30 | C162847 | 48780-1 | 2cef2736-5aef-d83d-e063-dadaa90ab31f | Hydrating Sheer Lip Balm SPF 30 Broad Spectrum SPF 30 UVA-UVB Sunscreen |
DailyMed Package Descriptions#
| Package NDC | Product | Description | Form | Quantity | Strength | SPL version |
|---|---|---|---|---|---|---|
| 49358-601-01 | Hydrating Sheer Lip Balm SPF 30 - BAREBroad Spectrum SPF 30 UVA-UVB Sunscreen | 1 in 1 CARTON | LIPSTICK | 1 | 2 | |
| 49358-601-01 | Hydrating Sheer Lip Balm SPF 30 - BAREBroad Spectrum SPF 30 UVA-UVB Sunscreen | 4.2 g in 1 APPLICATOR | LIPSTICK | 4.2 | 2 |
DailyMed Dashboard NDC Coverage#
| NDC | Dashboard title | SPL version | Validation | Dashboard ZIP |
|---|---|---|---|---|
| 49358-601 | HYDRATING SHEER LIP BALM SPF 30 -CRYSTAL BROAD SPECTRUM SPF 30 UVA-UVB SUNSCREEN (AVOBENZONE, OCTISALATE, AND HOMOSALATE) LIPSTICK HYDRATING SHEER LIP BALM SPF 30 - BARE BROAD SPECTRUM SPF 30 UVA-UVB SUNSCREEN (AVOBENZONE, OCTISALATE, AND HOMOSALATE) LIPSTICK HYDRATING SHEER LIP BALM SPF 30 - BLUSH BROAD SPECTRUM SPF 30 UVA-UVB SUNSCREEN (AVOBENZONE, OCTISALATE, AND HOMOSALATE) LIPSTICK HYDRATING SHEER LIP BALM SPF 30 - RUBY BROAD SPECTRUM SPF 30 UVA-UVB SUNSCREEN (AVOBENZONE, OCTISALATE, AND HOMOSALATE) LIPSTICK HYDRATING SHEER LIP BALM SPF 30 - SHIMMER BROAD SPECTRUM SPF 30 UVA-UVB SUNSCREEN (AVOBENZONE, OCTISALATE, AND HOMOSALATE) LIPSTICK HYDRATING SHEER LIP BALM SPF 30 - SPICE BROAD SPECTRUM SPF 30 UVA-UVB SUNSCREEN (AVOBENZONE, OCTISALATE, AND HOMOSALATE) LIPSTICK HYDRATING SHEER LIP BALM SPF 30 - DREAM BROAD SPECTRUM SPF 30 UVA-UVB SUNSCREEN (AVOBENZONE, OCTISALATE, AND HOMOSALATE) LIPSTICK [MDSOLARSCIENCES] | 1 | Current NDC, 2 package rows | 20230922_0f23441c-2399-4a72-9f0a-420d25db78af.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 | Sample | Exclude flag | Status |
|---|---|---|---|---|---|---|---|
| 49358-601-01 | 49358060101 | 1 APPLICATOR in 1 CARTON (49358-601-01) / 4.2 g in 1 APPLICATOR | 1 applicator | 2023-07-01 | No | No | Current |