Hydrating Sheer Lip Balm SPF 30 - SHIMMER
- Product NDC
- 49358-604
- 11-digit product format
- 493580604
- Labeler code
- 49358
- Product ID
- 49358-604_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 | 49358-604-01 | 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 | 49358-604-01 | 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 | 49358-604-01 | 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 | 49358-604-01 | 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 | 49358-604-01 | 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 | 49358-604-01 | 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 | 49358-604-01 | 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 - SHIMMER
- 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 |
|---|---|
| V06SV4M95S | Internal UNII lookup |
| 4X49Y0596W | Internal UNII lookup |
| G63QQF2NOX | 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 |
|---|---|---|---|---|---|
| 49358-604-01 | 2025-06-05 | C162847 | 48780-1 | 2cef2736-5aef-d83d-e063-dadaa90ab31f | Hydrating Sheer Lip Balm SPF 30 Broad Spectrum SPF 30 UVA-UVB Sunscreen |
| 49358-604-01 | 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 |
|---|---|---|---|---|---|---|
| 49358-604-01 | Hydrating Sheer Lip Balm SPF 30 - SHIMMERBroad Spectrum SPF 30 UVA-UVB Sunscreen | 1 in 1 CARTON | LIPSTICK | 1 | 2 | |
| 49358-604-01 | Hydrating Sheer Lip Balm SPF 30 - SHIMMERBroad 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 |
|---|---|---|---|---|
| 49358-604 | 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 |
|---|---|---|---|---|---|---|
| Jack Black L.L.C. | AVOBENZONE/HOMOSALATE/OCTISALATE/PETROLATUM | Jack Black L.L.C. | 3e0eb291-6bda-2f26-e063-6294a90ac466 | 2025-09-05 | Warnings | M020 |
| Jack Black | AVOBENZONE/HOMOSALATE/OCTISALATE/PETROLATUM | Jack Black L.L.C. | 3d5fafb9-62c9-ec69-e063-6394a90af8b9 | 2025-09-05 | Warnings | M020 |
| Jack Black | AVOBENZONE/HOMOSALATE/OCTISALATE/PETROLATUM | Jack Black L.L.C. | 3e0f655e-6100-f1dd-e063-6394a90af7b7 | 2025-09-05 | Warnings | M020 |
| Truskin SPF 30 Mineral Sunscreen Facial Serum | ZINC OXIDE | Allure Labs | 3e13299f-8d5d-373b-e063-6394a90ab256 | 2025-09-05 | Warnings | M020 |
| Powder | TITANIUM DIOXIDE | Oxygen Development LLC | 08b52f29-c1a0-c673-e063-6294a90a9a7a | 2025-09-05 | Warnings | M020 |
| Powder | TITANIUM DIOXIDE | Oxygen Development LLC | 08b8003f-40be-3380-e063-6294a90a4f6b | 2025-09-05 | Warnings | M020 |
| MAYDAY Everyday Sunscreen SPF 30 | ZINC OXIDE | Omniche Consumer Products Co. | 3f53fb40-6347-46b0-979c-3522d9948198 | 2025-09-04 | Warnings | M020 |
| PHOFAY Matte Sunscreen Liquid Foundation SPF 30, 1 | ENSULIZOLE, HOMOSALATE, OCTINOXATE, TITANIUM DIOXIDE | Hangzhou Jingshen Trading Co., Ltd. | 18130858-429c-4ed4-a75b-5bc014481250 | 2025-09-04 | Warnings | M020 |
| Introstem PrismaStem Face Shield Cream | OCTINOXATE, HOMOSALATE, OCTISALATE, OXYBENZONE AND AVOBENZONE | Innovation Brands Inc. | dd91374a-e3fc-42f1-a660-86b32a0cc8b8 | 2025-09-04 | Warnings | M020 |
| MEDICUBE COLLAGEN GLOW SUNSCREEN | HOMOSALATE, OCTOCRYLENE, OCTISALATE, AVOBENZONE | APR US INC | 34fae072-536c-ad41-e063-6394a90af0af | 2025-09-03 | Warnings | M020 |
| Basin Sugar Plum SPF 15 Broad Spectrum Sunscreen Lip Balm | AVOBENZONE, OCTINOXATE, OCTISALATE, OCTOCRYLENE | Retail Concepts of Minnesota, Inc. | 3de75cec-955e-4b3a-e063-6394a90a1543 | 2025-09-03 | Warnings | M020 |
| Basin Mint SPF 30 Broad Spectrum Sunscreen Lip Balm SPF 30 | AVOBENZONE, OCTINOXATE, OCTISALATE, OXYBENZONE | Retail Concepts of Minnesota, Inc. | 3de7d21b-4f88-d80c-e063-6394a90a8e4c | 2025-09-03 | Warnings | M020 |
| Dolce and Gabbana Everlast Foundation SPF 20 38C Deep | OCTISALATE, OCTOCRYLENE, TITANIUM DIOXIDE, ZINC OXIDE | Dolce & Gabbana Beauty S.R.L | 0358a87d-8002-4f3e-851a-3a582d356edf | 2025-09-03 | Warnings | M020 |
| Dolce and Gabbana Everlast Foundation SPF 20 39N Deep | OCTISALATE, OCTOCRYLENE, TITANIUM DIOXIDE, ZINC OXIDE | Dolce & Gabbana Beauty S.R.L | 34dfc4c5-44f7-4531-97ba-8846ebe14724 | 2025-09-03 | Warnings | M020 |
| Dolce and Gabbana Everlast Foundation SPF 20 40C Deep | OCTISALATE, OCTOCRYLENE, TITANIUM DIOXIDE, ZINC OXIDE | Dolce & Gabbana Beauty S.R.L | cf4b6f45-d4ae-4665-87b4-c5af4910befa | 2025-09-03 | Warnings | M020 |
| DOLCE and GABBANA MEET YOUR FLAWLESS MATTE SKIN DUO - EVERLAST PRIMER EVERLAST FOUNDATION | OCTISALATE, OCTOCRYLENE, TITANIUM DIOXIDE, ZINC OXIDE | DOLCE & GABBANA BEAUTY SRL | eb63e9c6-bdb0-4bdf-8822-e4561a56adc9 | 2025-09-03 | Warnings | M020 |
| Dolce and Gabbana Blueberry Nutri Tint SPF 20 1N Light | ZINC OXIDE | Dolce & Gabbana Beauty S.R.L | 9507681c-236c-41c1-9dc9-ed4c0c091741 | 2025-09-03 | Warnings | M020 |
| Pure6 ManiShield Hand Screen | ZINC OXIDE, TITANIUM DIOXIDE | GUANGZHOU SAWEILAN IMPORT & EXPORT TRADING CO., LTD | 3abcb6ba-1de8-55e7-e063-6294a90aecf1 | 2025-09-02 | Warnings | M020 |
| Round Lab Dodo s Pick Bestseller Set | AVOBENZONE, HOMOSALATE, OCTISALATE | SEORIN COMPANY Co., Ltd. | 3dd3db99-2e9f-16fc-e063-6294a90adda1 | 2025-09-02 | Warnings | M020 |
| Sun Bum Premium Sunscreen Face Stick Broad Spectrum SPF 30 Sunscreen - Pegged | AVOBENZONE, HOMOSALATE, OCTISALATE, OCTOCRYLENE | Sun Bum, LLC | 3d86da52-6354-f53e-e063-6394a90aac55 | 2025-09-02 | Warnings | M020 |
Packages#
| Package NDC | 11-digit format | Description | Units | Marketing start | Sample | Exclude flag | Status |
|---|---|---|---|---|---|---|---|
| 49358-604-01 | 49358060401 | 1 APPLICATOR in 1 CARTON (49358-604-01) / 4.2 g in 1 APPLICATOR | 1 applicator | 2023-07-01 | No | No | Current |