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 |
|---|---|
| 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 |
|---|---|---|---|---|---|
| 49358-604-01 | 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 |
|---|---|---|---|---|---|---|
| JAFRA ALWAYS LONG WEAR FOUNDATION BROAD SPECTRUM SPF 15 SUNSCREEN 241 | HOMOSALATE,OCTISALATE,ZINC OXIDE | Distribuidora Comercial Jafra, S.A. de C.V. | a100b05a-06b7-4c65-9822-3f62ca029f40 | 2026-01-22 | Warnings | M020 |
| JAFRA ALWAYS LONG WEAR FOUNDATION BROAD SPECTRUM SPF 15 SUNSCREEN 331 | HOMOSALATE,OCTISALATE,ZINC OXIDE | Distribuidora Comercial Jafra, S.A. de C.V. | c3dd293c-8819-4406-af60-41b632a8c00f | 2026-01-22 | Warnings | M020 |
| JAFRA ALWAYS LONG WEAR FOUNDATION BROAD SPECTRUM SPF 15 SUNSCREEN 342 | HOMOSALATE,OCTISALATE,ZINC OXIDE | Distribuidora Comercial Jafra, S.A. de C.V. | 99a92fc5-9a3e-434a-9a5b-3cc47efeea53 | 2026-01-22 | Warnings | M020 |
| JAFRA ALWAYS LONG WEAR FOUNDATION BROAD SPECTRUM SPF 15 SUNSCREEN 351 | HOMOSALATE,OCTISALATE,ZINC OXIDE | Distribuidora Comercial Jafra, S.A. de C.V. | e6cd9c7a-29ef-4132-a3e5-575dddb36a9e | 2026-01-22 | Warnings | M020 |
| JAFRA ALWAYS LONG WEAR FOUNDATION BROAD SPECTRUM SPF 15 SUNSCREEN 421 | HOMOSALATE,OCTISALATE,ZINC OXIDE | Distribuidora Comercial Jafra, S.A. de C.V. | ea630f2c-49a7-4900-a0ac-b0e1c554aff9 | 2026-01-22 | Warnings | M020 |
| JAFRA ALWAYS LONG WEAR FOUNDATION BROAD SPECTRUM SPF 15 SUNSCREEN 430 | HOMOSALATE,OCTISALATE,ZINC OXIDE | Distribuidora Comercial Jafra, S.A. de C.V. | cc9c9b69-a0ea-44ac-a590-2cd241ce3162 | 2026-01-22 | Warnings | M020 |
| JAFRA ALWAYS LONG WEAR FOUNDATION BROAD SPECTRUM SPF 15 SUNSCREEN 442 | HOMOSALATE,OCTISALATE,ZINC OXIDE | Distribuidora Comercial Jafra, S.A. de C.V. | e38a10a8-73ac-4fc5-bbde-537ccb845e6f | 2026-01-22 | Warnings | M020 |
| Designer Lip Smoothie SPF 15 Lip Balm | AVOBENZONE, OCTISALATE, HOMOSALATE, PETROLATUM | Australian Gold | 6fd1bd4f-ef94-42b5-a26c-2a02718c113f | 2026-01-22 | Warnings | M020 |
| Australian Gold SPF 15 Lip Balm | OCTINOXATE, OCTOCRYLENE, OXYBENZONE, OCTISALATE, PETROLEUM JELLY | Australian Gold | 92966c2d-b61a-4f8b-a5c1-8dfb6352c82f | 2026-01-22 | Warnings | M020 |
| LEBELAGE UV SUN ULTRA SHIELD SUN SCREENLOTION 50g | AVOBENZONE, HOMOSALATE, OCTINOXATE, OCTOCRYLENE, OCTISALATE | DONGDONGGURIMOO CO.,LTD. | 4907eb9c-3978-27ed-e063-6394a90a9f66 | 2026-01-22 | Warnings | M020 |
| AGE20S SIGNATURE ESSENCE PACT INTENSE COVER 13C | OCTINOXATE, OCTOCRYLENE, TITANIUM DIOXIDE | Aekyung Industrial Co., Ltd. | be9f7608-cfaa-4b16-83dd-0580047af56c | 2026-01-21 | Warnings | M020 |
| AGE20S SIGNATURE ESSENCE PACT INTENSE COVER 15C | OCTINOXATE, OCTOCRYLENE, TITANIUM DIOXIDE | Aekyung Industrial Co., Ltd. | 6b27df44-c441-4ae8-a1b0-a9cf2fff6f21 | 2026-01-21 | Warnings | M020 |
| AGE20S SIGNATURE ESSENCE PACT INTENSE COVER 17N | OCTINOXATE, OCTOCRYLENE, TITANIUM DIOXIDE | Aekyung Industrial Co., Ltd. | 3c295f6b-6202-a2e1-e063-6394a90a9a60 | 2026-01-21 | Warnings | M020 |
| AGE20S SIGNATURE ESSENCE PACT INTENSE COVER 19C | OCTINOXATE, OCTOCRYLENE, TITANIUM DIOXIDE | Aekyung Industrial Co., Ltd. | b2eee48f-b644-403c-a57e-04a1491bc386 | 2026-01-21 | Warnings | M020 |
| AGE20S SIGNATURE ESSENCE PACT INTENSE COVER 21N | OCTINOXATE, OCTOCRYLENE, TITANIUM DIOXIDE | Aekyung Industrial Co., Ltd. | ebcc2c6c-a039-48d5-8c1c-5b347254c4c2 | 2026-01-21 | Warnings | M020 |
| AGE20S SIGNATURE ESSENCE PACT INTENSE COVER 21W | OCTINOXATE, OCTOCRYLENE, TITANIUM DIOXIDE | Aekyung Industrial Co., Ltd. | 6967f8bc-3092-44a9-926a-6c11676425e5 | 2026-01-21 | Warnings | M020 |
| AGE20S SIGNATURE ESSENCE PACT INTENSE COVER 23W | OCTINOXATE, OCTOCRYLENE, TITANIUM DIOXIDE | Aekyung Industrial Co., Ltd. | 37d4d8c1-e76b-48a3-9a13-f0543af1b28f | 2026-01-21 | Warnings | M020 |
| AGE20S SIGNATURE ESSENCE PACT INTENSE COVER 24W | OCTINOXATE, OCTOCRYLENE, TITANIUM DIOXIDE | Aekyung Industrial Co., Ltd. | fa5046f2-a6db-4ac3-a78f-1b5df075d7e8 | 2026-01-21 | Warnings | M020 |
| AGE20S SIGNATURE ESSENCE PACT INTENSE COVER 25N | OCTINOXATE, OCTOCRYLENE, TITANIUM DIOXIDE | Aekyung Industrial Co., Ltd. | 0c5fc63f-1899-4406-944a-1cdcdf8b4277 | 2026-01-21 | Warnings | M020 |
| AGE20S SIGNATURE ESSENCE PACT INTENSE COVER 27C | OCTINOXATE, OCTOCRYLENE, TITANIUM DIOXIDE | Aekyung Industrial Co., Ltd. | 58a84ecd-3f27-40fc-8e0b-e29192679e6b | 2026-01-21 | 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 |