Advanced Formula Lip Balm SPF 25
- Product NDC
- 80949-002
- 11-digit product format
- 809490002
- Labeler code
- 80949
- Product ID
- 80949-002_4d248a7a-9dcc-8e9f-e063-6294a90aa703
- Type
- HUMAN OTC DRUG
- Nonproprietary name
- Avobenzone, Octinoxate
- Dosage form
- CREAM
- Route
- TOPICAL
- Labeler
- Anthony Skin LLC
- Application
- M020
- Marketing category
- OTC MONOGRAPH DRUG
- Marketing start
- 2020-01-05
- Substance
- AVOBENZONE; OCTINOXATE
- Active strength
- 3; 7.5 g/100g; g/100g
- NDC exclude flag
- No
- Listing certified through
- 2027-12-31
- 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 | Product NDC | Package NDC | Code | Status | Reporting period | Archive | Snapshot | Source SHA-256 |
|---|---|---|---|---|---|---|---|---|---|---|
| 2025-01-11 03:41 UTC · source 2025-01-10 | excluded product | product | 80949-002 | U | Excluded because listing certification expired | excluded / ndc_excluded.zip | 0efc9e666f02… | f202fb6c5f17… | ||
| 2025-01-11 03:41 UTC · source 2025-01-10 | excluded package | package | 80949-002 | 80949-002-07 | U | Excluded because listing certification expired | excluded / ndc_excluded.zip | 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
- Advanced Formula Lip Balm SPF 25
- Brand name suffix
- Blood Orange
- Listing expiration
- 2027-12-31
Active Ingredients#
| Ingredient | Strength |
|---|---|
| AVOBENZONE | 3 g/100g |
| OCTINOXATE | 7.5 g/100g |
Harmonized UNII identifiers#
| Identifier | FDA.report destination |
|---|---|
| G63QQF2NOX | Internal UNII lookup |
| 4Y5P7MUD51 | Internal UNII lookup |
Harmonized SPL set identifiers#
| Identifier | FDA.report destination |
|---|---|
| 74853b40-a773-4488-98a9-c8029ad21134 | Available on FDA.report |
DailyMed Package Descriptions#
| Package NDC | Product | Description | Form | Quantity | Strength | SPL version |
|---|---|---|---|---|---|---|
| 80949-002-07 | Advanced Formula Lip Balm SPF 25Blood Orange | 7 g in 1 TUBE | CREAM | 7 | 3 |
DailyMed Dashboard NDC Coverage#
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 |
|---|---|---|---|---|---|---|
| Mineral Sunscreen | ZINC OXIDE | ISIS GONZALEZ | 3f68b2ea-be23-100d-e063-6294a90a8b37 | 2025-12-16 | Warnings | M020 |
| Mineral Sunscreen | ZINC OXIDE | ISIS GONZALEZ | 3f682b78-e1c9-e174-e063-6294a90a17ed | 2025-12-16 | Warnings | M020 |
| Silk Screen Tinted | TITANIUM DIOXIDE, ZINC OXIDE | Skin Science Institute Inc | 36c3793a-ccb5-1e5f-e063-6294a90ad44f | 2025-12-16 | M020 | |
| Silk Screen Tinted | TITANIUM DIOXIDE, ZINC OXIDE | Skin Science Institute Inc | 36c3a721-6be1-3f7f-e063-6394a90a522f | 2025-12-16 | M020 | |
| True Tone Tinted | TITANIUM DIOXIDE, ZINC OXIDE | That Face PLLC | 36c2bb0e-479d-89cd-e063-6294a90aa3d4 | 2025-12-16 | M020 | |
| True Tone Non Tinted | ZINC OXIDE | That Face PLLC | 36c2f263-67cf-e8cf-e063-6394a90ad81f | 2025-12-16 | M020 | |
| Tinted Daily Protection Sunscreen | ZINC OXIDE | Kemmi Lee Skin Science | 37ef5a05-54d2-a8e4-e063-6394a90a8e48 | 2025-12-16 | M020 | |
| Aquaphor Lip Repair Stick and Sunscreen | AVOBENZONE, HOMOSALATE, OCTISALATE, OCTOCRYLENE, | Beiersdorf Inc | d469bddf-90d4-7b1c-e053-2a95a90a1ed9 | 2025-12-16 | Warnings | M020 |
| Eucerin Daily Protection Face | ENSULIZOLE, OCTINOXATE, OCTISALATE, TITANIUM DIOXIDE, ZINC OXIDE | Beiersdorf Inc | 76403f03-aee9-4c0b-b331-f79b6953118c | 2025-12-16 | Warnings | M020 |
| Tinted Mineral Sunscreen | TITANIUM DIOXIDE, ZINC OXIDE | JEFFREY J. ROTH, M.D., A PROFESSIONAL CORPORATION | 36c0400b-8ad9-654b-e063-6294a90ad040 | 2025-12-16 | M020 | |
| Non Tinted Mineral Sunscreen | TITANIUM DIOXIDE, ZINC OXIDE | JEFFREY J. ROTH, M.D., A PROFESSIONAL CORPORATION | 36c00301-ee41-333c-e063-6294a90a61d5 | 2025-12-16 | M020 | |
| Tinted Mineral Sunscreen | TITANIUM DIOXIDE, ZINC OXIDE | JEFFREY J. ROTH, M.D., A PROFESSIONAL CORPORATION | 36c078fa-05f9-ad80-e063-6394a90af3bb | 2025-12-16 | M020 | |
| 20Percent Zinc Oxide Non Tinted | ZINC OXIDE | JEFFREY J. ROTH, M.D., A PROFESSIONAL CORPORATION | 36c108f6-a928-0a54-e063-6394a90ae686 | 2025-12-16 | M020 | |
| 20Percent Zinc Oxide Non Tinted | ZINC OXIDE | JEFFREY J. ROTH, M.D., A PROFESSIONAL CORPORATION | 36c0ccca-c993-181e-e063-6294a90a7ae6 | 2025-12-16 | M020 | |
| Non Tinted Mineral Sunscreen | TITANIUM DIOXIDE, ZINC OXIDE | JEFFREY J. ROTH, M.D., A PROFESSIONAL CORPORATION | 36c0a55d-16d3-086a-e063-6394a90a30cf | 2025-12-16 | M020 | |
| Eucerin Radiant Tone | AVOBENZONE, HOMOSALATE, OCTISALATE, OCTOCRYLENE | Beiersdorf Inc | 2611e0cb-d56d-6ea1-e063-6294a90a745b | 2025-12-16 | Warnings | M020 |
| Really Great Lip Shield | TITANIUM DIOXIDE, ZINC OXIDE | JEFFREY J. ROTH, M.D., A PROFESSIONAL CORPORATION | 36c1341d-fbf5-56a5-e063-6294a90aa045 | 2025-12-16 | M020 | |
| Tinted Mineral Sunscreen | ZINC OXIDE | KLOE SALON LLC | 36c23c07-2011-3ddb-e063-6294a90a76e9 | 2025-12-16 | M020 | |
| Tinted Mineral Sun Defense | TITANIUM DIOXIDE, ZINC OXIDE | Helen's Haven | 36c465ea-979b-9474-e063-6394a90ab3f8 | 2025-12-16 | M020 | |
| Mineral Lip Sunscreen | TITANIUM DIOXIDE, ZINC OXIDE | Helen's Haven | 36c4a27b-96e9-4f30-e063-6294a90a5655 | 2025-12-16 | M020 |
Packages#
| Package NDC | 11-digit format | Description | Units | Marketing start | Sample | Exclude flag | Status |
|---|---|---|---|---|---|---|---|
| 80949-002-07 | 80949000207 | 7 g in 1 TUBE (80949-002-07) | 7 g | 2020-01-05 | No | No | Current |