OS-01 Face SPF BS SPF30 Tinted
- Product NDC
- 84451-002
- 11-digit product format
- 844510002
- Labeler code
- 84451
- Product ID
- 84451-002_2204e135-6a11-68a2-e063-6394a90ac019
- Type
- HUMAN OTC DRUG
- Nonproprietary name
- Zinc Oxide
- Dosage form
- CREAM
- Route
- TOPICAL
- Labeler
- ONESKIN INC.
- Application
- M020
- Marketing category
- OTC MONOGRAPH DRUG
- Marketing start
- 2023-09-13
- Substance
- ZINC OXIDE
- Active strength
- 17.5 g/100g
- NDC exclude flag
- No
- Listing certified through
- 2026-12-31
- Current FDA listing
- Yes
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
- OS-01 Face SPF BS SPF30 Tinted
- Listing expiration
- 2026-12-31
Active Ingredients#
| Ingredient | Strength |
|---|---|
| ZINC OXIDE | 17.5 g/100g |
Harmonized UNII identifiers#
| Identifier | FDA.report destination |
|---|---|
| SOI2LOH54Z | Internal UNII lookup |
Harmonized SPL set identifiers#
| Identifier | FDA.report destination |
|---|---|
| 2204e776-b1a1-be15-e063-6294a90af5de | Available on FDA.report |
DailyMed Product Concepts#
| Product concept | Relation | Version | Effective |
|---|---|---|---|
| e2db08c6-133f-4f4f-afb4-e90a2418d6f6 | Product name | 1 | 20230320 |
| c6f86816-7da6-43ea-8c25-ac9758311cc5 | Product name | 1 | 20220118 |
| 11ed6f83-cdd2-4637-8379-b1a1d3ae3cde | Product name | 1 | 20181101 |
| 86c45a79-b9f0-4476-a27c-6e10db098497 | Product name | 1 | 20180125 |
| 252e11b6-1a9a-4283-a242-df2c129c496d | Product name | 3 | 20170717 |
DailyMed Package Descriptions#
| Package NDC | Product | Description | Form | Quantity | Strength | SPL version |
|---|---|---|---|---|---|---|
| 84451-002-01 | OS-01 Face SPF BS SPF30 Tinted | 40 g in 1 TUBE | CREAM | 40 | 1 | |
| 84451-002-02 | OS-01 Face SPF BS SPF30 Tinted | 1 in 1 CARTON | CREAM | 1 | 1 |
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 |
|---|---|---|---|---|---|---|---|
| 84451-002-01 | 84451000201 | 40 g in 1 TUBE | 40 g | Historical | |||
| 84451-002-02 | 84451000202 | 1 TUBE in 1 CARTON (84451-002-02) / 40 g in 1 TUBE (84451-002-01) | 1 tube | 2023-09-13 | No | No | Current |