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 |
|---|---|---|---|---|---|---|
| Tinted Mineral Sunscreen | TITANIUM DIOXIDE, ZINC OXIDE | CLEARLY BEAUTIFUL SKIN AND ACNE CLINIC LLC | 35bdf417-45ba-f81a-e063-6394a90a7471 | 2025-12-15 | M020 | |
| Protection E And C Lightly Tinted | ZINC OXIDE | CLEAR SKIN SOLUTIONS, LLC | 35bce44e-d9f1-9279-e063-6394a90a6453 | 2025-12-15 | M020 | |
| Mineral Lip Protection | TITANIUM DIOXIDE, ZINC OXIDE | CLEAR SKIN SOLUTIONS, LLC | 35bd148c-43c7-aa93-e063-6394a90abc8b | 2025-12-15 | M020 | |
| Glow Shield | ZINC OXIDE | Kristina Lerner | 35be8766-1352-8967-e063-6294a90a896a | 2025-12-15 | M020 | |
| Sheer Tinted Protection | TITANIUM DIOXIDE, ZINC OXIDE | CLEAR SKIN SOLUTIONS, LLC | 35bd62d8-ebe3-b3fd-e063-6394a90a827c | 2025-12-15 | M020 | |
| PURE Tinted Mineral Sunscreen | TITANIUM DIOXIDE, ZINC OXIDE | LA JOLLA WELLNESS & AESTHETICS | 386bb911-9dbb-30fb-e063-6394a90a5e4d | 2025-12-15 | M020 | |
| PURE Tinted Mineral Sunscreen | TITANIUM DIOXIDE, ZINC OXIDE | LA JOLLA WELLNESS & AESTHETICS | 386c0261-68f9-6f27-e063-6294a90a8209 | 2025-12-15 | M020 | |
| PURE Lip Sunscreen | TITANIUM DIOXIDE, ZINC OXIDE | LA JOLLA WELLNESS & AESTHETICS | 386c320b-22c3-7d35-e063-6394a90a4e0b | 2025-12-15 | M020 | |
| Tinted Mineral Sunscreen | TITANIUM DIOXIDE, ZINC OXIDE | CLEARLY BEAUTIFUL SKIN AND ACNE CLINIC LLC | 35bdc7f4-4e47-ce35-e063-6294a90acf2d | 2025-12-15 | M020 | |
| Non Tinted Sunscreen | TITANIUM DIOXIDE, ZINC OXIDE | VIDA HEALTH & WELLNESS LLC | 3724cb53-0198-c604-e063-6294a90aa64b | 2025-12-15 | M020 | |
| Untinted Sheer Defense | TITANIUM DIOXIDE, ZINC OXIDE | Kristina Lerner | 35be50b7-a9af-29ee-e063-6394a90a45ba | 2025-12-15 | M020 | |
| Tinted Sunscreen | TITANIUM DIOXIDE, ZINC OXIDE | VIDA HEALTH & WELLNESS LLC | 3724ea3c-b018-c125-e063-6394a90a01f1 | 2025-12-15 | M020 | |
| Tinted Sunscreen | TITANIUM DIOXIDE, ZINC OXIDE | VIDA HEALTH & WELLNESS LLC | 37252429-d692-c05a-e063-6294a90a6af6 | 2025-12-15 | M020 | |
| Parasol Daily Mineral Sunscreen | ZINC OXIDE | Bodi & Wax, LLC | 35d2fbeb-935b-f0a9-e063-6294a90acd79 | 2025-12-15 | M020 | |
| BHSkin Sheer Tinted Zinc and Titanium SPF 40 | TITANIUM DIOXIDE, ZINC OXIDE | Don Mehrabi, M.D. A Professional Medical Corporation | 423c7e62-ad50-0dc3-e063-6294a90ad05a | 2025-12-15 | Warnings | M020 |
| Tined Mineral Sunscreen Whipped Mousse | TITANIUM DIOXIDE, ZINC OXIDE | ESTILO SALON & SPA LLC | 3699c107-d063-cc6f-e063-6394a90a6ad4 | 2025-12-15 | M020 | |
| BHSkin Sheer Tinted Zinc and Titanium SPF 40 | TITANIUM DIOXIDE, ZINC OXIDE | Don Mehrabi, M.D. A Professional Medical Corporation | 44776529-3aa6-4fa3-b2ce-f624c4cf41bd | 2025-12-15 | Warnings | M020 |
| Tinted Mineral Sunscreen | ZINC OXIDE | JMSE Management, LLC | 36ec860f-2066-196c-e063-6294a90a2121 | 2025-12-15 | M020 | |
| Parasol Daily Mineral Sunscreen | ZINC OXIDE | Bodi & Wax, LLC | 35d3262a-1d8d-2afa-e063-6294a90afd49 | 2025-12-15 | M020 | |
| Parasol Daily Mineral Sunscreen Non-Tinted | ZINC OXIDE | Bodi & Wax, LLC | 35d37c2e-abc0-6bda-e063-6294a90a8fc3 | 2025-12-15 | 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 |