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 |
|---|---|---|---|---|---|---|
| First Aid Beauty FAB Ultra Repair Face Moisturizer with Sunscreen Broad Spectrum SPF 30 | OCTOCRYLENE, AND ZINC OXIDE | The Procter & Gamble Manufacturing Company | f6801575-6081-7566-e053-2995a90a20a8 | 2025-12-18 | Warnings | M020 |
| Olay Regenerist Regenerating with Sunscreen Broad Spectrum SPF 15 | AVOBENZONE, HOMOSALATE, OCTISALATE, AND OCTOCRYLENE | The Procter & Gamble Manufacturing Company | 00280745-908b-468f-e063-6294a90aa12f | 2025-12-18 | Warnings | M020 |
| OLAY Prime plus Protect Facial Sunscreen with Vitamin C SPF35 Matte Finish | AVOBENZONE, HOMOSALATE, OCTISALATE, AND OCTOCRYLENE | The Procter & Gamble Manufacturing Company | 10bd41ac-9b96-840d-e063-6394a90a98d9 | 2025-12-18 | Warnings | M020 |
| Olay Glow plus Protect Sunscreen Dewy Glow SPF 50 | AVOBENZONE, HOMOSALATE, OCTISALATE, OCTOCRYLENE, AND OXYBENZONE | The Procter & Gamble Manufacturing Company | 10bc4127-7569-d0de-e063-6294a90a97bf | 2025-12-18 | Warnings | M020 |
| First Aid Beauty FAB Hydrating Sunscreen Milk Broad Spectrum SPF 45 | AVOBENZONE, HOMOSALATE, OCTISALATE, AND OCTOCRYLENE | The Procter & Gamble Manufacturing Company | 29645d90-a444-4090-e063-6294a90ac7e3 | 2025-12-18 | Warnings | M020 |
| Skin On Skin BC Foundation SPF 40 - Tan Golden | OCTISALATE, HOMOSALATE, ZINC OXIDE | YENSA Beauty, LLC | 46440bac-de69-e59c-e063-6394a90a76c0 | 2025-12-18 | Warnings | M020 |
| FUSIDYNE DERMA TROUBLE Zinc Calming Sunscreen | ZINC OXIDE | DONG WHA PHARM. CO., LTD. | 46457c78-74d6-ea6a-e063-6294a90a24ac | 2025-12-18 | Warnings | M020 |
| THE MUG GUARD Invisible Gel Suncare for Face | AVOBENZONE, HOMOSALATE, OCTISALATE, AND OCTOCRYLENE | Dune Suncare, Inc. | 4646988c-1060-ed5f-e063-6394a90aa765 | 2025-12-18 | Warnings | M020 |
| Sage and Zinc Facial Hydrating SPF15 | ZINC OXIDE | Emeis Cosmetics Pty Ltd | ccabd647-ecdd-7230-e053-2a95a90a7a96 | 2025-12-18 | Warnings | M020 |
| Avail Facial Sunscreen SPF 25 | HOMOSALATE, OCTOCRYLENE, OCTISALATE, AVOBENZONE | Emeis Cosmetics Pty Ltd | 7be903e4-5f07-35b2-e053-2991aa0a1340 | 2025-12-17 | Warnings | M020 |
| Mineral Sheer Stick | ZINC OXIDE | Supergoop, LLC | 0beed72e-51df-d15a-e063-6394a90af559 | 2025-12-17 | Warnings | M020 |
| Sunscreen Lotion118ml | ZINC OXIDE 12%,TITANIUM DIOXIDE 6%, HOMOSALATE 14%,OCTISALATE 5% | Foshan Sugar Max Cosmetics CO.,Ltd | 4620c41a-2188-00f5-e063-6394a90a613c | 2025-12-17 | Warnings | M020 |
| Sunscreen Cream | ZINC OXIDE 15%,TITANIUM DIOXIDE 6%,HOMOSALATE 5%,OCTISALATE 4% | Foshan Sugar Max Cosmetics CO.,Ltd | 46224dbe-a0fb-c242-e063-6394a90a2634 | 2025-12-17 | Warnings | M020 |
| CAPTURE TOTALE C.E.L.L. ENERGY SUPER POTENT SERUM FOUNDATION BROAD SPECTRUM SPF 20 0N | ENSULIZOLE, OCTISALATE | Parfums Christian Dior | 31141a45-54e2-4463-ab42-4df56d911650 | 2025-12-17 | Warnings | M020 |
| Perricone High Potency Face Finishing and Firming Moisturizer | TITANIUM DIOXIDE, ZINC OXIDE | THG Beauty USA LLC | 2409cea1-7077-dc12-e063-6294a90a4558 | 2025-12-17 | Warnings | M020 |
| Tinted Mineral Sunscreen | TITANIUM DIOXIDE, ZINC OXIDE | Glow Advanced Skin and Body Care, LLC | 3635a073-5484-f96c-e063-6394a90adef5 | 2025-12-17 | M020 | |
| Mineral Sunscreen Lip | TITANIUM DIOXIDE, ZINC OXIDE | Glow Advanced Skin and Body Care, LLC | 36362dc7-31d7-f766-e063-6294a90a129b | 2025-12-17 | M020 | |
| Mineral Sunscreen Non-Tinted | ZINC OXIDE | Glow Advanced Skin and Body Care, LLC | 3635e45b-6978-ac69-e063-6294a90a22ac | 2025-12-17 | M020 | |
| Prime and Protect | TITANIUM DIOXIDE, ZINC OXIDE | Shannon Cornelsen-Lewandowski | 36480f7f-37e8-decd-e063-6394a90ada60 | 2025-12-17 | M020 | |
| Prime and Protect | TITANIUM DIOXIDE, ZINC OXIDE | Shannon Cornelsen-Lewandowski | 364827bd-5781-eb53-e063-6394a90ab22f | 2025-12-17 | 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 |