OS-01 Face SPF BS SPF30 Untinted
- Product NDC
- 84451-003
- 11-digit product format
- 844510003
- Labeler code
- 84451
- Product ID
- 84451-003_22060b23-45e8-c29d-e063-6294a90a4be6
- 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
- 2023-08-15
- Substance
- ZINC OXIDE
- Active strength
- 17.5 g/100g
- NDC exclude flag
- No
- Listing certified through
- 2026-12-31
- Current FDA listing
- Yes
openFDA label cross-check#
Cross-check layer: openFDA label JSON enriches search and identifies hydration gaps. The DailyMed Structured Product Label remains the canonical label presentation on FDA.report.
Warnings cross-check#
openFDA text is shown for search and cross-checking; DailyMed SPL is canonical.
warnings
Warning – For external use only
Additional Listing Data#
- Finished product
- Yes
- Brand name base
- OS-01 Face SPF BS SPF30 Untinted
- Listing expiration
- 2026-12-31
Active Ingredients#
Ingredient, Strength table| Ingredient | Strength |
|---|
| ZINC OXIDE | 17.5 g/100g |
Harmonized Identifiers#
Field, Values table| Field | Values |
|---|
| Unii | SOI2LOH54Z |
DailyMed Product Concepts#
DailyMed Package Descriptions#
Package NDC, Product, Description table| Package NDC | Product | Description | Form | Quantity | Strength | SPL version |
|---|
| 84451-003-01 | OS-01 Face SPF BS SPF30 Untinted | 40 g in 1 TUBE | CREAM | 40 | | 1 |
| 84451-003-02 | OS-01 Face SPF BS SPF30 Untinted | 1 in 1 CARTON | CREAM | 1 | | 1 |
DailyMed Dashboard NDC Coverage#
NDC, Dashboard title, SPL version table| NDC | Dashboard title | SPL version | Validation | Dashboard ZIP |
|---|
| 84451-003 | OS-01 FACE SPF BS SPF30 UNTINTED (ZINC OXIDE) CREAM [ONESKIN INC.] | 1 | Current NDC, 2 package rows | 20240915_2205ec0e-ac3f-299f-e063-6294a90a2174.zip |
Packages#
Package NDC, 11-digit format, Description table| Package NDC | 11-digit format | Description | Units | Marketing start | Sample | Exclude flag | Status |
|---|
| 84451-003-01 | 84451000301 | 40 g in 1 TUBE | 40 g | | | | Historical |
| 84451-003-02 | 84451000302 | 1 TUBE in 1 CARTON (84451-003-02) / 40 g in 1 TUBE (84451-003-01) | 1 tube | 2023-08-15 | No | No | Current |