SPF 40 Broad Spectrum
- Product NDC
- 85339-203
- 11-digit product format
- 853390203
- Labeler code
- 85339
- Product ID
- 85339-203_45b3a342-878a-6db5-e063-6294a90aa648
- Type
- HUMAN OTC DRUG
- Nonproprietary name
- Titanium Dioxide, Zinc Oxide
- Dosage form
- CREAM
- Route
- TOPICAL
- Labeler
- Teton Dermatology Holdings, Inc.
- Application
- M020
- Marketing category
- OTC MONOGRAPH DRUG
- Marketing start
- 2023-10-27
- Substance
- TITANIUM DIOXIDE; ZINC OXIDE
- Active strength
- 80; 38 mg/g; mg/g
- NDC exclude flag
- No
- Listing certified through
- 2026-12-31
- Current FDA listing
- Yes
Additional Listing Data#
- Finished product
- Yes
- Brand name base
- SPF 40 Broad Spectrum
- Listing expiration
- 2026-12-31
Active Ingredients#
Ingredient, Strength table| Ingredient | Strength |
|---|
| TITANIUM DIOXIDE | 80 mg/g |
| ZINC OXIDE | 38 mg/g |
Harmonized Identifiers#
Field, Values table| Field | Values |
|---|
| Unii | 15FIX9V2JP, SOI2LOH54Z |
DailyMed Package Descriptions#
Package NDC, Product, Description table| Package NDC | Product | Description | Form | Quantity | Strength | SPL version |
|---|
| 85339-203-50 | SPF 40 Broad Spectrum | 53 g in 1 BOTTLE, PUMP | CREAM | 53 | | 2 |
DailyMed Dashboard NDC Coverage#
NDC, Dashboard title, SPL version table| NDC | Dashboard title | SPL version | Validation | Dashboard ZIP |
|---|
| 85339-203 | SPF 40 BROAD SPECTRUM (TITANIUM DIOXIDE, ZINC OXIDE) CREAM [TETON DERMATOLOGY HOLDINGS, INC.] | 1 | Current NDC, 1 package rows | 20250515_35081ce0-2203-ab86-e063-6294a90aefd5.zip |
Packages#
Package NDC, 11-digit format, Description table| Package NDC | 11-digit format | Description | Units | Marketing start | Sample | Exclude flag | Status |
|---|
| 85339-203-50 | 85339020350 | 53 g in 1 BOTTLE, PUMP (85339-203-50) | 53 g | 2023-10-27 | No | No | Current |