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
- ZINC OXIDE; TITANIUM DIOXIDE
- Active strength
- 38; 80 mg/g; mg/g
- NDC exclude flag
- No
- Listing certified through
- 2027-12-31
- 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
- SPF 40 Broad Spectrum
- Listing expiration
- 2027-12-31
Active Ingredients#
| Ingredient | Strength |
|---|---|
| ZINC OXIDE | 38 mg/g |
| TITANIUM DIOXIDE | 80 mg/g |
Harmonized UNII identifiers#
| Identifier | FDA.report destination |
|---|---|
| SOI2LOH54Z | Internal UNII lookup |
| 15FIX9V2JP | Internal UNII lookup |
Harmonized SPL set identifiers#
| Identifier | FDA.report destination |
|---|---|
| 35081ce0-2203-ab86-e063-6294a90aefd5 | Available on FDA.report |
DailyMed Package Descriptions#
| 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#
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 |
|---|---|---|---|---|---|---|
| Dolce and Gabbana Meet Your Flawless Matte Skin Duo | OCTISALATE, OCTOCRYLENE, TITANIUM DIOXIDE, ZINC OXIDE | Socoplan | 3541c41b-f114-4734-a66f-be309ca6f3bf | 2025-01-16 | Warnings | M020 |
| SUNSTATION USA SPF-30 SPORT SUNSCREEN- | SUNSTATION USA SPF-30 SPORT SUNSCREEN- | Sunstation USA, LLC | 2bd84b92-dcf0-404f-e063-6294a90a1060 | 2025-01-16 | M020 | |
| Snap On Racing Sunscreen Kit | AVOBENZONE, OCTINOXATE, OCTOCRYLENE, OCTISALATE, HOMOSALATE, OCTOCRYLENE, OCTISALATE, AVOBENZONE | Greater Pacific Industries, Inc. | 9f4f91d0-0fc5-43a3-be79-afce5afa2f95 | 2025-01-16 | Warnings | M020 |
| Emme Diane Pure Protection Tinted Antioxidant Sunscreen | ZINC OXIDE | Emme Diane, Inc. | b2b4daf5-765b-426d-8a72-9278f7cd43d7 | 2025-01-16 | Warnings | M020 |
| Emme Diane Tinted Mineral Sunscreen | TITANIUM DIOXIDE, ZINC OXIDE | Emme Diane, Inc | ab53ad98-b667-4447-8177-724dbf771e80 | 2025-01-16 | Warnings | M020 |
| Mineral Lip Sunscreen | TITANIUM DIOXIDE, ZINC OXIDE | Hutton, Kathleen MD | 2be51fdf-c3f2-463b-8c7d-bda07db17e1b | 2025-01-16 | Warnings | M020 |
| Sunny Sailor Captain s Classic Clear Mineral Sunscreen SPF 40 | ZINC OXIDE | SUNNY SAILOR LLC | 14ea2d11-c425-45d8-a23a-d4ed82a6439c | 2025-01-15 | Warnings | M020 |
| glo SKIN BEAUTY Oil-Free Tinted Primer SPF 30 | GLO SKIN BEAUTY OIL-FREE TINTED PRIMER SPF 30 | Hayden Caleel LLC | 00bf7331-c9dc-4a8a-9ff3-901e0d07eac6 | 2025-01-15 | Warnings | M020 |
| Black Girl Sunscreen Sunscreen SPF 30 Broad Spectrum | AVOBENZONE, HOMOSALATE, OCTISALATE, AND OCTOCRYLENE | Black Girl Sunscreen, LLC | 2bc42f6f-4eaf-fa28-e063-6294a90a93fb | 2025-01-15 | Warnings | M020 |
| Black Girl Sunscreen SPF 50 Broad Spectrum | HOMOSALATE, OCTOCRYLENE, OCTISALATE, ZINC OXIDE | Black Girl Sunscreen, LLC | 2bc419b3-4de2-7ed9-e063-6394a90a255f | 2025-01-15 | Warnings | M020 |
| Black Girl Sunscreen SPF 45 | AVOBENZONE, HOMOSALATE, OCTISALATE, OCTOCRYLENE | Black Girl Sunscreen, LLC | 2bc47bd0-d81b-f1b9-e063-6394a90ad375 | 2025-01-15 | Warnings | M020 |
| Black Girl Sunscreen SPF 50 | OCTOCRYLENE, OCTISALATE, HOMOSALATE, AVOBENZONE | Black Girl Sunscreen, LLC | 2bc46854-fe67-782b-e063-6294a90a79af | 2025-01-15 | Warnings | M020 |
| Black Girl Sunscreen SPF 50 broad Spectrum | AVOBENZONE, HOMOSALATE, OCTISALATE | Black Girl Sunscreen, LLC | 2bc471f0-c93e-0c51-e063-6394a90a77f0 | 2025-01-15 | Warnings | M020 |
| Black Girl Sunscreen SPF 45 | AVOBENZONE, HOMOSALATE, OCTISALATE, OCTOCRYLENE | Black Girl Sunscreen, LLC | 2bc4b1b1-5f19-7ba3-e063-6394a90a5de7 | 2025-01-15 | Warnings | M020 |
| Black Girl Sunscreen Sunscreen SPF 30 broad Spectrum | AVOBENZONE, HOMOSALATE, OCTISALATE, AND OCTOCRYLENE | Black Girl Sunscreen, LLC | 2bc4c639-787a-d2d3-e063-6394a90a5ded | 2025-01-15 | Warnings | M020 |
| Black Girl Sunscreen Sunscreen SPF 30 broad Spectrum | AVOBENZONE, HOMOSALATE, OCTISALATE, AND OCTOCRYLENE | Black Girl Sunscreen, LLC | 2bc4d937-77d0-273c-e063-6394a90a25e7 | 2025-01-15 | Warnings | M020 |
| Black Girl Sunscreen Sunscreen SPF 30 broad Spectrum | AVOBENZONE, HOMOSALATE, OCTISALATE, AND OCTOCRYLENE | Black Girl Sunscreen, LLC | 2bc4cfd9-e44c-9b93-e063-6394a90a96a6 | 2025-01-15 | Warnings | M020 |
| Black Girl Sunscreen Sunscreen SPF 30 broad Spectrum | AVOBENZONE, HOMOSALATE, OCTISALATE, OCTOCRYLENE | Black Girl Sunscreen, LLC | 2bc4e22d-6265-9c0b-e063-6394a90a1541 | 2025-01-15 | Warnings | M020 |
| Black Girl Sunscreen Sunscreen SPF 30 broad Spectrum | AVOBENZONE, HOMOSALATE, OCTISALATE, OCTOCRYLENE | Black Girl Sunscreen, LLC | 2bc4eb32-8c0b-32fc-e063-6294a90a1625 | 2025-01-15 | Warnings | M020 |
| Black Girl Sunscreen Sunscreen SPF 30 broad Spectrum | AVOBENZONE, HOMOSALATE, OCTISALATE, OCTOCRYLENE | Black Girl Sunscreen, LLC | 2bc50182-30f2-b77e-e063-6394a90a6355 | 2025-01-15 | Warnings | M020 |
Packages#
| 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 |