SHADED
- Product NDC
- 85319-203
- 11-digit product format
- 853190203
- Labeler code
- 85319
- Product ID
- 85319-203_459be416-0aae-a0d6-e063-6394a90a63ce
- Type
- HUMAN OTC DRUG
- Nonproprietary name
- Titanium dioxide, Zinc Oxide
- Dosage form
- CREAM
- Route
- TOPICAL
- Labeler
- Potency No. 710 LLC
- Application
- M020
- Marketing category
- OTC MONOGRAPH DRUG
- Marketing start
- 2020-08-14
- Substance
- TITANIUM DIOXIDE; ZINC OXIDE
- Active strength
- 80; 38 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
- SHADED
- Listing expiration
- 2027-12-31
Active Ingredients#
| Ingredient | Strength |
|---|---|
| TITANIUM DIOXIDE | 80 mg/g |
| ZINC OXIDE | 38 mg/g |
Harmonized UNII identifiers#
| Identifier | FDA.report destination |
|---|---|
| 15FIX9V2JP | Internal UNII lookup |
| SOI2LOH54Z | Internal UNII lookup |
Harmonized SPL set identifiers#
| Identifier | FDA.report destination |
|---|---|
| 3117e138-83a1-0931-e063-6394a90abe43 | Available on FDA.report |
DailyMed Package Descriptions#
| Package NDC | Product | Description | Form | Quantity | Strength | SPL version |
|---|---|---|---|---|---|---|
| 85319-203-15 | SHADED | 1.5 g in 1 PACKET | CREAM | 1.5 | 2 | |
| 85319-203-50 | SHADED | 53 g in 1 BOTTLE, PUMP | CREAM | 53 | 2 |
DailyMed Dashboard NDC Coverage#
| NDC | Dashboard title | SPL version | Validation | Dashboard ZIP |
|---|---|---|---|---|
| 85319-203 | SHADED (TITANIUM DIOXIDE, ZINC OXIDE) CREAM [POTENCY NO. 710 LLC] | 1 | Current NDC, 1 package rows | 20250326_31188175-a4ca-449f-e063-6394a90a3c05.zip |
| 85319-203 | SHADED (TITANIUM DIOXIDE, ZINC OXIDE) CREAM [POTENCY NO. 710 LLC] | 1 | Current NDC, 1 package rows | 20250326_3117e138-83a1-0931-e063-6394a90abe43.zip |
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 |
|---|---|---|---|---|---|---|
| Eclipse Face Tinted | ZINC OXIDE | DENISE BELL SKIN CARE | 396f0151-2d0d-f4da-e063-6394a90a5f7f | 2025-12-15 | M020 | |
| Eclipse Body Non Tinted | ZINC OXIDE | DENISE BELL SKIN CARE | 396f56df-d0de-1344-e063-6294a90a46ea | 2025-12-15 | M020 | |
| Solar Shield Tinted | TITANIUM DIOXIDE, ZINC OXIDE | DENISE BELL SKIN CARE | 396eb781-5947-3665-e063-6294a90a38dd | 2025-12-15 | M020 | |
| Sun Veil Illuminating Sunscreen SPF30 | ZINC OXIDE | Koco Life LLC | 46001097-540e-65da-e063-6294a90af299 | 2025-12-15 | Warnings | M020 |
| Mineral Primer tinted SPF40 | TITANIUM DIOXIDE, ZINC OXIDE | Oracle Esthetics, LLC | 3542d8d3-35a3-7d63-e063-6394a90a6fd1 | 2025-12-15 | M020 | |
| Mineral Primer non-tinted SPF40 | TITANIUM DIOXIDE, ZINC OXIDE | Oracle Esthetics, LLC | 354357de-1a85-3bdb-e063-6294a90aa9a2 | 2025-12-15 | M020 | |
| Mineral Primer tinted SPF40 | TITANIUM DIOXIDE, ZINC OXIDE | Oracle Esthetics, LLC | 35433254-1dc8-a8f3-e063-6394a90a29f0 | 2025-12-15 | M020 | |
| Sun Therapy Sunscreen | ZINC OXIDE | Skin Therapy Studio LLC | 3544916b-3f63-3a7a-e063-6394a90ae507 | 2025-12-15 | M020 | |
| Ultra Zinc Mineral Non Tinted | ZINC OXIDE | Skin Therapy Studio LLC | 3545d603-3d01-c51d-e063-6394a90a1599 | 2025-12-15 | M020 | |
| Sun Therapy Sunscreen | ZINC OXIDE | Skin Therapy Studio LLC | 357efafb-aa1c-0d69-e063-6394a90a5135 | 2025-12-15 | M020 | |
| Ultra Zinc Mineral Non Tinted | ZINC OXIDE | Skin Therapy Studio LLC | 35806102-6919-116f-e063-6294a90ad922 | 2025-12-15 | M020 | |
| Complexion Correction Primer Sunscreen clear | TITANIUM DIOXIDE, ZINC OXIDE | MCRAE MD MEDICAL LASER CENTER, A TEXAS PROFESSIONAL LIMITED LIABILITY COMPANY | 357eee3c-1c21-5efb-e063-6294a90a4bb7 | 2025-12-15 | M020 | |
| Complexion Correction Tinted Primer Sunscreen | TITANIUM DIOXIDE, ZINC OXIDE | MCRAE MD MEDICAL LASER CENTER, A TEXAS PROFESSIONAL LIMITED LIABILITY COMPANY | 357e75ec-473e-df76-e063-6294a90a70c7 | 2025-12-15 | M020 | |
| Complexion Correction Tinted Primer Sunscreen | TITANIUM DIOXIDE, ZINC OXIDE | MCRAE MD MEDICAL LASER CENTER, A TEXAS PROFESSIONAL LIMITED LIABILITY COMPANY | 357f2f62-904a-2234-e063-6394a90aee72 | 2025-12-15 | M020 | |
| Superscreen Daytime Mineral Sunscreen | ZINC OXIDE | MCRAE MD MEDICAL LASER CENTER, A TEXAS PROFESSIONAL LIMITED LIABILITY COMPANY | 357f915a-bd77-350b-e063-6294a90ad27f | 2025-12-15 | M020 | |
| Complexion Correction Primer Sunscreen clear | TITANIUM DIOXIDE, ZINC OXIDE | MCRAE MD MEDICAL LASER CENTER, A TEXAS PROFESSIONAL LIMITED LIABILITY COMPANY | 357ff025-84ad-6d77-e063-6394a90aad95 | 2025-12-15 | M020 | |
| Complexion Correction Tinted Primer Sunscreen | TITANIUM DIOXIDE, ZINC OXIDE | MCRAE MD MEDICAL LASER CENTER, A TEXAS PROFESSIONAL LIMITED LIABILITY COMPANY | 358021a2-235b-825b-e063-6394a90a76f5 | 2025-12-15 | M020 | |
| Superscreen Daytime Mineral Sunscreen | ZINC OXIDE | MCRAE MD MEDICAL LASER CENTER, A TEXAS PROFESSIONAL LIMITED LIABILITY COMPANY | 35805e66-18e6-0e45-e063-6294a90afe58 | 2025-12-15 | M020 | |
| Ultra Zinc Physical Defense | ZINC OXIDE | ATLANTA DERMOTOLOGY VEIN & RESEARCH CENTER | 35474ac4-8a9d-6a84-e063-6394a90a9bad | 2025-12-15 | M020 | |
| Ultra Zinc Physical Defense | ZINC OXIDE | ATLANTA DERMOTOLOGY VEIN & RESEARCH CENTER | 357e315e-8802-ad73-e063-6394a90a2495 | 2025-12-15 | M020 |
Packages#
| Package NDC | 11-digit format | Description | Units | Marketing start | Sample | Exclude flag | Status |
|---|---|---|---|---|---|---|---|
| 85319-203-15 | 85319020315 | 1.5 g in 1 PACKET (85319-203-15) | 1.5 g | 2020-05-18 | Yes | No | Current |
| 85319-203-50 | 85319020350 | 53 g in 1 BOTTLE, PUMP (85319-203-50) | 53 g | 2020-08-14 | No | No | Current |