Broad Spectrum SPF45
- Product NDC
- 83286-008
- Requested package NDC
- 83286-008-01
- 11-digit product format
- 832860008
- Labeler code
- 83286
- Product ID
- 83286-008_f6752fc2-97f8-4812-bd32-c91fb9b703be
- Type
- HUMAN OTC DRUG
- Nonproprietary name
- Zinc Oxide, Octinoxate
- Dosage form
- GEL
- Route
- TOPICAL
- Labeler
- Drmtlgy, LLC
- Application
- M020
- Marketing category
- OTC MONOGRAPH DRUG
- Marketing start
- 2025-04-08
- Marketing end
- 2027-04-30
- Substance
- ZINC OXIDE; OCTINOXATE
- Active strength
- 12; 7.5 g/100g; g/100g
- Pharmacologic classes
- Copper Absorption Inhibitor [EPC], Decreased Copper Ion Absorption [PE]
- NDC exclude flag
- No
- 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
- Broad Spectrum SPF45
Active Ingredients#
| Ingredient | Strength |
|---|---|
| ZINC OXIDE | 12 g/100g |
| OCTINOXATE | 7.5 g/100g |
Harmonized UNII identifiers#
| Identifier | FDA.report destination |
|---|---|
| SOI2LOH54Z | Internal UNII lookup |
| 4Y5P7MUD51 | Internal UNII lookup |
Harmonized SPL set identifiers#
| Identifier | FDA.report destination |
|---|---|
| ce93b371-26ab-4493-98e0-98234c3a9ba6 | Available on FDA.report |
DailyMed Product Concepts#
| Product concept | Relation | Version | Effective |
|---|---|---|---|
| f47a510b-6679-4664-b2d6-47b5c4afe7cc | Product name | 4 | 20260217 |
| 030ce964-9b2d-45aa-b5d3-f78ce03ef61c | Product name | 2 | 20250515 |
| 0306390c-dd77-4363-afe0-63c58088b2a1 | Product name | 1 | 20220120 |
| 503ea967-4b9c-48cf-9e87-c7975295849d | Product name | 2 | 20220120 |
| 190f2a5b-bbc8-65c7-fcb0-97891307b917 | Product name | 1 | 20140508 |
DailyMed Package Descriptions#
| Package NDC | Product | Description | Form | Quantity | Strength | SPL version |
|---|---|---|---|---|---|---|
| 83286-008-01 | Broad Spectrum SPF45 | 57 g in 1 BOTTLE | GEL | 57 | 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 |
|---|---|---|---|---|---|---|
| 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 | Marketing end | Sample | Exclude flag | Status |
|---|---|---|---|---|---|---|---|---|
| 83286-008-01 | 83286000801 | 57 g in 1 BOTTLE (83286-008-01) | 57 g | 2025-04-08 | 2027-04-30 | No | No | Historical |