Broad Spectrum SPF45
- Product NDC
- 83286-008
- 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 |
|---|---|---|---|---|---|---|
| Dr. Idriss Major Fade Disco Block Whipped Sunscreen SPF 50 | AVOBENZONE, HOMOSALATE, OCTOCRYLENE, OCTISALATE | PILLOWTALKDERM LLC | 30e10a62-8430-649b-e063-6394a90a97eb | 2025-11-11 | Warnings | M020 |
| Essential Defense Mineral Shield Broad Spectrum SPF 32 Sunscreen TINTED | TITANIUM DIOXIDE AND ZINC OXIDE | Allergan, Inc. | 279a5214-79b2-44e9-b003-378d0b992395 | 2025-11-11 | Warnings | M020 |
| Tinted Moisturizer SPF 46 Universal Tint | ZINC OXIDE, OCTINOXATE | Drmtlgy, LLC | 5304b568-f891-4094-9182-363ae7bcfbe4 | 2025-11-11 | Warnings | M020 |
| C Lip Serum Mineral Broad Spectrum SPF 30 | SUNSCREEN | Simply Active Cosmetics | 323661a6-3602-1ce2-e063-6394a90a8e91 | 2025-11-10 | Warnings | M020 |
| buttah Tinted Mineral Sunscreen SPF-30 | TITANIUM DIOXIDE, ZINC OXIDE | Buttah Enterprises, LLC. | 43458152-0775-dd9c-e063-6394a90a6140 | 2025-11-10 | Warnings | M020 |
| Aspen Glow 100% Mineral Broad Spectrum SPF 30 Powder Sunscreen 0.16 oz / 4.6 g | ZINC OXIDE | Aspen Glow Cosmetics, LLC | 142eda44-76e1-7960-e063-6394a90a9ad6 | 2025-11-10 | Warnings | M020 |
| TriLipiderm Broad Spectrum SPF 30 | BUTYL METHOXYDIBENZOYLMETHANE, ETHYLHEXYL METHOXYCINNAMATE, HOMOSALATE, OCTOCRYLENE | TriLipid Research Institute, LLC | 617fc696-c2a1-4855-bafb-0454e6497101 | 2025-11-10 | Warnings | M020 |
| TriLipiderm Protective Day | HOMOSALATE, ETHYLHEXYL METHOXYCINNAMATE,BUTYL METHOXYDIBENZOYLMETHANE, OCTOCRYLENE | TriLipid Research Institute, LLC | 66726c2b-27e9-5dd1-e053-2991aa0a1ba7 | 2025-11-10 | Warnings | M020 |
| Eucerin Sensitive Mineral SPF 50 Sunscreen | ZINC OXIDE | Beiersdorf Inc | cdb25154-e4e3-efc7-e053-2a95a90a2df6 | 2025-11-10 | Warnings | M020 |
| ESSENCE BY CATHERINE HINDS Broad Spectrum MINERAL PROTECTION SPF 50 | ZINC OXIDE | Catherine Hinds Company, Inc. | 956e6643-51c9-49c4-bd68-f5ee1b0ae4e0 | 2025-11-10 | Warnings | M020 |
| GoodSense SPF 50 Sunscreen | AVOBENZONE 3%, HOMOSALATE 15%, OCTISALATE 5%, OCTOCRYLENE 10% | Geiss, Destin, & Dunn, Inc. | c85d59a1-6ae1-bb2e-e053-2995a90af20e | 2025-11-09 | Warnings | M020 |
| GoodSense SPF 30 Sunscreen | AVOBENZONE 3%, HOMOSALATE 15%, OCTISALATE 5%, OCTOCRYLENE 6% | Geiss, Destin, & Dunn, Inc. | c85c5d2b-35f6-2fd5-e053-2995a90a4a53 | 2025-11-09 | Warnings | M020 |
| Walgreens SPF 50 Tinted Mineral Fluid | TITANIUM DIOXIDE | Walgreens | 345918e3-95f8-404c-e063-6394a90a3fca | 2025-11-09 | Warnings | M020 |
| Gold Dynamics Skin Boosting Moisturizer Broad Spectrum SPF 15 Sunscreen | AVOBENZONE, OXYBENZONE, OCTISALATE, OCTINOXATE | Distribuidora Comercial Jafra, S.A. de C.V. | ad6646c7-c6aa-4610-a0c7-ddd1ddd13cde | 2025-11-07 | Warnings | M020 |
| e.l.f Camo Semi-Matte CC Cream SPF 30 Deep 500 W | ZINC OXIDE, TITANIUM DIOXIDE, HOMOSALATE, OCTISALATE, OCTOCRYLENE | e.l.f. Cosmetics, Inc. | d690d5d1-e1fa-404f-a17e-7b97be17b44a | 2025-11-07 | Warnings | M020 |
| e.l.f Camo Semi-Matte CC Cream SPF 30 Deep 510 C | ZINC OXIDE, TITANIUM DIOXIDE, HOMOSALATE, OCTISALATE, OCTOCRYLENE | e.l.f. Cosmetics, Inc. | 2fbdeff7-4880-49ef-bb4d-e033d18e0459 | 2025-11-07 | Warnings | M020 |
| e.l.f Camo Semi-Matte CC Cream SPF 30 Deep 540 N | ZINC OXIDE, TITANIUM DIOXIDE, HOMOSALATE, OCTISALATE, OCTOCRYLENE | e.l.f. Cosmetics, Inc. | 6a86e5fd-6736-45e0-aa7d-d268fdaed4f8 | 2025-11-07 | Warnings | M020 |
| e.l.f Camo Semi-Matte CC Cream SPF 30 Deep 560 C | ZINC OXIDE, TITANIUM DIOXIDE, HOMOSALATE, OCTISALATE, OCTOCRYLENE | e.l.f. Cosmetics, Inc. | 42a3625f-5c58-4ec5-895f-b14f74428271 | 2025-11-07 | Warnings | M020 |
| e.l.f Camo Semi-Matte CC Cream SPF 30 Tan 415 C | ZINC OXIDE, TITANIUM DIOXIDE, HOMOSALATE, OCTISALATE, OCTOCRYLENE | e.l.f. Cosmetics, Inc. | 8e14fe81-cf7f-4a81-afec-e6c8466179c9 | 2025-11-07 | Warnings | M020 |
| e.l.f Camo Semi-Matte CC Cream SPF 30 Tan 425 N | ZINC OXIDE, TITANIUM DIOXIDE, HOMOSALATE, OCTISALATE, OCTOCRYLENE | e.l.f. Cosmetics, Inc. | 7dd9f4cb-78d8-4edc-a63c-d4a02930a0f8 | 2025-11-07 | Warnings | 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 |