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 |
|---|---|---|---|---|---|---|
| Mine Line Coconut Sunscreen SPF 50 | ZINC OXIDE | Spa de Soleil | 4642b1cc-43b1-6997-e063-6394a90ac764 | 2025-12-29 | Warnings | M020 |
| SnugZ SPF 30 Broad Spectrum Sunscreen | SPF 30 BROAD SPECTRUM SUNSCREEN | SnugZ/USA, LLC | 69ac1218-76e6-04ff-e053-2a91aa0a4080 | 2025-12-29 | Warnings | M020 |
| SnugZ SPF 50 Sunscreen Spry | SPF 50 SUNSCREEN SPRAY | SnugZ USA | 9390ea21-9f9f-14e2-e053-2a95a90ac577 | 2025-12-29 | Warnings | M020 |
| SnugZ SPF 15 Flavored Beeswax Lip Balm | SPF 15 FLAVORED BEESWAX LIP BALM | SnugZ/USA, LLC | 69bdfaaf-d49e-bf31-e053-2a91aa0affd3 | 2025-12-29 | Warnings | M020 |
| SnugZ SPF 50 Broad Spectrum Sunscreen | SPF 50 BROAD SPECTRUM SUNSCREEN | SnugZ/USA, LLC | b7a3eed5-c8ca-ffda-e053-2a95a90a73bb | 2025-12-29 | Warnings | M020 |
| SnugZ SPF 15 Beeswax Lip Balm | SPF 15 BEESWAX LIP BALM | SnugZ/USA, LLC | 68816d3a-dbe9-7ce3-e053-2a91aa0a395e | 2025-12-29 | Warnings | M020 |
| SnugZ SPF 30 Soy Lip Balm | SPF 30 SOY LIP BALM | SnugZ/USA, LLC | 687ff49d-2d0e-2534-e053-2991aa0a2864 | 2025-12-29 | Warnings | M020 |
| SnugZ SPF 50 Sunscreen Stick | SPF 50 SUNSTICK | SnugZ/USA, LLC | 6e1179cf-5bfb-1156-e053-2991aa0a5b46 | 2025-12-29 | Warnings | M020 |
| OUHOE Face Body Sunscreen | TITANIUM DIOXIDE | Shantou Ouhoe Technology Co., Ltd. | 46d36f60-2a5d-816e-e063-6294a90a2ddc | 2025-12-26 | Warnings | M020 |
| OUHOE Bean Sunscreen | TITANIUM DIOXIDE | Shantou Ouhoe Technology Co., Ltd. | 46d3b11f-93d9-0e38-e063-6294a90a41c3 | 2025-12-26 | Warnings | M020 |
| Cream | ZINC OXIDE | MONAT GLOBAL CORP | e922d89c-4232-77d8-e053-2995a90a85e5 | 2025-12-26 | Warnings | M020 |
| Cream | ZINC OXIDE | MONAT GLOBAL CORP | e9231470-9292-0e70-e053-2a95a90a767a | 2025-12-26 | Warnings | M020 |
| Cream | ZINC OXIDE | MONAT GLOBAL CORP | e92288bb-739a-2f73-e053-2995a90ac01f | 2025-12-26 | Warnings | M020 |
| StriVectin-SH NIA-114 UVA UVB Shields SPF 30 | HOMOSALATE, OCTISALATE, AVOBENZONE, OCTOCRYLENE, OXYBENZONE | StriVectin Operating Company Inc. | 232cbde4-d8ea-4831-9b44-c2e93203260a | 2025-12-26 | Warnings | M020 |
| Cardon | AVOBENZONE, HOMOSALATE, OCTYL SALICYLATE | Cardon, Inc | 72ee2c06-242e-29a2-e053-2991aa0ad8dc | 2025-12-26 | Warnings | M020 |
| OUHOE Water-Permeable Sunscreen | TITANIUM DIOXIDE | Shantou Ouhoe Technology Co., Ltd. | 46e63e1e-7851-ca26-e063-6394a90a9b53 | 2025-12-26 | Warnings | M020 |
| OUHOE Sun Milk | TITANIUM DIOXIDE | Shantou Ouhoe Technology Co., Ltd. | 46e678dd-13c5-b317-e063-6294a90aa989 | 2025-12-26 | Warnings | M020 |
| Dermatone Sport SPF 50 | AVOBENZONE 3%, HOMOSALATE 10%, OCTOCRYLENE 6% | Dermatone Labs LLC | 0e60e5bb-b941-4114-933a-29480bff5960 | 2025-12-24 | Warnings | M020 |
| Intelligent Elixirs Tinted Broad Spectrum SPF 30 - Natural | AVOBENZONE, OCTISALATE, OCTINOXATE | Intelligent Elixirs, LLC | 287a61d8-0056-6211-e063-6394a90aa3da | 2025-12-24 | Warnings | M020 |
| Sugargirl Glowy SPF 30 Face Screen Sunlight Shimmer Sunscreen for the face | HOMOSALATE,OCTOCRYLENE, OCTISALATE,OCTINOXATE, AVOBENZONE | Longway Technology(Guangzhou)Co.,Ltd. | 452b5997-d229-60ee-e063-6394a90a68db | 2025-12-23 | 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 |