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 |
|---|---|---|---|---|---|---|
| MARIO BADESCU ALOE SPF | AVOBENZONE, OCTINOXATE, OXYBENZONE | Bentley Laboratories LLC | 189a7421-8598-44fc-9506-13c6dff8989c | 2024-09-10 | Warnings | M020 |
| Aveeno Baby Continuous Protection Sensitive Skin Sunscreen Broad Spectrum SPF 50 | ZINC OXIDE | Kenvue Brands LLC | 17a7492b-5243-48c4-b808-5e9899db7530 | 2024-09-08 | Warnings | M020 |
| Proceuticals Private Label by TiZO tinted mineral sunscreen stick | TITANIUM DIOXIDE, ZINC OXIDE | Fallien Cosmeceuticals, Ltd | 2179a2ff-9425-5b2c-e063-6294a90a45b6 | 2024-09-06 | Warnings | M020 |
| EltaMD UV Physical Rosy Tint SPF40 | TITANIUM DIOXIDE, ZINC OXIDE SUNSCREEN | CP Skin Health Group, Inc | 6bc4d2d4-ef62-4ec0-b514-17257603bac2 | 2024-09-05 | Warnings | M020 |
| SPF15 lip balm 01 | OCTOCRYLENE, OCTISALATE | Cosmuses Cosmetics (Ningbo) Co., Ltd. | 20e122e2-09ad-63ad-e063-6294a90a83fc | 2024-08-30 | Warnings | M020 |
| Proceuticals Private Label by TiZO non-tinted mineral sunscreen stick | TITANIUM DIOXIDE, ZINC OXIDE | Fallien Cosmeceuticals, Ltd | 20e86260-d641-c9ac-e063-6394a90ac07d | 2024-08-30 | Warnings | M020 |
| OS-01 Body SPF 30 | ZINC OXIDE | ONESKIN, INC | 20eb4d43-cf4d-dde3-e063-6394a90a6cb8 | 2024-08-30 | Warnings | M020 |
| Freaks of Nature Peak Performance SPF50 | FREAKS OF NATURE PEAK PERFORMANCE SPF50 | Milbar Laboratories | 20b18cea-95e9-3527-e063-6294a90a4db4 | 2024-08-30 | Warnings | M020 |
| JACKET SPF-50 Broad Spectrum Sunscreen | ZINC OXIDE, HOMOSALATE, OCTISALATE, OCTOCRYLENE | BALSHI MD DERMACEUTICALS | fcc45edd-098c-4f27-9712-0db36cfa0fdc | 2024-08-29 | Warnings | M020 |
| LA MER THE BROAD SPECTRUM SPF 50 UV PROTECTING FLUID | AVOBENZONE, HOMOSALATE, OCTISALATE, OCTOCRYLENE, AND OXYBENZONE | MAX HUBER RESEARCH LAB INC | e06bb578-475c-4169-ac09-cefb6a37d392 | 2024-08-29 | Warnings | M020 |
| dr. brandt SUN SHIELD SPF 50 | ZINC OXIDE | Dr. Brandt | 6f8af59b-d423-4250-8ddc-061fea886e3e | 2024-08-28 | Warnings | M020 |
| dAlba Vegan Tone-Up Sunscreen | HOMOSALATE, ETHYLHEXYL METHOXYCINNAMATE,TITANIUM DIOXIDE | ADMTMAX LLC | 20adebef-2841-a5c2-e063-6394a90ab063 | 2024-08-27 | Warnings | M020 |
| doTERRA sun Lip Balm Mineral Sunscreen | MINERAL SUNSCREEN | doTERRA International, LLC | 20afcd34-efa6-30a7-e063-6394a90ab517 | 2024-08-27 | Warnings | M020 |
| SPF15 | AVOBENZONE, HOMOSALATE, OCTOCRYLENE, OCTISALATE | Zhejiang Ayan Biotech Co.,Ltd. | 2bb9798f-36a0-4d03-a316-8b746a9283d8 | 2024-08-26 | Warnings | M020 |
| Stay Ageless Tinted Mineral Sunscreen Broad Spectrum SPF30 | TITANIUM DIOXIDE AND ZINC OXIDE | Dermio Dermatology LLC | 204973ce-dba4-8235-e063-6394a90a015c | 2024-08-22 | Warnings | M020 |
| SUNSCREEN 01 | AVOBENZONE,HOMOSALATE,OCTOCRYLENE,OCTISALATE | Cosmuses Cosmetics (Ningbo) Co., Ltd. | 202e99ef-330e-ad94-e063-6294a90a2d2a | 2024-08-21 | Warnings | M020 |
| SUNSCREEN 01 | AVOBENZONE,HOMOSALATE,OCTOCRYLENE,OCTISALATE | Cosmuses Cosmetics (Ningbo) Co., Ltd. | 19a7dc68-6384-3783-e063-6394a90ac839 | 2024-08-19 | Warnings | M020 |
| Wegmans Sport and Kids Clear Continuous Sunscreen | AVOBENZONE, HOMOSALATE, OCTISALATE, OCTOCRYLENE | WEGMANS FOOD MARKETS INC | f424da9c-5218-1d8d-e053-2a95a90a29fb | 2024-08-19 | Warnings | M020 |
| Topcare Everyday Sport Continuous Broad Spectrum SPF 100 | AVOBENZONE, HOMOSALATE, OCTISALATE, OCTOCRYLENE | TOPCO ASSOCIATES LLC | 2010b724-e681-f544-e063-6294a90a2140 | 2024-08-19 | Warnings | M020 |
| MACKENZIES OCEAN SAFE SUNSCREEN | TITANIUM DIOXIDE | Naturally Uncommon, LLC | 1fd0a790-c66c-216f-e063-6294a90ae971 | 2024-08-16 | 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 |