warnings
WARNINGS For external use only. Do not use on damaged or broken skin. When using product keep out of eyes. Rinse with warm water to remove. Stop use and ask doctor if rash occurs
DERMA BRITE SPF 35
openFDA label record#
This page contains supplementary openFDA label data. For the canonical label presentation, use the corresponding DailyMed Structured Product Label.
Verified complete openFDA source JSON
- Brand name
- DERMA BRITE SPF 35
- Generic name
- OCTINOXATE, OCTISALATE, OXYBENZONE
- Manufacturer
- PHARMAGEL INTERNATIONAL INC
- Product type
- HUMAN OTC DRUG
- SPL set ID
- fe10912e-00e3-406c-a80c-d9c991dc9f8b
- SPL ID
- 1f945a92-b7d2-59f2-e063-6394a90a2483
- Version
- 6
- Effective date
- 2024-08-13
- Source export date
- 2026-09-28
- Source partition
- 5
- Source file
- https://download.open.fda.gov/drug/label/drug-label-0005-of-0014.json.zip
- Source object key
- raw/openfda/drug-label/2026-09-28/9839785a692b692224cd5f90f9e3a9514c9923a6f521ab83eed3bedc7c0e1d05/drug-label-0005-of-0014.json.zip
- Source manifest SHA-256
- cd2e66336a5cd2223fa3995098fdbdb84c6a7ee5c0a4addb236ccb22dd1e6887
- Import run
- 20260929T050834Z
- Imported at
- 2026-09-29 05:32:37
| Harmonized routes |
|---|
| TOPICAL |
Harmonized identifier links#
Every typed identifier imported from the complete openFDA harmonization object is paginated here; values are not reduced to a first match.
| Type | Scope | Identifier | Source field |
|---|---|---|---|
| application number | M020 | openfda.application_number | |
| brand name | DERMA BRITE SPF 35 | openfda.brand_name | |
| generic name | OCTINOXATE, OCTISALATE, OXYBENZONE | openfda.generic_name | |
| manufacturer name | PHARMAGEL INTERNATIONAL INC | openfda.manufacturer_name | |
| ndc | package | 67879-308-11 | openfda.package_ndc |
| ndc | package | 67879-308-51 | openfda.package_ndc |
| ndc | product | 67879-308 | openfda.product_ndc |
| ndc11 | package | 67879030851 | derived:openfda.package_ndc |
| ndc11 | package | 67879030811 | derived:openfda.package_ndc |
| spl id | 1f945a92-b7d2-59f2-e063-6394a90a2483 | id | |
| spl set id | fe10912e-00e3-406c-a80c-d9c991dc9f8b | set_id | |
| unii | 95OOS7VE0Y | openfda.unii | |
| unii | 4X49Y0596W | openfda.unii | |
| unii | 4Y5P7MUD51 | openfda.unii |
Warnings cross-check#
openFDA text is shown for search and cross-checking; DailyMed SPL is canonical.
Reported adverse events (FAERS/openFDA)#
Adverse event summaries are temporarily unavailable. Other product information remains available.