Instant Radiance Sun Defense
- Product NDC
- 58633-356
- 11-digit product format
- 586330356
- Labeler code
- 58633
- Product ID
- 58633-356_99829265-a77a-6d51-e053-2995a90a6206
- Type
- HUMAN OTC DRUG
- Nonproprietary name
- Titanium Dioxide and Zinc Oxide
- Dosage form
- CREAM
- Route
- TOPICAL
- Labeler
- Dr. Dennis Gross Skincare, LLC
- Application
- part352
- Marketing category
- OTC MONOGRAPH FINAL
- Marketing start
- 2016-06-03
- Marketing end
- 0000-00-00
- Substance
- TITANIUM DIOXIDE; ZINC OXIDE
- Active strength
- 49 mg/mL; mg/mL
- NDC exclude flag
- No
- Listing certified through
- 2020-12-31
- Current FDA listing
- Historical FDA.report record
Observed NDC auxiliary status history#
This history shows the information present in each captured FDA auxiliary file. It is not a continuous regulatory timeline, and a missing record does not establish a status.
| Captured / source date | Dataset | Scope | Product NDC | Package NDC | Code | Status | Reporting period | Archive | Snapshot | Source SHA-256 |
|---|---|---|---|---|---|---|---|---|---|---|
| 2019-12-08 06:16 UTC · source 2019-12-05 | excluded product | product | 58633-356 | E | Excluded after deficient or non-compliant submission was not corrected | excluded / ndc_excluded.zip | 110d247fa046… | a55b01930146… | ||
| 2019-12-08 06:16 UTC · source 2019-12-05 | excluded package | package | 58633-356 | 58633-356-10 | E | Excluded after deficient or non-compliant submission was not corrected | excluded / ndc_excluded.zip | 110d247fa046… | a55b01930146… | |
| 2019-12-08 06:16 UTC · source 2019-12-05 | excluded package | package | 58633-356 | 58633-356-40 | E | Excluded after deficient or non-compliant submission was not corrected | excluded / ndc_excluded.zip | 110d247fa046… | a55b01930146… |
Reported adverse events (FAERS/openFDA)#
Adverse event summaries are temporarily unavailable. Other product information remains available.