Protect and Prime Broad Spectrum SPF30
- Product NDC
- 70453-001
- 11-digit product format
- 704530001
- Labeler code
- 70453
- Product ID
- 70453-001_ed163f32-52c4-0873-e053-2995a90a6af9
- Type
- HUMAN OTC DRUG
- Nonproprietary name
- AVOBENZONE, OCTINOXATE, OCTOCRYLENE, OXYBENZONE
- Dosage form
- CREAM
- Route
- TOPICAL
- Labeler
- Emma Hardie Ltd
- Application
- part352
- Marketing category
- OTC MONOGRAPH NOT FINAL
- Marketing start
- 2016-02-03
- Marketing end
- 0000-00-00
- Substance
- AVOBENZONE; OCTINOXATE; OCTOCRYLENE; OXYBENZONE
- Active strength
- 30 mg/mL; mg/mL; mg/mL; mg/mL
- NDC exclude flag
- No
- Listing certified through
- 2023-12-31
- Current FDA listing
- Historical FDA.report record
NDC auxiliary status#
These records are reproduced from FDA’s unfinished, excluded, and compounder listings. They describe what appeared in the source files; a missing record does not establish a regulatory status. View all current auxiliary records, including entries without an NDC. · View the auxiliary file history.
| Dataset | Scope | Product NDC | Package NDC | Code | Status | Reporting period | Source date |
|---|---|---|---|---|---|---|---|
| excluded product | product | 70453-001 | D | Discontinued by firm | 2026-10-05 | ||
| excluded package | package | 70453-001 | 70453-001-01 | D | Discontinued by firm | 2026-10-05 |
Reported adverse events (FAERS/openFDA)#
Adverse event summaries are temporarily unavailable. Other product information remains available.
DailyMed Package Descriptions#
| Package NDC | Product | Description | Form | Quantity | Strength | SPL version |
|---|---|---|---|---|---|---|
| 70453-001-01 | Protect and Prime Broad Spectrum SPF30 | 1 in 1 BOX | CREAM | 1 | 5 | |
| 70453-001-01 | Protect and Prime Broad Spectrum SPF30 | 50 mL in 1 BOTTLE | CREAM | 50 | 5 |
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 |
|---|---|---|---|---|---|---|
| Protect and Prime Broad Spectrum SPF30 | AVOBENZONE, OCTINOXATE, OCTOCRYLENE, OXYBENZONE | Emma Hardie Ltd | cdd6ffe3-2ae6-44d8-a9b8-45bb134e928c | 2023-11-10 | Warnings | 70453-001 |
Packages#
| Package NDC | 11-digit format | Description | Units | Marketing start | Marketing end | Sample | Exclude flag | Status |
|---|---|---|---|---|---|---|---|---|
| 70453-001-01 | 70453000101 | 1 BOTTLE in 1 BOX (70453-001-01) > 50 mL in 1 BOTTLE | 1 bottle | 2016-02-03 | 0000-00-00 | No | No | Current |