COOLA 70 PERCENT PLUS ORGANIC MINERAL BODY SUNSCREEN SPF50
- Product NDC
- 79753-040
- 11-digit product format
- 797530040
- Labeler code
- 79753
- Product ID
- 79753-040_cb959320-66ae-e36e-e053-2995a90a5c9f
- Type
- HUMAN OTC DRUG
- Nonproprietary name
- Titanium Dioxide, Zinc Oxide
- Dosage form
- LOTION
- Route
- TOPICAL
- Labeler
- COOLA, LLC
- Application
- part352
- Marketing category
- OTC MONOGRAPH NOT FINAL
- Marketing start
- 2019-06-01
- Marketing end
- 0000-00-00
- Substance
- TITANIUM DIOXIDE; ZINC OXIDE
- Active strength
- 35 mg/mL; mg/mL
- NDC exclude flag
- No
- Listing certified through
- 2022-12-31
- 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 | 79753-040 | D | Discontinued by firm | 2026-10-05 | ||
| excluded package | package | 79753-040 | 79753-040-01 | D | Discontinued by firm | 2026-10-05 | |
| excluded package | package | 79753-040 | 79753-040-02 | D | Discontinued by firm | 2026-10-05 | |
| excluded package | package | 79753-040 | 79753-040-03 | D | Discontinued by firm | 2026-10-05 | |
| excluded package | package | 79753-040 | 79753-040-72 | D | Discontinued by firm | 2026-10-05 |
Reported adverse events (FAERS/openFDA)#
Adverse event summaries are temporarily unavailable. Other product information remains available.
DailyMed Dashboard NDC Coverage#
Packages#
| Package NDC | 11-digit format | Description | Units | Marketing start | Marketing end | Sample | Exclude flag | Status |
|---|---|---|---|---|---|---|---|---|
| 79753-040-01 | 79753004001 | 148 mL in 1 TUBE (79753-040-01) | 148 ml | 2019-06-01 | 0000-00-00 | No | No | Current |
| 79753-040-02 | 79753004002 | 100 mL in 1 TUBE (79753-040-02) | 100 ml | 2019-06-01 | 0000-00-00 | No | No | Current |