The Tinted Serum Broad Spectrum SPF 50+
- Product NDC
- 83108-001
- 11-digit product format
- 831080001
- Labeler code
- 83108
- Product ID
- 83108-001_efdc72a8-024f-3439-e053-2a95a90a85f1
- Type
- HUMAN OTC DRUG
- Nonproprietary name
- ZINC OXIDE
- Dosage form
- EMULSION
- Route
- TOPICAL
- Labeler
- Rationale Group Pty Ltd
- Application
- part352
- Marketing category
- OTC MONOGRAPH NOT FINAL
- Marketing start
- 2022-11-25
- Marketing end
- 0000-00-00
- Substance
- ZINC OXIDE
- Active strength
- 240 mg/mL
- Pharmacologic classes
- Copper Absorption Inhibitor [EPC], Decreased Copper Ion Absorption [PE]
- NDC exclude flag
- No
- Listing certified through
- 2023-12-31
- Current FDA listing
- Historical FDA.report record
Reported adverse events (FAERS/openFDA)#
Adverse event summaries are temporarily unavailable. Other product information remains available.
DailyMed Product Concepts#
DailyMed Package Descriptions#
Package NDC, Product, Description table| Package NDC | Product | Description | Form | Quantity | Strength | SPL version |
|---|
| 83108-001-00 | The Tinted Serum Broad Spectrum SPF 50 | 30 mL in 1 BOTTLE, DROPPER | EMULSION | 30 | | 5 |
| 83108-001-00 | The Tinted Serum Broad Spectrum SPF 50 | 1 in 1 BOX | EMULSION | 1 | | 5 |
| 83108-001-03 | The Tinted Serum Broad Spectrum SPF 50 | 3 mL in 1 BOTTLE, DROPPER | EMULSION | 3 | | 5 |
| 83108-001-05 | The Tinted Serum Broad Spectrum SPF 50 | 5 mL in 1 BOTTLE, DROPPER | EMULSION | 5 | | 5 |
| 83108-001-13 | The Tinted Serum Broad Spectrum SPF 50 | 3 mL in 1 BOTTLE | EMULSION | 3 | | 5 |
| 83108-001-15 | The Tinted Serum Broad Spectrum SPF 50 | 5 mL in 1 BOTTLE | EMULSION | 5 | | 5 |
DailyMed Dashboard NDC Coverage#
NDC, Dashboard title, SPL version table| NDC | Dashboard title | SPL version | Validation | Dashboard ZIP |
|---|
| 83108-001 | THE TINTED SERUM BROAD SPECTRUM SPF 50 (ZINC OXIDE) EMULSION [RATIONALE GROUP PTY LTD] | 4 | Legacy NDC, 6 package rows | 20231102_f8ffcbc0-0dd3-4fce-b38b-37d38d631b61.zip |
| 83108-001 | LUMINOSITY ACTIVATION DAY EDITION (ZINC OXIDE) KIT [RATIONALE GROUP PTY LTD] | 1 | Legacy NDC | 20231115_ba026282-38a6-4dd3-aa5a-fb6d215accc1.zip |
| 83108-001 | THE GLOBAL TRAVEL KIT (ZINC OXIDE) KIT [RATIONALE GROUP PTY LTD] | 1 | Legacy NDC | 20240901_8a75b057-e38d-40db-b54f-8674e25a67a9.zip |
Packages#
Package NDC, 11-digit format, Description table| Package NDC | 11-digit format | Description | Units | Marketing start | Marketing end | Sample | Exclude flag | Status |
|---|
| 83108-001-00 | 83108000100 | 1 BOTTLE, DROPPER in 1 BOX (83108-001-00) > 30 mL in 1 BOTTLE, DROPPER | | 2022-11-25 | 0000-00-00 | No | No | Current |
| 83108-001-03 | 83108000103 | 3 mL in 1 BOTTLE, DROPPER (83108-001-03) | 3 ml | 2022-12-08 | 0000-00-00 | Yes | No | Current |
| 83108-001-05 | 83108000105 | 5 mL in 1 BOTTLE, DROPPER (83108-001-05) | 5 ml | 2022-12-08 | 0000-00-00 | Yes | No | Current |
| 83108-001-13 | 83108000113 | 3 mL in 1 BOTTLE | 3 ml | | | | | Historical |
| 83108-001-15 | 83108000115 | 5 mL in 1 BOTTLE | 5 ml | | | | | Historical |