Tinted Replenishing Daily Protection
- Product NDC
- 85377-208
- 11-digit product format
- 853770208
- Labeler code
- 85377
- Product ID
- 85377-208_45ffabea-6e6f-930a-e063-6294a90a6df1
- Type
- HUMAN OTC DRUG
- Nonproprietary name
- Zinc Oxide
- Dosage form
- CREAM
- Route
- TOPICAL
- Labeler
- MANTRA WELLNESS SPA
- Application
- M020
- Marketing category
- OTC MONOGRAPH DRUG
- Marketing start
- 2023-03-31
- Substance
- ZINC OXIDE
- Active strength
- 160 mg/g
- NDC exclude flag
- No
- Listing certified through
- 2027-12-31
- Current FDA listing
- Yes
Reported adverse events (FAERS/openFDA)#
Adverse event summaries are temporarily unavailable. Other product information remains available.
Additional Listing Data#
- Finished product
- Yes
- Brand name base
- Tinted Replenishing Daily Protection
- Listing expiration
- 2027-12-31
Active Ingredients#
| Ingredient | Strength |
|---|---|
| ZINC OXIDE | 160 mg/g |
Harmonized UNII identifiers#
| Identifier | FDA.report destination |
|---|---|
| SOI2LOH54Z | Internal UNII lookup |
Harmonized SPL set identifiers#
| Identifier | FDA.report destination |
|---|---|
| 33898415-4ee6-a384-e063-6394a90ae8e1 | Available on FDA.report |
DailyMed Package Descriptions#
| Package NDC | Product | Description | Form | Quantity | Strength | SPL version |
|---|---|---|---|---|---|---|
| 85377-208-15 | Tinted Replenishing Daily Protection | 1.5 g in 1 PACKET | CREAM | 1.5 | 2 | |
| 85377-208-50 | Tinted Replenishing Daily Protection | 50 g in 1 BOTTLE, PUMP | CREAM | 50 | 2 |
DailyMed Dashboard NDC Coverage#
| NDC | Dashboard title | SPL version | Validation | Dashboard ZIP |
|---|---|---|---|---|
| 85377-208 | TINTED REPLENISHING DAILY PROTECTION (ZINC OXIDE) CREAM [MANTRA WELLNESS SPA] | 1 | Current NDC, 1 package rows | 20250426_338aa5a2-29e3-fe0e-e063-6294a90a18fd.zip |
| 85377-208 | TINTED REPLENISHING DAILY PROTECTION (ZINC OXIDE) CREAM [MANTRA WELLNESS SPA] | 1 | Current NDC, 1 package rows | 20250426_33898415-4ee6-a384-e063-6394a90ae8e1.zip |
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 |
|---|---|---|---|---|---|---|
| UV Defense me. Matte Airy-Fit Sunscreen | ZINC OXIDE | MAGNIF CO., LTD | 459f2b8d-453c-4dee-e063-6394a90a4509 | 2025-12-10 | Warnings | M020 |
| RoC Hydration Plus SPF 30 | AVOBENZONE, HOMOSALATE, OCTISALATE, OCTOCRYLENE | Roc Skincare | 45a3e250-8195-344d-e063-6294a90ae681 | 2025-12-10 | Warnings | M020 |
| ROC MULTI CORREXION HYDRATE AND PLUMP DAILY MOISTURISER SPF 30 | AVOBENZONE, HOMOSALATE, OCTISALATE, OCTOCRYLENE | Roc Skincare | bf3c1474-e353-63a5-e053-2a95a90a9b26 | 2025-12-10 | Warnings | M020 |
| ROC MULTI CORREXION EVEN TONE LIFT DAILY MOISTURIZER SPF30 | AVOBENZONE, HOMOSALATE, OCTISALATE, OCTOCRYLENE | Roc Skincare | f161d754-0c32-2fbe-e053-2a95a90a6b47 | 2025-12-10 | Warnings | M020 |
| AGE20S SIGNATURE ESSENCE PACT INTENSE COVER 35N | OCTINOXATE, OCTOCRYLENE, TITANIUM DIOXIDE | Aekyung Industrial Co., Ltd. | 242ff053-b8c0-4f90-e063-6294a90a7bb3 | 2025-12-09 | Warnings | M020 |
| AGE20S SIGNATURE ESSENCE COVER PACT INTENSE COVER 13 IVORY | OCTINOXATE, OCTOCRYLENE, TITANIUM DIOXIDE | Aekyung Industrial Co., Ltd. | 247ef1f8-ad12-4f80-e063-6394a90a3e3c | 2025-12-09 | Warnings | M020 |
| AGE20S SIGNATURE ESSENCE PACT INTENSE COVER 13C | OCTINOXATE, OCTOCRYLENE, TITANIUM DIOXIDE | Aekyung Industrial Co., Ltd. | e810d366-0c32-5b1c-e053-2a95a90a622e | 2025-12-09 | Warnings | M020 |
| AGE20S SIGNATURE ESSENCE PACT INTENSE COVER 17N | OCTINOXATE, OCTOCRYLENE, TITANIUM DIOXIDE | Aekyung Industrial Co., Ltd. | 242b7d0e-82d8-793c-e063-6294a90a4aa3 | 2025-12-09 | Warnings | M020 |
| AGE20S SIGNATURE ESSENCE PACT INTENSE COVER 23W | OCTINOXATE, OCTOCRYLENE, TITANIUM DIOXIDE | Aekyung Industrial Co., Ltd. | eb744367-f318-e1e2-e053-2a95a90a2cc4 | 2025-12-09 | Warnings | M020 |
| AGE20S SIGNATURE ESSENCE PACT INTENSE COVER 25N | OCTINOXATE, OCTOCRYLENE, TITANIUM DIOXIDE | Aekyung Industrial Co., Ltd. | 242faaed-e85a-a1d7-e063-6294a90aea92 | 2025-12-09 | Warnings | M020 |
| AGE20S SIGNATURE ESSENCE PACT INTENSE COVER 29W | OCTINOXATE, OCTOCRYLENE, TITANIUM DIOXIDE | Aekyung Industrial Co., Ltd. | 247d6c0e-8f88-faf0-e063-6394a90a10da | 2025-12-09 | Warnings | M020 |
| AGE20S UV DEFENSE HYDRO CALMING SUNSCREEN | OCTOCRYLENE, HOMOSALATE, OCTISALATE, AVOBENZONE | Aekyung Industrial Co., Ltd. | 1e9a5c77-7027-3b52-e063-6394a90ac0eb | 2025-12-09 | Warnings | M020 |
| AGE20S SIGNATURE ESSENCE PACT INTENSE COVER 21N | OCTINOXATE, OCTOCRYLENE, TITANIUM DIOXIDE | Aekyung Industrial Co., Ltd. | e8241828-17b2-96c5-e053-2a95a90a12e5 | 2025-12-09 | Warnings | M020 |
| AGE20S SIGNATURE ESSENCE PACT INTENSE COVER 27C | OCTINOXATE, OCTOCRYLENE, TITANIUM DIOXIDE | Aekyung Industrial Co., Ltd. | 1176181b-1331-ba68-e063-6394a90a961a | 2025-12-09 | Warnings | M020 |
| AGE20S SIGNATURE ESSENCE PACT INTENSE COVER 28N | OCTINOXATE, OCTOCRYLENE, TITANIUM DIOXIDE | Aekyung Industrial Co., Ltd. | 247b56ad-4b61-8b6f-e063-6394a90af3b6 | 2025-12-09 | Warnings | M020 |
| AGE20S SIGNATURE ESSENCE PACT INTENSE COVER 31N | OCTINOXATE, OCTOCRYLENE, TITANIUM DIOXIDE | Aekyung Industrial Co., Ltd. | 247afcae-855e-3f69-e063-6394a90a4231 | 2025-12-09 | Warnings | M020 |
| AGE20S SIGNATURE ESSENCE PACT INTENSE COVER 41N | OCTINOXATE, OCTOCRYLENE, TITANIUM DIOXIDE | Aekyung Industrial Co., Ltd. | 24306304-4d0d-c5f0-e063-6394a90afad5 | 2025-12-09 | Warnings | M020 |
| AGE20S UV DEFENSE HYDRO CALMING SUNSCREEN TWIN PACK | OCTOCRYLENE, HOMOSALATE, OCTISALATE, AVOBENZONE | Aekyung Industrial Co., Ltd. | 1f9c7718-6fde-236c-e063-6394a90afa19 | 2025-12-09 | Warnings | M020 |
| AGE20S SIGNATURE ESSENCE PACT INTENSE COVER 17N PACK OF 2 | OCTINOXATE, OCTOCRYLENE, TITANIUM DIOXIDE | Aekyung Industrial Co., Ltd. | 3482855b-de85-a5a7-e063-6294a90a55ae | 2025-12-09 | Warnings | M020 |
| AGE20S SIGNATURE ESSENCE PACT INTENSE COVER 25N PACK OF 2 | OCTINOXATE, OCTOCRYLENE, TITANIUM DIOXIDE | Aekyung Industrial Co., Ltd. | 3483e7e6-b301-136d-e063-6294a90aba18 | 2025-12-09 | Warnings | M020 |
Packages#
| Package NDC | 11-digit format | Description | Units | Marketing start | Sample | Exclude flag | Status |
|---|---|---|---|---|---|---|---|
| 85377-208-15 | 85377020815 | 1.5 g in 1 PACKET (85377-208-15) | 1.5 g | 2023-03-31 | Yes | No | Current |
| 85377-208-50 | 85377020850 | 50 g in 1 BOTTLE, PUMP (85377-208-50) | 50 g | 2023-03-31 | No | No | Current |