Calendula Essential Hydrating Broad Spectrum SPF 30 Sunscreen
- Product NDC
- 64657-007
- 11-digit product format
- 646570007
- Labeler code
- 64657
- Product ID
- 64657-007_41d75815-e282-bf88-e063-6294a90afeff
- Type
- HUMAN OTC DRUG
- Nonproprietary name
- Zinc Oxide
- Dosage form
- LOTION
- Route
- TOPICAL
- Labeler
- Naturopathica Holistic Health
- Application
- M020
- Marketing category
- OTC MONOGRAPH DRUG
- Marketing start
- 2025-10-23
- Substance
- ZINC OXIDE
- Active strength
- 150 mg/mL
- NDC exclude flag
- No
- Listing certified through
- 2026-12-31
- 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
- Calendula Essential Hydrating Broad Spectrum SPF 30 Sunscreen
- Listing expiration
- 2026-12-31
Active Ingredients#
| Ingredient | Strength |
|---|---|
| ZINC OXIDE | 150 mg/mL |
Harmonized UNII identifiers#
| Identifier | FDA.report destination |
|---|---|
| SOI2LOH54Z | Internal UNII lookup |
Harmonized SPL set identifiers#
| Identifier | FDA.report destination |
|---|---|
| 41d75815-e281-bf88-e063-6294a90afeff | Available on FDA.report |
DailyMed Product Concepts#
| Product concept | Relation | Version | Effective |
|---|---|---|---|
| d1c9d1af-bddd-448d-86f7-69052b7d5b47 | Product name | 1 | 20220627 |
DailyMed Package Descriptions#
| Package NDC | Product | Description | Form | Quantity | Strength | SPL version |
|---|---|---|---|---|---|---|
| 64657-007-01 | Calendula Essential Hydrating Broad Spectrum SPF 30 Sunscreen | 65 mL in 1 TUBE | LOTION | 65 | 1 | |
| 64657-007-02 | Calendula Essential Hydrating Broad Spectrum SPF 30 Sunscreen | 1 in 1 CARTON | LOTION | 1 | 1 |
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 |
|---|---|---|---|---|---|---|
| Tinted Mineral Sunscreen | TITANIUM DIOXIDE, ZINC OXIDE | Dermacare | 37643884-f186-fb54-e063-6394a90a450f | 2025-12-08 | M020 | |
| Tinted Mineral Sunscreen | TITANIUM DIOXIDE, ZINC OXIDE | Melinda Menezes, M.D., Inc. | 34b8208b-7328-1891-e063-6294a90abdd9 | 2025-12-08 | M020 | |
| Protect Mineral Sunscreen Non-Tinted | TITANIUM DIOXIDE, ZINC OXIDE | Melinda Menezes, M.D., Inc. | 34b8dedc-0575-9819-e063-6394a90afebf | 2025-12-08 | M020 | |
| Protect Mineral Stick Clear | TITANIUM DIOXIDE, ZINC OXIDE | Melinda Menezes, M.D., Inc. | 35bfa392-dfec-bd8a-e063-6394a90acffa | 2025-12-08 | M020 | |
| Tinted Mineral Sunscreen | TITANIUM DIOXIDE, ZINC OXIDE | Melinda Menezes, M.D., Inc. | 34b9d646-e049-6781-e063-6294a90ab101 | 2025-12-08 | M020 | |
| Protect 20 Zinc Oxide Mineral Sunscreen Non-Tinted | ZINC OXIDE | Melinda Menezes, M.D., Inc. | 35be70d5-aefe-fd6f-e063-6394a90ac436 | 2025-12-08 | M020 | |
| Protect 20 Zinc Oxide Mineral Sunscreen Tinted | ZINC OXIDE | Melinda Menezes, M.D., Inc. | 35be17ce-c3a7-fd59-e063-6394a90ad11d | 2025-12-08 | M020 | |
| Protect Mineral Stick Tinted | TITANIUM DIOXIDE, ZINC OXIDE | Melinda Menezes, M.D., Inc. | 35c044a6-90be-55f8-e063-6294a90aad48 | 2025-12-08 | M020 | |
| AGE20S SIGNATURE ESSENCE COVER PACT INTENSE COVER 27 MEDIUM | OCTINOXATE, OCTOCRYLENE, TITANIUM DIOXIDE | Aekyung Industrial Co., Ltd. | 247ed877-2926-1fd9-e063-6394a90aa153 | 2025-12-08 | Warnings | M020 |
| AGE20S SIGNATURE ESSENCE COVER PACT INTENSE COVER 29 CARAMEL | OCTINOXATE, TITANIUM DIOXIDE, OCTOCRYLENE | Aekyung Industrial Co., Ltd. | 11f1ad4c-af9a-c998-e063-6294a90a15db | 2025-12-08 | Warnings | M020 |
| AGE20S SIGNATURE ESSENCE COVER PACT INTENSE COVER 31 TAN | OCTINOXATE, TITANIUM DIOXIDE, OCTOCRYLENE | Aekyung Industrial Co., Ltd. | 11f37a57-47ce-4175-e063-6394a90a92ee | 2025-12-08 | Warnings | M020 |
| RECHARGE Protect Blur | TITANIUM DIOXIDE, ZINC OXIDE | Rodan & Fields Beauty, LLC | c787e3b9-33b1-4c47-95bd-b14cf6558938 | 2025-12-08 | Warnings | M020 |
| Mineral Mist SPF-50 | TITANIUM DIOXIDE, ZINC OXIDE | TUBBY TODD | dca54a19-af25-ce47-e053-2a95a90a22db | 2025-12-07 | Warnings | M020 |
| Inblair Elevate SPF15 Moisturizer | INBLAIR ELEVATE SPF15 MOISTURIZER | Guangzhou Fantesy Biotechnology Co.,Ltd | 4567d413-d8cc-677b-e063-6294a90a1a42 | 2025-12-07 | Warnings | M020 |
| HANCHOBIT Radiant Pink Tone Up Sun Cream | TITANIUM DIOXIDE | HANCHOYEANBIOTEC Co.,Ltd. | 45685047-166d-8af5-e063-6294a90aa7be | 2025-12-07 | Warnings | M020 |
| EELHOE Moisturiser Sun Stick | TITANIUM DIOXIDE | Shantou Eelhoe Daily Chemical Technology Co., Ltd. | 454004c9-07fa-64ad-e063-6394a90a0c8a | 2025-12-06 | Warnings | M020 |
| OUHOE Daily Exposure Lightweight Sunscreen | TITANIUM DIOXIDE | Shantou Ouhoe Technology Co., Ltd. | 454301b6-21a6-6153-e063-6294a90a1366 | 2025-12-06 | Warnings | M020 |
| OUHOE Cotton Soft Sun Stick | TITANIUM DIOXIDE | Shantou Ouhoe Technology Co., Ltd. | 4543a43e-acf7-6759-e063-6394a90a2f53 | 2025-12-06 | Warnings | M020 |
| OUHOE Centella Daily Sun | TITANIUM DIOXIDE | Shantou Ouhoe Technology Co., Ltd. | 4544f3a3-8c52-ea54-e063-6394a90a7a9c | 2025-12-06 | Warnings | M020 |
| EELHOE All Day Light Sunscreen Mist | TITANIUM DIOXIDE | Shantou Eelhoe Daily Chemical Technology Co., Ltd. | 45323ca3-c706-dcb5-e063-6394a90a96f7 | 2025-12-05 | Warnings | M020 |
Packages#
| Package NDC | 11-digit format | Description | Units | Marketing start | Sample | Exclude flag | Status |
|---|---|---|---|---|---|---|---|
| 64657-007-01 | 64657000701 | 65 mL in 1 TUBE | 65 ml | Historical | |||
| 64657-007-02 | 64657000702 | 1 TUBE in 1 CARTON (64657-007-02) / 65 mL in 1 TUBE (64657-007-01) | 1 tube | 2025-10-23 | No | No | Current |