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 |
|---|---|---|---|---|---|---|
| Avebonzone, Homosalate, Octisalate | AVEBONZONE, HOMOSALATE, OCTISALATE | Amazon.com Services LLC | 4ab66c16-5f4c-6987-e063-6294a90add86 | 2026-02-26 | Warnings, Adverse reactions | M020 |
| Seonglow Daily Moisturizing Sunscreen SPF 50 | AVOBENZONE, HOMOSALATE, OCTISALATE, OCTOCRYLENE | SeonGlow Inc. | 01f3479f-3a0d-420b-bbf8-62a0a225bc9b | 2026-02-26 | Warnings | M020 |
| Avebonzone, Homosalate, Octisalate | AVEBONZONE, HOMOSALATE, OCTISALATE | Amazon.com Services LLC | 4ab5d5ca-26bf-1c5f-e063-6394a90a00ca | 2026-02-26 | Warnings, Adverse reactions | M020 |
| SPF50 Moisturizer with Aloe, Green Tea and Shea Butter | ZINC OXIDE | Audrey Morris Cosmetics International, LLC | 92960e14-9845-49aa-b3ce-c8023aa109b6 | 2026-02-26 | Warnings | M020 |
| Naturalessa SPF50 Moisturizer | ZINC OXIDE | Audrey Morris Cosmetics International, LLC | 816ddfa1-cb55-4591-a90b-71631cb17626 | 2026-02-26 | Warnings | M020 |
| UV DEFENSE FACE MINERAL SPF 50 | ZINC OXIDE | BETTER INVENTION LTD | 4b9a9efe-9aba-0ed0-e063-6394a90a2c6b | 2026-02-26 | Warnings | M020 |
| MISTINE UV DEFENSE FACE SUNSCREEN SPF50 | AVOBENZONE, HOMOSOLATE, OCTISALATE, OCTOCRYLENE | BETTER INVENTION LTD | 4b9a8f28-9043-8fb7-e063-6294a90a34d3 | 2026-02-26 | Warnings | M020 |
| MISTINE UV INVISIBLE FACE SHEER SUNSCREEN SPF 50 | AVOBENZONE, HOMOSALATE, OCTISALATE, OCTOCRYLENE | BETTER INVENTION LTD | 4b9a8f28-9041-8fb7-e063-6294a90a34d3 | 2026-02-26 | Warnings | M020 |
| Rationale The Discovery Travel Kit | ZINC OXIDE | RATIONALE GROUP PTY LTD | 0c919aea-4bd4-427e-97e7-9c153b42f491 | 2026-02-25 | Warnings | M020 |
| Kiss My Face Purely Mineral Daily 50 Sunscreen SPF 50 | ZINC OXIDE | Windmill Health Products, LLC | ebfb149c-0371-4492-b03a-5fdcb7821753 | 2026-02-25 | Warnings | M020 |
| SHISEIDO UV PROTECTIVE COMPACT (REFILL) FAIR IVORY | OCTINOXATE, OCTOCRYLENE, AND TITANIUM DIOXIDE | SHISEIDO AMERICAS CORPORATION | c05cef12-a6a7-4682-9357-6d77f4ca3267 | 2026-02-25 | Warnings | M020 |
| cle de peau BEAUTE Protective Day | AVOBENZONE, OCTINOXATE, OCTOCRYLENE | Shiseido Americas Corporation | dea8e4c1-6a9c-44c6-abc8-6cdd50f35f49 | 2026-02-25 | Warnings | M020 |
| Aura Defense | ZINC OXIDE | Grace and Glow MD LLC | 4ba75eff-74ef-278b-e063-6394a90a8ef0 | 2026-02-25 | Warnings | M020 |
| AM Shield plus | ZINC OXIDE | Grace and Glow MD LLC | 4ba7c282-c68e-8719-e063-6394a90a3814 | 2026-02-25 | Warnings | M020 |
| cle de peau BEAUTE RADIANT FOUNDATION N M I10 | OCTINOXATE AND TITANIUM DIOXIDE | Shiseido Americas Corporation | 3be1fe06-bd3b-4078-bee9-d3caf8d068ff | 2026-02-25 | Warnings | M020 |
| Jack Black | AVOBENZONE/HOMOSALATE/OCTISALATE/PETROLATUM | Jack Black L.L.C. | 4babe2ab-c5da-9a83-e063-6294a90aee4c | 2026-02-25 | Warnings | M020 |
| Daily Facial Moisturizer SPF 25 | SUNSCREEN | Person and Covey | 6b9258e4-c7c6-765e-e053-2991aa0a9f4e | 2026-02-25 | Warnings | M020 |
| Jack Black | AVOBENZONE/HOMOSALATE/OCTISALATE/PETROLATUM | Jack Black L.L.C. | 4bac1c33-36fe-8d29-e063-6394a90a32a5 | 2026-02-25 | Warnings | M020 |
| Jack Black | AVOBENZONE/HOMOSALATE/OCTISALATE/PETROLATUM | Jack Black L.L.C. | 4bac5550-c45f-a738-e063-6394a90ae5c8 | 2026-02-25 | Warnings | M020 |
| Jack Black | AVOBENZONE/HOMOSALATE/OCTISALATE/PETROLATUM | Jack Black L.L.C. | 4baca374-7aaa-8d1d-e063-6394a90a5a55 | 2026-02-25 | 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 |