Home NDC 64657-007 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 table Ingredient Strength ZINC OXIDE 150 mg/mL
Harmonized UNII identifiers# UNII identifiers page 1 of 1 · 1 matching rows.
Identifier, FDA.report destination table Identifier FDA.report destination SOI2LOH54Z Internal UNII lookup
Harmonized SPL set identifiers# SPL set identifiers page 1 of 1 · 1 matching rows.
DailyMed Product Concepts# DailyMed Package Descriptions# Package NDC, Product, Description table 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.
Matched openFDA labels page 117 of 357 · 7,139 matching rows.
Brand, Generic, Manufacturer table Brand Generic Manufacturer SPL set ID Effective date Available safety fields Join Total Eye 3-In-1 Renewal Therapy SPF 35 TITANIUM DIOXIDE AND ZINC OXIDE Colorescience 4b116cc4-94d2-4bfc-b7f9-5f486a194c6c 2025-12-16 Warnings Exact identifier application number: M020 Daily SPF Facial SunscreenLotion Broad Spectrum SPF 32 ZINC OXIDE Onekind.25 c11197f4-cee0-04b3-e053-2995a90a1ba8 2025-12-15 Warnings Exact identifier application number: M020 Crunchi Sunlight Tinted Sunscreen SPF 30 Medium Deep ZINC OXIDE Crunchi, LLC. 69618265-2ebb-4cdc-a28f-e36c07fe5b8f 2025-12-15 Warnings Exact identifier application number: M020 Crunchi Sunlight Tinted Sunscreen SPF 30 Medium ZINC OXIDE Crunchi, LLC. 23248bc3-1b82-443a-b38a-df7f0efb5d2a 2025-12-15 Warnings Exact identifier application number: M020 Crunchi Sunlight Tinted Sunscreen SPF 30 Light ZINC OXIDE Crunchi, LLC. cf4039f5-00ee-4227-a3dc-61995c800135 2025-12-15 Warnings Exact identifier application number: M020 Crunchi Sunlight Body Sunscreen SPF 30 ZINC OXIDE Crunchi, LLC. 227f5a41-8c3c-492d-947f-e2b046208bca 2025-12-15 Warnings Exact identifier application number: M020 Crunchi Sunlight Tinted Sunscreen SPF 30 Light Medium ZINC OXIDE Crunchi, LLC. 5b3f2766-065b-4817-a5ff-bd1c7882bfc9 2025-12-15 Warnings Exact identifier application number: M020 Crunchi Sunlight Daily Facial Sunscreen SPF 30 ZINC OXIDE Cruchi, LLC. 4f3bcfa0-e43e-4284-afaa-6488ddd749f0 2025-12-15 Warnings Exact identifier application number: M020 Tinted Mineral Sunscreen TITANIUM DIOXIDE, ZINC OXIDE The Essential Brazilian Spa LLC 3543a22c-34d5-e572-e063-6394a90ad579 2025-12-15 Exact identifier application number: M020 Stellar Tinted Mineral Sunscreen Stick TITANIUM DIOXIDE, ZINC OXIDE The Essential Brazilian Spa LLC 3bb6488c-d216-8742-e063-6394a90a16e2 2025-12-15 Warnings Exact identifier application number: M020 Tinted Mineral Sunscreen TITANIUM DIOXIDE, ZINC OXIDE The Essential Brazilian Spa LLC 3bb8ee19-81b2-daed-e063-6394a90a0fb3 2025-12-15 Warnings Exact identifier application number: M020 Tinted Mineral Sunscreen TITANIUM DIOXIDE, ZINC OXIDE The Essential Brazilian Spa LLC 3bb6cfd4-fa4a-d1d9-e063-6394a90a8e43 2025-12-15 Warnings Exact identifier application number: M020 Mineral Lip Sunscreen TITANIUM DIOXIDE, ZINC OXIDE The Essential Brazilian Spa LLC 35442ac0-c361-e08f-e063-6294a90a5cb2 2025-12-15 Exact identifier application number: M020 Tinted Mineral Sunscreen TITANIUM DIOXIDE, ZINC OXIDE The Essential Brazilian Spa LLC 3543e85d-9bc7-b8ed-e063-6294a90ae7d3 2025-12-15 Exact identifier application number: M020 Mineral Lip Sunscreen TITANIUM DIOXIDE, ZINC OXIDE The Essential Brazilian Spa LLC 3bc8593d-fc6c-04aa-e063-6394a90a6d56 2025-12-15 Warnings Exact identifier application number: M020 Mineral Sunscreen 20percent Zinc Oxide ZINC OXIDE MANTRA WELLNESS SPA 338855fd-3008-44d9-e063-6294a90a5e07 2025-12-15 Exact identifier application number: M020 Tinted Replenishing Daily Protection ZINC OXIDE MANTRA WELLNESS SPA 33898415-4ee6-a384-e063-6394a90ae8e1 2025-12-15 Exact identifier application number: M020 Mineral Lip Sunscreen TITANIUM DIOXIDE, ZINC OXIDE Mantra Wellness Spa 3389b0a3-40f9-b411-e063-6394a90a9959 2025-12-15 Exact identifier application number: M020 Mineral Sunscreen 20percent Zinc Oxide ZINC OXIDE Mantra Wellness Spa 338a11fb-24c6-8a0b-e063-6294a90a761e 2025-12-15 Exact identifier application number: M020 Tinted Replenishing Daily Protection ZINC OXIDE Mantra Wellness Spa 338aa5a2-29e3-fe0e-e063-6294a90a18fd 2025-12-15 Exact identifier application number: M020
Packages# Package NDC, 11-digit format, Description table 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