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 109 of 357 · 7,139 matching rows.
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