Home NDC 79753-053 COOLA Mineral Body SPF 30 Tropical Coconut
Product NDC 79753-053
11-digit product format 797530053
Labeler code 79753
Product ID 79753-053_29b70f22-a6e3-4c0b-e063-6294a90a8d1d
Type HUMAN OTC DRUG
Nonproprietary name Zinc Oxide
Dosage form LOTION
Route TOPICAL
Labeler COOLA, LLC
Application M020
Marketing category OTC MONOGRAPH DRUG
Marketing start 2019-11-01
Substance ZINC OXIDE
Active strength 14.2 g/100mL
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 COOLA Mineral Body SPF 30 Tropical Coconut
Listing expiration 2026-12-31 Active Ingredients# Ingredient, Strength table Ingredient Strength ZINC OXIDE 14.2 g/100mL
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 79753-053-01 COOLA Mineral Body SPF 30 Tropical Coconut 1 in 1 CARTON LOTION 1 4 79753-053-01 COOLA Mineral Body SPF 30 Tropical Coconut 148 mL in 1 TUBE LOTION 148 4 79753-053-02 COOLA Mineral Body SPF 30 Tropical Coconut 100 mL in 1 TUBE LOTION 100 4 79753-053-02 COOLA Mineral Body SPF 30 Tropical Coconut 1 in 1 CARTON LOTION 1 4
DailyMed Dashboard NDC Coverage# NDC, Dashboard title, SPL version table NDC Dashboard title SPL version Validation Dashboard ZIP 79753-053 COOLA MINERAL BODY SPF 30 TROPICAL COCONUT (ZINC OXIDE) LOTION [COOLA, LLC] 4 Current NDC, Legacy NDC, 4 package rows 20241222_eeb5d4f1-8cba-9ef6-e053-2a95a90a823f.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.
Matched openFDA labels page 81 of 357 · 7,139 matching rows.
Packages# Package NDC, 11-digit format, Description table Package NDC 11-digit format Description Units Marketing start Marketing end Sample Exclude flag Status 79753-053-01 79753005301 1 TUBE in 1 CARTON (79753-053-01) / 148 mL in 1 TUBE 1 tube 2019-11-01 0000-00-00 No No Current 79753-053-02 79753005302 1 TUBE in 1 CARTON (79753-053-02) / 100 mL in 1 TUBE 1 tube 2019-11-01 No No Current