Home NDC 79753-108 COOLA Zinc Oxide BodyLotion SPF 50 Fragrance-Free
Product NDC 79753-108
11-digit product format 797530108
Labeler code 79753
Product ID 79753-108_4cad89a5-325d-b3c2-e063-6294a90ac225
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 2026-03-01
Substance ZINC OXIDE
Active strength 12.61 g/100mL
NDC exclude flag No
Listing certified through 2027-12-31
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 Zinc Oxide BodyLotion SPF 50 Fragrance-Free
Listing expiration 2027-12-31 Active Ingredients# Ingredient, Strength table Ingredient Strength ZINC OXIDE 12.61 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 Package Descriptions# Package NDC, Product, Description table Package NDC Product Description Form Quantity Strength SPL version 79753-108-01 COOLA Zinc Oxide BodyLotion SPF 50 Fragrance-Free 100 mL in 1 TUBE LOTION 100 1 79753-108-02 COOLA Zinc Oxide BodyLotion SPF 50 Fragrance-Free 41 mL in 1 TUBE LOTION 41 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 26 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 79753-108-01 79753010801 100 mL in 1 TUBE (79753-108-01) 100 ml 2026-03-01 No No Current 79753-108-02 79753010802 41 mL in 1 TUBE (79753-108-02) 41 ml 2026-03-01 No No Current