Home NDC 79753-070 COOLA Mineral Sun Silk Creme Sunscreen
Product NDC 79753-070
11-digit product format 797530070
Labeler code 79753
Product ID 79753-070_1eebd16e-0749-460d-927e-784ea1c2efa6
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 2023-02-01
Substance ZINC OXIDE
Active strength 158 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 COOLA Mineral Sun Silk Creme Sunscreen
Brand name suffix SPF 30
Listing expiration 2026-12-31
Active Ingredients# Ingredient, Strength table Ingredient Strength ZINC OXIDE 158 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 Package Descriptions# Package NDC, Product, Description table Package NDC Product Description Form Quantity Strength SPL version 79753-070-01 COOLA Mineral Sun Silk Creme SunscreenSPF 30 44 mL in 1 BOTTLE LOTION 44 2 79753-070-01 COOLA Mineral Sun Silk Creme SunscreenSPF 30 1 in 1 BOX LOTION 1 2
DailyMed Dashboard NDC Coverage# NDC, Dashboard title, SPL version table NDC Dashboard title SPL version Validation Dashboard ZIP 79753-070 COOLA MINERAL SUN SILK CREME SUNSCREEN SPF 30 (ZINC OXIDE) LOTION [COOLA LLC] 2 Current NDC, 2 package rows 20241228_bb9dd9a9-ec01-4e94-9172-3a72e68a417a.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 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 79753-070-01 79753007001 1 BOTTLE in 1 BOX (79753-070-01) / 44 mL in 1 BOTTLE 1 bottle 2023-02-01 No No Current