Home NDC 82516-101 sunscreen
Product NDC 82516-101
11-digit product format 825160101
Labeler code 82516
Product ID 82516-101_24c1c21b-f96e-484b-e063-6394a90a895f
Type HUMAN OTC DRUG
Nonproprietary name Skin Barrier Sun Shield SPF 30
Dosage form CREAM
Route TOPICAL
Labeler True Botanicals, Inc.
Application M020
Marketing category OTC MONOGRAPH DRUG
Marketing start 2022-04-11
Substance ZINC OXIDE
Active strength 19 g/100g
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 sunscreen
Listing expiration 2027-12-31 Active Ingredients# Ingredient, Strength table Ingredient Strength ZINC OXIDE 19 g/100g
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 82516-101-01 sunscreen 50 g in 1 BOTTLE CREAM 50 7 82516-101-02 sunscreen 1 in 1 CARTON CREAM 1 7
DailyMed Dashboard NDC Coverage# NDC, Dashboard title, SPL version table NDC Dashboard title SPL version Validation Dashboard ZIP 82516-101 SUNSCREEN (SKIN BARRIER SUN SHIELD SPF 30) CREAM [TRUE BOTANICALS, INC.] 7 Current NDC, Legacy NDC, 2 package rows 20241020_d70eea23-7715-c17b-e053-2a95a90a839f.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 Marketing end Sample Exclude flag Status 82516-101-01 82516010101 50 g in 1 BOTTLE 50 g Historical 82516-101-02 82516010102 1 BOTTLE in 1 CARTON (82516-101-02) / 50 g in 1 BOTTLE (82516-101-01) 1 bottle 2022-06-02 0000-00-00 No No Current