Home NDC 85331-208 Tinted Sunscreen
Product NDC 85331-208
11-digit product format 853310208
Labeler code 85331
Product ID 85331-208_45af1972-d2cc-1b3f-e063-6394a90a88dd
Type HUMAN OTC DRUG
Nonproprietary name Zinc Oxide
Dosage form CREAM
Route TOPICAL
Labeler Scottsdale Skin Boutique and Dermatology Pllc
Application M020
Marketing category OTC MONOGRAPH DRUG
Marketing start 2022-07-20
Substance ZINC OXIDE
Active strength 160 mg/g
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 Tinted Sunscreen
Listing expiration 2026-12-31 Active Ingredients# Ingredient, Strength table Ingredient Strength ZINC OXIDE 160 mg/g
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 85331-208-15 Tinted Sunscreen 15 g in 1 PACKET CREAM 15 2 85331-208-50 Tinted Sunscreen 53 g in 1 BOTTLE, PUMP CREAM 53 2
DailyMed Dashboard NDC Coverage# NDC, Dashboard title, SPL version table NDC Dashboard title SPL version Validation Dashboard ZIP 85331-208 TINTED SUNSCREEN (ZINC OXIDE) CREAM [SCOTTSDALE SKIN BOUTIQUE AND DERMATOLOGY PLLC] 1 Current NDC, 1 package rows 20250510_34a54441-c741-0c46-e063-6294a90a9be8.zip 85331-208 TINTED SUNSCREEN (ZINC OXIDE) CREAM [SCOTTSDALE SKIN BOUTIQUE AND DERMATOLOGY PLLC] 1 Current NDC, 1 package rows 20250510_34a66140-0d36-005a-e063-6394a90a2a0b.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 27 of 361 · 7,213 matching rows.
Packages# Package NDC, 11-digit format, Description table Package NDC 11-digit format Description Units Marketing start Sample Exclude flag Status 85331-208-15 85331020815 15 g in 1 PACKET (85331-208-15) 15 g 2022-07-28 Yes No Current 85331-208-50 85331020850 53 g in 1 BOTTLE, PUMP (85331-208-50) 53 g 2022-07-20 No No Current