Home NDC 85508-208 Tinted Replenishing SPF40
Product NDC 85508-208
11-digit product format 855080208
Labeler code 85508
Product ID 85508-208_45c70c10-47da-8885-e063-6294a90adf67
Type HUMAN OTC DRUG
Nonproprietary name Zinc Oxide
Dosage form CREAM
Route TOPICAL
Labeler RSL89 LLC
Application M020
Marketing category OTC MONOGRAPH DRUG
Marketing start 2023-05-05
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 Replenishing SPF40
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 85508-208-15 Tinted Replenishing SPF40 1.5 g in 1 PACKET CREAM 1.5 2 85508-208-50 Tinted Replenishing SPF40 50 g in 1 BOTTLE, PUMP CREAM 50 2
DailyMed Dashboard NDC Coverage# NDC, Dashboard title, SPL version table NDC Dashboard title SPL version Validation Dashboard ZIP 85508-208 TINTED REPLENISHING SPF40 (ZINC OXIDE) CREAM [RSL89 LLC] 1 Current NDC, 1 package rows 20250519_353257db-6c30-4a03-e063-6294a90ae45d.zip 85508-208 TINTED REPLENISHING SPF40 (ZINC OXIDE) CREAM [RSL89 LLC] 1 Current NDC, 1 package rows 20250519_35334c75-b3fd-37fa-e063-6294a90ab3b0.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 85508-208-15 85508020815 1.5 g in 1 PACKET (85508-208-15) 1.5 g 2023-07-06 Yes No Current 85508-208-50 85508020850 50 g in 1 BOTTLE, PUMP (85508-208-50) 50 g 2023-05-05 No No Current