Home NDC 85415-208 SPF 101 Lightly Tinted
Product NDC 85415-208
11-digit product format 854150208
Labeler code 85415
Product ID 85415-208_4573ea0f-0267-2e3b-e063-6394a90abb90
Type HUMAN OTC DRUG
Nonproprietary name Zinc Oxide
Dosage form CREAM
Route TOPICAL
Labeler The Acne Lab LLC
Application M020
Marketing category OTC MONOGRAPH DRUG
Marketing start 2024-07-15
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 SPF 101 Lightly Tinted
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 85415-208-15 SPF 101 Lightly Tinted 15 g in 1 PACKET CREAM 15 2 85415-208-50 SPF 101 Lightly Tinted 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 85415-208 SPF 101 LIGHTLY TINTED (ZINC OXIDE) CREAM [THE ACNE LAB LLC] 1 Current NDC, 1 package rows 20250423_334afdc8-1e12-d787-e063-6294a90aed7c.zip 85415-208 SPF 101 LIGHTLY TINTED (ZINC OXIDE) CREAM [THE ACNE LAB LLC] 1 Current NDC, 1 package rows 20250423_334d694a-f9e4-ae86-e063-6394a90abfe1.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 354 · 7,077 matching rows.
Packages# Package NDC, 11-digit format, Description table Package NDC 11-digit format Description Units Marketing start Sample Exclude flag Status 85415-208-15 85415020815 15 g in 1 PACKET (85415-208-15) 15 g 2024-07-15 Yes No Current 85415-208-50 85415020850 50 g in 1 BOTTLE, PUMP (85415-208-50) 50 g 2024-07-15 No No Current