Home NDC 83100-1763 pavise Lip Defense tinted hydrating oil (hue 774)
Product NDC 83100-1763
11-digit product format 831001763
Labeler code 83100
Product ID 83100-1763_40bd9f77-280c-1c69-e063-6394a90a09a1
Type HUMAN OTC DRUG
Nonproprietary name Zinc Oxide
Dosage form LOTION
Route TOPICAL
Labeler B.A.I. Biosciences INC.
Application M020
Marketing category OTC MONOGRAPH DRUG
Marketing start 2023-02-17
Substance ZINC OXIDE
Active strength 100 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 pavise Lip Defense tinted hydrating oil (hue 774)
Listing expiration 2026-12-31 Active Ingredients# Ingredient, Strength table Ingredient Strength ZINC OXIDE 100 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 83100-1763-1 pavise Lip Defense tinted hydrating oil (hue 774) 5 mL in 1 BOTTLE LOTION 5 4 83100-1763-2 pavise Lip Defense tinted hydrating oil (hue 774) 1 in 1 CARTON LOTION 1 4
DailyMed Dashboard NDC Coverage# NDC, Dashboard title, SPL version table NDC Dashboard title SPL version Validation Dashboard ZIP 83100-1763 PAVISE LIP DEFENSE TINTED HYDRATING OIL (HUE 774) (ZINC OXIDE) LOTION [B.A.I. BIOSCIENCES INC.] 2 Current NDC, 2 package rows 20241004_f4ebd850-11a8-0d43-e053-2a95a90a2d34.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 83100-1763-1 83100176301 5 mL in 1 BOTTLE 5 ml Historical 83100-1763-2 83100176302 1 BOTTLE in 1 CARTON (83100-1763-2) / 5 mL in 1 BOTTLE (83100-1763-1) 1 bottle 2023-02-17 No No Current