Home NDC 76354-478 Well People Bio Tint SPF 30 Sunscreen 13w
Product NDC 76354-478
11-digit product format 763540478
Labeler code 76354
Product ID 76354-478_4309d3da-cfee-9bd8-e063-6394a90a475c
Type HUMAN OTC DRUG
Nonproprietary name ZINC OXIDE
Dosage form CREAM
Route TOPICAL
Labeler e.l.f. Cosmetics, Inc
Application M020
Marketing category OTC MONOGRAPH DRUG
Marketing start 2021-09-01
Substance ZINC OXIDE
Active strength 200 mg/mL
Pharmacologic classes Copper Absorption Inhibitor [EPC], Decreased Copper Ion Absorption [PE]
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 Well People Bio Tint SPF 30 Sunscreen 13w
Listing expiration 2026-12-31 Active Ingredients# Ingredient, Strength table Ingredient Strength ZINC OXIDE 200 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 Product Concepts# DailyMed Package Descriptions# Package NDC, Product, Description table Package NDC Product Description Form Quantity Strength SPL version 76354-478-01 Well People Bio Tint SPF 30 Sunscreen 13w 35.5 mL in 1 BOTTLE CREAM 35.5 5 76354-478-01 Well People Bio Tint SPF 30 Sunscreen 13w 1 in 1 BOX CREAM 1 5
DailyMed Dashboard NDC Coverage# NDC, Dashboard title, SPL version table NDC Dashboard title SPL version Validation Dashboard ZIP 76354-478 WELL PEOPLE BIO TINT SPF 30 SUNSCREEN 13W (ZINC OXIDE) CREAM [E.L.F. COSMETICS, INC] 4 Current NDC, Legacy NDC, 2 package rows 20241208_c8a9bf6c-80cd-5884-e053-2a95a90a4a66.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 302 of 346 · 6,912 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 76354-478-01 76354047801 1 BOTTLE in 1 BOX (76354-478-01) / 35.5 mL in 1 BOTTLE 1 bottle 2021-09-01 0000-00-00 No No Current