Home NDC 84416-391 Woro Beauty SPFortless
Product NDC 84416-391
11-digit product format 844160391
Labeler code 84416
Product ID 84416-391_43ce6885-6cbf-9569-e063-6394a90a9b24
Type HUMAN OTC DRUG
Nonproprietary name Titanium dioxide, Zinc Oxide
Dosage form LOTION
Route TOPICAL
Labeler Woro Beauty
Application M020
Marketing category OTC MONOGRAPH DRUG
Marketing start 2025-02-28
Substance TITANIUM DIOXIDE; ZINC OXIDE
Active strength 19.4; 9.7 mg/mL; 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 Woro Beauty SPFortless
Listing expiration 2026-12-31 Active Ingredients# Ingredient, Strength table Ingredient Strength TITANIUM DIOXIDE 19.4 mg/mL ZINC OXIDE 9.7 mg/mL
Harmonized UNII identifiers# UNII identifiers page 1 of 1 · 2 matching rows.
Identifier, FDA.report destination table Identifier FDA.report destination 15FIX9V2JP Internal UNII lookup 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 84416-391-01 Woro Beauty SPFortless 45 mL in 1 BOTTLE LOTION 45 2 84416-391-02 Woro Beauty SPFortless 1 in 1 CARTON LOTION 1 2
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 84416-391-01 84416039101 45 mL in 1 BOTTLE 45 ml Historical 84416-391-02 84416039102 1 BOTTLE in 1 CARTON (84416-391-02) / 45 mL in 1 BOTTLE (84416-391-01) 1 bottle 2025-02-28 No No Current