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

Additional Listing Data#

Finished product
Yes
Brand name base
Woro Beauty SPFortless
Listing expiration
2026-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
TITANIUM DIOXIDE19.4 mg/mL
ZINC OXIDE9.7 mg/mL

Harmonized Identifiers#

Field, Values table
FieldValues
Unii15FIX9V2JP, SOI2LOH54Z

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
84416-391-01Woro Beauty SPFortless45 mL in 1 BOTTLELOTION452
84416-391-02Woro Beauty SPFortless1 in 1 CARTONLOTION12

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startSampleExclude flagStatus
84416-391-018441603910145 mL in 1 BOTTLE45 mlHistorical
84416-391-02844160391021 BOTTLE in 1 CARTON (84416-391-02) / 45 mL in 1 BOTTLE (84416-391-01) 1 bottle2025-02-28NoNoHistorical