Sonni SunDay Body Balm

Product NDC
85260-492
11-digit product format
852600492
Labeler code
85260
Product ID
85260-492_41adca2e-cf6b-ccd9-e063-6294a90a0dc0
Type
HUMAN OTC DRUG
Nonproprietary name
Titanium dioxide, Zinc Oxide
Dosage form
LOTION
Route
TOPICAL
Labeler
Sonni
Application
M020
Marketing category
OTC MONOGRAPH DRUG
Marketing start
2025-08-28
Substance
TITANIUM DIOXIDE; ZINC OXIDE
Active strength
22; 11 mg/mL; mg/mL
NDC exclude flag
No
Listing certified through
2026-12-31
Current FDA listing
Yes

openFDA Listing Details

Product ID
85260-492_41adca2e-cf6b-ccd9-e063-6294a90a0dc0
Product type
HUMAN OTC DRUG
Finished product
Yes
Brand name base
Sonni SunDay Body Balm
Generic name
Titanium dioxide, Zinc Oxide
Dosage form
LOTION
Route
TOPICAL
Marketing start
2025-08-28
Marketing category
OTC MONOGRAPH DRUG
Application number
M020
Listing expiration
2026-12-31

Related Records

openFDA Active Ingredients

IngredientStrength
TITANIUM DIOXIDE22 mg/mL
ZINC OXIDE11 mg/mL

openFDA Harmonized Identifiers

FieldValues
Unii15FIX9V2JP, SOI2LOH54Z
Spl Set Id41adca2e-cf69-ccd9-e063-6294a90a0dc0
Manufacturer NameSonni

Related Records

Related UNII Ingredients

UNIIPreferred termRegistry numberMatched term
15FIX9V2JPTITANIUM DIOXIDE13463-67-7TITANIUM DIOXIDE
SOI2LOH54ZZINC OXIDE1314-13-2ZINC OXIDE

Packages

Package NDC11-digit formatDescriptionMarketing startSampleExclude flagStatus
85260-492-02852600492021 BOTTLE, PUMP in 1 CARTON (85260-492-02) / 150000 mL in 1 BOTTLE, PUMP (85260-492-01) 2025-08-28NoNoCurrent

Related DailyMed Labels

TitleManufacturerEffective dateTypeVersion
Sonni SunDay Body BalmSonni2025-10-21HUMAN OTC DRUG LABEL1