Non-Tinted Mineral Foaming Sunscreen

Product NDC
85313-211
11-digit product format
853130211
Labeler code
85313
Product ID
85313-211_459bfcc2-12be-82a9-e063-6294a90a6ca3
Type
HUMAN OTC DRUG
Nonproprietary name
Titanium Dioxide, Zinc Oxide
Dosage form
AEROSOL, FOAM
Route
TOPICAL
Labeler
Restore Skin Therapy, LLC
Application
M020
Marketing category
OTC MONOGRAPH DRUG
Marketing start
2019-08-05
Substance
TITANIUM DIOXIDE; ZINC OXIDE
Active strength
30; 100 mg/g; mg/g
NDC exclude flag
No
Listing certified through
2026-12-31
Current FDA listing
Yes

Additional Listing Data#

Finished product
Yes
Brand name base
Non-Tinted Mineral Foaming Sunscreen
Listing expiration
2026-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
TITANIUM DIOXIDE30 mg/g
ZINC OXIDE100 mg/g

Harmonized Identifiers#

Field, Values table
FieldValues
Unii15FIX9V2JP, SOI2LOH54Z

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
85313-211-04Non-Tinted Mineral Foaming Sunscreen113 g in 1 BOTTLE, PUMPAEROSOL, FOAM1132

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startSampleExclude flagStatus
85313-211-0485313021104113 g in 1 BOTTLE, PUMP (85313-211-04) 113 g2019-08-05NoNoHistorical