Tinted Mineral Sunscreen Broad Spectrum SPF 40

Product NDC
85747-203
11-digit product format
857470203
Labeler code
85747
Product ID
85747-203_461407d0-fbf4-47e9-e063-6394a90a9a83
Type
HUMAN OTC DRUG
Nonproprietary name
Titanium Dioxide, Zinc Oxide
Dosage form
CREAM
Route
TOPICAL
Labeler
WECARE FRISCO PLLC
Application
M020
Marketing category
OTC MONOGRAPH DRUG
Marketing start
2022-11-16
Substance
TITANIUM DIOXIDE; ZINC OXIDE
Active strength
80; 38 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
Tinted Mineral Sunscreen Broad Spectrum SPF 40
Listing expiration
2026-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
TITANIUM DIOXIDE80 mg/g
ZINC OXIDE38 mg/g

Harmonized Identifiers#

Field, Values table
FieldValues
Unii15FIX9V2JP, SOI2LOH54Z

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
85747-203-50Tinted Mineral Sunscreen Broad Spectrum SPF 4053 g in 1 BOTTLE, PUMPCREAM532

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startSampleExclude flagStatus
85747-203-508574702035053 g in 1 BOTTLE, PUMP (85747-203-50) 53 g2022-11-16NoNoHistorical