Tinted Mineral Sunscreen

Product NDC
85597-203
11-digit product format
855970203
Labeler code
85597
Product ID
85597-203_46171295-53fd-c2c3-e063-6394a90acd21
Type
HUMAN OTC DRUG
Nonproprietary name
Titanium Dioxide, Zinc Oxide
Dosage form
CREAM
Route
TOPICAL
Labeler
ESTHETIC ACADEMY LLC
Application
M020
Marketing category
OTC MONOGRAPH DRUG
Marketing start
2022-04-29
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
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
85597-203-15Tinted Mineral Sunscreen1.5 g in 1 PACKETCREAM1.52
85597-203-50Tinted Mineral Sunscreen53 g in 1 BOTTLE, PUMPCREAM532

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startSampleExclude flagStatus
85597-203-15855970203151.5 g in 1 PACKET (85597-203-15) 1.5 g2022-04-29YesNoCurrent
85597-203-508559702035053 g in 1 BOTTLE, PUMP (85597-203-50) 53 g2022-04-29NoNoCurrent