Non Tinted Mineral Sunscreen

Product NDC
85395-205
11-digit product format
853950205
Labeler code
85395
Product ID
85395-205_45b0e255-c610-d7db-e063-6294a90a79ec
Type
HUMAN OTC DRUG
Nonproprietary name
Zinc Oxide
Dosage form
CREAM
Route
TOPICAL
Labeler
SPECKTRA6 LLC
Application
M020
Marketing category
OTC MONOGRAPH DRUG
Marketing start
2021-04-19
Substance
ZINC OXIDE
Active strength
200 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 Sunscreen
Listing expiration
2026-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
ZINC OXIDE200 mg/g

Harmonized Identifiers#

Field, Values table
FieldValues
UniiSOI2LOH54Z

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
85395-205-04Non Tinted Mineral Sunscreen113 g in 1 BOTTLE, PUMPCREAM1132
85395-205-15Non Tinted Mineral Sunscreen1.5 g in 1 PACKETCREAM1.52

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startSampleExclude flagStatus
85395-205-0485395020504113 g in 1 BOTTLE, PUMP (85395-205-04) 113 g2021-04-19NoNoHistorical
85395-205-15853950205151.5 g in 1 PACKET (85395-205-15) 1.5 g2021-04-19YesNoHistorical