FDA.reportPublic FDA data

Replenishing Mineral Sunscreen

Product NDC
85330-208
11-digit product format
853300208
Labeler code
85330
Product ID
85330-208_45c7f3ec-f430-d1c1-e063-6394a90a925e
Type
HUMAN OTC DRUG
Nonproprietary name
Zinc Oxide
Dosage form
CREAM
Route
TOPICAL
Labeler
Skin Philosophy by Kelly
Application
M020
Marketing category
OTC MONOGRAPH DRUG
Marketing start
2023-05-10
Substance
ZINC OXIDE
Active strength
160 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
Replenishing Mineral Sunscreen
Listing expiration
2026-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
ZINC OXIDE160 mg/g

Harmonized Identifiers#

Field, Values table
FieldValues
UniiSOI2LOH54Z

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
85330-208-15Replenishing Mineral Sunscreen1.5 g in 1 PACKETCREAM1.52
85330-208-50Replenishing Mineral Sunscreen50 g in 1 BOTTLE, PUMPCREAM502

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
85330-208REPLENISHING MINERAL SUNSCREEN (ZINC OXIDE) CREAM [SKIN PHILOSOPHY BY KELLY]1Current NDC, 1 package rows20250521_35828e76-66db-49de-e063-6294a90a2b99.zip
85330-208REPLENISHING MINERAL SUNSCREEN (ZINC OXIDE) CREAM [SKIN PHILOSOPHY BY KELLY]1Current NDC, 1 package rows20250522_359371f2-2407-e1a1-e063-6294a90a2165.zip

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startSampleExclude flagStatus
85330-208-15853300208151.5 g in 1 PACKET (85330-208-15) 1.5 g2023-05-10YesNoHistorical
85330-208-508533002085050 g in 1 BOTTLE, PUMP (85330-208-50) 50 g2023-05-10NoNoHistorical