FDA.reportPublic FDA data

Gentle Defense Sunscreen

Product NDC
85533-205
11-digit product format
855330205
Labeler code
85533
Product ID
85533-205_45b4d0dd-b3e0-cef5-e063-6394a90aa410
Type
HUMAN OTC DRUG
Nonproprietary name
Zinc Oxide
Dosage form
CREAM
Route
TOPICAL
Labeler
Mint Skin Incroporated
Application
M020
Marketing category
OTC MONOGRAPH DRUG
Marketing start
2021-07-06
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
Gentle Defense 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
85533-205-04Gentle Defense Sunscreen113 g in 1 BOTTLE, PUMPCREAM1132
85533-205-15Gentle Defense Sunscreen1.5 g in 1 PACKETCREAM1.52

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
85533-205GENTLE DEFENSE SUNSCREEN (ZINC OXIDE) CREAM [MINT SKIN INCORPORATED]1Current NDC, 1 package rows20250516_3530898c-7bdf-6ffe-e063-6394a90aa037.zip
85533-205GENTLE DEFENSE SUNSCREEN (ZINC OXIDE) CREAM [MINT SKIN INCROPORATED]1Current NDC, 1 package rows20250516_352fe5e4-8b3f-248f-e063-6394a90ab42c.zip

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startSampleExclude flagStatus
85533-205-0485533020504113 g in 1 BOTTLE, PUMP (85533-205-04) 113 g2021-07-06NoNoHistorical
85533-205-15855330205151.5 g in 1 PACKET (85533-205-15) 1.5 g2021-07-06YesNoHistorical