FDA.reportPublic FDA data

Glass Skin Sunscreen Tinted

Product NDC
85428-204
11-digit product format
854280204
Labeler code
85428
Product ID
85428-204_459c0193-3a86-878d-e063-6294a90afc31
Type
HUMAN OTC DRUG
Nonproprietary name
Zinc Oxide
Dosage form
CREAM
Route
TOPICAL
Labeler
Fleur de Lune, LLC
Application
M020
Marketing category
OTC MONOGRAPH DRUG
Marketing start
2023-12-01
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
Glass Skin Sunscreen Tinted
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
85428-204-15Glass Skin Sunscreen Tinted1.5 g in 1 PACKETCREAM1.52
85428-204-60Glass Skin Sunscreen Tinted60 g in 1 BOTTLE, PUMPCREAM602

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
85428-204GLASS SKIN SUNSCREEN TINTED (ZINC OXIDE) CREAM [FLEUR DE LUNE, LLC]1Current NDC, 1 package rows20250503_3418394b-fede-65ce-e063-6394a90ad5f9.zip
85428-204GLASS SKIN SUNSCREEN TINTED (ZINC OXIDE) CREAM [FLEUR DE LUNE, LLC]1Current NDC, 1 package rows20250504_34288989-35b8-3aa3-e063-6394a90ac2c4.zip

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startSampleExclude flagStatus
85428-204-15854280204151.5 g in 1 PACKET (85428-204-15) 1.5 g2023-12-01YesNoHistorical
85428-204-608542802046060 g in 1 BOTTLE, PUMP (85428-204-60) 60 g2023-07-13NoNoHistorical