WOODSLEEP Tallow Sunscreen

Product NDC
85053-002
11-digit product format
850530002
Labeler code
85053
Product ID
85053-002_448bdbfa-2de6-fce8-e063-6394a90a2cf7
Type
HUMAN OTC DRUG
Nonproprietary name
TITANIUM DIOXIDE
Dosage form
CREAM
Route
TOPICAL
Labeler
Shantou Woodsleep Biotechnology Co., Ltd.
Application
M020
Marketing category
OTC MONOGRAPH DRUG
Marketing start
2025-04-18
Substance
TALLOW
Active strength
.0114 mg/57mg
NDC exclude flag
No
Listing certified through
2026-12-31
Current FDA listing
Yes

Additional Listing Data#

Finished product
Yes
Brand name base
WOODSLEEP Tallow Sunscreen
Listing expiration
2026-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
TALLOW.0114 mg/57mg

Harmonized Identifiers#

Field, Values table
FieldValues
Unii98HPY76U4W

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
85053-002-01WOODSLEEP Tallow Sunscreen57 mg in 1 BOXCREAM572

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
85053-002WOODSLEEP TALLOW SUNSCREEN (TITANIUM DIOXIDE) CREAM [SHANTOU WOODSLEEP BIOTECHNOLOGY CO., LTD.]1Current NDC, 1 package rows20250419_330a9f2e-7ce1-f83f-e063-6394a90a184a.zip

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startSampleExclude flagStatus
85053-002-018505300020157 mg in 1 BOX (85053-002-01) 57 mg2025-04-18NoNoHistorical