FDA.reportPublic FDA data

ONE PERCENT Sunscreen

Product NDC
85176-001
11-digit product format
851760001
Labeler code
85176
Product ID
85176-001_2d604423-c953-e1d0-e063-6394a90a7d6b
Type
HUMAN OTC DRUG
Nonproprietary name
ONE PERCENT Sunscreen
Dosage form
CREAM
Route
TRANSDERMAL
Labeler
Beijing Keyan Biotechnology Co., Ltd.
Application
M020
Marketing category
OTC MONOGRAPH DRUG
Marketing start
2025-02-05
Substance
ALUMINUM HYDROXIDE; ETHYLHEXYL METHOXYCINNAMATE; ETHYLHEXYL SALICYLATE; PHENYLBENZIMIDAZOLE SULFONIC ACID; TITANIUM DIOXIDE; ZINC OXIDE
Active strength
.6; 8.49405; 4; 1; 3.9; 10.45 g/100mL; g/100mL; g/100mL; g/100mL; g/100mL; g/100mL
NDC exclude flag
No
Listing certified through
2026-12-31
Current FDA listing
Yes

Additional Listing Data#

Finished product
Yes
Brand name base
ONE PERCENT Sunscreen
Listing expiration
2026-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
ALUMINUM HYDROXIDE.6 g/100mL
ETHYLHEXYL METHOXYCINNAMATE8.49405 g/100mL
ETHYLHEXYL SALICYLATE4 g/100mL
PHENYLBENZIMIDAZOLE SULFONIC ACID1 g/100mL
TITANIUM DIOXIDE3.9 g/100mL
ZINC OXIDE10.45 g/100mL

Harmonized Identifiers#

Field, Values table
FieldValues
Unii5QB0T2IUN0, 4Y5P7MUD51, 4X49Y0596W, 9YQ9DI1W42, 15FIX9V2JP, SOI2LOH54Z

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
85176-001-01ONE PERCENT Sunscreen60 mL in 1 BOTTLECREAM601

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
85176-001ONE PERCENT SUNSCREEN CREAM [BEIJING KEYAN BIOTECHNOLOGY CO., LTD.]1Current NDC, 1 package rows20250209_2d604579-7883-e4cb-e063-6394a90a7d92.zip

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startSampleExclude flagStatus
85176-001-018517600010160 mL in 1 BOTTLE (85176-001-01) 60 ml2025-02-05NoNoCurrent