FDA.reportPublic FDA data

Coppertone Kids Tear Free Mineral Sunscreen SPF 50

Product NDC
66800-2450
11-digit product format
668002450
Labeler code
66800
Product ID
66800-2450_4746bd79-50f5-423c-e063-6394a90a17e1
Type
HUMAN OTC DRUG
Nonproprietary name
Octinoxate 7.5%, Octisalate 5%, Zinc Oxide 14.5%
Dosage form
LOTION
Route
TOPICAL
Labeler
Beiersdorf Inc
Application
M020
Marketing category
OTC MONOGRAPH DRUG
Marketing start
2021-10-04
Substance
OCTINOXATE; OCTISALATE; ZINC OXIDE
Active strength
7.5; 5; 14.5 g/100g; g/100g; g/100g
NDC exclude flag
No
Listing certified through
2026-12-31
Current FDA listing
Yes

Additional Listing Data#

Finished product
Yes
Brand name base
Coppertone Kids Tear Free Mineral Sunscreen SPF 50
Listing expiration
2026-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
OCTINOXATE7.5 g/100g
OCTISALATE5 g/100g
ZINC OXIDE14.5 g/100g

Harmonized Identifiers#

Field, Values table
FieldValues
Unii4Y5P7MUD51, 4X49Y0596W, SOI2LOH54Z

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
66800-2450-8Coppertone Kids Tear Free Mineral Sunscreen SPF 50237 g in 1 BOTTLE, PLASTICLOTION2375

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
66800-2450COPPERTONE KIDS TEAR FREE MINERAL SUNSCREEN SPF 50 (OCTINOXATE 7.5%, OCTISALATE 5%, ZINC OXIDE 14.5%) LOTION [BEIERSDORF INC]4Current NDC, Legacy NDC, 1 package rows20241127_c054fd86-b0d9-24fc-e053-2a95a90aea2c.zip

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
66800-2450-866800245008237 g in 1 BOTTLE, PLASTIC (66800-2450-8) 237 g2021-10-040000-00-00NoNoCurrent