Sunscreen for Babies SPF 50

Product NDC
11344-947
11-digit product format
113440947
Labeler code
11344
Product ID
11344-947_4ceb1800-c9d1-86f7-e063-6294a90a785a
Type
HUMAN OTC DRUG
Nonproprietary name
Avobenzone, Homosalate, Octisalate
Dosage form
LOTION
Route
TOPICAL
Labeler
Nice-Pak Products, LLC
Application
M020
Marketing category
OTC MONOGRAPH DRUG
Marketing start
2024-05-06
Substance
AVOBENZONE; HOMOSALATE; OCTISALATE
Active strength
30; 120; 50 mg/mL; mg/mL; mg/mL
NDC exclude flag
No
Listing certified through
2027-12-31
Current FDA listing
Yes

Additional Listing Data#

Finished product
Yes
Brand name base
Sunscreen for Babies SPF 50
Listing expiration
2027-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
AVOBENZONE30 mg/mL
HOMOSALATE120 mg/mL
OCTISALATE50 mg/mL

Harmonized Identifiers#

Field, Values table
FieldValues
UniiG63QQF2NOX, V06SV4M95S, 4X49Y0596W

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
11344-947-34Sunscreen for Babies SPF 50236 mL in 1 BOTTLE, PLASTICLOTION2363

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
11344-947SUNSCREEN FOR BABIES SPF 50 (AVOBENZONE, HOMOSALATE, OCTISALATE) LOTION [CONSUMER PRODUCT PARTNERS, LLC]2Current NDC, 1 package rows20250510_a4b9d7c0-dc09-4f0e-8b65-90ba180552bf.zip

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startSampleExclude flagStatus
11344-947-3411344094734236 mL in 1 BOTTLE, PLASTIC (11344-947-34) 236 ml2024-05-06NoNoHistorical