FDA.reportPublic FDA data

CVS Health SPF 50 Ultra Protection

Product NDC
51316-024
11-digit product format
513160024
Labeler code
51316
Product ID
51316-024_24af02e9-1a04-57e3-e063-6394a90ad845
Type
HUMAN OTC DRUG
Nonproprietary name
Avobenzone Homosalate Octisalate Octocrylene
Dosage form
LOTION
Route
TOPICAL
Labeler
CVS PHARMACY
Application
M020
Marketing category
OTC MONOGRAPH DRUG
Marketing start
2019-01-03
Substance
AVOBENZONE; HOMOSALATE; OCTISALATE; OCTOCRYLENE
Active strength
30; 150; 50; 70 mg/mL; mg/mL; mg/mL; mg/mL
NDC exclude flag
No
Listing certified through
2026-12-31
Current FDA listing
Yes

Additional Listing Data#

Finished product
Yes
Brand name base
CVS Health SPF 50 Ultra Protection
Listing expiration
2026-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
AVOBENZONE30 mg/mL
HOMOSALATE150 mg/mL
OCTISALATE50 mg/mL
OCTOCRYLENE70 mg/mL

Harmonized Identifiers#

Field, Values table
FieldValues
UniiG63QQF2NOX, V06SV4M95S, 4X49Y0596W, 5A68WGF6WM

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
777d68c6-a5ab-e06c-d314-677b0b9af0c8Product name220240508

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
51316-024-11CVS Health SPF 50 Ultra Protection237 mL in 1 BOTTLELOTION2372

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
51316-024CVS HEALTH SPF 50 ULTRA PROTECTION (AVOBENZONE HOMOSALATE OCTISALATE OCTOCRYLENE) LOTION [CVS PHARMACY]2Current NDC, Legacy NDC, 1 package rows20241019_f11650bb-90a0-78a1-e053-2995a90a8e4c.zip

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
51316-024-1151316002411237 mL in 1 BOTTLE (51316-024-11) 237 ml2019-01-030000-00-00NoNoCurrent