FDA.reportPublic FDA data

SUNSCREEN BROAD SPECTRUM SPF 50 FACE AND BODY

Product NDC
51531-7287
11-digit product format
515317287
Labeler code
51531
Product ID
51531-7287_2c4eaf2e-b035-8185-e063-6394a90a8275
Type
HUMAN OTC DRUG
Nonproprietary name
Avobenzone/Octisalate/Octocrylene
Dosage form
LOTION
Route
TOPICAL
Labeler
Mary Kay Inc.
Application
M020
Marketing category
OTC MONOGRAPH DRUG
Marketing start
2025-03-01
Substance
AVOBENZONE; OCTISALATE; OCTOCRYLENE
Active strength
3; 4.5; 9 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
SUNSCREEN BROAD SPECTRUM SPF 50 FACE AND BODY
Listing expiration
2026-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
AVOBENZONE3 g/100g
OCTISALATE4.5 g/100g
OCTOCRYLENE9 g/100g

Harmonized Identifiers#

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

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
51531-7287-1SUNSCREEN BROAD SPECTRUM SPF 50 FACE AND BODY118 g in 1 TUBELOTION1181
51531-7287-1SUNSCREEN BROAD SPECTRUM SPF 50 FACE AND BODY1 in 1 CARTONLOTION11

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
51531-7287SUNSCREEN BROAD SPECTRUM SPF 50 FACE AND BODY (AVOBENZONE/OCTISALATE/OCTOCRYLENE) LOTION [MARY KAY INC.]1Current NDC, 2 package rows20250306_2c4eaf2e-b034-8185-e063-6394a90a8275.zip

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startSampleExclude flagStatus
51531-7287-1515317287011 TUBE in 1 CARTON (51531-7287-1) / 118 g in 1 TUBE1 tube2025-03-01NoNoCurrent