FDA.reportPublic FDA data

Sun Protection SPF 50

Product NDC
83694-011
11-digit product format
836940011
Labeler code
83694
Product ID
83694-011_386fedd0-893e-f833-e063-6294a90a41b1
Type
HUMAN OTC DRUG
Nonproprietary name
Avobenzone 2.9%, Homosalate 4.0%, Octisalate 4.9%, Octocrylene 9.5%
Dosage form
SPRAY
Route
TOPICAL
Labeler
Skinresource.md, L.L.C.
Application
M020
Marketing category
OTC MONOGRAPH DRUG
Marketing start
2024-09-01
Substance
AVOBENZONE; HOMOSALATE; OCTISALATE; OCTOCRYLENE
Active strength
5.133; 7.08; 8.673; 16.815 g/177g; g/177g; g/177g; g/177g
NDC exclude flag
No
Listing certified through
2026-12-31
Current FDA listing
Yes

Additional Listing Data#

Finished product
Yes
Brand name base
Sun Protection SPF 50
Listing expiration
2026-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
HOMOSALATE5.133 g/177g
OCTOCRYLENE7.08 g/177g
OCTISALATE8.673 g/177g
AVOBENZONE16.815 g/177g

Harmonized Identifiers#

Field, Values table
FieldValues
UniiV06SV4M95S, 5A68WGF6WM, 4X49Y0596W, G63QQF2NOX

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
83694-011-01Sun Protection SPF 50177 g in 1 BOTTLE, SPRAYSPRAY1773

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
83694-011SUN PROTECTION SPF 50 (AVOBENZONE 2.9%, HOMOSALATE 4.0%, OCTISALATE 4.9%, OCTOCRYLENE 9.5%) SPRAY [SKINRESOURCE.MD, L.L.C.]1Current NDC, 1 package rows20250410_2a0c3dd1-4bc0-6664-e063-6294a90af4b3.zip

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startSampleExclude flagStatus
83694-011-0183694001101177 g in 1 BOTTLE, SPRAY (83694-011-01) 177 g2025-03-01NoNoHistorical