FDA.reportPublic FDA data

Sun Shades Sunscreen

Product NDC
54473-404
11-digit product format
544730404
Labeler code
54473
Product ID
54473-404_46903e8d-f15c-5ddc-e063-6394a90a354e
Type
HUMAN OTC DRUG
Nonproprietary name
avobenzone, homosalate, octisalate, octocrylene
Dosage form
SPRAY
Route
TOPICAL
Labeler
Melaleuca Inc.
Application
M020
Marketing category
OTC MONOGRAPH DRUG
Marketing start
2020-05-01
Substance
AVOBENZONE; HOMOSALATE; OCTISALATE; OCTOCRYLENE
Active strength
4.89; 24.45; 8.15; 13.04 g/163mL; g/163mL; g/163mL; g/163mL
NDC exclude flag
No
Listing certified through
2026-12-31
Current FDA listing
Yes

Additional Listing Data#

Finished product
Yes
Brand name base
Sun Shades Sunscreen
Brand name suffix
Sunscreen SPF 50
Listing expiration
2026-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
AVOBENZONE4.89 g/163mL
HOMOSALATE24.45 g/163mL
OCTISALATE8.15 g/163mL
OCTOCRYLENE13.04 g/163mL

Harmonized Identifiers#

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

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
54473-404-01Sun Shades SunscreenSunscreen SPF 50163 mL in 1 BOTTLE, SPRAYSPRAY1632

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
54473-404SUN SHADES SUNSCREEN SUNSCREEN SPF 50 (AVOBENZONE, HOMOSALATE, OCTISALATE, OCTOCRYLENE) SPRAY [MELALEUCA INC.]1Current NDC, 1 package rows20240829_1f982f03-9542-29f9-e063-6294a90a959c.zip

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startSampleExclude flagStatus
54473-404-0154473040401163 mL in 1 BOTTLE, SPRAY (54473-404-01) 163 ml2020-05-01NoNoHistorical