FDA.reportPublic FDA data

PRISMA PROTECT SPF30

Product NDC
68479-852
11-digit product format
684790852
Labeler code
68479
Product ID
68479-852_88cf9604-438b-4397-8606-6cc609f17709
Type
HUMAN OTC DRUG
Nonproprietary name
Octocrylene, Homosalate, Octisalate, and Avobenzone
Dosage form
LOTION
Route
TOPICAL
Labeler
Dermalogica, LLC.
Application
M020
Marketing category
OTC MONOGRAPH DRUG
Marketing start
2024-02-09
Substance
AVOBENZONE; HOMOSALATE; OCTISALATE; OCTOCRYLENE
Active strength
3; 7; 5; 10 g/100mL; g/100mL; g/100mL; g/100mL
NDC exclude flag
No
Listing certified through
2026-12-31
Current FDA listing
Yes

Additional Listing Data#

Finished product
Yes
Brand name base
PRISMA PROTECT SPF30
Listing expiration
2026-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
AVOBENZONE3 g/100mL
HOMOSALATE7 g/100mL
OCTISALATE5 g/100mL
OCTOCRYLENE10 g/100mL

Harmonized Identifiers#

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

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
68479-852-02PRISMA PROTECT SPF3050 mL in 1 TUBELOTION501
68479-852-02PRISMA PROTECT SPF301 in 1 CARTONLOTION11

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
68479-852PRISMA PROTECT SPF30 (OCTOCRYLENE, HOMOSALATE, OCTISALATE, AND AVOBENZONE) LOTION [DERMALOGICA, LLC.]1Current NDC, 2 package rows20240427_e0e6d779-c491-43ed-acc9-274d1b60c1ff.zip

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startSampleExclude flagStatus
68479-852-02684790852021 TUBE in 1 CARTON (68479-852-02) / 50 mL in 1 TUBE1 tube2024-02-09NoNoHistorical