FDA.reportPublic FDA data

RoC Barrier Renew AM Moisturizer SPF 30

Product NDC
73496-011
11-digit product format
734960011
Labeler code
73496
Product ID
73496-011_44ec05e8-e104-9a62-e063-6394a90a61ab
Type
HUMAN OTC DRUG
Nonproprietary name
Avobenzone, Homosalate, Octisalate, Octocrylene
Dosage form
LOTION
Route
TOPICAL
Labeler
RoC Skincare
Application
M020
Marketing category
OTC MONOGRAPH DRUG
Marketing start
2023-06-01
Substance
AVOBENZONE; HOMOSALATE; OCTISALATE; OCTOCRYLENE
Active strength
2; 5.5; 4.5; 4 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
RoC Barrier Renew AM Moisturizer SPF 30
Listing expiration
2026-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
AVOBENZONE2 g/100mL
HOMOSALATE5.5 g/100mL
OCTISALATE4.5 g/100mL
OCTOCRYLENE4 g/100mL

Harmonized Identifiers#

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

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
3c386306-c48a-413e-bb69-70cb268496f3Product name120210727

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
73496-011-00RoC Barrier Renew AM Moisturizer SPF 3074 mL in 1 TUBELOTION744

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
73496-011ROC BARRIER RENEW AM MOISTURIZER SPF 30 (AVOBENZONE, HOMOSALATE, OCTISALATE, OCTOCRYLENE) LOTION [ROC SKINCARE]3Current NDC, 1 package rows20241129_020aa79f-4fd6-1ea1-e063-6394a90a4464.zip

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startSampleExclude flagStatus
73496-011-007349600110074 mL in 1 TUBE (73496-011-00) 74 ml2023-06-01NoNoCurrent