PRO-COLLAGEN SKIN PROTECTION FLUID SPF 50

Product NDC
65912-012
11-digit product format
659120012
Labeler code
65912
Product ID
65912-012_440ead21-3238-12ec-e063-6394a90a4acb
Type
HUMAN OTC DRUG
Nonproprietary name
Avobenzone, Homosalate, Octisalate and Octocrylene
Dosage form
CREAM
Route
TOPICAL
Labeler
Elemis Ltd.
Application
M020
Marketing category
OTC MONOGRAPH DRUG
Marketing start
2025-01-01
Substance
AVOBENZONE; HOMOSALATE; OCTISALATE; OCTOCRYLENE
Active strength
3; 5; 5; 7 mg/100g; mg/100g; mg/100g; mg/100g
NDC exclude flag
No
Listing certified through
2026-12-31
Current FDA listing
Yes

Additional Listing Data#

Finished product
Yes
Brand name base
PRO-COLLAGEN SKIN PROTECTION FLUID SPF 50
Listing expiration
2026-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
AVOBENZONE3 mg/100g
HOMOSALATE5 mg/100g
OCTISALATE5 mg/100g
OCTOCRYLENE7 mg/100g

Harmonized Identifiers#

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

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
c6f86816-7da6-43ea-8c25-ac9758311cc5Product name120220118
124351b2-6dbf-42d0-9ea7-f0e299215f9aProduct name120210115
252e11b6-1a9a-4283-a242-df2c129c496dProduct name320170717
d5e51f11-ad28-caa4-4b49-4143974782adProduct name120150831

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
65912-012-40PRO-COLLAGEN SKIN PROTECTION FLUID SPF 501 in 1 CARTONCREAM12
65912-012-40PRO-COLLAGEN SKIN PROTECTION FLUID SPF 5040 g in 1 TUBECREAM402
65912-012-41PRO-COLLAGEN SKIN PROTECTION FLUID SPF 5040 g in 1 TUBECREAM402

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
65912-012PRO-COLLAGEN SKIN PROTECTION FLUID SPF 50 (AVOBENZONE, HOMOSALATE, OCTISALATE AND OCTOCRYLENE) CREAM [ELEMIS LTD.]1Current NDC, 3 package rows20250101_23f9222f-60ba-72fb-e063-6394a90a9965.zip

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startSampleExclude flagStatus
65912-012-40659120012401 TUBE in 1 CARTON (65912-012-40) / 40 g in 1 TUBE1 tube2025-01-01NoNoHistorical
65912-012-416591200124140 g in 1 TUBE (65912-012-41) 40 g2025-01-01NoNoHistorical