EB-5 Super Hydrating Anti-Aging SPF-50

Product NDC
84060-439
11-digit product format
840600439
Labeler code
84060
Product ID
84060-439_1b1351b4-4425-3bb5-e063-6394a90a683f
Type
HUMAN OTC DRUG
Nonproprietary name
OCTOCRYLENE, ZINC OXIDE, OCTISALATE
Dosage form
CREAM
Route
TOPICAL
Labeler
LIFE O, INC.
Application
M020
Marketing category
OTC MONOGRAPH DRUG
Marketing start
2023-12-26
Substance
OCTISALATE; OCTOCRYLENE; ZINC OXIDE
Active strength
50; 100; 80 mg/mL; mg/mL; mg/mL
Pharmacologic classes
Copper Absorption Inhibitor [EPC], Decreased Copper Ion Absorption [PE]
NDC exclude flag
No
Listing certified through
2026-12-31
Current FDA listing
Yes

Additional Listing Data#

Finished product
Yes
Brand name base
EB-5 Super Hydrating Anti-Aging SPF-50
Listing expiration
2026-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
OCTISALATE50 mg/mL
OCTOCRYLENE100 mg/mL
ZINC OXIDE80 mg/mL

Harmonized Identifiers#

Field, Values table
FieldValues
Unii4X49Y0596W, 5A68WGF6WM, SOI2LOH54Z

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
f47a510b-6679-4664-b2d6-47b5c4afe7ccProduct name420260217
030ce964-9b2d-45aa-b5d3-f78ce03ef61cProduct name220250515
0306390c-dd77-4363-afe0-63c58088b2a1Product name120220120
503ea967-4b9c-48cf-9e87-c7975295849dProduct name220220120
c5cd4727-ac49-4409-82b1-5bd8006c3ec7Product name120171122
190f2a5b-bbc8-65c7-fcb0-97891307b917Product name120140508

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
84060-439-00EB-5 Super Hydrating Anti-Aging SPF-5050 mL in 1 TUBECREAM503
84060-439-00EB-5 Super Hydrating Anti-Aging SPF-501 in 1 BOXCREAM13

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
84060-439EB-5 SUPER HYDRATING ANTI-AGING SPF-50 (OCTOCRYLENE, ZINC OXIDE, OCTISALATE) CREAM [LIFE O, INC.]3Current NDC, 2 package rows20240618_b9521112-d119-4d48-8504-4e46b434f76f.zip

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startSampleExclude flagStatus
84060-439-00840600439001 TUBE in 1 BOX (84060-439-00) / 50 mL in 1 TUBE1 tube2023-12-26NoNoCurrent