Advanced Sun Resistance SPF 30

Product NDC
65278-319
11-digit product format
652780319
Labeler code
65278
Product ID
65278-319_18f879f0-3d5c-0067-e063-6394a90a9db3
Type
HUMAN OTC DRUG
Nonproprietary name
Homosalate, Octinoxate, Oxybenzone, Octisalate, Avobenzone
Dosage form
CREAM
Route
TOPICAL
Labeler
June Jacobs Labs, LLC
Application
M020
Marketing category
OTC MONOGRAPH DRUG
Marketing start
2021-03-20
Substance
AVOBENZONE; HOMOSALATE; OCTINOXATE; OCTISALATE; OXYBENZONE
Active strength
3.371; 11.238; 8.429; 5.619; 6.743 g/112.38g; g/112.38g; g/112.38g; g/112.38g; g/112.38g
NDC exclude flag
No
Listing certified through
2026-12-31
Current FDA listing
Yes

Additional Listing Data#

Finished product
Yes
Brand name base
Advanced Sun Resistance SPF 30
Listing expiration
2026-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
AVOBENZONE3.371 g/112.38g
HOMOSALATE11.238 g/112.38g
OCTINOXATE8.429 g/112.38g
OCTISALATE5.619 g/112.38g
OXYBENZONE6.743 g/112.38g

Harmonized Identifiers#

Field, Values table
FieldValues
UniiG63QQF2NOX, V06SV4M95S, 4Y5P7MUD51, 4X49Y0596W, 95OOS7VE0Y

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
59361619-24d9-b610-eca6-5a7f25ed5e03Product name520240909
c5cd4727-ac49-4409-82b1-5bd8006c3ec7Product name120171122
5e18e798-5614-cf5c-0185-38b1cb77a093Product name220160822
60c52429-fcef-eb54-2387-43bc9e4f296bProduct name120140508

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
65278-319-01Advanced Sun Resistance SPF 30112.38 g in 1 TUBECREAM112.381
65278-319-02Advanced Sun Resistance SPF 30112.38 g in 1 CARTONCREAM112.381

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
65278-319ADVANCED SUN RESISTANCE SPF 30 (HOMOSALATE, OCTINOXATE, OXYBENZONE, OCTISALATE, AVOBENZONE) CREAM [JUNE JACOBS LABS, LLC]1Current NDC, 2 package rows20240529_18f879f0-3d5b-0067-e063-6394a90a9db3.zip

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startSampleExclude flagStatus
65278-319-0165278031901112.38 g in 1 TUBE (65278-319-01) 112.38 g2021-03-20NoNoHistorical
65278-319-0265278031902112.38 g in 1 CARTON (65278-319-02) 112.38 g2021-03-20NoNoHistorical