Home NDC 65278-319 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; OXYBENZONE; OCTINOXATE; HOMOSALATE; OCTISALATE
Active strength 3.371; 6.743; 8.429; 11.238; 5.619 g/112.38g; g/112.38g; g/112.38g; g/112.38g; g/112.38g
NDC exclude flag No
Listing certified through 2027-12-31
Current FDA listing Yes Reported adverse events (FAERS/openFDA)# Adverse event summaries are temporarily unavailable. Other product information remains available.
Additional Listing Data#
Finished product Yes
Brand name base Advanced Sun Resistance SPF 30
Listing expiration 2027-12-31 Active Ingredients# Ingredient, Strength table Ingredient Strength AVOBENZONE 3.371 g/112.38g OXYBENZONE 6.743 g/112.38g OCTINOXATE 8.429 g/112.38g HOMOSALATE 11.238 g/112.38g OCTISALATE 5.619 g/112.38g
Harmonized UNII identifiers# UNII identifiers page 1 of 1 · 5 matching rows.
Harmonized SPL set identifiers# SPL set identifiers page 1 of 1 · 1 matching rows.
DailyMed Product Concepts# DailyMed Package Descriptions# Package NDC, Product, Description table Package NDC Product Description Form Quantity Strength SPL version 65278-319-01 Advanced Sun Resistance SPF 30 112.38 g in 1 TUBE CREAM 112.38 1 65278-319-02 Advanced Sun Resistance SPF 30 112.38 g in 1 CARTON CREAM 112.38 1
DailyMed Dashboard NDC Coverage# NDC, Dashboard title, SPL version table NDC Dashboard title SPL version Validation Dashboard ZIP 65278-319 ADVANCED SUN RESISTANCE SPF 30 (HOMOSALATE, OCTINOXATE, OXYBENZONE, OCTISALATE, AVOBENZONE) CREAM [JUNE JACOBS LABS, LLC] 1 Current NDC, 2 package rows 20240529_18f879f0-3d5b-0067-e063-6394a90a9db3.zip
openFDA label cross-check# OpenFDA label data provides additional search and identifier links. DailyMed’s Structured Product Label is the canonical label on FDA.report. Matching records are deduplicated before they are shown below.
Matched openFDA labels page 26 of 357 · 7,139 matching rows.
Packages# Package NDC, 11-digit format, Description table Package NDC 11-digit format Description Units Marketing start Sample Exclude flag Status 65278-319-01 65278031901 112.38 g in 1 TUBE (65278-319-01) 112.38 g 2021-03-20 No No Current 65278-319-02 65278031902 112.38 g in 1 CARTON (65278-319-02) 112.38 g 2021-03-20 No No Current