Home NDC 82866-005 PRIDEFUL SPF 15 LIP BALM-passion fruit
Product NDC 82866-005
11-digit product format 828660005
Labeler code 82866
Product ID 82866-005_089fcbdc-abce-8534-e063-6394a90a2923
Type HUMAN OTC DRUG
Nonproprietary name HOMOSALATE, OCTISALATE, OCTOCRYLENE, AVOBENZONE
Dosage form STICK
Route TOPICAL
Labeler PRIDEFUL LLC
Application M020
Marketing category OTC MONOGRAPH DRUG
Marketing start 2022-07-28
Substance HOMOSALATE; OCTISALATE; OCTOCRYLENE; AVOBENZONE
Active strength 100; 50; 30; 20 mg/g; mg/g; mg/g; mg/g
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 PRIDEFUL SPF 15 LIP BALM-passion fruit
Listing expiration 2027-12-31 Active Ingredients# Ingredient, Strength table Ingredient Strength HOMOSALATE 100 mg/g OCTISALATE 50 mg/g OCTOCRYLENE 30 mg/g AVOBENZONE 20 mg/g
Harmonized UNII identifiers# UNII identifiers page 1 of 1 · 4 matching rows.
Harmonized SPL set identifiers# SPL set identifiers page 1 of 1 · 1 matching rows.
DailyMed Package Descriptions# Package NDC, Product, Description table Package NDC Product Description Form Quantity Strength SPL version 82866-005-00 PRIDEFUL SPF 15 LIP BALM-passion fruit 3 g in 1 TUBE STICK 3 2
DailyMed Dashboard NDC Coverage# NDC, Dashboard title, SPL version table NDC Dashboard title SPL version Validation Dashboard ZIP 82866-005 PRIDEFUL SPF 15 LIP BALM-PASSION FRUIT (HOMOSALATE, OCTISALATE, OCTOCRYLENE, AVOBENZONE) STICK [PRIDEFUL LLC] 2 Current NDC, Legacy NDC, 1 package rows 20231027_d6b6389b-c8bd-4aca-8ccf-455dbc22070d.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 242 of 353 · 7,041 matching rows.
Packages# Package NDC, 11-digit format, Description table Package NDC 11-digit format Description Units Marketing start Marketing end Sample Exclude flag Status 82866-005-00 82866000500 3 g in 1 TUBE (82866-005-00) 3 g 2022-07-28 0000-00-00 No No Current