Home NDC 85536-585 Back9ine Skincare Pure Invisible Sunscreen SPF 50
Product NDC 85536-585
11-digit product format 855360585
Labeler code 85536
Product ID 85536-585_335d5ea9-9bfc-ed5c-e063-6394a90aa169
Type HUMAN OTC DRUG
Nonproprietary name AVOBENZONE, HOMOSALATE, OCTISALATE, OCTOCRYLENE
Dosage form GEL
Route TOPICAL
Labeler Back 9ine Skincare, LLC
Application M020
Marketing category OTC MONOGRAPH DRUG
Marketing start 2025-01-31
Substance AVOBENZONE; HOMOSALATE; OCTISALATE; OCTOCRYLENE
Active strength 30; 70; 50; 100 mg/mL; mg/mL; mg/mL; mg/mL
NDC exclude flag No
Listing certified through 2026-12-31
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 Back9ine Skincare Pure Invisible Sunscreen SPF 50
Listing expiration 2026-12-31 Active Ingredients# Ingredient, Strength table Ingredient Strength AVOBENZONE 30 mg/mL HOMOSALATE 70 mg/mL OCTISALATE 50 mg/mL OCTOCRYLENE 100 mg/mL
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 85536-585-00 Back9ine Skincare Pure Invisible Sunscreen SPF 50 1 in 1 BOX GEL 1 1 85536-585-00 Back9ine Skincare Pure Invisible Sunscreen SPF 50 50 mL in 1 BOTTLE, PUMP GEL 50 1
DailyMed Dashboard NDC Coverage# NDC, Dashboard title, SPL version table NDC Dashboard title SPL version Validation Dashboard ZIP 85536-585 BACK9INE SKINCARE PURE INVISIBLE SUNSCREEN SPF 50 (AVOBENZONE, HOMOSALATE, OCTISALATE, OCTOCRYLENE) GEL [BACK 9INE SKINCARE, LLC] 1 Current NDC, 2 package rows 20250424_974ede40-cfb5-4612-b168-5d42dd137f63.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 Marketing start Sample Exclude flag Status 85536-585-00 85536058500 1 BOTTLE, PUMP in 1 BOX (85536-585-00) / 50 mL in 1 BOTTLE, PUMP 2025-01-31 No No Current