Home NDC 70809-1235 Sunscreen Lip Balm SPF 30 Cool Mint
Product NDC 70809-1235
11-digit product format 708091235
Labeler code 70809
Product ID 70809-1235_32e678d4-d203-1ee5-e063-6394a90ac69b
Type HUMAN OTC DRUG
Nonproprietary name AVOBENZONE 3%, HOMOSALATE 7%, OCTISALATE 4.5%, OCTOCRYLENE 9%
Dosage form STICK
Route TOPICAL
Labeler USRX
Application M020
Marketing category OTC MONOGRAPH DRUG
Marketing start 2025-05-15
Substance AVOBENZONE; OCTOCRYLENE; OCTISALATE; HOMOSALATE
Active strength 3; 9; 4.5; 7 g/100g; g/100g; g/100g; g/100g
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 Sunscreen Lip Balm SPF 30 Cool Mint
Listing expiration 2026-12-31 Active Ingredients# Ingredient, Strength table Ingredient Strength AVOBENZONE 3 g/100g OCTOCRYLENE 9 g/100g OCTISALATE 4.5 g/100g HOMOSALATE 7 g/100g
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 70809-1235-1 Sunscreen Lip Balm SPF 30 Cool Mint 4.8 g in 1 TUBE STICK 4.8 2 70809-1235-2 Sunscreen Lip Balm SPF 30 Cool Mint 1 in 1 BOX STICK 1 2
DailyMed Dashboard NDC Coverage# NDC, Dashboard title, SPL version table NDC Dashboard title SPL version Validation Dashboard ZIP 70809-1235 SUNSCREEN LIP BALM SPF 30 COOL MINT (AVOBENZONE 3%, HOMOSALATE 7%, OCTISALATE 4.5%, OCTOCRYLENE 9%) STICK [USRX] 2 Current NDC, 2 package rows 20250515_3271ab14-3bf5-a24f-e063-6294a90a59bc.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 70809-1235-1 70809123501 4.8 g in 1 TUBE 4.8 g Historical 70809-1235-2 70809123502 1 TUBE in 1 BOX (70809-1235-2) / 4.8 g in 1 TUBE (70809-1235-1) 1 tube 2025-05-15 No No Current