Home NDC 85033-005 SPF 30 Sunscreen
Product NDC 85033-005
11-digit product format 850330005
Labeler code 85033
Product ID 85033-005_55f6816c-afae-807e-e063-6394a90ae791
Type HUMAN OTC DRUG
Nonproprietary name Homosalate 10% Octisalate 5% Avobenzone 3%
Dosage form SPRAY
Route TOPICAL
Labeler Coconut Caliente Costa Rica LLC
Application M020
Marketing category OTC MONOGRAPH DRUG
Marketing start 2025-10-16
Substance HOMOSALATE; OCTISALATE; AVOBENZONE
Active strength 10; 5; 3 g/100mL; g/100mL; g/100mL
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 SPF 30 Sunscreen
Listing expiration 2027-12-31 Active Ingredients# Ingredient, Strength table Ingredient Strength HOMOSALATE 10 g/100mL OCTISALATE 5 g/100mL AVOBENZONE 3 g/100mL
Harmonized UNII identifiers# UNII identifiers page 1 of 1 · 3 matching rows.
Identifier, FDA.report destination table Identifier FDA.report destination V06SV4M95S Internal UNII lookup 4X49Y0596W Internal UNII lookup G63QQF2NOX Internal UNII lookup
Harmonized SPL set identifiers# SPL set identifiers page 1 of 1 · 1 matching rows.
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 85033-005-04 85033000504 117 mL in 1 CAN (85033-005-04) 117 ml 2025-10-16 No No Current