Home NDC 85678-997 Cloud Brush On Sunscreen Clear Broad Spectrum SPF 50
Product NDC 85678-997
11-digit product format 856780997
Labeler code 85678
Product ID 85678-997_47eee82b-b169-fcf6-e063-6394a90ace25
Type HUMAN OTC DRUG
Nonproprietary name AVOBENZONE, HOMOSALATE, OCTISALATE, OCTOCRYLENE
Dosage form GEL
Route TOPICAL
Labeler FUTURE 8 LLC
Application M020
Marketing category OTC MONOGRAPH DRUG
Marketing start 2024-12-04
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 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 Cloud Brush On Sunscreen Clear Broad Spectrum SPF 50
Listing expiration 2027-12-31 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 85678-997-00 Cloud Brush On Sunscreen Clear Broad Spectrum SPF 50 20 mL in 1 BOTTLE, WITH APPLICATOR GEL 20 1 85678-997-00 Cloud Brush On Sunscreen Clear Broad Spectrum SPF 50 1 in 1 BOX GEL 1 1
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 85678-997-00 85678099700 1 BOTTLE, WITH APPLICATOR in 1 BOX (85678-997-00) / 20 mL in 1 BOTTLE, WITH APPLICATOR 2024-12-04 No No Current