Home NDC 65692-0577 Broad Spectrum SPF 30 Tropical Sunscreen
Product NDC 65692-0577
11-digit product format 656920577
Labeler code 65692
Product ID 65692-0577_18e7fc6b-b40b-f790-e063-6294a90ad0f4
Type HUMAN OTC DRUG
Nonproprietary name Broad Spectrum SPF 30 Tropical Sunscreen
Dosage form LOTION
Route TOPICAL
Labeler Raining Rose, Inc
Application M020
Marketing category OTC MONOGRAPH DRUG
Marketing start 2024-05-20
Substance OCTISALATE; AVOBENZONE; OCTOCRYLENE; HOMOSALATE
Active strength 1.5; .9; 2.4; 3 g/30mL; g/30mL; g/30mL; g/30mL
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 Broad Spectrum SPF 30 Tropical Sunscreen
Listing expiration 2026-12-31 Active Ingredients# Ingredient, Strength table Ingredient Strength OCTISALATE 1.5 g/30mL AVOBENZONE .9 g/30mL OCTOCRYLENE 2.4 g/30mL HOMOSALATE 3 g/30mL
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 Product Concepts# DailyMed Package Descriptions# Package NDC, Product, Description table Package NDC Product Description Form Quantity Strength SPL version 65692-0577-1 Broad Spectrum SPF 30 Tropical Sunscreen 30 mL in 1 BOTTLE, PLASTIC LOTION 30 1
DailyMed Dashboard NDC Coverage# NDC, Dashboard title, SPL version table NDC Dashboard title SPL version Validation Dashboard ZIP 65692-0577 BROAD SPECTRUM SPF 30 TROPICAL SUNSCREEN LOTION [RAINING ROSE, INC] 1 Current NDC, 1 package rows 20240522_18e7fc6b-b40a-f790-e063-6294a90ad0f4.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 65692-0577-1 65692057701 30 mL in 1 BOTTLE, PLASTIC (65692-0577-1) 30 ml 2024-05-20 No No Current