Home NDC 82657-002 Cay Skin Isle Glow Face SPF 45
Product NDC 82657-002
11-digit product format 826570002
Labeler code 82657
Product ID 82657-002_2889f129-f28a-1164-e063-6394a90a688d
Type HUMAN OTC DRUG
Nonproprietary name Avobenzone, Octisalate, Octocrylene
Dosage form LOTION
Route TOPICAL
Labeler Cay Skin, Inc.
Application M020
Marketing category OTC MONOGRAPH DRUG
Marketing start 2022-03-29
Substance OCTOCRYLENE; AVOBENZONE; OCTISALATE
Active strength 100; 30; 50 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 Cay Skin Isle Glow Face SPF 45
Listing expiration 2027-12-31 Active Ingredients# Ingredient, Strength table Ingredient Strength OCTOCRYLENE 100 mg/mL AVOBENZONE 30 mg/mL OCTISALATE 50 mg/mL
Harmonized UNII identifiers# UNII identifiers page 1 of 1 · 3 matching rows.
Identifier, FDA.report destination table Identifier FDA.report destination 5A68WGF6WM Internal UNII lookup G63QQF2NOX Internal UNII lookup 4X49Y0596W Internal UNII lookup
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 82657-002-01 Cay Skin Isle Glow Face SPF 45 1 in 1 CARTON LOTION 1 2 82657-002-01 Cay Skin Isle Glow Face SPF 45 45 mL in 1 BOTTLE, PUMP LOTION 45 2
DailyMed Dashboard NDC Coverage# NDC, Dashboard title, SPL version table NDC Dashboard title SPL version Validation Dashboard ZIP 82657-002 CAY SKIN ISLE GLOW FACE SPF 45 (AVOBENZONE, OCTISALATE, OCTOCRYLENE) LOTION [CAY SKIN, INC.] 2 Current NDC, Legacy NDC, 2 package rows 20241208_d91bba06-fd9b-3eb5-e053-2995a90a6124.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 81 of 354 · 7,077 matching rows.
Packages# Package NDC, 11-digit format, Description table Package NDC 11-digit format Description Marketing start Marketing end Sample Exclude flag Status 82657-002-01 82657000201 1 BOTTLE, PUMP in 1 CARTON (82657-002-01) / 45 mL in 1 BOTTLE, PUMP 2022-03-29 0000-00-00 No No Current