Home NDC 82657-003 Cay Skin Isle Glow Body SPF 45
Product NDC 82657-003
11-digit product format 826570003
Labeler code 82657
Product ID 82657-003_2889eedb-0de1-204f-e063-6394a90aaa96
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 AVOBENZONE; OCTISALATE; OCTOCRYLENE
Active strength 30; 50; 100 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 Body SPF 45
Listing expiration 2027-12-31 Active Ingredients# Ingredient, Strength table Ingredient Strength AVOBENZONE 30 mg/mL OCTISALATE 50 mg/mL OCTOCRYLENE 100 mg/mL
Harmonized UNII identifiers# UNII identifiers page 1 of 1 · 3 matching rows.
Identifier, FDA.report destination table Identifier FDA.report destination G63QQF2NOX Internal UNII lookup 4X49Y0596W Internal UNII lookup 5A68WGF6WM 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 82657-003-01 Cay Skin Isle Glow Body SPF 45 100 mL in 1 BOTTLE, PUMP LOTION 100 2 82657-003-01 Cay Skin Isle Glow Body SPF 45 1 in 1 CARTON LOTION 1 2
DailyMed Dashboard NDC Coverage# NDC, Dashboard title, SPL version table NDC Dashboard title SPL version Validation Dashboard ZIP 82657-003 CAY SKIN ISLE GLOW BODY SPF 45 (AVOBENZONE, OCTISALATE, OCTOCRYLENE) LOTION [CAY SKIN, INC.] 2 Current NDC, Legacy NDC, 2 package rows 20241208_db5f6bad-65ae-2b05-e053-2a95a90a8569.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 Marketing start Marketing end Sample Exclude flag Status 82657-003-01 82657000301 1 BOTTLE, PUMP in 1 CARTON (82657-003-01) / 100 mL in 1 BOTTLE, PUMP 2022-03-29 0000-00-00 No No Current