Home NDC 82657-007 Cay Skin Isle Sheen Sunstick SPF 35
Product NDC 82657-007
11-digit product format 826570007
Labeler code 82657
Product ID 82657-007_288c3aeb-01b3-ce39-e063-6394a90ad04a
Type HUMAN OTC DRUG
Nonproprietary name Avobenzone, Homosalate, Octisalate, Octocrylene
Dosage form STICK
Route TOPICAL
Labeler Cay Skin, Inc.
Application M020
Marketing category OTC MONOGRAPH DRUG
Marketing start 2024-07-19
Substance OCTISALATE; AVOBENZONE; HOMOSALATE; OCTOCRYLENE
Active strength 49; 29; 49; 95 mg/g; mg/g; mg/g; mg/g
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 Sheen Sunstick SPF 35
Listing expiration 2027-12-31 Active Ingredients# Ingredient, Strength table Ingredient Strength OCTISALATE 49 mg/g AVOBENZONE 29 mg/g HOMOSALATE 49 mg/g OCTOCRYLENE 95 mg/g
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 82657-007-01 Cay Skin Isle Sheen Sunstick SPF 35 1 in 1 CARTON STICK 1 1 82657-007-01 Cay Skin Isle Sheen Sunstick SPF 35 15 g in 1 CONTAINER STICK 15 1
DailyMed Dashboard NDC Coverage# NDC, Dashboard title, SPL version table NDC Dashboard title SPL version Validation Dashboard ZIP 82657-007 CAY SKIN ISLE SHEEN SUNSTICK SPF 35 (AVOBENZONE, HOMOSALATE, OCTISALATE, OCTOCRYLENE) STICK [CAY SKIN, INC.] 1 Current NDC, 2 package rows 20241208_288c3aeb-01b2-ce39-e063-6394a90ad04a.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 45 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 82657-007-01 82657000701 1 CONTAINER in 1 CARTON (82657-007-01) / 15 g in 1 CONTAINER 1 container 2024-07-19 No No Current