Home NDC 82657-006 Cay Skin Isle Body Oil SPF 30
Product NDC 82657-006
11-digit product format 826570006
Labeler code 82657
Product ID 82657-006_d91b2097-9272-21d0-e053-2a95a90ac39f
Type HUMAN OTC DRUG
Nonproprietary name Avobenzone, Homosalate, Octisalate, Octocrylene
Dosage form OIL
Route TOPICAL
Labeler Cay Skin, Inc.
Application part352
Marketing category OTC MONOGRAPH NOT FINAL
Marketing start 2022-03-29
Marketing end 0000-00-00
Substance AVOBENZONE; HOMOSALATE; OCTISALATE; OCTOCRYLENE
Active strength 30 mg/mL; mg/mL; mg/mL; mg/mL
NDC exclude flag No
Listing certified through 2023-12-31
Current FDA listing Historical FDA.report record
Observed NDC auxiliary status history# This history shows the information present in each captured FDA auxiliary file. It is not a continuous regulatory timeline, and a missing record does not establish a status.
Historic NDC status page 1 of 1 · 2 matching rows.
View current auxiliary records. · View the auxiliary file history.
Captured / source date, Dataset, Scope table Captured / source date Dataset Scope Product NDC Package NDC Code Status Reporting period Archive Snapshot Source SHA-256 2025-12-14 17:58 UTC · source 2025-12-05 excluded product product 82657-006 D Discontinued by firm excluded / ndc_excluded.zip d630ba8d3edf…732f749b63fb…2025-12-14 17:58 UTC · source 2025-12-05 excluded package package 82657-006 82657-006-01 D Discontinued by firm excluded / ndc_excluded.zip d630ba8d3edf…732f749b63fb…
Reported adverse events (FAERS/openFDA)# Adverse event summaries are temporarily unavailable. Other product information remains available.
DailyMed Product Concepts# DailyMed Dashboard NDC Coverage# NDC, Dashboard title, SPL version table NDC Dashboard title SPL version Validation Dashboard ZIP 82657-006 CAY SKIN ISLE BODY OIL SPF 30 (AVOBENZONE, HOMOSALATE, OCTISALATE, OCTOCRYLENE) OIL [CAY SKIN, INC.] 2 Legacy NDC 20241208_d91b2097-9271-21d0-e053-2a95a90ac39f.zip
Packages# Package NDC, 11-digit format, Description table Package NDC 11-digit format Description Marketing start Marketing end Sample Exclude flag Status 82657-006-01 82657000601 1 BOTTLE, PUMP in 1 CARTON (82657-006-01) > 110 mL in 1 BOTTLE, PUMP 2022-03-29 0000-00-00 No No Current