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 125 of 353 · 7,049 matching rows.
Brand, Generic, Manufacturer table Brand Generic Manufacturer SPL set ID Effective date Available safety fields Join Daily Restore ZINC OXIDE TYRLIN ENTERPRISES, INC. 35cead50-86a7-2cf2-e063-6294a90a5f99 2025-12-15 Exact identifier application number: M020 Daily Defense Facial Sunscreen Plus Primer TITANIUM DIOXIDE, ZINC OXIDE LAURA CATHERINE, LLC 36e81e8e-0ba7-93e6-e063-6294a90a4e62 2025-12-15 Exact identifier application number: M020 Sacred Aura ZINC OXIDE IRIA SKIN OASIS LLC 36eaaa54-e288-6590-e063-6394a90a403d 2025-12-15 Exact identifier application number: M020 Daily Defense Facial Sunscreen Plus Primer TITANIUM DIOXIDE, ZINC OXIDE LAURA CATHERINE, LLC 36e84147-5dcd-517a-e063-6394a90a54ee 2025-12-15 Exact identifier application number: M020 Sacred Glow ZINC OXIDE IRIA SKIN OASIS LLC 36ead65c-a46c-7395-e063-6394a90a9e04 2025-12-15 Exact identifier application number: M020 Sheer Mineral Face And Body Sunscreen Non Tinted ZINC OXIDE LAURA CATHERINE, LLC 36e91877-c4c4-7fa3-e063-6294a90a1326 2025-12-15 Exact identifier application number: M020 Sheer Mineral Face And Body Sunscreen Tinted ZINC OXIDE LAURA CATHERINE, LLC 36e880af-debc-657f-e063-6394a90ab6ff 2025-12-15 Exact identifier application number: M020 Sheer Mineral Face And Body Sunscreen Tinted ZINC OXIDE LAURA CATHERINE, LLC 36e8b631-03e7-c1de-e063-6294a90aa530 2025-12-15 Exact identifier application number: M020 Sheer Mineral Face And Body Sunscreen Non Tinted ZINC OXIDE LAURA CATHERINE, LLC 36e957cf-cfa5-b122-e063-6294a90a78ce 2025-12-15 Exact identifier application number: M020 Skin Shield Plus ZINC OXIDE LAURA CATHERINE, LLC 36e9c2f3-ea89-0de3-e063-6394a90a9fb6 2025-12-15 Exact identifier application number: M020 Skin Shield Plus ZINC OXIDE LAURA CATHERINE, LLC 36e9958b-cc5c-f7ff-e063-6394a90ac80d 2025-12-15 Exact identifier application number: M020 Tinted Mineral Sunscreen Plus Primer Matte TITANIUM DIOXIDE, ZINC OXIDE Simply Bare Waxing & Skin Care LLC 36d8e8ba-a3dd-257d-e063-6294a90a30d6 2025-12-15 Exact identifier application number: M020 Tinted Lip Sunscreen TITANIUM DIOXIDE, ZINC OXIDE LAURA CATHERINE, LLC 36e9e8d7-3fcf-1e94-e063-6394a90a8dc6 2025-12-15 Exact identifier application number: M020 Tinted Mineral Sunscreen Plus Primer CPlusE Glow ZINC OXIDE Simply Bare Waxing & Skin Care LLC 36d968df-5168-61bf-e063-6294a90a94b7 2025-12-15 Exact identifier application number: M020 Advanced Sun Protection TITANIUM DIOXIDE, ZINC OXIDE HELLO BEAUTIFUL SKIN STUDIO 36d45b48-e08d-ef40-e063-6394a90a635c 2025-12-15 Exact identifier application number: M020 Advanced Sun Protection TITANIUM DIOXIDE, ZINC OXIDE HELLO BEAUTIFUL SKIN STUDIO 36d439fb-b9cf-2774-e063-6294a90ae885 2025-12-15 Exact identifier application number: M020 Tinted Mineral Sunscreen Plus Primer CPlusE Glow ZINC OXIDE Simply Bare Waxing & Skin Care LLC 36d9b48d-e3db-6ae2-e063-6294a90abbf5 2025-12-15 Exact identifier application number: M020 Tinted Mineral Sunscreen Plus Primer Matte TITANIUM DIOXIDE, ZINC OXIDE Simply Bare Waxing & Skin Care LLC 36d9d83b-7da7-a006-e063-6394a90a9d84 2025-12-15 Exact identifier application number: M020 Advanced Sun Protection TITANIUM DIOXIDE, ZINC OXIDE HELLO BEAUTIFUL SKIN & ACNE 36d3ebc0-1de6-1998-e063-6294a90a02e6 2025-12-15 Exact identifier application number: M020 Sun Safe Lip Balm TITANIUM DIOXIDE, ZINC OXIDE REVIVE IN SOLANO 36c4f0c9-5789-ca58-e063-6394a90a2323 2025-12-15 Exact identifier application number: M020
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