Home NDC 82657-014 Cay Skin Isle Lip Balm SPF 30 Bad Gyal Berry
Product NDC 82657-014
11-digit product format 826570014
Labeler code 82657
Product ID 82657-014_4ce8a97f-d746-1572-e063-6294a90af82c
Type HUMAN OTC DRUG
Nonproprietary name Avobenzone, Homosalate, Octisalate
Dosage form CREAM
Route TOPICAL
Labeler Cay Skin, Inc.
Application M020
Marketing category OTC MONOGRAPH DRUG
Marketing start 2023-01-01
Substance AVOBENZONE; OCTISALATE; HOMOSALATE
Active strength 30; 50; 100 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 Lip Balm SPF 30 Bad Gyal Berry
Listing expiration 2027-12-31 Active Ingredients# Ingredient, Strength table Ingredient Strength AVOBENZONE 30 mg/g OCTISALATE 50 mg/g HOMOSALATE 100 mg/g
Harmonized UNII identifiers# UNII identifiers page 1 of 1 · 3 matching rows.
Identifier, FDA.report destination table Identifier FDA.report destination 4X49Y0596W Internal UNII lookup G63QQF2NOX Internal UNII lookup V06SV4M95S Internal UNII lookup
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 82657-014-01 Cay Skin Isle Lip Balm SPF 30 Bad Gyal Berry 10 g in 1 TUBE, WITH APPLICATOR CREAM 10 5 82657-014-01 Cay Skin Isle Lip Balm SPF 30 Bad Gyal Berry 1 in 1 CARTON CREAM 1 5
DailyMed Dashboard NDC Coverage# NDC, Dashboard title, SPL version table NDC Dashboard title SPL version Validation Dashboard ZIP 82657-014 CAY SKIN ISLE LIP BALM SPF 30 CORAL (AVOBENZONE, HOMOSALATE, OCTISALATE) CREAM CAY SKIN ISLE LIP BALM SPF 30 BAD GYAL BERRY (AVOBENZONE, HOMOSALATE, OCTISALATE) CREAM CAY SKIN ISLE LIP BALM SPF 30 NUDE TING (AVOBENZONE, HOMOSALATE, OCTISALATE) CREAM CAY SKIN ISLE LIP BALM SPF 30 COCOA CABANA (AVOBENZONE, HOMOSALATE, OCTISALATE) CREAM CAY SKIN ISLE LIP BALM SPF 30 (AVOBENZONE, HOMOSALATE, OCTISALATE) CREAM CAY SKIN ISLE LIP BALM SPF 30 IRIE ROSE (AVOBENZONE, HOMOSALATE, OCTISALATE) CREAM [CAY SKIN, INC.] 4 Current NDC, 2 package rows 20250119_d92a17c4-9827-5fb1-e053-2a95a90a9ca1.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 Sample Exclude flag Status 82657-014-01 82657001401 1 TUBE, WITH APPLICATOR in 1 CARTON (82657-014-01) / 10 g in 1 TUBE, WITH APPLICATOR 2023-01-01 No No Current