FDA.reportPublic FDA data

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
IngredientStrength
AVOBENZONE30 mg/g
OCTISALATE50 mg/g
HOMOSALATE100 mg/g

Harmonized UNII identifiers#

UNII identifiers page 1 of 1 · 3 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
4X49Y0596WInternal UNII lookup
G63QQF2NOXInternal UNII lookup
V06SV4M95SInternal UNII lookup

Harmonized SPL set identifiers#

SPL set identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
d92a17c4-9827-5fb1-e053-2a95a90a9ca1Available on FDA.report

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
82657-014-01Cay Skin Isle Lip Balm SPF 30 Bad Gyal Berry10 g in 1 TUBE, WITH APPLICATORCREAM105
82657-014-01Cay Skin Isle Lip Balm SPF 30 Bad Gyal Berry1 in 1 CARTONCREAM15

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
82657-014CAY 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.]4Current NDC, 2 package rows20250119_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 175 of 346 · 6,912 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Hello Bello Kids SPF 50 Face and Body Sunscreen StickZINC OXIDEHello Bello4127e49a-eb27-e8e2-e063-6294a90a469e2025-10-16WarningsExact identifier
application number: M020
ELEVEN UNRIVALED SERUMZINC OXIDEEco Chic, LLCf4bdacb9-bedd-c9cc-e053-2995a90a57862025-10-16WarningsExact identifier
application number: M020
ELEVEN BY VENUS WILLIAMS ACE THE DAY FaceZINC OXIDEEco-Chic LLCde438665-72d9-9b1b-e053-2a95a90ab9ef2025-10-16WarningsExact identifier
application number: M020
Neutrogena Beach Defense Water Plus Sun Protection Sunscreen Broad Spectrum SPF 30AVOBENZONE, HOMOSALATE, OCTISALATE, AND OCTOCRYLENEKenvue Brands LLC6bb07f16-c3a3-49e7-ae13-718bb00558732025-10-16WarningsExact identifier
application number: M020
Illuminizing Blendrops Broad Spectrum SPF 40HOMOSALATE, OCTISALATE, ZINC OXIDEWasatch Product Development, LLC124e6702-97a4-95bf-e063-6394a90afc0d2025-10-16WarningsExact identifier
application number: M020
Perfecting Blendrops Broad Spectrum SPF 46HOMOSALATE, OCTISALATE, ZINC OXIDEWasatch Product Development, LLC414c1186-6f68-3828-e063-6294a90a66cf2025-10-16WarningsExact identifier
application number: M020
Bronzing Blendrops Broad Spectrum SPF 46HOMOSALATE, OCTISALATE, ZINC OXIDEWasatch Product Development, LLC414c2db8-3122-60d3-e063-6394a90ae1c82025-10-16WarningsExact identifier
application number: M020
DD CreamDD CREAMDERMAdoctor, Inc.08c9a0cf-ee78-483b-e054-00144ff88e882025-10-16WarningsExact identifier
application number: M020
Ciele Bronze and ProtectZINC OXIDECiele LLC22003cbf-5a6d-001b-e063-6394a90aefdd2025-10-15WarningsExact identifier
application number: M020
Ciele Blush and ProtectZINC OXIDECiele0162c891-ba2d-a78f-e063-6394a90a156c2025-10-15WarningsExact identifier
application number: M020
Ciele Filter and ProtectTITANIUM DIOXIDE, ZINC OXIDECiele0309b0ef-baca-b41d-e063-6294a90a49d72025-10-15WarningsExact identifier
application number: M020
Ciele Sculpt and ProtectZINC OXIDECiele LLC21ff7f78-b543-0bea-e063-6294a90aed702025-10-15WarningsExact identifier
application number: M020
LATHER- DAILY DEFENSE MINERAL SPF 50 BODY SUNSCREENZINC OXIDELather, Inc.3158a2d7-0db5-f5bf-e063-6294a90a31262025-10-15WarningsExact identifier
application number: M020
LATHER- DAILY DEFENSE MINERAL SPF 50ZINC OXIDELather, Inc.81cf57b0-6072-432f-b421-7d1a708da1c42025-10-15WarningsExact identifier
application number: M020
Ciele Glow and ProtectZINC OXIDECiele Cosmetics27310d47-de1b-2149-e063-6394a90abe832025-10-15WarningsExact identifier
application number: M020
Sunforgettable Total Protection Sport StickZINC OXIDEColorescienced3c0d2b0-f411-565d-e053-2a95a90a081b2025-10-15WarningsExact identifier
application number: M020
Defend and Balance TInted Mineral Sunscreen SPF 50SUNSCREENEpicuren Discovery41367f05-59d8-6736-e063-6394a90a5f172025-10-15WarningsExact identifier
application number: M020
Banana BoatAVOBENZONE HOMOSALATE OCTOCRYLENEEdgewell Personal Care Brands LLC41376da3-5274-b133-e063-6394a90afa132025-10-15WarningsExact identifier
application number: M020
Curology Daily Moisturizing Sunscreen SPF 30AVOBENZONE, HOMOSALATE, OCTISALATE, OCTOCRYLENECurologyee59d52e-5dc6-4fb4-96d8-0bda40e230092025-10-15WarningsExact identifier
application number: M020
SUNFORGETTABLE TOTAL PROTECTION COLOR BALM COLLECTION ENDLESSS ENDLESS SUNSETZINC OXIDEColoresciencef4aa14ed-6c6f-8301-e053-2a95a90a5e232025-10-15WarningsExact identifier
application number: M020

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionMarketing startSampleExclude flagStatus
82657-014-01826570014011 TUBE, WITH APPLICATOR in 1 CARTON (82657-014-01) / 10 g in 1 TUBE, WITH APPLICATOR2023-01-01NoNoCurrent