Cay Skin Isle Lip Balm SPF 30 Coral

Product NDC
82657-011
11-digit product format
826570011
Labeler code
82657
Product ID
82657-011_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
2025-01-01
Substance
AVOBENZONE; HOMOSALATE; OCTISALATE
Active strength
30; 100; 50 mg/g; mg/g; mg/g
NDC exclude flag
No
Listing certified through
2027-12-31
Current FDA listing
Yes

Additional Listing Data#

Finished product
Yes
Brand name base
Cay Skin Isle Lip Balm SPF 30 Coral
Listing expiration
2027-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
AVOBENZONE30 mg/g
HOMOSALATE100 mg/g
OCTISALATE50 mg/g

Harmonized Identifiers#

Field, Values table
FieldValues
Unii4X49Y0596W, V06SV4M95S, G63QQF2NOX

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
82657-011-01Cay Skin Isle Lip Balm SPF 30 Coral1 in 1 CARTONCREAM15
82657-011-01Cay Skin Isle Lip Balm SPF 30 Coral10 g in 1 TUBE, WITH APPLICATORCREAM105

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
82657-011CAY 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

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionMarketing startSampleExclude flagStatus
82657-011-01826570011011 TUBE, WITH APPLICATOR in 1 CARTON (82657-011-01) / 10 g in 1 TUBE, WITH APPLICATOR2025-01-01NoNoHistorical