FDA.reportPublic FDA data

SUNLEYA Age minimizing sun care

Product NDC
66097-002
11-digit product format
660970002
Labeler code
66097
Product ID
66097-002_28f039ed-b0dd-1225-e063-6394a90a80e1
Type
HUMAN OTC DRUG
Nonproprietary name
AVOBENZONE, OCTINOXATE, OCTISALATE, OXYBENZONE
Dosage form
CREAM
Route
TOPICAL
Labeler
C.F.E.B. Sisley
Application
M020
Marketing category
OTC MONOGRAPH DRUG
Marketing start
2013-01-21
Substance
AVOBENZONE; OCTINOXATE; OCTISALATE; OXYBENZONE
Active strength
30; 50; 50; 40 mg/g; mg/g; mg/g; mg/g
NDC exclude flag
No
Listing certified through
2026-12-31
Current FDA listing
Yes

Additional Listing Data#

Finished product
Yes
Brand name base
SUNLEYA Age minimizing sun care
Brand name suffix
SPF 15
Listing expiration
2026-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
AVOBENZONE30 mg/g
OCTINOXATE50 mg/g
OCTISALATE50 mg/g
OXYBENZONE40 mg/g

Harmonized Identifiers#

Field, Values table
FieldValues
UniiG63QQF2NOX, 4Y5P7MUD51, 4X49Y0596W, 95OOS7VE0Y

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
0ca1d589-929b-4b33-bc5b-1d84abdafa6aProduct name120150324
fc363c46-397b-4476-ac0f-70e43e8e4592Product name120150324
1681bc73-b05f-12c3-1075-382ae39f449cProduct name120140508

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
66097-002-50SUNLEYA Age minimizing sun care SPF 151 in 1 BOXCREAM16
66097-002-50SUNLEYA Age minimizing sun care SPF 1550.3 g in 1 BOTTLECREAM50.36

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIIDailyMed labelSPL versionUploaded
AVOBENZONEACTIVE INGREDIENTG63QQF2NOXSUNLEYA AGE MINIMIZING SUN CARE SPF 15 (AVOBENZONE, OCTINOXATE, OCTISALATE, OXYBENZONE) CREAM [C.F.E.B. SISLEY]3
OCTINOXATEACTIVE INGREDIENT4Y5P7MUD51SUNLEYA AGE MINIMIZING SUN CARE SPF 15 (AVOBENZONE, OCTINOXATE, OCTISALATE, OXYBENZONE) CREAM [C.F.E.B. SISLEY]3
OCTISALATEACTIVE INGREDIENT4X49Y0596WSUNLEYA AGE MINIMIZING SUN CARE SPF 15 (AVOBENZONE, OCTINOXATE, OCTISALATE, OXYBENZONE) CREAM [C.F.E.B. SISLEY]3
OXYBENZONEACTIVE INGREDIENT95OOS7VE0YSUNLEYA AGE MINIMIZING SUN CARE SPF 15 (AVOBENZONE, OCTINOXATE, OCTISALATE, OXYBENZONE) CREAM [C.F.E.B. SISLEY]3
AVOBENZONEACTIVE MOIETYG63QQF2NOXSUNLEYA AGE MINIMIZING SUN CARE SPF 15 (AVOBENZONE, OCTINOXATE, OCTISALATE, OXYBENZONE) CREAM [C.F.E.B. SISLEY]3
OCTINOXATEACTIVE MOIETY4Y5P7MUD51SUNLEYA AGE MINIMIZING SUN CARE SPF 15 (AVOBENZONE, OCTINOXATE, OCTISALATE, OXYBENZONE) CREAM [C.F.E.B. SISLEY]3
OCTISALATEACTIVE MOIETY4X49Y0596WSUNLEYA AGE MINIMIZING SUN CARE SPF 15 (AVOBENZONE, OCTINOXATE, OCTISALATE, OXYBENZONE) CREAM [C.F.E.B. SISLEY]3
OXYBENZONEACTIVE MOIETY95OOS7VE0YSUNLEYA AGE MINIMIZING SUN CARE SPF 15 (AVOBENZONE, OCTINOXATE, OCTISALATE, OXYBENZONE) CREAM [C.F.E.B. SISLEY]3
.ALPHA.-TOCOPHEROL ACETATEINACTIVE INGREDIENT9E8X80D2L0SUNLEYA AGE MINIMIZING SUN CARE SPF 15 (AVOBENZONE, OCTINOXATE, OCTISALATE, OXYBENZONE) CREAM [C.F.E.B. SISLEY]3
1,2-HEXANEDIOLINACTIVE INGREDIENTTR046Y3K1GSUNLEYA AGE MINIMIZING SUN CARE SPF 15 (AVOBENZONE, OCTINOXATE, OCTISALATE, OXYBENZONE) CREAM [C.F.E.B. SISLEY]3
ALLANTOININACTIVE INGREDIENT344S277G0ZSUNLEYA AGE MINIMIZING SUN CARE SPF 15 (AVOBENZONE, OCTINOXATE, OCTISALATE, OXYBENZONE) CREAM [C.F.E.B. SISLEY]3
ARACHIDYL ALCOHOLINACTIVE INGREDIENT1QR1QRA9BUSUNLEYA AGE MINIMIZING SUN CARE SPF 15 (AVOBENZONE, OCTINOXATE, OCTISALATE, OXYBENZONE) CREAM [C.F.E.B. SISLEY]3
ARACHIDYL GLUCOSIDEINACTIVE INGREDIENT6JVW35JOOJSUNLEYA AGE MINIMIZING SUN CARE SPF 15 (AVOBENZONE, OCTINOXATE, OCTISALATE, OXYBENZONE) CREAM [C.F.E.B. SISLEY]3
ARGININEINACTIVE INGREDIENT94ZLA3W45FSUNLEYA AGE MINIMIZING SUN CARE SPF 15 (AVOBENZONE, OCTINOXATE, OCTISALATE, OXYBENZONE) CREAM [C.F.E.B. SISLEY]3
BUTYLATED HYDROXYTOLUENEINACTIVE INGREDIENT1P9D0Z171KSUNLEYA AGE MINIMIZING SUN CARE SPF 15 (AVOBENZONE, OCTINOXATE, OCTISALATE, OXYBENZONE) CREAM [C.F.E.B. SISLEY]3
C13-14 ISOPARAFFININACTIVE INGREDIENTE4F12ROE70SUNLEYA AGE MINIMIZING SUN CARE SPF 15 (AVOBENZONE, OCTINOXATE, OCTISALATE, OXYBENZONE) CREAM [C.F.E.B. SISLEY]3
CAPRYLYL GLYCOLINACTIVE INGREDIENT00YIU5438USUNLEYA AGE MINIMIZING SUN CARE SPF 15 (AVOBENZONE, OCTINOXATE, OCTISALATE, OXYBENZONE) CREAM [C.F.E.B. SISLEY]3
CETEARETH-33INACTIVE INGREDIENTR42C2O714BSUNLEYA AGE MINIMIZING SUN CARE SPF 15 (AVOBENZONE, OCTINOXATE, OCTISALATE, OXYBENZONE) CREAM [C.F.E.B. SISLEY]3
CETEARYL GLUCOSIDEINACTIVE INGREDIENT09FUA47KNASUNLEYA AGE MINIMIZING SUN CARE SPF 15 (AVOBENZONE, OCTINOXATE, OCTISALATE, OXYBENZONE) CREAM [C.F.E.B. SISLEY]3
CETOSTEARYL ALCOHOLINACTIVE INGREDIENT2DMT128M1SSUNLEYA AGE MINIMIZING SUN CARE SPF 15 (AVOBENZONE, OCTINOXATE, OCTISALATE, OXYBENZONE) CREAM [C.F.E.B. SISLEY]3
CUCUMBERINACTIVE INGREDIENTYY7C30VXJTSUNLEYA AGE MINIMIZING SUN CARE SPF 15 (AVOBENZONE, OCTINOXATE, OCTISALATE, OXYBENZONE) CREAM [C.F.E.B. SISLEY]3
DIISOPROPYL SEBACATEINACTIVE INGREDIENTJ8T3X564IHSUNLEYA AGE MINIMIZING SUN CARE SPF 15 (AVOBENZONE, OCTINOXATE, OCTISALATE, OXYBENZONE) CREAM [C.F.E.B. SISLEY]3
DIMETHICONEINACTIVE INGREDIENT92RU3N3Y1OSUNLEYA AGE MINIMIZING SUN CARE SPF 15 (AVOBENZONE, OCTINOXATE, OCTISALATE, OXYBENZONE) CREAM [C.F.E.B. SISLEY]3
DOCOSANOLINACTIVE INGREDIENT9G1OE216XYSUNLEYA AGE MINIMIZING SUN CARE SPF 15 (AVOBENZONE, OCTINOXATE, OCTISALATE, OXYBENZONE) CREAM [C.F.E.B. SISLEY]3
EDETATE SODIUMINACTIVE INGREDIENTMP1J8420LUSUNLEYA AGE MINIMIZING SUN CARE SPF 15 (AVOBENZONE, OCTINOXATE, OCTISALATE, OXYBENZONE) CREAM [C.F.E.B. SISLEY]3
GLYCERININACTIVE INGREDIENTPDC6A3C0OXSUNLEYA AGE MINIMIZING SUN CARE SPF 15 (AVOBENZONE, OCTINOXATE, OCTISALATE, OXYBENZONE) CREAM [C.F.E.B. SISLEY]3
LAURETH-7INACTIVE INGREDIENTZ95S6G8201SUNLEYA AGE MINIMIZING SUN CARE SPF 15 (AVOBENZONE, OCTINOXATE, OCTISALATE, OXYBENZONE) CREAM [C.F.E.B. SISLEY]3
LINALOOL, (+/-)-INACTIVE INGREDIENTD81QY6I88ESUNLEYA AGE MINIMIZING SUN CARE SPF 15 (AVOBENZONE, OCTINOXATE, OCTISALATE, OXYBENZONE) CREAM [C.F.E.B. SISLEY]3
MANGANESE CARBONATEINACTIVE INGREDIENT9ZV57512ZMSUNLEYA AGE MINIMIZING SUN CARE SPF 15 (AVOBENZONE, OCTINOXATE, OCTISALATE, OXYBENZONE) CREAM [C.F.E.B. SISLEY]3
PEG-8 LAURATEINACTIVE INGREDIENT762O8IWA10SUNLEYA AGE MINIMIZING SUN CARE SPF 15 (AVOBENZONE, OCTINOXATE, OCTISALATE, OXYBENZONE) CREAM [C.F.E.B. SISLEY]3
PENTYLENE GLYCOLINACTIVE INGREDIENT50C1307PZGSUNLEYA AGE MINIMIZING SUN CARE SPF 15 (AVOBENZONE, OCTINOXATE, OCTISALATE, OXYBENZONE) CREAM [C.F.E.B. SISLEY]3
PHENOXYETHANOLINACTIVE INGREDIENTHIE492ZZ3TSUNLEYA AGE MINIMIZING SUN CARE SPF 15 (AVOBENZONE, OCTINOXATE, OCTISALATE, OXYBENZONE) CREAM [C.F.E.B. SISLEY]3
PHYSALIS ALKEKENGI CALYXINACTIVE INGREDIENTAL7F9NO9HRSUNLEYA AGE MINIMIZING SUN CARE SPF 15 (AVOBENZONE, OCTINOXATE, OCTISALATE, OXYBENZONE) CREAM [C.F.E.B. SISLEY]3
POTASSIUM CETYL PHOSPHATEINACTIVE INGREDIENT03KCY6P7UTSUNLEYA AGE MINIMIZING SUN CARE SPF 15 (AVOBENZONE, OCTINOXATE, OCTISALATE, OXYBENZONE) CREAM [C.F.E.B. SISLEY]3
POTASSIUM SORBATEINACTIVE INGREDIENT1VPU26JZZ4SUNLEYA AGE MINIMIZING SUN CARE SPF 15 (AVOBENZONE, OCTINOXATE, OCTISALATE, OXYBENZONE) CREAM [C.F.E.B. SISLEY]3
PROPYLENE GLYCOLINACTIVE INGREDIENT6DC9Q167V3SUNLEYA AGE MINIMIZING SUN CARE SPF 15 (AVOBENZONE, OCTINOXATE, OCTISALATE, OXYBENZONE) CREAM [C.F.E.B. SISLEY]3
SAGE OILINACTIVE INGREDIENTU27K0H1H2OSUNLEYA AGE MINIMIZING SUN CARE SPF 15 (AVOBENZONE, OCTINOXATE, OCTISALATE, OXYBENZONE) CREAM [C.F.E.B. SISLEY]3
SHEANUT OILINACTIVE INGREDIENTO88E196QRFSUNLEYA AGE MINIMIZING SUN CARE SPF 15 (AVOBENZONE, OCTINOXATE, OCTISALATE, OXYBENZONE) CREAM [C.F.E.B. SISLEY]3
SORBIC ACIDINACTIVE INGREDIENTX045WJ989BSUNLEYA AGE MINIMIZING SUN CARE SPF 15 (AVOBENZONE, OCTINOXATE, OCTISALATE, OXYBENZONE) CREAM [C.F.E.B. SISLEY]3
STEARYL ALCOHOLINACTIVE INGREDIENT2KR89I4H1YSUNLEYA AGE MINIMIZING SUN CARE SPF 15 (AVOBENZONE, OCTINOXATE, OCTISALATE, OXYBENZONE) CREAM [C.F.E.B. SISLEY]3
THYMUS MASTICHINA FLOWERING TOP OILINACTIVE INGREDIENT9NP0832457SUNLEYA AGE MINIMIZING SUN CARE SPF 15 (AVOBENZONE, OCTINOXATE, OCTISALATE, OXYBENZONE) CREAM [C.F.E.B. SISLEY]3
WATERINACTIVE INGREDIENT059QF0KO0RSUNLEYA AGE MINIMIZING SUN CARE SPF 15 (AVOBENZONE, OCTINOXATE, OCTISALATE, OXYBENZONE) CREAM [C.F.E.B. SISLEY]3

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
66097-002SUNLEYA AGE MINIMIZING SUN CARE SPF 15 (AVOBENZONE, OCTINOXATE, OCTISALATE, OXYBENZONE) CREAM [C.F.E.B. SISLEY]6Current NDC, Legacy NDC, 2 package rows20241212_67498d45-0871-4806-8854-81d3e50c4b90.zip

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
66097-002-50660970002501 BOTTLE in 1 BOX (66097-002-50) / 50.3 g in 1 BOTTLE1 bottle2013-01-210000-00-00NoNoCurrent