FDA.reportPublic FDA data

SUNLEYA Age minimizing sun care

Product NDC
66097-003
11-digit product format
660970003
Labeler code
66097
Product ID
66097-003_28f03e3f-943c-a31c-e063-6394a90a7245
Type
HUMAN OTC DRUG
Nonproprietary name
AVOBENZONE, HOMOSALTE, OCTISALATE, OCTOCRYLENE
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; HOMOSALATE; OCTISALATE; OCTOCRYLENE
Active strength
30; 150; 50; 100 mg/g; mg/g; mg/g; mg/g
NDC exclude flag
No
Listing certified through
2026-12-31
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
SUNLEYA Age minimizing sun care
Brand name suffix
SPF 50 plus
Listing expiration
2026-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
AVOBENZONE30 mg/g
HOMOSALATE150 mg/g
OCTISALATE50 mg/g
OCTOCRYLENE100 mg/g

Harmonized UNII identifiers#

UNII identifiers page 1 of 1 · 4 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
G63QQF2NOXInternal UNII lookup
V06SV4M95SInternal UNII lookup
4X49Y0596WInternal UNII lookup
5A68WGF6WMInternal UNII lookup

Harmonized SPL set identifiers#

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

Identifier, FDA.report destination table
IdentifierFDA.report destination
7c9fadaf-b961-4df0-89ae-87141b50b2c1Available on FDA.report

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
66097-003-51SUNLEYA Age minimizing sun care SPF 50 plus1 in 1 BOXCREAM18
66097-003-51SUNLEYA Age minimizing sun care SPF 50 plus51.5 g in 1 BOTTLECREAM51.58

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIIDailyMed labelSPL versionUploaded
AVOBENZONEACTIVE INGREDIENTG63QQF2NOXSUNLEYA AGE MINIMIZING SUN CARE SPF 50 PLUS (AVOBENZONE, HOMOSALTE, OCTISALATE, OCTOCRYLENE) CREAM [C.F.E.B. SISLEY]3
HOMOSALATEACTIVE INGREDIENTV06SV4M95SSUNLEYA AGE MINIMIZING SUN CARE SPF 50 PLUS (AVOBENZONE, HOMOSALTE, OCTISALATE, OCTOCRYLENE) CREAM [C.F.E.B. SISLEY]3
OCTISALATEACTIVE INGREDIENT4X49Y0596WSUNLEYA AGE MINIMIZING SUN CARE SPF 50 PLUS (AVOBENZONE, HOMOSALTE, OCTISALATE, OCTOCRYLENE) CREAM [C.F.E.B. SISLEY]3
OCTOCRYLENEACTIVE INGREDIENT5A68WGF6WMSUNLEYA AGE MINIMIZING SUN CARE SPF 50 PLUS (AVOBENZONE, HOMOSALTE, OCTISALATE, OCTOCRYLENE) CREAM [C.F.E.B. SISLEY]3
AVOBENZONEACTIVE MOIETYG63QQF2NOXSUNLEYA AGE MINIMIZING SUN CARE SPF 50 PLUS (AVOBENZONE, HOMOSALTE, OCTISALATE, OCTOCRYLENE) CREAM [C.F.E.B. SISLEY]3
HOMOSALATEACTIVE MOIETYV06SV4M95SSUNLEYA AGE MINIMIZING SUN CARE SPF 50 PLUS (AVOBENZONE, HOMOSALTE, OCTISALATE, OCTOCRYLENE) CREAM [C.F.E.B. SISLEY]3
OCTISALATEACTIVE MOIETY4X49Y0596WSUNLEYA AGE MINIMIZING SUN CARE SPF 50 PLUS (AVOBENZONE, HOMOSALTE, OCTISALATE, OCTOCRYLENE) CREAM [C.F.E.B. SISLEY]3
OCTOCRYLENEACTIVE MOIETY5A68WGF6WMSUNLEYA AGE MINIMIZING SUN CARE SPF 50 PLUS (AVOBENZONE, HOMOSALTE, OCTISALATE, OCTOCRYLENE) CREAM [C.F.E.B. SISLEY]3
.ALPHA.-TOCOPHEROL ACETATEINACTIVE INGREDIENT9E8X80D2L0SUNLEYA AGE MINIMIZING SUN CARE SPF 50 PLUS (AVOBENZONE, HOMOSALTE, OCTISALATE, OCTOCRYLENE) CREAM [C.F.E.B. SISLEY]3
ALLANTOININACTIVE INGREDIENT344S277G0ZSUNLEYA AGE MINIMIZING SUN CARE SPF 50 PLUS (AVOBENZONE, HOMOSALTE, OCTISALATE, OCTOCRYLENE) CREAM [C.F.E.B. SISLEY]3
BUTYLENE GLYCOLINACTIVE INGREDIENT3XUS85K0RASUNLEYA AGE MINIMIZING SUN CARE SPF 50 PLUS (AVOBENZONE, HOMOSALTE, OCTISALATE, OCTOCRYLENE) CREAM [C.F.E.B. SISLEY]3
CITRIC ACID MONOHYDRATEINACTIVE INGREDIENT2968PHW8QPSUNLEYA AGE MINIMIZING SUN CARE SPF 50 PLUS (AVOBENZONE, HOMOSALTE, OCTISALATE, OCTOCRYLENE) CREAM [C.F.E.B. SISLEY]3
CUCUMBERINACTIVE INGREDIENTYY7C30VXJTSUNLEYA AGE MINIMIZING SUN CARE SPF 50 PLUS (AVOBENZONE, HOMOSALTE, OCTISALATE, OCTOCRYLENE) CREAM [C.F.E.B. SISLEY]3
EDETATE DISODIUMINACTIVE INGREDIENT7FLD91C86KSUNLEYA AGE MINIMIZING SUN CARE SPF 50 PLUS (AVOBENZONE, HOMOSALTE, OCTISALATE, OCTOCRYLENE) CREAM [C.F.E.B. SISLEY]3
GLYCERININACTIVE INGREDIENTPDC6A3C0OXSUNLEYA AGE MINIMIZING SUN CARE SPF 50 PLUS (AVOBENZONE, HOMOSALTE, OCTISALATE, OCTOCRYLENE) CREAM [C.F.E.B. SISLEY]3
GLYCERYL MONOSTEARATEINACTIVE INGREDIENT230OU9XXE4SUNLEYA AGE MINIMIZING SUN CARE SPF 50 PLUS (AVOBENZONE, HOMOSALTE, OCTISALATE, OCTOCRYLENE) CREAM [C.F.E.B. SISLEY]3
LINALOOL, (+/-)-INACTIVE INGREDIENTD81QY6I88ESUNLEYA AGE MINIMIZING SUN CARE SPF 50 PLUS (AVOBENZONE, HOMOSALTE, OCTISALATE, OCTOCRYLENE) CREAM [C.F.E.B. SISLEY]3
MANGANESE CARBONATEINACTIVE INGREDIENT9ZV57512ZMSUNLEYA AGE MINIMIZING SUN CARE SPF 50 PLUS (AVOBENZONE, HOMOSALTE, OCTISALATE, OCTOCRYLENE) CREAM [C.F.E.B. SISLEY]3
PEG-100 STEARATEINACTIVE INGREDIENTYD01N1999RSUNLEYA AGE MINIMIZING SUN CARE SPF 50 PLUS (AVOBENZONE, HOMOSALTE, OCTISALATE, OCTOCRYLENE) CREAM [C.F.E.B. SISLEY]3
PENTYLENE GLYCOLINACTIVE INGREDIENT50C1307PZGSUNLEYA AGE MINIMIZING SUN CARE SPF 50 PLUS (AVOBENZONE, HOMOSALTE, OCTISALATE, OCTOCRYLENE) CREAM [C.F.E.B. SISLEY]3
PHENOXYETHANOLINACTIVE INGREDIENTHIE492ZZ3TSUNLEYA AGE MINIMIZING SUN CARE SPF 50 PLUS (AVOBENZONE, HOMOSALTE, OCTISALATE, OCTOCRYLENE) CREAM [C.F.E.B. SISLEY]3
PHYSALIS ALKEKENGI CALYXINACTIVE INGREDIENTAL7F9NO9HRSUNLEYA AGE MINIMIZING SUN CARE SPF 50 PLUS (AVOBENZONE, HOMOSALTE, OCTISALATE, OCTOCRYLENE) CREAM [C.F.E.B. SISLEY]3
POTASSIUM CETYL PHOSPHATEINACTIVE INGREDIENT03KCY6P7UTSUNLEYA AGE MINIMIZING SUN CARE SPF 50 PLUS (AVOBENZONE, HOMOSALTE, OCTISALATE, OCTOCRYLENE) CREAM [C.F.E.B. SISLEY]3
POTASSIUM SORBATEINACTIVE INGREDIENT1VPU26JZZ4SUNLEYA AGE MINIMIZING SUN CARE SPF 50 PLUS (AVOBENZONE, HOMOSALTE, OCTISALATE, OCTOCRYLENE) CREAM [C.F.E.B. SISLEY]3
SAGE OILINACTIVE INGREDIENTU27K0H1H2OSUNLEYA AGE MINIMIZING SUN CARE SPF 50 PLUS (AVOBENZONE, HOMOSALTE, OCTISALATE, OCTOCRYLENE) CREAM [C.F.E.B. SISLEY]3
SHEANUT OILINACTIVE INGREDIENTO88E196QRFSUNLEYA AGE MINIMIZING SUN CARE SPF 50 PLUS (AVOBENZONE, HOMOSALTE, OCTISALATE, OCTOCRYLENE) CREAM [C.F.E.B. SISLEY]3
SILICON DIOXIDEINACTIVE INGREDIENTETJ7Z6XBU4SUNLEYA AGE MINIMIZING SUN CARE SPF 50 PLUS (AVOBENZONE, HOMOSALTE, OCTISALATE, OCTOCRYLENE) CREAM [C.F.E.B. SISLEY]3
SODIUM ACRYLOYLDIMETHYLTAURATEINACTIVE INGREDIENT2T9Q6EKI0GSUNLEYA AGE MINIMIZING SUN CARE SPF 50 PLUS (AVOBENZONE, HOMOSALTE, OCTISALATE, OCTOCRYLENE) CREAM [C.F.E.B. SISLEY]3
SODIUM HYDROXIDEINACTIVE INGREDIENT55X04QC32ISUNLEYA AGE MINIMIZING SUN CARE SPF 50 PLUS (AVOBENZONE, HOMOSALTE, OCTISALATE, OCTOCRYLENE) CREAM [C.F.E.B. SISLEY]3
SORBIC ACIDINACTIVE INGREDIENTX045WJ989BSUNLEYA AGE MINIMIZING SUN CARE SPF 50 PLUS (AVOBENZONE, HOMOSALTE, OCTISALATE, OCTOCRYLENE) CREAM [C.F.E.B. SISLEY]3
STEARYL ALCOHOLINACTIVE INGREDIENT2KR89I4H1YSUNLEYA AGE MINIMIZING SUN CARE SPF 50 PLUS (AVOBENZONE, HOMOSALTE, OCTISALATE, OCTOCRYLENE) CREAM [C.F.E.B. SISLEY]3
THYMUS MASTICHINA FLOWERING TOP OILINACTIVE INGREDIENT9NP0832457SUNLEYA AGE MINIMIZING SUN CARE SPF 50 PLUS (AVOBENZONE, HOMOSALTE, OCTISALATE, OCTOCRYLENE) CREAM [C.F.E.B. SISLEY]3
WATERINACTIVE INGREDIENT059QF0KO0RSUNLEYA AGE MINIMIZING SUN CARE SPF 50 PLUS (AVOBENZONE, HOMOSALTE, OCTISALATE, OCTOCRYLENE) CREAM [C.F.E.B. SISLEY]3
XANTHAN GUMINACTIVE INGREDIENTTTV12P4NEESUNLEYA AGE MINIMIZING SUN CARE SPF 50 PLUS (AVOBENZONE, HOMOSALTE, OCTISALATE, OCTOCRYLENE) CREAM [C.F.E.B. SISLEY]3

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
66097-003SUNLEYA AGE MINIMIZING SUN CARE SPF 50 PLUS (AVOBENZONE, HOMOSALTE, OCTISALATE, OCTOCRYLENE) CREAM [C.F.E.B. SISLEY]8Current NDC, Legacy NDC, 2 package rows20241212_7c9fadaf-b961-4df0-89ae-87141b50b2c1.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 336 of 346 · 6,912 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Artistry Exact Fit Longwearing Foundation Shade Tawny L3N1TITANIUM DIOXIDEAmway Corp706e1504-fad7-44fa-9030-f5b948e3e79b2023-10-22WarningsExact identifier
application number: M020
Artistry Exact Fit Longwearing Foundation Shade Cappuccino L5W1TITANIUM DIOXIDEAmway Corpb785af89-1134-4fc6-8388-c47c52d153e02023-10-22WarningsExact identifier
application number: M020
Artistry Exact Fit Longwearing Foundation Shade Natural L2N2TITANIUM DIOXIDEAmway Corpdb24e10a-6957-4ce7-8b03-572caacc647a2023-10-22WarningsExact identifier
application number: M020
Artistry Exact Fit Longwearing Foundation Shade Caramel L5N1TITANIUM DIOXIDEAmway Corpe7d8616d-3e79-4b5e-b05b-fbb506c0203d2023-10-22WarningsExact identifier
application number: M020
Artistry Exact Fit Longwearing Foundation Shade Plush L3C1TITANIUM DIOXIDEAmway Corpff387c87-4ada-41c6-b62b-07a1432137702023-10-22WarningsExact identifier
application number: M020
Artistry Exact Fit Longwearing Foundation Shade Walnut L6N1TITANIUM DIOXIDEAmway Corp48c0bb8b-2f89-465e-9ae6-98690a2f877c2023-10-22WarningsExact identifier
application number: M020
Artistry Youth Xtend Lifting Smoothing Foundation Shade Buff L1W1OCTINOXATE, OXYBENZONEAmway Corp11a8cc16-33f1-43d1-9f35-aa0f6e70adf62023-10-22WarningsExact identifier
application number: M020
CoreTex Sun X SPF 30 ThinAVOBENZONE, HOMOSALATE, OCTINOXATE, OCTISALATE, OXYBENZONECoreTex Products Inc980388b5-8314-3143-e053-2995a90a72882023-10-22WarningsExact identifier
application number: M020
CoreTex Sun X SPF 30 Multipack NewAVOBENZONE, HOMOSALATE, OCTISALATE, OCTOCRYLENECoreTex Productsf4ed9d7f-2d03-87d1-e053-2a95a90a3b4f2023-10-22WarningsExact identifier
application number: M020
Artistry Youth Xtend Lifting Smoothing Foundation Shade Chablis L1C1OCTINOXATE, OXYBENZONEAmway Corp8cdf7dcf-c2fa-4e41-8d56-c4f6cebe0a902023-10-22WarningsExact identifier
application number: M020
Artistry Youth Xtend Lifting Smoothing Foundation Shade Mink L6W1OCTINOXATE, OXYBENZONEAmway Corp429044b1-f7b8-4d1e-8360-0feb380161dd2023-10-22WarningsExact identifier
application number: M020
Artistry Youth Xtend Lifting Smoothing Foundation Shade Cream L1W2OCTINOXATE, OXYBENZONEAmway Corpe7e89303-f399-46c7-a029-c6d3d0a2dc4e2023-10-22WarningsExact identifier
application number: M020
Artistry Skin Nutrition BALANCING Matte DayAVOBENZONE, OCTISALATE, OCTOCRYLENEAccess Business Group LLCd4a87153-7ef0-4365-ad91-dced9b1d80552023-10-21WarningsExact identifier
application number: M020
Artistry Ideal Radiance Illuminating CC SPF 50 Broad Spectrum Sunscreen Light/MediumENSULIZOLE,OCTINOXATE, OXYBENZONE, TITANIUM DIOXIDE, ZINC OXIDEAmway Corp830a748f-bb14-47f6-ab6f-48d8bd7063212023-10-21WarningsExact identifier
application number: M020
Artistry Skin Nutrition HYDRATING DayAVOBENZONE, OCTISALATE, OCTOCRYLENEAccess Business Group LLC06313228-7a79-48c5-8fd0-b210da6d037b2023-10-21WarningsExact identifier
application number: M020
Artistry Skin Nutrition RENEWING Reactivation Day SPF 30AVOBENZONE, OCTISALATE, OCTOCRYLENEAccess Business Group LLCbd4818b3-d5db-4812-96ec-1bd91aa1508b2023-10-21WarningsExact identifier
application number: M020
Artistry Ideal Radiance Illuminating CC SPF 50 Broad Spectrum Med/DeepENSULIZOLE, OCTINOXATE, OXYBENZONE, TITANIUM DIOXIDE, ZINC OXIDEAmway Corp20c432e2-4c63-485b-9dd5-2bc73b6f42852023-10-21WarningsExact identifier
application number: M020
Artistry Ideal Radiance Illuminating CC SPF50 Broad Spectrum Sunscreen - LightENSULIZOLE,OCTINOXATE, OXYBENZONE, TITANIUM DIOXIDE, ZINC OXIDEAccess Business Group LLC070f9538-4b36-471a-aa06-6669e9ecfdf02023-10-21WarningsExact identifier
application number: M020
Artistry Ideal Radiance Illuminating CC SPF 50 Broad Spectrum Sunscreen MediumENSULIZOLE,OCTINOXATE, OXYBENZONE, TITANIUM DIOXIDE, ZINC OXIDEAmway Corp40a82d20-b84b-4ae8-818d-1f503ceef5812023-10-21WarningsExact identifier
application number: M020
Artistry Skin Nutrition RENEWING Reactivation Day Cream SPF 30AVOBENZONE, OCTISALATE, OCTOCRYLENEAccess Business Group LLC4a0af0e9-04da-4b5f-a57a-967bef7257892023-10-21WarningsExact identifier
application number: M020

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
66097-003-51660970003511 BOTTLE in 1 BOX (66097-003-51) / 51.5 g in 1 BOTTLE1 bottle2013-01-210000-00-00NoNoCurrent