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 231 of 353 · 7,041 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
JAFRA Beauty advanced SILK MOISTURIZING SERUM FOUNDATION SUNSCREEN BROAD SPECTRUM SPF 15 RICH COCOA ND20HOMOSALATE, OCTISALATE, ZINC OXIDEDistribuidora Comercial Jafra, S.A. de C.V.2e307ca4-9975-47ef-b13f-2cfbcc8467192025-02-03WarningsExact identifier
application number: M020
JAFRA Beauty advanced SILK MOISTURIZING SERUM FOUNDATION SUNSCREEN BROAD SPECTRUM SPF 15 CAPUCCINO D8HOMOSALATE, OCTISALATE, ZINC OXIDEDistribuidora Comercial Jafra, S.A. de C.V.08628240-327d-4329-a0ff-fed239dde2062025-02-03WarningsExact identifier
application number: M020
JAFRA Beauty advanced SILK MOISTURIZING SERUM FOUNDATION SUNSCREEN BROAD SPECTRUM SPF 15 NATURAL LG14HOMOSALATE, OCTISALATE, ZINC OXIDEDistribuidora Comercial Jafra, S.A. de C.V.768100d6-efd6-4a98-bdb8-2d1561ee356c2025-02-03WarningsExact identifier
application number: M020
JAFRA Beauty advanced SILK MOISTURIZING SERUM FOUNDATION SUNSCREEN BROAD SPECTRUM SPF 15 IVORY LN18HOMOSALATE, OCTISALATE, ZINC OXIDEDistribuidora Comercial Jafra, S.A. de C.V.e6f33ec7-691f-4d4b-9086-b981c19f80d32025-02-03WarningsExact identifier
application number: M020
JAFRA Beauty advanced SILK MOISTURIZING SERUM FOUNDATION SUNSCREEN BROAD SPECTRUM SPF 15 SUNTAN MDG14HOMOSALATE, OCTISALATE, ZINC OXIDEDistribuidora Comercial Jafra, S.A. de C.V.784bb8c4-ee3c-4a73-a828-5781f01f621d2025-02-03WarningsExact identifier
application number: M020
Brush On Block SPF 30 Mineral Powder Translucent Zinc Only-RefillZINC OXIDESPF Ventures, LLC2d47eb76-e644-4e04-e063-6294a90a93cc2025-02-03WarningsExact identifier
application number: M020
Brush On Block Sun Shine SPF 30 Protective Lip Oil Peony TintTITANIUM DIOXIDE/ZINC OXIDESPF Ventures LLC2d490531-af36-87d0-e063-6394a90acf492025-02-03WarningsExact identifier
application number: M020
YOUR TINTED MOISTURIZER HYDRATING ANTI AGING BROAD SPECTRUM SPF 30OCTISALATE, OCTINOXATE, OXYBENZONE, AVOBENZONESkin Ai, LLC2d8b7d07-2249-898b-e063-6394a90af6ad2025-02-01WarningsExact identifier
application number: M020
ESSENCE LIGHT SUNSCREEN SPF 50 PAAVOBENZONE, HOMOSALATE, OCTISALATE, OCTOCRYLENEENGLEWOOD LAB, INC.f5c79f1a-cecd-2409-e053-2995a90ad06f2025-01-31WarningsExact identifier
application number: M020
RODAN - FIELDS ESSENTIALS Body Sunscreen BROAD SPECTRUM SPF 30AVOBENZONE, HOMOSALATE, OCTISALATE, OCTOCRYLENERodan & Fields67b55df8-9623-4352-b136-b0bc8d1efe022025-01-31WarningsExact identifier
application number: M020
Oil-Free Daily Hydration SPF 15OCTINOXATE, AVOBENZONEBoscia LLCec322ae5-ab03-4c7b-9c6d-0bda3327c72a2025-01-31WarningsExact identifier
application number: M020
PAULAS CHOICE HYDRALIGHT SHINE-FREE DAILY MINERAL COMPLEX Broad Spectrum SPF 30TITANIUM DIOXIDE, ZINC OXIDEPaula's Choice, Incb90658d0-e422-4265-a6ee-39c29b6c116a2025-01-31WarningsExact identifier
application number: M020
SunStation USA SPF-30 SPORT SUNSCREENZINC OXIDERENU LABORATORIES, LLC11d3c60e-238d-999e-e063-6394a90a624b2025-01-31WarningsExact identifier
application number: M020
Stay Ageless Tinted Mineral Sunscreen Broad Spectrum SPF30TITANIUM DIOXIDE AND ZINC OXIDEDERM ASSO. MID OHIO2d04bc5d-6f11-4f56-e063-6294a90ae7552025-01-31WarningsExact identifier
application number: M020
TiZO Mineral Sun Defense SPF 50TITANIUM DIOXIDE, ZINC OXIDEFallien Cosmeceuticals Ltd.2d0766a1-4091-e84a-e063-6394a90a004a2025-01-31WarningsExact identifier
application number: M020
Hello Sunday The Shimmer One Mineral Glow SPF 45ZINC OXIDEKao USA Inc.0c935521-4e8b-0605-e063-6394a90a0bbc2025-01-31WarningsExact identifier
application number: M020
Hello Sunday The Invisible One Sunscreen Plus Primer SPF 50AVOBENZONE, HOMOSALATE, OCTISALATE, OCTOCRYLENEKao USA Inc.0c7ce5b9-5ab4-d845-e063-6394a90afa762025-01-31WarningsExact identifier
application number: M020
Hello Sunday The Mineral One Lightweight Serum SPF 50ZINC OXIDEKao USA Inc.0c91894f-a40e-73e9-e063-6394a90ab8072025-01-31WarningsExact identifier
application number: M020
Hello Sunday The One Thats a Serum Hydrating Serum SPF 45AVOBENZONE, HOMOSALATE, OCTISALATE, OCTOCRYLENEKao USA Inc.0c913096-c000-4336-e063-6394a90a560c2025-01-31WarningsExact identifier
application number: M020
Hello Sunday Bestseller Daily SPF DuoAVOBENZONE, HOMOSALATE, OCTISALATE, OCTOCRYLENEKao USA Inc.26cf264b-f68d-5691-e063-6394a90a8ab42025-01-31WarningsExact 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