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 272 of 346 · 6,912 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
CVS Health SPF 70 SunAVOBENZONE, HOMOSALATE, OCTISALATE, OCTOCRYLENE, OXYBENZONECVS Pharmacy63b420ba-ac69-5670-e053-2a91aa0a864b2024-10-22WarningsExact identifier
application number: M020
CVS Health Ultra Sheer SPF 100 SunscreenAVOBENZONE, HOMOSALATE, OCTISALATE, OCTOCRYLENE, OXYBENZONECVS PHARMACYc52a7e9b-5401-f6e7-e053-2995a90a95192024-10-22WarningsExact identifier
application number: M020
CVS Health Ultra Sheer Broad Spectrum SPF 70AVOBENZONE, HOMOSALATE, OCTISALATE, OCTOCRYLENE, OXYBENZONECVS Pharmacyc68c3d6a-b656-abaf-e053-2a95a90a48db2024-10-22WarningsExact identifier
application number: M020
CVS Health Ultra Sheer Broad Spectrum SPF 45 SunscreenAVOBENZONE, HOMOSALATE, OCTISALATE, OCTOCRYLENECVS Pharmacyc5e8fcc9-db5c-9ee7-e053-2a95a90ac9402024-10-22WarningsExact identifier
application number: M020
CVS Health SPF 55 Ultra SheerAVOBENZONE, HOMOSALATE, OCTISALATE, OCTOCRYLENECVS Pharmacyc617cdec-b489-22d2-e053-2995a90a1ec62024-10-22WarningsExact identifier
application number: M020
TRADER JOES ILLUMINATING DAILY FACIAL SUNSCREEN BROAD SPECTRUM SPF 40AVOBENZONE, HOMOSALATE, OCTISALATE, OCTOCRYLENETrader Joe's Company1b7c2f13-81b8-7af5-e063-6294a90a35012024-10-22WarningsExact identifier
application number: M020
CVS Health SPF 50 Beach GuardAVOBENZONE, HOMOSALATE, OCTISALATE, OCTOCRYLENECVS Pharmacydf25c35d-6b6d-1ef8-e053-2995a90aaef52024-10-22WarningsExact identifier
application number: M020
CVS Health Kids SPF 50 ClearAVOBENZONE, HOMOSALATE, OCTISALATE, OCTOCRYLENECVS PHARMACYe4581d0e-ce6d-7898-e053-2a95a90a02b52024-10-22WarningsExact identifier
application number: M020
CVS Health SPF 55 Ultra Sheer Face MistAVOBENZONE, HOMOSALATE, OCTISALATE, OCTOCRYLENECVS Pharmacydfb55b46-e88f-4949-e053-2995a90adabc2024-10-22WarningsExact identifier
application number: M020
CVS Health Sport SPF 30 Clear Broad SpectrumAVOBENZONE, HOMOSALATE,OCTISALATE,OCTOCRYLENECVS PHARMACYe4589114-87c5-56b8-e053-2995a90a09342024-10-22WarningsExact identifier
application number: M020
TRADER JOES ENRICH MOISTURIZING FACE BROAD SPECTRUM SPF 15OCTINOXATE, ZINC OXIDETrader Joe's Companya6805675-916c-4a19-b993-d465fcef58a12024-10-22WarningsExact identifier
application number: M020
TRADER JOES FACE AND BODY SUNSCREEN SPF 30AVOBENZONE, HOMOSALATE, OCTISALATE, OCTOCRYLENETrader Joe's Company057ac99c-60e8-47c1-a32d-984bbd1818462024-10-22WarningsExact identifier
application number: M020
TRADER JOES ZINC OXIDE MINERAL SUNSCREEN SPF 30ZINC OXIDETrader Joe's Company9e48de83-cb72-4c03-a819-939db8793e1f2024-10-22WarningsExact identifier
application number: M020
TRADER JOES DAILY FACIAL SUNSCREEN SPF 40AVOBENZONE, HOMOSALATE, OCTISALATE, OCTOCRYLENETrader Joe's Companydb3c2210-0e11-0a0e-e053-2a95a90aecbf2024-10-22WarningsExact identifier
application number: M020
Philosophy Hope in a Jar Smooth-glow Multi-tasking Moisturizer Broad Spectrum SPF 30 with Pro-vitamin P, glycolic and hyaluronic acidsAVOBENZONE, HOMOSALATE, OCTISALATE AND OCTOCRYLENEPhilosophy, Inc.24ffeef6-ca72-5f30-e063-6394a90a41d12024-10-21WarningsExact identifier
application number: M020
Bali Body BB Cream SPF 15 NaturalOCTOCRYLENE, OCTINOXATE, AVOBENZONE, OXYBENZONEBali Body Pty Ltddb0edf56-4f39-7b48-e053-2a95a90a9b422024-10-21WarningsExact identifier
application number: M020
Bali Body Tinted Super Serum Natural SPF 30OCTISALATE, OCTOCRYLENE, TITANIUM DIOXIDE, ZINC OXIDEBali Body Pty Ltdf5eeaf37-33f2-2c0c-e053-2a95a90abcc02024-10-21WarningsExact identifier
application number: M020
Bali Body BB Cream SPF 15 TanOCTOCRYLENE, OCTINOXATE, AVOBENZONE, OXYBENZONEBali Body Pty Ltddb0f6a36-27dd-3301-e053-2995a90aff652024-10-21WarningsExact identifier
application number: M020
Bali Body Watermelon Tanning Oil SPF 6OCTOCRYLENE, OCTISALATE, AVOBENZONEBali Body Pty Ltd03705641-feaf-2cbd-e063-6394a90a806e2024-10-21WarningsExact identifier
application number: M020
Bali Body Pineapple Tanning Oil SPF15OCTOCRYLENE, OCTISALATE, AVOBENZONEBali Body Pty Ltd21c49bbf-97b1-c8c0-e063-6394a90ab4122024-10-21WarningsExact 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