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

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 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 UNII identifiers#

UNII identifiers page 1 of 1 · 4 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
G63QQF2NOXInternal UNII lookup
4Y5P7MUD51Internal UNII lookup
4X49Y0596WInternal UNII lookup
95OOS7VE0YInternal UNII lookup

Harmonized SPL set identifiers#

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

Identifier, FDA.report destination table
IdentifierFDA.report destination
67498d45-0871-4806-8854-81d3e50c4b90Available on FDA.report

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

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
66097-002-50660970002501 BOTTLE in 1 BOX (66097-002-50) / 50.3 g in 1 BOTTLE1 bottle2013-01-210000-00-00NoNoCurrent