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
Ingredient	Strength
AVOBENZONE	30 mg/g
OCTINOXATE	50 mg/g
OCTISALATE	50 mg/g
OXYBENZONE	40 mg/g

Harmonized UNII identifiers#

UNII identifiers page 1 of 1 · 4 matching rows.

Identifier, FDA.report destination table
Identifier	FDA.report destination
G63QQF2NOX	Internal UNII lookup
4Y5P7MUD51	Internal UNII lookup
4X49Y0596W	Internal UNII lookup
95OOS7VE0Y	Internal UNII lookup

Harmonized SPL set identifiers#

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

Identifier, FDA.report destination table
Identifier	FDA.report destination
67498d45-0871-4806-8854-81d3e50c4b90	Available on FDA.report

DailyMed Product Concepts#

Product concept, Relation, Version table
Product concept	Relation	Version	Effective
0ca1d589-929b-4b33-bc5b-1d84abdafa6a	Product name	1	20150324
fc363c46-397b-4476-ac0f-70e43e8e4592	Product name	1	20150324
1681bc73-b05f-12c3-1075-382ae39f449c	Product name	1	20140508

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDC	Product	Description	Form	Quantity	Strength	SPL version
66097-002-50	SUNLEYA Age minimizing sun care SPF 15	1 in 1 BOX	CREAM	1		6
66097-002-50	SUNLEYA Age minimizing sun care SPF 15	50.3 g in 1 BOTTLE	CREAM	50.3		6

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
Ingredient	Type	UNII	DailyMed label	SPL version
AVOBENZONE	ACTIVE INGREDIENT	G63QQF2NOX	SUNLEYA AGE MINIMIZING SUN CARE SPF 15 (AVOBENZONE, OCTINOXATE, OCTISALATE, OXYBENZONE) CREAM [C.F.E.B. SISLEY]	3
OCTINOXATE	ACTIVE INGREDIENT	4Y5P7MUD51	SUNLEYA AGE MINIMIZING SUN CARE SPF 15 (AVOBENZONE, OCTINOXATE, OCTISALATE, OXYBENZONE) CREAM [C.F.E.B. SISLEY]	3
OCTISALATE	ACTIVE INGREDIENT	4X49Y0596W	SUNLEYA AGE MINIMIZING SUN CARE SPF 15 (AVOBENZONE, OCTINOXATE, OCTISALATE, OXYBENZONE) CREAM [C.F.E.B. SISLEY]	3
OXYBENZONE	ACTIVE INGREDIENT	95OOS7VE0Y	SUNLEYA AGE MINIMIZING SUN CARE SPF 15 (AVOBENZONE, OCTINOXATE, OCTISALATE, OXYBENZONE) CREAM [C.F.E.B. SISLEY]	3
AVOBENZONE	ACTIVE MOIETY	G63QQF2NOX	SUNLEYA AGE MINIMIZING SUN CARE SPF 15 (AVOBENZONE, OCTINOXATE, OCTISALATE, OXYBENZONE) CREAM [C.F.E.B. SISLEY]	3
OCTINOXATE	ACTIVE MOIETY	4Y5P7MUD51	SUNLEYA AGE MINIMIZING SUN CARE SPF 15 (AVOBENZONE, OCTINOXATE, OCTISALATE, OXYBENZONE) CREAM [C.F.E.B. SISLEY]	3
OCTISALATE	ACTIVE MOIETY	4X49Y0596W	SUNLEYA AGE MINIMIZING SUN CARE SPF 15 (AVOBENZONE, OCTINOXATE, OCTISALATE, OXYBENZONE) CREAM [C.F.E.B. SISLEY]	3
OXYBENZONE	ACTIVE MOIETY	95OOS7VE0Y	SUNLEYA AGE MINIMIZING SUN CARE SPF 15 (AVOBENZONE, OCTINOXATE, OCTISALATE, OXYBENZONE) CREAM [C.F.E.B. SISLEY]	3
.ALPHA.-TOCOPHEROL ACETATE	INACTIVE INGREDIENT	9E8X80D2L0	SUNLEYA AGE MINIMIZING SUN CARE SPF 15 (AVOBENZONE, OCTINOXATE, OCTISALATE, OXYBENZONE) CREAM [C.F.E.B. SISLEY]	3
1,2-HEXANEDIOL	INACTIVE INGREDIENT	TR046Y3K1G	SUNLEYA AGE MINIMIZING SUN CARE SPF 15 (AVOBENZONE, OCTINOXATE, OCTISALATE, OXYBENZONE) CREAM [C.F.E.B. SISLEY]	3
ALLANTOIN	INACTIVE INGREDIENT	344S277G0Z	SUNLEYA AGE MINIMIZING SUN CARE SPF 15 (AVOBENZONE, OCTINOXATE, OCTISALATE, OXYBENZONE) CREAM [C.F.E.B. SISLEY]	3
ARACHIDYL ALCOHOL	INACTIVE INGREDIENT	1QR1QRA9BU	SUNLEYA AGE MINIMIZING SUN CARE SPF 15 (AVOBENZONE, OCTINOXATE, OCTISALATE, OXYBENZONE) CREAM [C.F.E.B. SISLEY]	3
ARACHIDYL GLUCOSIDE	INACTIVE INGREDIENT	6JVW35JOOJ	SUNLEYA AGE MINIMIZING SUN CARE SPF 15 (AVOBENZONE, OCTINOXATE, OCTISALATE, OXYBENZONE) CREAM [C.F.E.B. SISLEY]	3
ARGININE	INACTIVE INGREDIENT	94ZLA3W45F	SUNLEYA AGE MINIMIZING SUN CARE SPF 15 (AVOBENZONE, OCTINOXATE, OCTISALATE, OXYBENZONE) CREAM [C.F.E.B. SISLEY]	3
BUTYLATED HYDROXYTOLUENE	INACTIVE INGREDIENT	1P9D0Z171K	SUNLEYA AGE MINIMIZING SUN CARE SPF 15 (AVOBENZONE, OCTINOXATE, OCTISALATE, OXYBENZONE) CREAM [C.F.E.B. SISLEY]	3
C13-14 ISOPARAFFIN	INACTIVE INGREDIENT	E4F12ROE70	SUNLEYA AGE MINIMIZING SUN CARE SPF 15 (AVOBENZONE, OCTINOXATE, OCTISALATE, OXYBENZONE) CREAM [C.F.E.B. SISLEY]	3
CAPRYLYL GLYCOL	INACTIVE INGREDIENT	00YIU5438U	SUNLEYA AGE MINIMIZING SUN CARE SPF 15 (AVOBENZONE, OCTINOXATE, OCTISALATE, OXYBENZONE) CREAM [C.F.E.B. SISLEY]	3
CETEARETH-33	INACTIVE INGREDIENT	R42C2O714B	SUNLEYA AGE MINIMIZING SUN CARE SPF 15 (AVOBENZONE, OCTINOXATE, OCTISALATE, OXYBENZONE) CREAM [C.F.E.B. SISLEY]	3
CETEARYL GLUCOSIDE	INACTIVE INGREDIENT	09FUA47KNA	SUNLEYA AGE MINIMIZING SUN CARE SPF 15 (AVOBENZONE, OCTINOXATE, OCTISALATE, OXYBENZONE) CREAM [C.F.E.B. SISLEY]	3
CETOSTEARYL ALCOHOL	INACTIVE INGREDIENT	2DMT128M1S	SUNLEYA AGE MINIMIZING SUN CARE SPF 15 (AVOBENZONE, OCTINOXATE, OCTISALATE, OXYBENZONE) CREAM [C.F.E.B. SISLEY]	3
CUCUMBER	INACTIVE INGREDIENT	YY7C30VXJT	SUNLEYA AGE MINIMIZING SUN CARE SPF 15 (AVOBENZONE, OCTINOXATE, OCTISALATE, OXYBENZONE) CREAM [C.F.E.B. SISLEY]	3
DIISOPROPYL SEBACATE	INACTIVE INGREDIENT	J8T3X564IH	SUNLEYA AGE MINIMIZING SUN CARE SPF 15 (AVOBENZONE, OCTINOXATE, OCTISALATE, OXYBENZONE) CREAM [C.F.E.B. SISLEY]	3
DIMETHICONE	INACTIVE INGREDIENT	92RU3N3Y1O	SUNLEYA AGE MINIMIZING SUN CARE SPF 15 (AVOBENZONE, OCTINOXATE, OCTISALATE, OXYBENZONE) CREAM [C.F.E.B. SISLEY]	3
DOCOSANOL	INACTIVE INGREDIENT	9G1OE216XY	SUNLEYA AGE MINIMIZING SUN CARE SPF 15 (AVOBENZONE, OCTINOXATE, OCTISALATE, OXYBENZONE) CREAM [C.F.E.B. SISLEY]	3
EDETATE SODIUM	INACTIVE INGREDIENT	MP1J8420LU	SUNLEYA AGE MINIMIZING SUN CARE SPF 15 (AVOBENZONE, OCTINOXATE, OCTISALATE, OXYBENZONE) CREAM [C.F.E.B. SISLEY]	3
GLYCERIN	INACTIVE INGREDIENT	PDC6A3C0OX	SUNLEYA AGE MINIMIZING SUN CARE SPF 15 (AVOBENZONE, OCTINOXATE, OCTISALATE, OXYBENZONE) CREAM [C.F.E.B. SISLEY]	3
LAURETH-7	INACTIVE INGREDIENT	Z95S6G8201	SUNLEYA AGE MINIMIZING SUN CARE SPF 15 (AVOBENZONE, OCTINOXATE, OCTISALATE, OXYBENZONE) CREAM [C.F.E.B. SISLEY]	3
LINALOOL, (+/-)-	INACTIVE INGREDIENT	D81QY6I88E	SUNLEYA AGE MINIMIZING SUN CARE SPF 15 (AVOBENZONE, OCTINOXATE, OCTISALATE, OXYBENZONE) CREAM [C.F.E.B. SISLEY]	3
MANGANESE CARBONATE	INACTIVE INGREDIENT	9ZV57512ZM	SUNLEYA AGE MINIMIZING SUN CARE SPF 15 (AVOBENZONE, OCTINOXATE, OCTISALATE, OXYBENZONE) CREAM [C.F.E.B. SISLEY]	3
PEG-8 LAURATE	INACTIVE INGREDIENT	762O8IWA10	SUNLEYA AGE MINIMIZING SUN CARE SPF 15 (AVOBENZONE, OCTINOXATE, OCTISALATE, OXYBENZONE) CREAM [C.F.E.B. SISLEY]	3
PENTYLENE GLYCOL	INACTIVE INGREDIENT	50C1307PZG	SUNLEYA AGE MINIMIZING SUN CARE SPF 15 (AVOBENZONE, OCTINOXATE, OCTISALATE, OXYBENZONE) CREAM [C.F.E.B. SISLEY]	3
PHENOXYETHANOL	INACTIVE INGREDIENT	HIE492ZZ3T	SUNLEYA AGE MINIMIZING SUN CARE SPF 15 (AVOBENZONE, OCTINOXATE, OCTISALATE, OXYBENZONE) CREAM [C.F.E.B. SISLEY]	3
PHYSALIS ALKEKENGI CALYX	INACTIVE INGREDIENT	AL7F9NO9HR	SUNLEYA AGE MINIMIZING SUN CARE SPF 15 (AVOBENZONE, OCTINOXATE, OCTISALATE, OXYBENZONE) CREAM [C.F.E.B. SISLEY]	3
POTASSIUM CETYL PHOSPHATE	INACTIVE INGREDIENT	03KCY6P7UT	SUNLEYA AGE MINIMIZING SUN CARE SPF 15 (AVOBENZONE, OCTINOXATE, OCTISALATE, OXYBENZONE) CREAM [C.F.E.B. SISLEY]	3
POTASSIUM SORBATE	INACTIVE INGREDIENT	1VPU26JZZ4	SUNLEYA AGE MINIMIZING SUN CARE SPF 15 (AVOBENZONE, OCTINOXATE, OCTISALATE, OXYBENZONE) CREAM [C.F.E.B. SISLEY]	3
PROPYLENE GLYCOL	INACTIVE INGREDIENT	6DC9Q167V3	SUNLEYA AGE MINIMIZING SUN CARE SPF 15 (AVOBENZONE, OCTINOXATE, OCTISALATE, OXYBENZONE) CREAM [C.F.E.B. SISLEY]	3
SAGE OIL	INACTIVE INGREDIENT	U27K0H1H2O	SUNLEYA AGE MINIMIZING SUN CARE SPF 15 (AVOBENZONE, OCTINOXATE, OCTISALATE, OXYBENZONE) CREAM [C.F.E.B. SISLEY]	3
SHEANUT OIL	INACTIVE INGREDIENT	O88E196QRF	SUNLEYA AGE MINIMIZING SUN CARE SPF 15 (AVOBENZONE, OCTINOXATE, OCTISALATE, OXYBENZONE) CREAM [C.F.E.B. SISLEY]	3
SORBIC ACID	INACTIVE INGREDIENT	X045WJ989B	SUNLEYA AGE MINIMIZING SUN CARE SPF 15 (AVOBENZONE, OCTINOXATE, OCTISALATE, OXYBENZONE) CREAM [C.F.E.B. SISLEY]	3
STEARYL ALCOHOL	INACTIVE INGREDIENT	2KR89I4H1Y	SUNLEYA AGE MINIMIZING SUN CARE SPF 15 (AVOBENZONE, OCTINOXATE, OCTISALATE, OXYBENZONE) CREAM [C.F.E.B. SISLEY]	3
THYMUS MASTICHINA FLOWERING TOP OIL	INACTIVE INGREDIENT	9NP0832457	SUNLEYA AGE MINIMIZING SUN CARE SPF 15 (AVOBENZONE, OCTINOXATE, OCTISALATE, OXYBENZONE) CREAM [C.F.E.B. SISLEY]	3
WATER	INACTIVE INGREDIENT	059QF0KO0R	SUNLEYA 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
NDC	Dashboard title	SPL version	Validation	Dashboard ZIP
66097-002	SUNLEYA AGE MINIMIZING SUN CARE SPF 15 (AVOBENZONE, OCTINOXATE, OCTISALATE, OXYBENZONE) CREAM [C.F.E.B. SISLEY]	6	Current NDC, Legacy NDC, 2 package rows	20241212_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 339 of 346 · 6,912 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
Peppermint SPF 15 Broad Spectrum Lip Balm	PEPPERMINT SPF 15 BROAD SPECTRUM LIP BALM	Raining Rose, Inc	a901a7f7-af83-0aa1-e053-2995a90aa32b	2023-10-18	Warnings	Exact identifier application number: M020
Mineral SPF 15 Broad Spectrum Lip Balm	MINERAL SPF 15 BROAD SPECTRUM LIP BALM	Raining Rose, Inc	44d2759a-d95d-7525-e054-00144ff88e88	2023-10-18	Warnings	Exact identifier application number: M020
La Roche Posay Laboratoire Dermatologique Mela B3 UV Daily Sunscreen Broad Spectrum SPF 30	AVOBENZONE, HOMOSALATE, OCTISALATE AND OCTOCRYLENE	L'Oreal USA Products Inc	8d1c89b2-55f4-4d49-a4c2-bb0aa220ff1d	2023-10-18	Warnings	Exact identifier application number: M020
La Roche Posay Laboratoire Dermatologique Mela B3 UV Daily Sunscreen Broad Spectrum SPF 30	AVOBENZONE, HOMOSALATE, OCTISALATE AND OCTOCRYLENE	Cosmetique Active Production	d60887aa-7586-4d4b-88af-35b4f982aacf	2023-10-18	Warnings	Exact identifier application number: M020
JESS BEAUTY Sun Drops Protection SPF 30	AVOBENZONE, HOMOSALATE, OCTISALATE, OCTOCRYLENE	JESS BEAUTY PRODUCTS LLC	d13da7be-a419-4416-96be-8421665dbd82	2023-10-17	Warnings	Exact identifier application number: M020
Broad Spectrum SPF 15 Sunscreen Vanilla Lip Balm	BROAD SPECTRUM SPF 15 SUNSCREEN VANILLA LIP BALM	Raining Rose	efe27e7e-e805-1c47-e053-2995a90af22e	2023-10-17	Warnings	Exact identifier application number: M020
CLINIQUE FOR MEN SUPER ENGERGIZER ANTI -FATIGUE HYDRATING Concentrate BROAD SPECTRUM SPF 25	AVOBENZONE AND OCTISALATE	CLINIQUE LABORATORIES LLC	f1109f0e-ebf5-450e-8a4e-b314a91b2483	2023-10-13	Warnings	Exact identifier application number: M020
CLINIQUE BROAD SPECTRUM SPF 50 SUNSCREEN FACE WITH SOLAR SMART	AVOBENZONE, HOMOSALATE, OCTISALATE, OCTOCRYLENE, AND OXYBENZONE	CLINIQUE LABORATORIES LLC	8c7c0e3f-6092-413c-90f1-b3466c8a9501	2023-10-13	Warnings	Exact identifier application number: M020
Clinique Broad Spectrum SPF 30 Oil Free Face With Solar Smart	OCTINOXATE, OCTISALATE, TITANIUM DIOXIDE, AND ZINC OXIDE	CLINIQUE LABORATORIES LLC	3d23406b-5252-4ab0-b666-77c0132b0d00	2023-10-13	Warnings	Exact identifier application number: M020
CLINIQUE BROAD SPECTRUM SPF 50 SUNSCREEN BODY WITH SOLAR SMART	AVOBENZONE, HOMOSALATE, OCTISALATE, OCTOCRYLENE, AND OXYBENZONE	CLINIQUE LABORATORIES LLC	94274343-3892-4c27-9d2f-c025310e2959	2023-10-13	Warnings	Exact identifier application number: M020
REDNESS solutions MAKEUP BROAD SPECTRUM SPF 15 WITH PROBIOTIC TECHNOLOGY	OCTINOXATE, TITANIUM DIOXIDE, AND ZINC OXIDE	CLINIQUE LABORATORIES LLC	e557e7f3-1fa7-4dde-977f-fe3f942496c0	2023-10-13	Warnings	Exact identifier application number: M020
PEP-STAR DAILY UV PROTECTOR BROAD SPECTRUM SPF 50	TITANIUM DIOXIDE AND ZINC OXIDE	CLINIQUE LABORATORIES LLC	68cfcbc2-a214-437e-9956-f77c90d74888	2023-10-13	Warnings	Exact identifier application number: M020
MOISTURE SURGE SHEERTINT HYDRATOR BROAD SPECTRUM SPF 25	OCTINOXATE, OCTISALATE, TITANIUM DIOXIDE, AND ZINC OXIDE	CLINIQUE LABORATORIES LLC	159410d4-4479-4442-b371-bde72aae3e1e	2023-10-13	Warnings	Exact identifier application number: M020
CLARINS UV PLUS ANTI-POLLUTION BROAD SPECTRUM SPF 50 NON-TINTED Sunscreen Multi-Protection	HOMOSALATE, OCTOCRYLENE, OXYBENZONE, TITANIUM DIOXIDE	Laboratoires Clarins	0695e3a4-0e8f-419e-b128-9b02bdb8b02a	2023-10-11	Warnings	Exact identifier application number: M020
Orange Soda SPF 15 Broad Spectrum Lip Balm	ORANGE SODA SPF 15 BROAD SPECTRUM LIP BALM	Raining Rose, Inc	a0c362ae-b878-c630-e053-2995a90ad4c4	2023-10-10	Warnings	Exact identifier application number: M020
Skin Laundry Sun Defense Mineral SPF 30 Sunscreen Broad Spectrum SPF 30 UVA UVB	ZINC OXIDE	Skin Laundry Holdings, Inc.	071038d9-8179-6953-e063-6394a90a8a84	2023-10-06	Warnings	Exact identifier application number: M020
TOM FORD SHADE AND ILLUMINATE SOFT RADIANCE FOUNDATION BROAD SPECTRUM SPF 50	ENSULIZOLE, OCTINOXATE, OCTISALATE, AND ZINC OXIDE	TOM FORD BEAUTY DIST	4bae83b7-2c98-4928-8e71-bb4f19cc48f0	2023-10-05	Warnings	Exact identifier application number: M020
BB Broad Spectrum SPF 15 Light	ZINC OXIDE TITANIUM DIOXIDE	Burt's Bees	3150ef71-2ea1-25d0-e054-00144ff88e88	2023-10-05	Warnings	Exact identifier application number: M020
BB Broad Spectrum SPF 15 Medium	ZINC OXIDE TITANIUM DIOXIDE	Burt's Bees	3346f41e-32d0-35d0-e054-00144ff88e88	2023-10-05	Warnings	Exact identifier application number: M020
CLINIQUE SMART CUSTOM REPAIR MOISTURIZER BROAD SPECTRUM SPF 15 - VERY DRY/DRY	AVOBENZONE AND OCTISALATE	CLINIQUE LABORATORIES LLC	59eeb180-1ac6-44b3-9742-dc65287896bf	2023-10-05	Warnings	Exact identifier application number: M020

UNII, Preferred term, Registry number table
UNII	Preferred term	Registry number	Matched term
G63QQF2NOX	AVOBENZONE	70356-09-1	AVOBENZONE
4Y5P7MUD51	OCTINOXATE	83834-59-7	OCTINOXATE
4X49Y0596W	OCTISALATE	118-60-5	OCTISALATE
95OOS7VE0Y	OXYBENZONE	131-57-7	OXYBENZONE

Packages#

Package NDC, 11-digit format, Description table
Package NDC	11-digit format	Description	Units	Marketing start	Marketing end	Sample	Exclude flag	Status
66097-002-50	66097000250	1 BOTTLE in 1 BOX (66097-002-50) / 50.3 g in 1 BOTTLE	1 bottle	2013-01-21	0000-00-00	No	No	Current