FDA.reportPublic FDA data

Sunscreen Oil - Soleil Collective LLC

Manufacturer
Soleil Collective LLC
Effective date
2025-12-29
Label type
HUMAN OTC DRUG LABEL
Version
1
Source
full-release
Hydrated at
2026-06-01 01:52:13

Label at a glance#

ProductCOCO AND EVE SUNNY HONEY PROTECT TAN BOOSTING ANTI-AGING SPF 20
Active ingredientHOMOSALATE, AVOBENZONE, OCTOCRYLENE, OCTISALATE
Label structure10 sections

Indications and uses

Helps prevent sunburn. If used as directed with other sun protection measures (see Directions), decreases the risk of skin cancer and early skin aging caused by the sun.

Dosage and administration

Apply generously all over the body 20 minutes before sun exposure, ensuring every part of the body is covered. Reapply after 40 minutes of swimming or sweating, immediately after towel drying and at least after every 2 hours.

Label contents#

Full prescribing information#

Drug Facts

DOSAGE & ADMINISTRATION SECTION

Drug Facts

Active ingredients

OTC - ACTIVE INGREDIENT SECTION

Homosalate 15%
Octocrylene 10%
Octisalate 5%
Avobenzone 3%

Purpose

OTC - PURPOSE SECTION

Sunscreen

Uses

INDICATIONS & USAGE SECTION

Helps prevent sunburn. If used as directed with other sun protection measures (see Directions), decreases the risk of skin cancer and early skin aging caused by the sun.

Warnings

WARNINGS SECTION

For external use only.
Store below 30°C / 86°F and avoid direct sunlight.

OTC - DO NOT USE SECTION

Do not use on damaged or broken skin.

OTC - STOP USE SECTION

Stop use and ask a doctor if rash occurs.

OTC - KEEP OUT OF REACH OF CHILDREN SECTION

Keep out of reach of children. When using this product keep out of eyes.
Rinse with water to remove.

Directions

INSTRUCTIONS FOR USE SECTION

Apply generously all over the body 20 minutes before sun exposure, ensuring every part of the body is covered. Reapply after 40 minutes of swimming or sweating, immediately after towel drying and at least after every 2 hours.

Other information

OTHER SAFETY INFORMATION

Protect this product from excessive heat and direct sun.

Inactive ingredients

INACTIVE INGREDIENT SECTION

Ethylhexyl Palmitate, Diethylhexyl 2,6-Naphthalate, VP/Eicosene Copolymer, Isopropyl Palmitate, Caprylic/Capric Triglyceride, Coco-Caprylate, C13-15 Alkane, Prunus Armeniaca (Apricot) Kernel Oil, Helianthus Annuus (Sunflower) Seed Oil, Citrullus Lanatus (Watermelon) Seed Oil, Psidium Guajava (Guava) Fruit Extract, Ananas Sativus (Pineapple) Fruit Extract, Theobroma Cacao (Cocoa) Seed Extract, Acetyl Hexapeptide-1, Tocopherol, Lecithin, Diethylhexyl Syringylidenemalonate, Fragrance, Water

Questions?

OTC - QUESTIONS SECTION

Contact (626) 616-5811

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

P251126-CE_SPF_Body_Oil-Secondary_Packaging-US-2233_Page_1P251126-CE_SPF_Body_Oil-Secondary_Packaging-US-2233_Page_1

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
85624-004-15COCO AND EVE SUNNY HONEY PROTECTTAN BOOSTING ANTI-AGING SPF 201 in 1 CARTONOIL11
85624-004-15COCO AND EVE SUNNY HONEY PROTECTTAN BOOSTING ANTI-AGING SPF 20150 mg in 1 BOTTLEOIL1501

Products#

Every source-derived product name is available through these pages.

DailyMed product names page 1 of 1 · 24 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
85624-00485624-004-15

Ingredients#

Every source-derived ingredient row is available through these pages.

DailyMed ingredient rows page 1 of 1 · 22 matching rows.

Name, UNII, Kind table
NameUNIIKind
HOMOSALATEV06SV4M95SACTIB
AVOBENZONEG63QQF2NOXACTIB
ISOPROPYL PALMITATE8CRQ2TH63MIACT
DIETHYLHEXYL SYRINGYLIDENEMALONATE3V5U97P248IACT
C13-15 ALKANE114P5I43UJIACT
PSIDIUM GUAJAVA FRUIT74O70D6VG0IACT
PRUNUS ARMENIACA (APRICOT) KERNEL EXTRACT75356789IWIACT
COCO-CAPRYLATE4828G836N6IACT
VINYLPYRROLIDONE/EICOSENE COPOLYMER035MV9S1C3IACT
DIETHYLHEXYL 2,6-NAPHTHALATEI0DQJ7YGXMIACT
CITRULLUS LANATUS (WATERMELON) SEED OILL33J06UQTTIACT
HELIANTHUS ANNUUS (SUNFLOWER) SEED OIL3W1JG795YIIACT
THEOBROMA CACAO (COCOA) SEED BUTTER512OYT1CRRIACT
OCTOCRYLENE5A68WGF6WMACTIB
ANANAS SATIVUS (PINEAPPLE) FRUIT2A88ZO081OIACT
TOCOPHEROLR0ZB2556P8IACT
LECITHIN, SOYBEAN1DI56QDM62IACT
WATER059QF0KO0RIACT
OCTISALATE4X49Y0596WACTIB
ETHYLHEXYL PALMITATE2865993309IACT
CAPRYLIC/CAPRIC TRIGLYCERIDEC9H2L21V7UIACT
ACETYL HEXAPEPTIDE-149ZWR266MZIACT

Source Document#

Source XML

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 1 of 1 · 1 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
COCO AND EVE SUNNY HONEY PROTECT TAN BOOSTING ANTI-AGING SPF 20SUNSCREEN OILSoleil Collective LLC471b3028-2c13-ab70-e063-6394a90aa6602025-12-29WarningsExact identifier
ndc (package): 85624-004-15
ndc (product): 85624-004
ndc11 (package): 85624000415
spl id: 471b3028-2c14-ab70-e063-6394a90aa660
spl set id: 471b3028-2c13-ab70-e063-6394a90aa660

Reported adverse events (FAERS/openFDA)#

Adverse event summaries are temporarily unavailable. Other product information remains available.