Sunsei SPF 45 Sunscreen

Manufacturer: Shimoda Prime Products, LLC | Southeast Holdings Corp
Effective date: 2026-03-09
Label type: HUMAN OTC DRUG LABEL
Version: 2
Source: full-release
Hydrated at: 2026-06-01 01:49:58

Label at a glance#

ProductSunsei SPF 45 Sunscreen

Active ingredientZINC OXIDE

Label structure13 sections

Indications and uses

Helps prevent sunburn.

Dosage and administration

Apply evenly to exposed skin 15 minutes before sun exposure. Re-apply immediately after swimming and sweating and at least every 2 hours.

Label contents#

Full prescribing information#

Active Ingredient

OTC - ACTIVE INGREDIENT SECTION

Zinc Oxide 25%

Purpose

OTC - PURPOSE SECTION

Sunscreen

Uses

INDICATIONS & USAGE SECTION

Helps prevent sunburn.

Warnings

WARNINGS SECTION

For external use only.

Keep out of reach of children

OTC - KEEP OUT OF REACH OF CHILDREN SECTION

Keep out of reach of children. If swallowed, get medical help or contact a Poison Control Center right away.

Do not use

OTC - DO NOT USE SECTION

Do not use on damaged or broken skin.

Stop use

OTC - STOP USE SECTION

Stop use and ask doctor if rash occurs.

Ask a doctor before use

OTC - ASK DOCTOR SECTION

Children under 6 months of age. Ask a doctor.

When using this product

OTC - WHEN USING SECTION

Avoid contact with eyes. If contact occurs, rinse thoroughly with water.

Directions

DOSAGE & ADMINISTRATION SECTION

Apply evenly to exposed skin 15 minutes before sun exposure. Re-apply immediately after swimming and sweating and at least every 2 hours.

Inactive Ingredients

INACTIVE INGREDIENT SECTION

Water, Coconut Oil, Jojoba Oil, Almond Oil, Olive Oil, Aloe Vera Leaf Juice, Shea Butter, Chamomile Flower Oil, Castor Oil, Sunflower Oil, Canola Oil, Salt (Sodium Chloride), Salt (Sodium Benzoate), Salt (Potassium Sorbate), Grape Seed Extract, Pomegranate Extract, Green Tea Leaf Extract, Fragrance

Other Information

OTHER SAFETY INFORMATION

Protect the product in this container from excessive heat and direct sun.

Principal Display Panel

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

85791-4531-01

Product Linked Resources#

Resource, Code type, Value table
Resource	Code type	Value	Equivalent identifiers	Source image
QR code link	QR Code	sunseisunscreen.com/		85791-4531-01.jpg

DailyMed Product Concepts#

Product concept, Relation, Version table
Product concept	Relation	Version	Effective
ebc62596-fc97-4d03-9483-7ba095d25db7	Product name	1	20151210

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDC	Product	Description	Form	Quantity	Strength	SPL version
85791-4531-1	Sunsei SPF 45 Sunscreen	89 mL in 1 TUBE	LIQUID	89		2

Products#

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

DailyMed product names page 1 of 1 · 20 matching rows.

Sunsei SPF 45 Sunscreen
Zinc Oxide
WATER
COCONUT OIL
JOJOBA OIL
ALMOND OIL
OLIVE OIL
ALOE VERA LEAF JUICE
SHEA BUTTER
CHAMOMILE FLOWER OIL
CASTOR OIL
SUNFLOWER OIL
CANOLA OIL
SODIUM CHLORIDE
SODIUM BENZOATE
POTASSIUM SORBATE
GRAPE SEED EXTRACT
POMEGRANATE
GREEN TEA LEAF
FRAGRANCE 13576

NDC Codes#

Product NDC, Package NDC table
Product NDC	Package NDC
85791-4531	85791-4531-1

Ingredients#

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

DailyMed ingredient rows page 1 of 1 · 19 matching rows.

Name, UNII, Kind table
Name	UNII	Kind
WATER	059QF0KO0R	IACT
COCONUT OIL	Q9L0O73W7L	IACT
JOJOBA OIL	724GKU717M	IACT
ALMOND OIL	66YXD4DKO9	IACT
OLIVE OIL	6UYK2W1W1E	IACT
ALOE VERA LEAF JUICE	RUE8E6T4NB	IACT
SHEA BUTTER	K49155WL9Y	IACT
CHAMOMILE FLOWER OIL	60F80Z61A9	IACT
CASTOR OIL	D5340Y2I9G	IACT
SUNFLOWER OIL	3W1JG795YI	IACT
CANOLA OIL	331KBJ17RK	IACT
SODIUM CHLORIDE	451W47IQ8X	IACT
SODIUM BENZOATE	OJ245FE5EU	IACT
POTASSIUM SORBATE	1VPU26JZZ4	IACT
GRAPE SEED EXTRACT	RDS2V6DVY5	IACT
POMEGRANATE	56687D1Z4D	IACT
GREEN TEA LEAF	W2ZU1RY8B0	IACT
FRAGRANCE 13576	5EM498GW35	IACT
ZINC OXIDE	SOI2LOH54Z	ACTIB

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
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
Sunsei SPF 45 Sunscreen	ZINC OXIDE	Shimoda Prime Products, LLC	3d48e3e2-18c7-e004-e063-6294a90af4f2	2026-03-09	Warnings	Exact identifier ndc (package): 85791-4531-1 ndc (product): 85791-4531 ndc11 (package): 85791453101 spl id: 4c9e0316-7c08-d8a8-e063-6294a90a895b spl set id: 3d48e3e2-18c7-e004-e063-6294a90af4f2

Reported adverse events (FAERS/openFDA)#

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