Active Ingredient
Zinc Oxide 25%
Sunsei Spf 45 Sunscreen Liquid
FDA Label NDC 85791-4531
Full FDA labeling including Indications, Dosage, Usage, and Precautions
Structured Product Label
The following Structured Product Label (SPL) was submitted to the FDA by Shimoda Prime Products, Llc for the product Sunsei Spf 45 Sunscreen (NDC 85791-4531). This document serves as the official prescribing information, containing essential scientific data and clinical materials required for healthcare providers and patients.
This specific version of the label includes detailed information regarding active ingredient, purpose, uses, warnings, keep out of reach of children, do not use, stop use, ask a doctor before use, and other regulatory disclosures. Use the navigation below to review specific sections of the FDA submission.
Label Section Quick Index
Purpose
Sunscreen
Uses
Helps prevent sunburn.
Warnings
For external use only.
Keep Out Of Reach Of Children
Keep out of reach of children. If swallowed, get medical help or contact a Poison Control Center right away.
Do Not Use
Do not use on damaged or broken skin.
Stop Use
Stop use and ask doctor if rash occurs.
Ask A Doctor Before Use
Children under 6 months of age. Ask a doctor.
When Using This Product
Avoid contact with eyes. If contact occurs, rinse thoroughly with water.
Directions
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
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
Protect the product in this container from excessive heat and direct sun.
Principal Display Panel
85791-4531-01 (85791 4531 01)
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