Drug Facts
Drug Facts
Coco And Eve Sunny Honey Protect Oil
FDA Label NDC 85624-003
Full FDA labeling including Indications, Dosage, Usage, and Precautions
Structured Product Label
The following Structured Product Label (SPL) was submitted to the FDA by Soleil Collective Llc for the product Coco And Eve Sunny Honey Protect (NDC 85624-003). 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 drug facts, active ingredients, purpose, uses, warnings, otc - do not use, otc - when using, otc - stop use, and other regulatory disclosures. Use the navigation below to review specific sections of the FDA submission.
Label Section Quick Index
Active Ingredients
Homosalate 15%
Octocrylene 10%
Octisalate 5%
Avobenzone 3%
Purpose
Sunscreen
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.
Warnings
For external use only.
Otc - Do Not Use
Do not use on damaged or broken skin
Otc - When Using
When using this product keep out of eyes. Rinse with water to remove.
Otc - Stop Use
Stop use and ask a doctor if rash occurs.
Otc - Keep Out Of Reach Of Children
Do not stay too long in the sun, even while using a sunscreen product.
Keep out of reach of children. Keep babies and young children out of direct sunlight.
Over-exposure to the sun is a serious health threat.
Directions
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 every 2 hours.
● Sun Protection Measures. Spending time in the sun increases your risk of skin cancer and early skin aging. To decrease this risk, regularly use a sunscreen with a broad-spectrum SPF of 15 or higher and other sun protection measures including: •
limit time in the sun, especially from 10 a.m. - 2. p.m. • wear long-sleeve shirts, pants, hats, and sunglasses.
● Children under 6 months: ask a doctor.
Other Information
Protect this product from excessive heat and direct sun.
Inactive Ingredients
Ethylhexyl Palmitate, Diethylhexyl 2,6-Naphthalate, Butyloctyl Salicylate, Polyester-8, Polyamide-8, Isopropyl Palmitate, Diethylhexyl Syringylidenemalonate, Helianthus Annuus (Sunflower) Seed Oil, Lecithin, Fragrance, Prunus Armeniaca (Apricot) Kernel Oil, Citrullus Lanatus (Watermelon) Seed Oil, Tocopherol, Psidium Guajava Fruit Extract, Ananas Sativus (Pineapple) Fruit Extract, Theobroma Cacao (Cocoa) Seed Extract, Acetyl Hexapeptide-1, Caprylic/Capric Triglyceride, Vanillin, Tetramethyl Acetyloctahydronaphthalenes, Rose Ketones, Water
Questions?
Contact (626) 616-5811
Package Label.Principal Display Panel
P251125-ce_spf45_body_oil-secondary_packaging-us_page_1 (P251125 Ce Spf45 Body Oil Secondary Packaging Us Page 1)
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