Drug Facts
Drug Facts
Coco And Eve Sunny Honey Protect Spf 50 Oil
FDA Label NDC 85624-001
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 Spf 50 (NDC 85624-001). 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, do not use, when using this product, stop use and ask a doctor, 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
Do Not Use
on damaged skin or broken skin
When Using This Product
keep out of eyes. Rince with water to remove.
Stop Use And Ask A Doctor
if rash occurs
Keep Out Of Reach Of Children.
If swallowed, get medical help or contact a Poison Control Center right away.
Directions
• Shake well before use. 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 ever 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 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-sleeved shirts, pants, hats, and sunglasses.
• Children under 6 months: ask a doctor.
Other Information
Protect the product from excessive heat and direct sun.
Inactive Ingredients
ETHYLHEXYL PALMITATE, DIETHYLHEXYL 2,6-NAPHTHALATE, BUTYLOCTYL SALICYLATE, POLYESTER-8, DEXTRIN PALMITATE, SILICA, DIETHYLHEXYL SYRINGYLIDENEMALONATE, PARFUM (FRAGRANCE), HELIANTHUS ANNUUS (SUNFLOWER) SEED OIL, TOCOPHEROL, SYNTHETIC FLUORPHLOGOPITE, CITRULLUS LANATUS (WATERMELON) SEED OIL, PRUNUS ARMENIACA (APRICOT) KERNEL OIL, CAPRYLIC/CAPRIC TRIGLYCERIDE, CI 77891 (TITANIUM DIOXIDE), COCOS NUCIFERA (COCONUT) OIL, ANANAS SATIVUS (PINEAPPLE) FRUIT EXTRACT, PSIDIUM GUAJAVA FRUIT EXTRACT, THEOBROMA CACAO (COCOA) SEED EXTRACT, CI 77491 (IRON OXIDES), TIN OXIDE.
Questions?
Contact (609) 320-4845
Package Label.Principal Display Panel
P250722-sh-spf_shimmer_body_oil-150ml-pr-us.jpg (P250722 Sh Spf Shimmer Body Oil 150ml Pr Us)
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