Otc - Active Ingredient
Active Ingredients
Homosalate 15%
Octocrylene 10%
Octisalate 5%
Avobenzone 3%
Coco Eve Sunny Honey Highlighter Body Spf 50 Lotion
FDA Label NDC 68577-244
Full FDA labeling including Indications, Dosage, Usage, and Precautions
Structured Product Label
The following Structured Product Label (SPL) was submitted to the FDA by Cosmax Usa for the product Coco Eve Sunny Honey Highlighter Body Spf 50 (NDC 68577-244). 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 otc - active ingredient, otc - purpose, uses, warnings, otc - do not use, otc - when using, otc - stop use, otc - keep out of reach of children, and other regulatory disclosures. Use the navigation below to review specific sections of the FDA submission.
Label Section Quick Index
Otc - Purpose
Purpose
Sunscreen
Uses
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
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
Keep out of reach of children. If swallowed, get medical help or contact a Poison Control Center right away.
Directions
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 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
Inactive Ingredient
Inactive Ingredients: Ethylhexyl Palmitate, Diethylhexyl 2,6-Naphthalate, Butyloctyl Salicylate, Polyester-8, Dextrin Palmitate, Silica, Diethylhexyl Syringylidenemalonate, Fragrance (Parfum), Helianthus Annuus (Sunflower) Seed Oil, Tocopherol, Synthetic Fluorphlogopite, Caprylic/Capric Triglyceride, Citrullus Lanatus (Watermelon) Seed Oil, Prunus Armeniaca (Apricot) Kernel Oil, CI 77891, Cocos Nucifera (Coconut) Oil, Ananas Sativus (Pineapple) Fruit Extract, Psidium Guajava Fruit Extract, Theobroma Cacao (Cocoa) Seed Extract, CI 77491, Tin Oxide.
Other Information
Other Information
Protect the product from excessive heat and direct sun.
Questions?
Questions? Contact (609) 320-4845
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