Otc - Active Ingredient
Active Ingredients
Homosalate 15%
Octocrylene 10%
Octisalate 5%
Avobenzone 3%
Coco-eve Coconut Milk Body Spf 50 Cream
FDA Label NDC 68577-243
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 Coconut Milk Body Spf 50 (NDC 68577-243). 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
- Apply generously all over the body 20 minutes before sun exposure, ensuring every part of the body is convered. Reapply at least every 2 hours. Use a water resistant sunscreen if swimming or sweating.
- 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 or 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: Water, Butyloctyl Salicylate, Silica, Diisopropyl Adipate, Propanediol, Polyglyceryl-3 Methylglucose Distearate, Polyester-7, Lauryl Glucoside, Microcrystalline Cellulose, Polyglyceryl-6 Laurate, Phenoxyethanol, Neopentyl Glycol Diheptanoate, Saccharide Isomerate, Fragrance (Parfum), Myristyl Glucoside, Sodium Stearoyl Glutamate, Diethylhexyl Syringylidenemalonate, Cellulose Gum, Helianthus Annuus (Sunflower) Seed Oil, Tocopherol, Ethylhexylglycerin, Tetrasodium Glutamate Diacetate, Glycerin, Caprylic/Capric Triglyceride, Ananas Sativus (Pineapple) Fruit Extract, Citrullus Lanatus (Watermelon) Seed Oil, Hylocereus Undatus Fruit Extract, Citric Acid, Sodium Citrate, Carica Papaya (Papaya) Fruit Extract, Cocos Nucifera (Coconut) Fruit Extract, Mangifera Indica (Mango) Fruit Extract, Sodium Hydroxide, Potassium Sorbate, Sodium Metabisulfite.
Other Information
Other Information
Protect the product from excessive heat and direct sun.
Questions?
Questions? Contact (609) 320-4845
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