Otc - Active Ingredient
Active ingredients
Avobenzone 2.9%
Octisalate 4.9%
Octocrylene 9.5%
The following Structured Product Label (SPL) was submitted to the FDA by Allure Labs for the product Daily Prevention Protect And Refresh Mist Spf 40 (NDC 62742-4257). 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, indications & usage, 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.
Active ingredients
Avobenzone 2.9%
Octisalate 4.9%
Octocrylene 9.5%
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: Flammable. Keep away from fire or flame. • For external use only
Do not use • on damaged or broken skin
When using this product • keep out of eyes. Rinse 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 • hold container 4 to 6 inches from the skin to apply • spray liberally and spread evenly by hand 15 minutes before sun exposure • avoid contact with eyes • reapply: • after 80 minutes of swimming or sweating • immediately after towel drying • at least every 2 hours • children under 6 months of age: ask a doctor • 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 value 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
Other information • protect the product in this container from excessive heat and direct sun.
Inactive ingredients: Alcohol, Diisooctyl Succinate, Butyloctyl Salicylate, Aqua/water/Eau, Ethylhexyl Methoxycrylene, VA/Butyl Maleate/ Isobornyl Acrylate Copolymer, Alcohol Denat., Acetyl Zingerone, Caprylie/Capric Triglyceride, Ethyl Ferulate, Polyester-8, Mauritia Flexuosa Fruit Oil, Limnanthes Alba Seed Oil, Glycerin, Brassica Campestris Seed Oil, Rubus Idaeus Seed Oil, T-Butyl Alcohol, Vanilla Planifolia Fruit Extract, Glycyrrhiza Glabra Root Extract, Polyglyceryl-3 Diisostearate, Opuntia Ficus-Indica Leaf Cell Extract, Camellia Sinensis Leaf Extract, Bisabolol, Phosphatidylcholine, Althaea Officinalis Root Extract, Oryza Sativa Bran Extract, Mannitol, Methylpropanediol, Ectoin, Caprylyl Glycol, Denatonium Benzoate, Stearic Acid, Palmitic Acid, Haematococcus Pluvialis Extract, Tetrahexyldecyl Ascorbate, Panthenol, Phenylpropanol, Sodium Benzoate, Potassium Sorbate.
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