Active Ingredient
Octinoxate 3%
The following Structured Product Label (SPL) was submitted to the FDA by Bps 60 for the product Teint Miracle Octinoxate Sunscreen Broad Spectrum Spf 15 (NDC 70581-004). 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 active ingredient, purpose, uses, warnings, do not use, when using this product, stop use and ask a doctor if, keep out of reach of children., and other regulatory disclosures. Use the navigation below to review specific sections of the FDA submission.
Octinoxate 3%
Sunscreen
For external use only
Flammable untill dry. Do not use near fire, flame or heat.
on damaged or broken skin
keep out of eyes, Rinse with water to remove.
rash occurs.
If swallowed, get medical help or contact a Poison Control Center right away.
For sunscreen use: •shake well • apply liberally 15 minutes before sun exposure • reaply at least every 2 hours • use a water resistant sunscreen if swimming or sweating
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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
• children under 6 months of age: Ask a doctor
water, cyclopentasiloxane, alcohol denat., phenyl trimethicone, glycerin, PEG-10 dimethicone, bis-PEG/PPG-14/14 dimethicone, tin oxide, PEG/PPG/polybutylene glycol-8/5/3 glycerin, rosa gallica flower extract, talc, dimethicone, dimethicone/polyglycerin-3 crosspolymer, methicone, silica silylate, alumina, aluminum hydroxide, magnesium silicate, magnesium sulfate, disodium stearoyl glutamate, synthetic fluorphlogopite, ethylhexyl hydroxystearate, tocopheryl acetate, fragrance, linalool, limonene, hydroxyisohexyl 3-cyclohexene carboxaldehyde, butylphenyl methylpropional, hexyl cinnamal; may contain: red28 lake, red 7, mica, titanium dioxide, blue 1 lake, bismuth oxychloride, Iron oxides
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