Otc - Active Ingredient
Active Ingredients Purpose
Avobenzone 3% Sunscreen
Homosalate 10% Sunscreen
Octinoxate 7.5% Sunscreen
Octisalate 5% Sunscreen
Octocrylene 10% Sunscreen
The following Structured Product Label (SPL) was submitted to the FDA by Taylor James, Ltd. for the product Sunscreen Mist Broad Spectrum Spf 30 (NDC 75936-123). 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, otc - keep out of reach of children, indications & usage, warnings, dosage & administration, inactive ingredient, package label.principal display panel, and other regulatory disclosures. Use the navigation below to review specific sections of the FDA submission.
Active Ingredients Purpose
Avobenzone 3% Sunscreen
Homosalate 10% Sunscreen
Octinoxate 7.5% Sunscreen
Octisalate 5% Sunscreen
Octocrylene 10% 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
Keep out of reach of children.
Stop use and ask a doctor if rash occurs
Warnings Flamamble. Keep away from flames and sparks
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
If swallowed, get medical help or contact a Poison Control Center right away.
Directions Apply Liberally 15 minutes before sun exposure
Reapply: after 80 minutes of swimming or sweating
immediately after towel drying
at least every 2 hours when exposed to sunlight
children under 6 months: 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.-2p.m.
wear long-sleved shirts, pants, hats, and sunglasses
Inactive Ingredients Alcohol Denat, Camellia Sinensis Leaf Extract, Cananga Odorata Flower Oil, Caprylic/Capric Triglyceride, Citrus Aurantifolia (Lime) Oil, Citrus Grandis (Grapefruit) Peel Oil, Citrus Limon Fruit Oil, Citrus Nobilis (Mandarin Orange) Peel Oil, Citrus Reticulata (Tangerine) Peel Oil, Citrus Sinensis Peel Oil, Dicaprylyl Carbonate, Diisopropyl Adipate, Euterpe Oleracea Fruit Extract, Helianthus Annuus (Sunflower) Seed Oil, Isodecyl Neoppentanoate, Lavandula Angustifolia (lavender) Oil, Mentha Piperita (Peppermint Oil) Mentha Viridis (Spearmint) Leaf Oil, Tetrahexyldecyl Ascorbate (Vitamin C), Tridecyl Neopentanoate, VA/Butyl Maleate/Isobornyl Acrylate Coploymer, Vitis Vinifera (Grape) Seed Oil.
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