Otc - Active Ingredient
Active Ingredients Purpose
Avobenzone 3% Sunscreen
Homosalate 10% Sunscreen
Octinoxate 7.5% Sunscreen
Octisalate 5% Sunscreen
Octocrylene 10% Sunscreen
Sunscreen Mist Broad Spectrum Spf 50
FDA Label NDC 75936-124
Full FDA labeling including Indications, Dosage, Usage, and Precautions
Structured Product Label
The following Structured Product Label (SPL) was submitted to the FDA by Taylor James, Ltd. for the product Sunscreen Mist Broad Spectrum Spf 50 (NDC 75936-124). 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.
Label Section Quick Index
Otc - Purpose
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
Otc - Keep Out Of Reach Of Children
Keep out of reach of children
Indications & Usage
Stop use and ask a doctor if rash occurs
Warnings
Warnings Flammable. 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.
Dosage & Administration
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
Inactive Ingredient
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, Helianthuus Annuus (Sunflower) Seed Oil, Isodecyl Neopentanoate, Lavandula Angustifolia Mentha Piperita (Peppermint) Oil, Mentha Viridis (Spearmint) Leaf Oil, Tetrahexyldecyl Ascorbate (vitamin C), Tridecyl Neopentanoate, VA/Butyl Maleate/Isobornyl Acrylate Copolymer, Vitis Vinifera (Grape) Seed Oil.
Package Label.Principal Display Panel
Water resistant (80 minutes)
Apply to wet or dry skin
twist-lock cap
SPF 50 sunscreen
Antioxidant-Infused
Sunscreen Mist
with Vitamin C
Broad Spectrum
* Please review the disclaimer below.
