Otc - Active Ingredient
Active ingredients Purpose
Avobenzone 2.0 % Sunscreen
Octinoxate 7.5 % Sunscreen
Octisalate 5.0 % Sunscreen
Octocrylene 7.5 % Sunscreen
Oxybenzone 5.0% Sunscreen
Ray Defense
FDA Label NDC 49825-121
Full FDA labeling including Indications, Dosage, Usage, and Precautions
Structured Product Label
The following Structured Product Label (SPL) was submitted to the FDA by Bioelements, Inc. for the product Ray Defense (NDC 49825-121). 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 measure (see Direction) 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. If swallowed, get medical help or contact a Poison Control Center right away.
Indications & Usage
Stop use and ask a doctor if rash occurs
Warnings
Warnings
For external Use only
Do not use on broken skin.
When using this product keep out of eyes. Rinse with water to remove.
Dosage & Administration
Directions
Apply liberally 15 minutes before sun exposure
Use a water resistant sunscreen if swimming or sweating
Reapply at least every 2 hours
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 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-sleeve shirts, pants, hats, and sunglasses
Inactive Ingredient
Inactive Ingredients
Allantoin, Aloe Barbadensis Leaf Extract, C12-15 Alkyl Benzoate, Camellia Sinensis (Green Tea) Leaf Extract, Caprylic/Capric Triglyceride, Carbomer, Cetyl alcohol, Chamomilla Recutita (Matricaria) Flower Extract, Citrus Aurantium (Bitter Orange) Flower Oil, Citrus Reticulata (Tangerine) Leaf Oil, Cyclopentasiloxane, Dimethicone, Dimethiconol, Ehtylhexylglycerin, Glycerin, Glyceryl Stearate, Glycol Distearate, Isohexadecane, Lavandula Angustifolia (Lavender) Oil, PEG-100 Stearate, Polysorbate 80, Potassium Cetyl Phophate, Salvia Officinalis (Sage) Oil, Salvea Sclarea (Clary Oil), Sodium Acrylate/Sodium Acryloyldimethyl Taurate Copolymer, Sodium Hydroxide, Stearyl Alcohol, Tetrasodium EDTA,Titanium Dioxide, Tocopheryl Acetate, Water (Aqua, Eau)
Image Of Carton (Carton)
Package Label.Principal Display Panel
Bioelements
Ray Defense SPF 30Broad Spectrum SPF 30 Sunscreen
Moisturizes and decreases the risk of early skin aging caused by the sun when used as directed.
118 mL / 4 Fl.Oz.
Image Of Tube Art (Tube)
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