Otc - Active Ingredient
Active ingredients Sunscreen
Avobenzone 2.0% Sunscreen
Octinoxate 7.5% Sunscreen
Octisalate 5.0% Sunscreen
Octocrylene 7.0% Sunscreen
Oxybenzone 5.0% Sunscreen
Ray Defense Borad Spectrum Spf 30 Sunscreen
FDA Label NDC 49825-132
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 Borad Spectrum Spf 30 Sunscreen (NDC 49825-132). 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. If product is 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 damaged or 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
· Reapply at least every 2 hours
· Use a water resistant sunscreen if swimming or sweating
· 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 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
Allantoin, Aloe Barbdadenesis 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, Ethylhexylglycerin, Glycerin, Glyceryl Stearate, Glycol Distearate Isohexadecane, Lavandula Angustifolia (Lavender) Oil, PEG-100 Stearate, Polysorbate 80, Potassium Cetyl Phosphate, Salvia Officinalis (Sage) Oil, Salvia Sclarea (Clary) Oil, Sodium Acrylate/Sodium Acryloyldimethyl Taurate Copolymer, Sodium Hydroxide, Stearyl Alcohol, Tetrasodium EDTA, Titanium Dioxide, Tocopheryl Acetate, Water (Aqua, Eau).
Package Label.Principal Display Panel
Carton (Carton)
Tube (Tube)
Label (Label)
Bioelements
Ray defense Broad Spectrum SPF 30 Sunscreen
Hydrating moisturizer to protect skin
Decreases the risk of Skin Cancer and early skin aging caused by the sun when used as directed
* Please review the disclaimer below.
