Country: United States
Language: English
Source: NLM (National Library of Medicine)
AVOBENZONE (UNII: G63QQF2NOX) (AVOBENZONE - UNII:G63QQF2NOX), HOMOSALATE (UNII: V06SV4M95S) (HOMOSALATE - UNII:V06SV4M95S), OCTOCRYLENE (UNII: 5A68WGF6WM) (OCTOCRYLENE - UNII:5A68WGF6WM), OCTISALATE (UNII: 4X49Y0596W) (OCTISALATE - UNII:4X49Y0596W), OXYBENZONE (UNII: 95OOS7VE0Y) (OXYBENZONE - UNII:95OOS7VE0Y)
Bioelements Inc
TOPICAL
OTC DRUG
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. Stop use and ask a doctor if rash occurs.
OTC monograph final
SUN DIFFUSING PROTECTOR SPF 15 BIOELEMENTS- AVOBENZONE, HOMOSALATE, OCTOCRYLENE, OCTYL SALICYLATE, OXYBENZONE LOTION BIOELEMENTS INC _Disclaimer: Most OTC drugs are not reviewed and approved by FDA, however they may be marketed if they_ _comply with applicable regulations and policies. FDA has not evaluated whether this product complies._ ---------- SUN DIFFUSING PROTECTOR SPF 15 Active Ingredients Purpose Avobenzone 2.0% Sunscreen Homosalate 7.5% Sunscreen Octocrylene 1.8 % Sunscreen Octyl Salicylate 5.0% Sunscreen Oxybenzone 0.49% 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. If product is swallowed, get medical help or contact a Poison Control Center right away Stop use and ask a doctor if rash occurs. 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. Directions Apply liberally 15 minutes before sun exposure Use a water resistant sunscreen if swimming or sweating Reapply 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 measure including: Limit time in the sun, especially from 10 a.m. - 2 p.m. Wear long-sleeve shirts, pants, hats and sunglasses Aminomethyl Propanol, C12-15 Alkyl Benzoate, Caprylic/Capric Triglyceride, Carbomer, Cetyl Alcohol, Citric Acid, Citrus Aurantium (Bitter Orange) Flower Oil, Citrus Reticulata (Tangerine) Leaf Oil, Dimethicone, Lavandula Angustifolia (Lavender) Oil, Phenoxyethanol, Potassium Cetyl Phosphate, Potassium Sorbate, Salvia Officinalis (Sage) Oil, Salvia Sclarea (Clary) Oil, Sorbitol, Stearic Acid, Tetra Sodium Blutamate Diacetate Water (Aqau, Eau) Bioelements Sun Diffusing Protector SPF 15 Broad Spectru Read the complete document