Country: United States
Language: English
Source: NLM (National Library of Medicine)
Avobenzone (UNII: G63QQF2NOX) (AVOBENZONE - UNII:G63QQF2NOX), Homosalate (UNII: V06SV4M95S) (HOMOSALATE - UNII:V06SV4M95S), Octisalate (UNII: 4X49Y0596W) (OCTISALATE - UNII:4X49Y0596W), Octocrylene (UNII: 5A68WGF6WM) (OCTOCRYLENE - UNII:5A68WGF6WM), Oxybenzone (UNII: 95OOS7VE0Y) (OXYBENZONE - UNII:95OOS7VE0Y)
Sun Bum
Avobenzone
Avobenzone 2 g in 100 mL
TOPICAL
OTC DRUG
Avobenzone 2.00% Sunscreen Homosalate 5.00% Octisalate 2.00% Octocrylene 1.85% Oxybenzone 3.00% Uses - helps prevent sunburn - if used as directed with other sun protection messures (see Directions ) decreases the risk of skin cancer and early skin aging caused by sun.
OTC monograph not final
SUNBUM SPF 15- AVOBENZONE 2.00% HOMOSALATE 5.00% OCTISALATE 2.00% OCTOCRYLENE 1.85% OXYBENZONE 3.00% LOTION SUN BUM _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._ ---------- DRUG FACTS ACTIVE INGREDIENTS PURPOSE Avobenzone 2.00% Sunscreen Homosalate 5.00% Octisalate 2.00% Octocrylene 1.85% Oxybenzone 3.00% US ES - helps prevent sunburn - if used as directed with other sun protection messures (SEE DIRECTIONS) decreases the risk of skin cancer and early skin aging caused by sun. 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. STOP USE AND ASK A DOCTOR IF rash occurs KEEP OUT OF REACH OF CHILDREN. If product is 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 • 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 • children under 6 months: Ask a doctor INACTIVE INGREDIENTS Behenyl Alcohol BHT Butyloctyl Salicylate Caprylyl Methicone Dimethicone Dimethyl Capramide Disodium EDTA Ethylhexyl Stearate Ethylhexylglycerin Fragrance Glyceryl Stearate Hydrated Silica Methylisothiazolinone PEG-100 Stearate Polyaminopropyl Biguanide Polyester-8 Sodium Polyacrylate Styrene/Acrylates Copolymer Tocopheryl Acetate Trideceth-6 T rimethylsiloxysilicate VP/Hexadecene Copolymer Water Xanthan Gum SUNBUM SPF 15 avobenzone 2.00% homosalate 5.00% octisalate 2.00% octocrylene 1.85% oxyb Read the complete document