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)
Cardinal Health
TOPICAL
OTC DRUG
Sunscreen • 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 Do not use on damaged or broken skin.
OTC monograph not final
LEADER GENERAL PROTECTION SUNSCREEN SPF 50- AVOBENZONE, HOMOSALATE, OCTISALATE, OCTOCRYLENE, OXYBENZONE LOTION CARDINAL HEALTH _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._ ---------- LEADER GENERAL PROTECTION SUNSCREEN MOISTURIZING LOTION SPF 50 ACTIVE INGREDIENTS Avobenzone 3.0%, Homosalate 13.0%, Octisalate 5.0%, Octocrylene 7.0%, Oxybenzone 4.0% PURPOSE 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 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 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 water, sorbitol, aluminum starch octenylsuccinate, VP/eicosene copolymer, stearic acid, triethanolamine, sorbitan isostearate, benzyl alcohol, dimethicone, tocopherol (vitamin E), polyglyceryl-3 distearate, fragrance, methylparaben, carbomer, propylparaben, disodium EDTA OTHER INFOMATION protect this product from excessive heat and direct sun may stain or damage some fabrics, materials or surfaces Leader General Protection Sunscreen Moisturizing L Read the complete document