Country: United States
Language: English
Source: NLM (National Library of Medicine)
AVOBENZONE (UNII: G63QQF2NOX) (AVOBENZONE - UNII:G63QQF2NOX), HOMOSALATE (UNII: V06SV4M95S) (HOMOSALATE - UNII:V06SV4M95S), OCTINOXATE (UNII: 4Y5P7MUD51) (OCTINOXATE - UNII:4Y5P7MUD51), OCTISALATE (UNII: 4X49Y0596W) (OCTISALATE - UNII:4X49Y0596W)
TAYLOR JAMES, LTD.
AVOBENZONE
AVOBENZONE 3 g in 100 mL
TOPICAL
OTC DRUG
Uses - Helps prevent and tempararily protect chafed, chapped, cracked, or windburned skin and/or lips - 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
SHINE ON LIP SUNSCREEN BROAD SPECTRUM SPF 50- AVOBENZONE, HOMOSALATE, OCTINOXATE, OCTISALATE CREAM TAYLOR JAMES, LTD. _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._ ---------- SHINE-ON LIP SUNSCREEN BROAD SPECTRUM SPF 50 Active Ingredients Purpose Avobenzone 3% ............. Sunscreen Homosalate 10% ............ Sunscreen Octinoxate 7.5% ............ Sunscreen Octisalate 5% ................ Sunscreen Uses Helps prevent and tempararily protect chafed, chapped, cracked, or windburned skin and/or lips 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 Children under 6 months: Ask a doctor 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 minuts before sun exposure Reapply after 80 minuts of swimming or sweating Immediately after towel drying At least every two 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 value of 15 or higher and other sun protection measures including: Limit time in the sun, especially from 10a.m. - 2p.m. Wear long-sleeved shirts, pants, hats, and sunglasses Inactive Ingredients Hydrogenated Polyisobutene, Butyloctyl Salicylate, Polyester-7, Diisopropyl Sebacte, Isodecyl Neopentanoate, Lauryl Lactate, Neopentyl Glycol Diheptanoate, Polyester-8, Tibehenin, Phenoxyethanol, Trihydroxystearin, Menthone Glycerin Acetal, Diethylhexy Syringylidenemalonate, Polybutene, Tocopheryl Acetate, Polysilicone-15, Octyldodecanol, Elaeis Guineensis (Palm) Oil, Benzoic Acid, Tocotrienols, Helianthus Annuus (Sunflower) Seed Oil, Dehydroacetic Acid, To Read the complete document