Country: United States
Language: English
Source: NLM (National Library of Medicine)
AVOBENZONE (UNII: G63QQF2NOX) (AVOBENZONE - UNII:G63QQF2NOX), OCTISALATE (UNII: 4X49Y0596W) (OCTISALATE - UNII:4X49Y0596W), HOMOSALATE (UNII: V06SV4M95S) (HOMOSALATE - UNII:V06SV4M95S), OCTOCRYLENE (UNII: 5A68WGF6WM) (OCTOCRYLENE - UNII:5A68WGF6WM)
Supergoop, LLC
TOPICAL
OTC DRUG
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
GLOWSCREEN SPF 40 - DAWN- AVOBENZONE, HOMOSALATE, OCTISALATE, OCTOCRYLENE LOTION SUPERGOOP, LLC _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._ ---------- Active Ingredients Purpose Avobenzone 3%.......................................Sunscreen Homosalate 4%.......................................Sunscreen Octisalate 5%.......................................Sunscreen Octocrylene 8%.......................................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 Keep out of reach of children. If product is swallowed, get medical help, or contact a poison control center right away. 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 Directions Apply generously and evenly 15 minutes before sun exposure Reapply at least every 2 hours Use a water resistant sunscreen if swimming or sweating 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 10 a.m.- 2 p.m. Wear long-sleeved shirts, pants, hats, and sunglasses Children under 6 months: Ask a doctor Water, Butyloctyl Salicylate, Propanediol, Titanium Dioxide, Glycerin, C12-15 Alkyl Benzoate, Mica, Glyceryl Stearate Citrate, Isododecane, Niacinamide, Polymethylsilsesquioxane, Glyceryl Stearate, Caprylic/Capric Triglyceride, Cetyl Phosphate, Diisopropyl Sebacate, Isodecyl Neopentanoate, Lauryl Lactate, Coco- Caprylate, Arginine, Silica, Butylene Glycol, 1,2-Hexanediol, Caprylyl Glycol, Hydroxyacetophenone, Sodium Hyaluronate, Chlorphene Read the complete document