Country: United States
Language: English
Source: NLM (National Library of Medicine)
Homosalate (UNII: V06SV4M95S) (HOMOSALATE - UNII:V06SV4M95S), Octinoxate (UNII: 4Y5P7MUD51) (OCTINOXATE - UNII:4Y5P7MUD51), Octisalate (UNII: 4X49Y0596W) (OCTISALATE - UNII:4X49Y0596W), Octocrylene (UNII: 5A68WGF6WM) (OCTOCRYLENE - UNII:5A68WGF6WM), Zinc Oxide (UNII: SOI2LOH54Z) (ZINC CATION - UNII:13S1S8SF37)
TopCo
TOPICAL
OTC DRUG
Uses • helps prevent sunburn • higher SPF gives more sunburn protection • retains SPF after 40 minutes of activity in the water • provides high protection against sunburn
OTC monograph not final
SPORT SUNSCREEN SPF 50 TOPCARE- HOMOSALATE 6.00% OCTINOXATE 7.50% OCTISALATE 5.00% OCTOCRYLENE 10.00% ZINC OXIDE 8.00% STICK TOPCO _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 Homosalate 6.0%....................................................................Sunscreen Octinoxate 7.5%......................................................................Sunscreen Octisalate 5.0%.......................................................................Sunscreen Octocrylene 10.0%..................................................................Sunscreen Zinc Oxide 8.0%......................................................................Sunscreen USES • helps prevent sunburn • higher SPF gives more sunburn protection • retains SPF after 40 minutes of activity in the water • provides high protection against sunburn 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 swallowed, get medical help or contact a Poison Control Center right away. DIRECTIONS • Apply liberally 15 minutes before sun exposure. • Reapply: • after 40 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 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 of age: ask a doctor OTHER INFORMATION • protect the product in this container from excessive heat and direct sun INACTIVE I Read the complete document