Country: United States
Language: English
Source: NLM (National Library of Medicine)
ZINC OXIDE (UNII: SOI2LOH54Z) (ZINC OXIDE - UNII:SOI2LOH54Z), TITANIUM DIOXIDE (UNII: 15FIX9V2JP) (TITANIUM DIOXIDE - UNII:15FIX9V2JP)
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 on damaged or broken skin. if rash occurs.
OTC monograph not final
LEADER KIDS SUNSCREEN SPF 50- TITANIUM DIOXIDE, ZINC OXIDE 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 KID'S SUNSCREEN SPF 50 LOTION ACTIVE INGREDIENTS Titanium Dioxide 4.5%, Zinc Oxide 6.5% 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 Children under 6 months: Ask a doctor 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 OTHER INFOMATION protect the product in this container from excessive heat and direct sun may stain or damage some fabrics, materials or surfaces INACTIVE INGREDIENTS water, caprylic/capric triglyceride, isohexadecane, butyloctyl salicylate, octyldodecyl citrate crosspolymer, cetyl PEG/PPG-10/1 dimethicone, lauryl PEG-8 dimethicone, C30-38 olefin/isopropyl maleate/MA copolymer, sodium chloride, ethylhexyl methoxycrylene, dimethicone, caprylyl glycol, PEG-8, silica, triethoxycaprylylsilane, glycerin, sodium citrate, tocopheryl acetate, benzyl alcohol, benzoic acid, sorbic aci Read the complete document