Country: United States
Language: English
Source: NLM (National Library of Medicine)
Active ingredients, (To Deliver) Avobenzone 3%, Homosalate 10%, Octisalate 4.5%,, Octocrylene 9%, Oxybenzone 2%
Bayer HealthCare LLC.
TOPICAL
OTC DRUG
Purpose Sunscreen Uses ■ helps prevent sunburn Flammable : Do not use near heat, flame, or while smoking Do not use on damaged or broken skin Stop use and ask a doctor if rash occurs
OTC monograph final
COPPERTONE DEFEND AND CARE ULTRA HYDRATE SPF 50- AVOBENZONE,HOMOSALATE,OCTISALATE,OCTOCRYLENE,OXYBENZONE SPRAY BAYER HEALTHCARE 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._ ---------- DEFEND & CARE ULTRA HYDRATE SPRAY SPF 50 DRUG FACTS _Drug Facts_ ACTIVE INGREDIENTS _ACTIVE INGREDIENTS_ (To Deliver) Avobenzone 3%, Homosalate 10%, Octisalate 4.5%, Octocrylene 9%, Oxybenzone 2% PURPOS E _PURPOSE_ Sunscreen US ES _USES_ ■ helps prevent sunburn WARNINGS _WARNINGS_ For external use only DO NOT USE FLAMMABLE: Do not use near heat, flame, or while smoking DO NOT USE on damaged or broken skin WHEN USING THIS PRODUCT WHEN USING THIS PRODUCT ■ keep out of eyes. Rinse with water to remove. ■ use only as directed. Intentional misuse by deliberately concentrating and inhaling the contents can be harmful or fatal. ■ do not puncture or incinerate. Contents under pressure. Do not store at temperatures above 120˚F. STOP USE AND ASK A DOCTOR IF STOP USE AND ASK A DOCTOR IF rash occurs KEEP OUT OF REACH OF CHILDREN KEEP OUT OF REACH OF CHILDREN. If product is swallowed, get medical help or contact a Poison Control Center right away. DIRECTIONS _DIRECTIONS_ ■ shake well before use ■ apply liberally 15 minutes before sun exposure and rub into skin ■ do not spray directly on face. Spray into hands and apply to face. ■ use in well-ventilated areas ■ 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 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-sleeve shirts, pants, hats, and sunglasses ■ children under 6 mo Read the complete document