COPPERTONE DEFEND AND CARE ULTRA HYDRATE SPF 50- avobenzone,homosalate,octisalate,octocrylene,oxybenzone spray

Country: United States

Language: English

Source: NLM (National Library of Medicine)

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Active ingredient:

Active ingredients, (To Deliver) Avobenzone 3%, Homosalate 10%, Octisalate 4.5%,, Octocrylene 9%, Oxybenzone 2%

Available from:

Bayer HealthCare LLC.

Administration route:

TOPICAL

Prescription type:

OTC DRUG

Therapeutic indications:

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

Authorization status:

OTC monograph final

Summary of Product characteristics

                                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._
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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
                                
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