COPPERTONE ULTRA GUARD SPF 50- avobenzone, homosalate, octisalate, octocrylene and oxybenzone spray

Country: United States

Language: English

Source: NLM (National Library of Medicine)

Active ingredient:

Active ingredients, Avobenzone 3%, Homosalate 10%, Octisalate 5%,, Octocrylene 4%, Oxybenzone 5%

Available from:

Bayer HealthCare LLC.

Administration route:

TOPICAL

Prescription type:

OTC DRUG

Therapeutic indications:

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 Do not use on damaged or broken skin Stop use and ask a doctor if rash occurs

Authorization status:

OTC monograph not final

Summary of Product characteristics

COPPERTONE ULTRA GUARD SPF 50- AVOBENZONE, HOMOSALATE, OCTISALATE,
OCTOCRYLENE AND
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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COPPERTONE ULTRA GUARD SPRAY SPF 50
_DRUG FACTS_
ACTIVE INGREDIENTS
_ACTIVE INGREDIENTS_
Avobenzone 3%, Homosalate 10%, Octisalate 5%,
Octocrylene 4%, Oxybenzone 5%
PURPOS E
_PURPOSE_
Sunscreen
US ES
_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
_WARNINGS_
For external use only
FLAMMABLE: Do not use near heat, flame, or while smoking
DO NOT USE
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.
■ 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_
■ apply liberally 15 minutes before sun exposure
■ 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 months: Ask a doctor
OTHER INFORMATION
_OTHER INFORMATION_
■