SUNSCREEN- avobenzone, homosalate, octisalate, octocrylene spray

Country: United States

Language: English

Source: NLM (National Library of Medicine)

Active ingredient:

Avobenzone 3% Homosalate 15% Octisalate 5% Octocrylene 8%

Available from:

Retail Business Services, LLC

Administration route:

TOPICAL

Prescription type:

OTC DRUG

Therapeutic indications:

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 - rash occurs

Authorization status:

OTC monograph final

Summary of Product characteristics

SUNSCREEN- AVOBENZONE, HOMOSALATE, OCTISALATE, OCTOCRYLENE SPRAY
RETAIL BUSINESS SERVICES, 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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SPORT SUNSCREEN SPRAY SPF 50
938.002/938AB
ACTIVE INGREDIENTS
Avobenzone 3%
Homosalate 15%
Octisalate 5%
Octocrylene 8%
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
FLAMMABLE
Keep away from fire or flame.
after application, wait until product dries before approacing a souce
of heat or flame,
or before smoking
DO NOT USE
on damaged or broken skin
WHEN USING THIS PRODUCT
keep out of eyes. Rinse with water to remove.
contents under pressure. Do not
puncture or incinerate. Do not store at temperature above 120ºF.
STOP USE AND ASK A DOCTOR IF
rash occurs
KEEP OUT OF REACH OF CHILDREN
if swallowed, get medical help or contact a Poison Conrol Center right
away
DIRECTION
■ spray liberally and spread evenly by hand 15 minutes before sun
exposure
■ apply to all skin exposed to the sun
■ hold container 4 to 6 inches from the skin to apply
■ do not spray directly into face. Spray on hands then apply to
face.
■ do not apply in windy conditions
■ use in a well-ventilated area and avoid inhalation
■ 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-sleeved shirts, pants, hats and sunglasses
■ children under 6 months of age: Ask a doct