AVOBENZONE, HOMOSALATE, OCTISALATE, OCTOCRYLENE lotion

Country: United States

Language: English

Source: NLM (National Library of Medicine)

Active ingredient:

Avobenzone 3%, Homosalate 10%, Octisalate 4.5%, 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 rist 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

AVOBENZONE, HOMOSALATE, OCTISALATE, OCTOCRYLENE- AVOBENZONE,
HOMOSALATE, OCTISALATE, OCTOCRYLENE LOTION
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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SUNSCREEN FOR BABIES SPF 50
950.000/950AA
ACTIVE INGREDIENTS
Avobenzone 3%
Homosalate 10%
Octisalate 4.5%
Octocrylene 8%
PURPOSE
Sunscreen
USES
helps prevent sunburn
if used as directed with other sun protection measures (See
_DIRECTIONS_), decreases
the rist of skin cancer and early skin aging caused by the sun
WARNINGS
For external use only
DO NOT USE
on damaged or broken skin
STOP USE AND ASK A DOCTOR IF
rash occurs
KEEP OUT OF REACH OF CHILDREN.
If swallowed, get medical help or contact a Poison Control Center
right away.
DIRECTIONS
apply liberaly 15 minutes before sun exposure
apply to all skin exposed to the sun
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 rist, regularly use a
sunscreen with
Broad Spectrum SPF value of 15 or higher and other sun protection
measures
including:
limit time in the sun, especialy from 10 a.m. -2 p.m.
wear long-sleeved shirts, pants, hats and sunglasses
children under 6 months of age: Ask a doctor
OTHER INFORMATION
protect the product in this container from excessive heat and direct
sun
INACTIVE INGREDIENTS
water, glycerin, aluminum starch octenylsuccinate, styrene/acrylates
copolymer, behenyl
alcohol, glyceryl stearate, benzyl alcohol, PEG-100 stearate,
polyester-7, tocopherol,
arachidyl alcohol, acrylates/C10-30 alkyl acrylate crosspolymer,
arachidyl glucoside,
chlorphenesin, beeswax, silica, neopentyl glycol diheptanoate,
potassium hydroxide,
disodium EDTA
May stain or damage some fabrics or surfaces
Dist by Foodhold USA, LLC Landover, MD 20733