CARDINAL HEALTH LEADER SPF30 GENERAL PROTECTION SUNSCREEN- avobenzone, oxybenzone. homosalate, octisalate, octocrylene lotion

Country: United States

Language: English

Source: NLM (National Library of Medicine)

Active ingredient:

Avobenzone 2.0% Homosalate 10.5% Octisalate 5.0% Octocrylene 2.0% Oxybenzone 2.0%

Available from:

CARDINAL HEALTH, INC.

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 • rash occurs.

Authorization status:

OTC monograph not final

Summary of Product characteristics

CARDINAL HEALTH LEADER SPF30 GENERAL PROTECTION SUNSCREEN-
AVOBENZONE, OXYBENZONE. HOMOSALATE, OCTISALATE, OCTOCRYLENE LOTION
CARDINAL HEALTH, INC.
_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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DRUG FACTS
_ACTIVE INGREDIENTS_
Avobenzone 2.0%
Homosalate 10.5%
Octisalate 5.0%
Octocrylene 2.0%
Oxybenzone 2.0%
_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
DO NOT USE • on damaged or broken skin.
WHEN USING THIS PRODUCT • keep out of eyes. Rinse with water to
remove
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 liberally 15 minutes before sun exposure
• reapply:
• after 80 minutes of swimming or sweating
• immediately after towel drying
• at least every 2 hours
• children under 6 months of age: ask a doctor
• 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 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
_OTHER INFORMATION_
• protect this product from excessive heat and direct sun
• may stain or damage some fabrics/materials or surfaces
_INACTIVE INGREDIENTS_
Water,Sorbitan isostearate, Sorbitol, Triethanolamine,Polyglyceryl-3
distearate,Stearic
acid,Octadecene/MA Copolymer,barium sulfate,benzyl
alcohol,VP/eiocosene copolymer,dimethicone,
carbomer,methylparaben,aloebarbedensis leaf extract,SIMMONDSIA
CHINENSIS (jojoba) SEED
oil,tocopherol (vitamin E),cocos nucifer