CARDINAL HEALTH LEADER GENERAL PROTECTION SUNSCREEN SPF 50- avobenzone, homosalate, octisalate, octocrylene lotion

Country: United States

Language: English

Source: NLM (National Library of Medicine)

Active ingredient:

Avobenzone 3.0%, Homosalate 15.0%, Octisalate 5.0%, Octocrylene 7.0%

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 • on damaged or broken skin. • rash occurs.

Authorization status:

OTC monograph not final

Summary of Product characteristics

CARDINAL HEALTH LEADER GENERAL PROTECTION SUNSCREEN SPF 50-
AVOBENZONE, 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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CARDINAL HEALTH LEADER GENERAL PROTECTION SUNSCREEN SPF 50 LOTION
ACTIVE INGREDIENTS
Avobenzone 3.0%, Homosalate 15.0%, Octisalate 5.0%, Octocrylene 7.0%
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 and evenly 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 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
OTHER INFORMATION
• protect the product in this container from excessive heat and
direct sun
• may stain or damage some fabrics, materials or surfaces
INACTIVE INGREDIENTS
water, tridecyl salicylate, sorbitol, stearic acid, aluminum starch
octenylsuccinate,
triethanolamine, polyethyloxazoline, carbomer, dimethicone,
tocopherol, disodium EDTA,
polyglyceryl-3 distearate, caprylyl glycol, phenoxyethanol,
ethylhexylglycerin, so