OTC Medication Information: Leader Sport SPF 30

LEADER SPORT SPF 30- homosalate, octisalate, octocrylene, oxybenzone and avobenzone aerosol, spray
Cardinal Health

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.

Active Ingredients

Avobenzone 3.0%,

Homosalate 10.0%,

Octisalate 5.0%,

Oxybenzone 4.0%,

Octocrylene 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

FLAMMABLE

  • do not use near heat, flame or while smoking
  • avoid long term storage above 104°F (40°C)

Do not use

on damaged or broken skin

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 rash occurs.

Keep out of reach of children.

If product is swallowed, get medical help or contact a Poison Control Center right away.

Directions

  • Apply liberally 15 minutes before sun exposure
  • Hold can 4-6 inches away from body, spray evenly to ensure complete coverage
  • Do not spray into face.
  • Spray into hand and apply to face.
  • Use in well ventilated, but not windy areas

  • Reapply:
  • After 80 minutes of swimming or sweating
  • Immediately after towel drying
  • At least every 2 hours
  • 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 am — 2 pm
  • wear long-sleeved shirts, pants, hats, and sunglasses

Inactive Ingredients

Alcohol denat. (76.2% V/V), acrylates/octylacrylamide copolymer, stearoxytrimethylsilane, glycerin, diethylhexyl syringylidenemalonate, tocopherol (vitamin E), fragrance, retinyl palmitate (vitamin A palmitate), caprylic/capric triglyceride

CL11787D1
(click image for full-size original)

LEADER SPORT SPF 30
homosalate, octisalate, oxybenzone, octocrylene, avobenzone aerosol, spray
Product Information
Product Type HUMAN OTC DRUG Item Code (Source) NDC:37205-726
Route of Administration TOPICAL DEA Schedule
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
HOMOSALATE (HOMOSALATE) HOMOSALATE 100 mg in 1 mL
OCTISALATE (OCTISALATE) OCTISALATE 50 mg in 1 mL
OCTOCRYLENE (OCTOCRYLENE) OCTOCRYLENE 20 mg in 1 mL
OXYBENZONE (OXYBENZONE) OXYBENZONE 40 mg in 1 mL
AVOBENZONE (AVOBENZONE) AVOBENZONE 30 mg in 1 mL
Inactive Ingredients
Ingredient Name Strength
ALCOHOL
STEAROXYTRIMETHYLSILANE
GLYCERIN
DIETHYLHEXYL SYRINGYLIDENEMALONATE
TOCOPHEROL
VITAMIN A PALMITATE
MEDIUM-CHAIN TRIGLYCERIDES
ACRYLATE/ISOBUTYL METHACRYLATE/N-TERT-OCTYLACRYLAMIDE COPOLYMER (75000 MW)
Packaging
# Item Code Package Description Multilevel Packaging
1 NDC:37205-726-30 177 mL in 1 CAN None
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
OTC monograph not final part352 01/15/2012
Labeler — Cardinal Health (097537435)

Revised: 01/2022 Cardinal Health

Our database comes directly from the FDA’s central repository of drug labels and package inserts under the Structured Product Labeling standard. OTCLabels.com provides the full over the counter products subset of the FDA’s repository. Medication information provided here is not intended as a substitute for direct consultation with a qualified health professional.

Our database comes directly from the FDA's central repository of drug labels and package inserts under the Structured Product Labeling standard. OTCLabels.com provides the full over the counter products subset of the FDA's repository. Medication information provided here is not intended as a substitute for direct consultation with a qualified health professional.

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