Leader Sport Sunscreen SPF 50 Moisturizing Lotion

Leader Sport Sunscreen SPF 50 Moisturizing Lotion

Drug Labeling and Warnings

Drug Details

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LEADER SPORT SUNSCREEN SPF 50 MOISTURIZING- 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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Leader Sport Sunscreen SPF 50 Moisturizing Lotion

Active ingredients

Avobenzone 3.0%

Homosalate 10.0%

Octisalate 4.5%

Octocrylene 8.0%

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, Polyester-7, Neopentyl Glycol Diheptanoate, Aluminum Starch Octenylsuccinate, Styrene/Acrylates Copolymer, Silica, Phenoxyethanol, Isododecane, Arachidyl Alcohol, Beeswax, Ethylhexylglycerin, Acrylates/C10-30 Alkyl Acrylate Crosspolymer, Behenyl Alcohol, Tocopherol (Vitamin E), Arachidyl Glucoside, Glyceryl Stearate, PEG-100 Stearate, Potassium Hydroxide, Disodium EDTA, Sodium Ascorbyl Phosphate, Fragrance.

Questions or comments?

Call toll free 1-800-527-7731

Leader Sport Sunscreen SPF 50 Moisturizing Lotion

8 FL OZ (237mL)

NDC: 70000-0257-1

Label

LEADER  SPORT SUNSCREEN SPF 50 MOISTURIZING
avobenzone, homosalate, octisalate, octocrylene lotion
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC: 70000-0257
Route of AdministrationTOPICAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
AVOBENZONE (UNII: G63QQF2NOX) (AVOBENZONE - UNII:G63QQF2NOX) AVOBENZONE30 mg  in 1 mL
HOMOSALATE (UNII: V06SV4M95S) (HOMOSALATE - UNII:V06SV4M95S) HOMOSALATE100 mg  in 1 mL
OCTISALATE (UNII: 4X49Y0596W) (OCTISALATE - UNII:4X49Y0596W) OCTISALATE45 mg  in 1 mL
OCTOCRYLENE (UNII: 5A68WGF6WM) (OCTOCRYLENE - UNII:5A68WGF6WM) OCTOCRYLENE80 mg  in 1 mL
Inactive Ingredients
Ingredient NameStrength
POLYESTER-7 (UNII: 0841698D2F)  
NEOPENTYL GLYCOL DIHEPTANOATE (UNII: 5LKW3C543X)  
ALUMINUM STARCH OCTENYLSUCCINATE (UNII: I9PJ0O6294)  
SILICON DIOXIDE (UNII: ETJ7Z6XBU4)  
BUTYL METHACRYLATE/METHYL METHACRYLATE/METHACRYLIC ACID/STYRENE CROSSPOLYMER (UNII: V5RS026Q0H)  
YELLOW WAX (UNII: 2ZA36H0S2V)  
ARACHIDYL GLUCOSIDE (UNII: 6JVW35JOOJ)  
GLYCERYL MONOSTEARATE (UNII: 230OU9XXE4)  
PEG-100 STEARATE (UNII: YD01N1999R)  
PHENOXYETHANOL (UNII: HIE492ZZ3T)  
ISODODECANE (UNII: A8289P68Y2)  
ETHYLHEXYLGLYCERIN (UNII: 147D247K3P)  
CARBOMER COPOLYMER TYPE A (UNII: 71DD5V995L)  
DOCOSANOL (UNII: 9G1OE216XY)  
TOCOPHEROL (UNII: R0ZB2556P8)  
POTASSIUM HYDROXIDE (UNII: WZH3C48M4T)  
SODIUM ASCORBYL PHOSPHATE (UNII: 836SJG51DR)  
WATER (UNII: 059QF0KO0R)  
ARACHIDYL ALCOHOL (UNII: 1QR1QRA9BU)  
EDETATE DISODIUM (UNII: 7FLD91C86K)  
GLYCERIN (UNII: PDC6A3C0OX)  
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC: 70000-0257-1237 mL in 1 BOTTLE; Type 0: Not a Combination Product11/22/2019
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph not finalpart35211/22/2019
Labeler - CARDINAL HEALTH, INC. (097537435)
Registrant - FRUIT OF THE EARTH, INC. (079559467)
Establishment
NameAddressID/FEIBusiness Operations
Fruit Of The Earth Research Laboratories, Inc.008193513manufacture(70000-0257)

Revised: 11/2019
 
CARDINAL HEALTH, INC.


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