Leader General Protection Sunscreen Moisturizing Lotion SPF 50

Leader General Protection Sunscreen Moisturizing Lotion SPF 50

Drug Labeling and Warnings

Drug Details

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LEADER GENERAL PROTECTION SUNSCREEN SPF 50- avobenzone, homosalate, octisalate, octocrylene, oxybenzone lotion 
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.

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Leader General Protection Sunscreen Moisturizing Lotion SPF 50

Active Ingredients

Avobenzone 3.0%, Homosalate 13.0%, Octisalate 5.0%, Octocrylene 7.0%, Oxybenzone 4.0%

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 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
  • 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 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

  • Children under 6 months: ask a doctor

Inactive Ingredients

water, sorbitol, aluminum starch octenylsuccinate, VP/eicosene copolymer, stearic acid, triethanolamine, sorbitan isostearate, benzyl alcohol, dimethicone, tocopherol (vitamin E), polyglyceryl-3 distearate, fragrance, methylparaben, carbomer, propylparaben, disodium EDTA

Other infomation

  • protect this product from excessive heat and direct sun
  • may stain or damage some fabrics, materials or surfaces

Questions or Comments?

Call toll free 1-800-527-7731

Leader General Protection Sunscreen Moisturizing Lotion SPF 50

Product NDC: 37205-729 Image of label

LEADER  GENERAL PROTECTION SUNSCREEN SPF 50
avobenzone, homosalate, octisalate, octocrylene, oxybenzone lotion
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC: 37205-729
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) HOMOSALATE130 mg  in 1 mL
OCTISALATE (UNII: 4X49Y0596W) (OCTISALATE - UNII:4X49Y0596W) OCTISALATE50 mg  in 1 mL
OCTOCRYLENE (UNII: 5A68WGF6WM) (OCTOCRYLENE - UNII:5A68WGF6WM) OCTOCRYLENE70 mg  in 1 mL
OXYBENZONE (UNII: 95OOS7VE0Y) (OXYBENZONE - UNII:95OOS7VE0Y) OXYBENZONE40 mg  in 1 mL
Inactive Ingredients
Ingredient NameStrength
WATER (UNII: 059QF0KO0R)  
SORBITOL (UNII: 506T60A25R)  
ALUMINUM STARCH OCTENYLSUCCINATE (UNII: I9PJ0O6294)  
COPOVIDONE K25-31 (UNII: D9C330MD8B)  
STEARIC ACID (UNII: 4ELV7Z65AP)  
TROLAMINE (UNII: 9O3K93S3TK)  
SORBITAN ISOSTEARATE (UNII: 01S2G2C1E4)  
BENZYL ALCOHOL (UNII: LKG8494WBH)  
DIMETHICONE (UNII: 92RU3N3Y1O)  
TOCOPHEROL (UNII: R0ZB2556P8)  
POLYGLYCERYL-3 DISTEARATE (UNII: ZI1LK470XV)  
METHYLPARABEN (UNII: A2I8C7HI9T)  
CARBOMER INTERPOLYMER TYPE A (ALLYL SUCROSE CROSSLINKED) (UNII: 59TL3WG5CO)  
PROPYLPARABEN (UNII: Z8IX2SC1OH)  
EDETATE DISODIUM (UNII: 7FLD91C86K)  
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC: 37205-729-34237 mL in 1 CAN; Type 0: Not a Combination Product01/15/2012
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph not finalpart35201/15/2012
Labeler - Cardinal Health (097537435)
Registrant - Fruit Of The Earth, Inc. (079559467)
Establishment
NameAddressID/FEIBusiness Operations
Fruit Of The Earth Research Laboratories, Inc.008193513manufacture(37205-729)

Revised: 11/2019
 
Cardinal Health


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