Leader General Protection SPF 15 Continuous Spray

Leader by

Drug Labeling and Warnings

Leader by is a Otc medication manufactured, distributed, or labeled by Cardinal Health, Fruit of the Earth. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

LEADER GP SPF 15 CS- homosalate, octisalate, oxybenzone, 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.

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Leader General Protection SPF 15 Continuous Spray

Active Ingredients

Avobenzone 2.0%, Homosalate 10.0%, Octisalate 5.0%, Oxybenzone 3.0%

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 deg F (40 degC)

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 deg 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 form 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

Immdiately 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 theis 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 am - 2 pm

wear long sleeve shirts, pants, hats, and sunglasses

Inactive Ingredients

Alcohol denat., acrylates/octylacrylamide copolymer, glycerin, aloe barbadensis leaf juice, tocopherol (vitamin E), cocos nucifera (coconut) oil, mineral oil, fragrance

Questions or Comments?

Call toll free 1-800-200-6313

Leader General Protection SPF 15 Continuous Spray

Product NDC: 37205-730 Label

LEADER  GP SPF 15 CS
homosalate, octisalate, oxybenzone, avobenzone aerosol, spray
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC: 37205-730
Route of AdministrationTOPICAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
HOMOSALATE (UNII: V06SV4M95S) (HOMOSALATE - UNII:V06SV4M95S) HOMOSALATE87 mg  in 1 mL
OCTISALATE (UNII: 4X49Y0596W) (OCTISALATE - UNII:4X49Y0596W) OCTISALATE43.5 mg  in 1 mL
OXYBENZONE (UNII: 95OOS7VE0Y) (OXYBENZONE - UNII:95OOS7VE0Y) OXYBENZONE26.1 mg  in 1 mL
AVOBENZONE (UNII: G63QQF2NOX) (AVOBENZONE - UNII:G63QQF2NOX) AVOBENZONE17.4 mg  in 1 mL
Inactive Ingredients
Ingredient NameStrength
ALCOHOL (UNII: 3K9958V90M)  
MINERAL OIL (UNII: T5L8T28FGP)  
GLYCERIN (UNII: PDC6A3C0OX)  
COCONUT OIL (UNII: Q9L0O73W7L)  
TOCOPHEROL (UNII: R0ZB2556P8)  
ALOE VERA LEAF (UNII: ZY81Z83H0X)  
ACRYLATE/ISOBUTYL METHACRYLATE/N-TERT-OCTYLACRYLAMIDE COPOLYMER (75000 MW) (UNII: JU3XHR8VWK)  
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC: 37205-730-30177 mL in 1 CAN; Type 0: Not a Combination Product01/15/201211/21/2019
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph not finalpart35201/15/201211/21/2019
Labeler - Cardinal Health (097537435)
Registrant - Fruit Of The Earth, Inc. (079559467)
Establishment
NameAddressID/FEIBusiness Operations
Fruit Of The Earth Research Laboratories, Inc.008193513manufacture(37205-730)

Revised: 11/2019
 

Trademark Results [Leader]

Mark Image

Registration | Serial
Company
Trademark
Application Date
LEADER
LEADER
98683492 not registered Live/Pending
Heartland Footwear Inc.
2024-08-05
LEADER
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98581059 not registered Live/Pending
LEADER ELECTRONICS CORPORATION
2024-06-03
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97350922 not registered Live/Pending
MODA FOODS LLC
2022-04-07
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88649986 not registered Live/Pending
Leader Technologies, Incorporated
2019-10-10
LEADER
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88648937 not registered Live/Pending
Leader Technologies, Incorporated
2019-10-10
LEADER
LEADER
88644972 not registered Live/Pending
Rosen's, Inc.
2019-10-07
LEADER
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87936678 not registered Live/Pending
Must Have Info Inc.
2018-05-25
LEADER
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86876788 not registered Live/Pending
Leader Drugstores, Inc.
2016-01-15
LEADER
LEADER
86876782 not registered Live/Pending
Leader Drugstores, Inc.
2016-01-15
LEADER
LEADER
86852768 5423902 Live/Registered
The Hilsinger Company
2015-12-17
LEADER
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86852696 5423901 Live/Registered
The Hilsinger Company
2015-12-17
LEADER
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86663286 4889242 Live/Registered
ZhongKeRuiDeng Science & Technology Development (Beijing) Co., Ltd.
2015-06-15

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