Leader Kids SPF 90 Continuous Spray Sunscreen

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 KIDS SPF 90- avobenzone, homosalate, octisalate, octocrylene, oxybenzone 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 Kids SPF 90 Continuous Spray Sunscreen

Active Ingredients

Avobenzone 3.0%, Homosalate 15.0%, Octisalate 5.0%, Octocrylene 10.0%, Oxybenzone 6.0%

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

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

Alcohol denat., butyloctyl salicylate, polyester-10, propylene glycol dibenzoate, acrylates/octylacrylamide copolymer, glycerin, diethylhexyl syringylidenemalonate, fragrance, caprylic/capric triglyceride

Other Information

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

Questions or Comments?

Call toll free 1-800-200-6313

Leader Kids SPF 90 Continuous Spray Sunscreen

Product NDC: 37205-724

LEADER  KIDS SPF 90
avobenzone, homosalate, octisalate, octocrylene, oxybenzone aerosol, spray

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 37205-724
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
AVOBENZONE (UNII: G63QQF2NOX) (AVOBENZONE - UNII:G63QQF2NOX)	AVOBENZONE	27.75 mg  in 1 mL
HOMOSALATE (UNII: V06SV4M95S) (HOMOSALATE - UNII:V06SV4M95S)	HOMOSALATE	138.75 mg  in 1 mL
OCTISALATE (UNII: 4X49Y0596W) (OCTISALATE - UNII:4X49Y0596W)	OCTISALATE	46.25 mg  in 1 mL
OCTOCRYLENE (UNII: 5A68WGF6WM) (OCTOCRYLENE - UNII:5A68WGF6WM)	OCTOCRYLENE	92.5 mg  in 1 mL
OXYBENZONE (UNII: 95OOS7VE0Y) (OXYBENZONE - UNII:95OOS7VE0Y)	OXYBENZONE	55.5 mg  in 1 mL

Inactive Ingredients
Ingredient Name	Strength
ACRYLATE/ISOBUTYL METHACRYLATE/N-TERT-OCTYLACRYLAMIDE COPOLYMER (75000 MW) (UNII: JU3XHR8VWK)
ALCOHOL (UNII: 3K9958V90M)
BUTYLOCTYL SALICYLATE (UNII: 2EH13UN8D3)
POLYESTER-10 (UNII: 212N9O2MMZ)
PROPYLENE GLYCOL DIBENZOATE (UNII: EQY32Z1AN4)
GLYCERIN (UNII: PDC6A3C0OX)
DIETHYLHEXYL SYRINGYLIDENEMALONATE (UNII: 3V5U97P248)
MEDIUM-CHAIN TRIGLYCERIDES (UNII: C9H2L21V7U)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 37205-724-30	177 mL in 1 CAN; Type 0: Not a Combination Product	01/15/2012	11/21/2019

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC monograph not final	part352	01/15/2012	11/21/2019

Labeler - Cardinal Health (097537435)

Registrant - Fruit Of The Earth, Inc. (079559467)

Establishment
Name	Address	ID/FEI	Business Operations
Fruit Of The Earth Research Laboratories, Inc.		008193513	manufacture(37205-724)

Revised: 11/2019

Document Id: 97d9de03-0dad-36e0-e053-2a95a90ae4e9

34390-5

Set id: 7d23ae9b-ede6-4e7a-8054-265d9bf51f1a

Version: 3

Effective Time: 20191121

 

Cardinal Health