CARDINAL HEALTH LEADER KIDS SUNSCREEN SPF 50- avobenzone, homosalate, octisalate, octocrylene spray 
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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Cardinal Health Leader Kids Sunscreen SPF 50 Clear Continuous Spray

Active ingredients

Avobenzone 3.0%, Homosalate 10.0%, Octisalate 5.0%, Octocrylene 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

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.

• keep away from face to avoid breathing it.

• 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 swallowed, get medical help or contact a Poison Control Center right away.

Directions

• spray liberally and spread evenly by hand 15 minutes before sun exposure

• hold can 4-6 inches away from skin to apply

• do not spray directly into face. Spray into hand and then apply to face.

• do not apply in windy conditions

• use in well-ventilated area

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 value 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-sleeved shirts, pants, hats, and sunglasses

Other information

• protect the product in this container from excessive heat and direct sun

• may stain or damage some fabrics, materials or surfaces

Inactive ingredients

alcohol denat., butyloctyl salicylate, acrylates/octylacrylamide copolymer, panthenol, tocopherol (vitamin E), fragrance, stearoxytrimethylsilane, caprylic/capric triglyceride, glycerin

Label

CL14041D

CARDINAL HEALTH LEADER KIDS SUNSCREEN SPF 50 
avobenzone, homosalate, octisalate, octocrylene spray
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:70000-0071
Route of AdministrationTOPICAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
HOMOSALATE (UNII: V06SV4M95S) (HOMOSALATE - UNII:V06SV4M95S) HOMOSALATE100 mg  in 1 g
OCTISALATE (UNII: 4X49Y0596W) (OCTISALATE - UNII:4X49Y0596W) OCTISALATE50 mg  in 1 g
AVOBENZONE (UNII: G63QQF2NOX) (AVOBENZONE - UNII:G63QQF2NOX) AVOBENZONE30 mg  in 1 g
OCTOCRYLENE (UNII: 5A68WGF6WM) (OCTOCRYLENE - UNII:5A68WGF6WM) OCTOCRYLENE40 mg  in 1 g
Inactive Ingredients
Ingredient NameStrength
MEDIUM-CHAIN TRIGLYCERIDES (UNII: C9H2L21V7U)  
ALCOHOL (UNII: 3K9958V90M)  
PANTHENOL (UNII: WV9CM0O67Z)  
ACRYLATE/ISOBUTYL METHACRYLATE/N-TERT-OCTYLACRYLAMIDE COPOLYMER (75000 MW) (UNII: JU3XHR8VWK)  
GLYCERIN (UNII: PDC6A3C0OX)  
STEAROXYTRIMETHYLSILANE (UNII: 9862TW94B2)  
BUTYLOCTYL SALICYLATE (UNII: 2EH13UN8D3)  
.ALPHA.-TOCOPHEROL, DL- (UNII: 7QWA1RIO01)  
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:70000-0071-1156 g in 1 CAN; Type 0: Not a Combination Product12/09/2020
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph not finalpart35212/09/2020
Labeler - CARDINAL HEALTH, INC. (063997360)

Revised: 7/2022
Document Id: e3de7290-f06e-a3e5-e053-2a95a90abf50
Set id: b60b9aa3-0fc4-3684-e053-2a95a90a0b1d
Version: 3
Effective Time: 20220715
 
CARDINAL HEALTH, INC.