LEADER KIDS SUNSCREEN SPF 50- titanium dioxide, zinc oxide 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 Kid's Sunscreen SPF 50 Lotion

Active Ingredients

Titanium Dioxide 4.5%, Zinc Oxide 6.5%

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

- after 80 minutes of swimming or sweating

- immediately after towel drying

- at least every 2 hours

- limit time in the sun, especially from 10 a.m. - 2 p.m.

- wear long sleeved shirts, pants, hats, and sunglasses

Other infomation

Inactive Ingredients

water, caprylic/capric triglyceride, isohexadecane, butyloctyl salicylate, octyldodecyl citrate crosspolymer, cetyl PEG/PPG-10/1 dimethicone, lauryl PEG-8 dimethicone, C30-38 olefin/isopropyl maleate/MA copolymer, sodium chloride, ethylhexyl methoxycrylene, dimethicone, caprylyl glycol, PEG-8, silica, triethoxycaprylylsilane, glycerin, sodium citrate, tocopheryl acetate, benzyl alcohol, benzoic acid, sorbic acid.

Label

CL13910E-F

LEADER  KIDS SUNSCREEN SPF 50
titanium dioxide, zinc oxide lotion
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:70000-0545
Route of AdministrationTOPICAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
ZINC OXIDE (UNII: SOI2LOH54Z) (ZINC OXIDE - UNII:SOI2LOH54Z) ZINC OXIDE65 mg  in 1 mL
TITANIUM DIOXIDE (UNII: 15FIX9V2JP) (TITANIUM DIOXIDE - UNII:15FIX9V2JP) TITANIUM DIOXIDE45 mg  in 1 mL
Inactive Ingredients
Ingredient NameStrength
LAURYL PEG/PPG-18/18 METHICONE (UNII: ZJ5S27D9NX)  
POLYETHYLENE GLYCOL 4000 (UNII: 4R4HFI6D95)  
OCTYLDODECYL CITRATE CROSSPOLYMER (UNII: X323T6QO4M)  
ETHYLHEXYL METHOXYCRYLENE (UNII: S3KFG6Q5X8)  
SILICON DIOXIDE (UNII: ETJ7Z6XBU4)  
MEDIUM-CHAIN TRIGLYCERIDES (UNII: C9H2L21V7U)  
SORBIC ACID (UNII: X045WJ989B)  
WATER (UNII: 059QF0KO0R)  
CETYL PEG/PPG-10/1 DIMETHICONE (HLB 5) (UNII: 035JKJ76MT)  
SODIUM CHLORIDE (UNII: 451W47IQ8X)  
GLYCERIN (UNII: PDC6A3C0OX)  
ALPHA-TOCOPHEROL ACETATE (UNII: 9E8X80D2L0)  
TRIETHOXYCAPRYLYLSILANE (UNII: LDC331P08E)  
BENZYL ALCOHOL (UNII: LKG8494WBH)  
1,5-PENTANEDIOL (UNII: 07UXZ0SCST)  
SODIUM CITRATE (UNII: 1Q73Q2JULR)  
BENZOIC ACID (UNII: 8SKN0B0MIM)  
CAPRYLYL GLYCOL (UNII: 00YIU5438U)  
ISOHEXADECANE (UNII: 918X1OUF1E)  
BUTYLOCTYL SALICYLATE (UNII: 2EH13UN8D3)  
DIMETHICONE (UNII: 92RU3N3Y1O)  
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:70000-0545-1177 mL in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product12/11/2019
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph not finalpart35212/11/2019
Labeler - Cardinal Health (063997360)

Revised: 11/2022
Document Id: ecb20e59-ea53-0799-e053-2a95a90aad1a
Set id: 9cbd9d67-9455-4094-9450-2eb42f6895ce
Version: 4
Effective Time: 20221104
 
Cardinal Health