CARDINAL HEALTH LEADER SPF 50 GENERAL PROTECTION SUNSCREEN- avobenzone,homosalate, octisalate, octocrylene, oxybenzone. lotion 
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 SPF 50 General Protection Sunscreen

Active ingredients

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

Purpose

Sunscreen

Uses

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 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

• apply liberally 15 minutes before sun exposure
• 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

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

Label

CL13534E-F

CARDINAL HEALTH LEADER SPF 50 GENERAL PROTECTION SUNSCREEN 
avobenzone,homosalate, octisalate, octocrylene, oxybenzone. lotion
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:70000-0408
Route of AdministrationTOPICAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
OCTISALATE (UNII: 4X49Y0596W) (OCTISALATE - UNII:4X49Y0596W) OCTISALATE50 mg  in 1 mL
AVOBENZONE (UNII: G63QQF2NOX) (AVOBENZONE - UNII:G63QQF2NOX) AVOBENZONE30 mg  in 1 mL
OXYBENZONE (UNII: 95OOS7VE0Y) (OXYBENZONE - UNII:95OOS7VE0Y) OXYBENZONE40 mg  in 1 mL
HOMOSALATE (UNII: V06SV4M95S) (HOMOSALATE - UNII:V06SV4M95S) HOMOSALATE130 mg  in 1 mL
OCTOCRYLENE (UNII: 5A68WGF6WM) (OCTOCRYLENE - UNII:5A68WGF6WM) OCTOCRYLENE70 mg  in 1 mL
Inactive Ingredients
Ingredient NameStrength
EICOSYL POVIDONE (UNII: XQQ9MKE2BJ)  
BENZYL ALCOHOL (UNII: LKG8494WBH)  
STEARIC ACID (UNII: 4ELV7Z65AP)  
TROLAMINE (UNII: 9O3K93S3TK)  
PROPYLPARABEN (UNII: Z8IX2SC1OH)  
CARBOMER INTERPOLYMER TYPE A (ALLYL SUCROSE CROSSLINKED) (UNII: 59TL3WG5CO)  
WATER (UNII: 059QF0KO0R)  
DIMETHICONE (UNII: 92RU3N3Y1O)  
POLYGLYCERYL-3 DISTEARATE (UNII: ZI1LK470XV)  
SORBITAN ISOSTEARATE (UNII: 01S2G2C1E4)  
TOCOPHEROL (UNII: R0ZB2556P8)  
ALUMINUM STARCH OCTENYLSUCCINATE (UNII: I9PJ0O6294)  
METHYLPARABEN (UNII: A2I8C7HI9T)  
EDETATE DISODIUM (UNII: 7FLD91C86K)  
SORBITOL (UNII: 506T60A25R)  
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:70000-0408-1237 mL in 1 BOTTLE; Type 0: Not a Combination Product11/01/2019
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph not finalpart35211/01/2019
Labeler - CARDINAL HEALTH, INC. (063997360)

Revised: 11/2022
Document Id: c6a39b7d-295e-bd32-e053-2995a90a4893
Set id: ad1af8ef-dcf3-4c91-9496-ef52c12893cc
Version: 4
Effective Time: 20221104
 
CARDINAL HEALTH, INC.