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

Active ingredients

Avobenzone 3.0%, Homosalate 15.0%, Octisalate 5.0%, Octocrylene 7.0%

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

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 and evenly 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, tridecyl salicylate, sorbitol, stearic acid, aluminum starch octenylsuccinate, triethanolamine, polyethyloxazoline, carbomer, dimethicone, tocopherol, disodium EDTA, polyglyceryl-3 distearate, caprylyl glycol, phenoxyethanol, ethylhexylglycerin, sorbitan isostearate, benzyl alcohol, fragrance

Label

Cardinal Health Leader General Protection Sunscreen SPF 50 Lotion

8 fl oz (237 mL)

NDC 70000-0075-1

CL14045 Front

CL14045 Back

CARDINAL HEALTH LEADER GENERAL PROTECTION SUNSCREEN SPF 50 
avobenzone, homosalate, octisalate, octocrylene lotion
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:70000-0075
Route of AdministrationTOPICAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
AVOBENZONE (UNII: G63QQF2NOX) (AVOBENZONE - UNII:G63QQF2NOX) AVOBENZONE30 mg  in 1 g
OCTOCRYLENE (UNII: 5A68WGF6WM) (OCTOCRYLENE - UNII:5A68WGF6WM) OCTOCRYLENE70 mg  in 1 g
HOMOSALATE (UNII: V06SV4M95S) (HOMOSALATE - UNII:V06SV4M95S) HOMOSALATE150 mg  in 1 g
OCTISALATE (UNII: 4X49Y0596W) (OCTISALATE - UNII:4X49Y0596W) OCTISALATE50 mg  in 1 g
Inactive Ingredients
Ingredient NameStrength
WATER (UNII: 059QF0KO0R)  
CARBOMER INTERPOLYMER TYPE A (ALLYL SUCROSE CROSSLINKED) (UNII: 59TL3WG5CO)  
SORBITOL (UNII: 506T60A25R)  
TROLAMINE (UNII: 9O3K93S3TK)  
POLYETHYLOXAZOLINE (5000 MW) (UNII: HNX7574GTX)  
DIMETHICONE (UNII: 92RU3N3Y1O)  
TRIDECYL SALICYLATE (UNII: AZQ08K38Z1)  
PHENOXYETHANOL (UNII: HIE492ZZ3T)  
ETHYLHEXYLGLYCERIN (UNII: 147D247K3P)  
EDETATE DISODIUM (UNII: 7FLD91C86K)  
STEARIC ACID (UNII: 4ELV7Z65AP)  
.ALPHA.-TOCOPHEROL, DL- (UNII: 7QWA1RIO01)  
BENZYL ALCOHOL (UNII: LKG8494WBH)  
ALUMINUM STARCH OCTENYLSUCCINATE (UNII: I9PJ0O6294)  
POLYGLYCERYL-3 DISTEARATE (UNII: ZI1LK470XV)  
CAPRYLYL GLYCOL (UNII: 00YIU5438U)  
SORBITAN ISOSTEARATE (UNII: 01S2G2C1E4)  
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:70000-0075-1237 g in 1 BOTTLE; Type 0: Not a Combination Product12/10/2020
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph not finalpart35212/10/2020
Labeler - CARDINAL HEALTH, INC. (063997360)

Revised: 11/2022
Document Id: ecb04a97-493b-b148-e053-2995a90abf15
Set id: b623defb-4a9d-6fc5-e053-2995a90ae846
Version: 2
Effective Time: 20221104
 
CARDINAL HEALTH, INC.