CARDINAL HEALTH LEADER BABY 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 Baby Sunscreen SPF 50 Moisturizing Lotion

Active ingredients

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

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 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, propylene glycol, styrene/acrylates copolymer, polyamide-8, neopentyl glycol diheptanoate, oleth-3, acrylates/C10-30 alkyl acrylate crosspolymer, triethanolamine, tocopherol, disodium EDTA, chlorphenesin, benzyl alcohol, fragrance.

Label

Cardinal Health Leader Baby Sunscreen SPF 50 Moisturizing Lotion

8 FL OZ (237 mL)

NDC 70000-0076-1

CL14046EF

CARDINAL HEALTH LEADER BABY SUNSCREEN SPF 50 
avobenzone, homosalate, octisalate, octocrylene lotion
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:70000-0076
Route of AdministrationTOPICAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
OCTOCRYLENE (UNII: 5A68WGF6WM) (OCTOCRYLENE - UNII:5A68WGF6WM) OCTOCRYLENE50 mg  in 1 g
OCTISALATE (UNII: 4X49Y0596W) (OCTISALATE - UNII:4X49Y0596W) OCTISALATE50 mg  in 1 g
HOMOSALATE (UNII: V06SV4M95S) (HOMOSALATE - UNII:V06SV4M95S) HOMOSALATE150 mg  in 1 g
AVOBENZONE (UNII: G63QQF2NOX) (AVOBENZONE - UNII:G63QQF2NOX) AVOBENZONE30 mg  in 1 g
Inactive Ingredients
Ingredient NameStrength
PROPYLENE GLYCOL (UNII: 6DC9Q167V3)  
NEOPENTYL GLYCOL DIHEPTANOATE (UNII: 5LKW3C543X)  
CHLORPHENESIN (UNII: I670DAL4SZ)  
.ALPHA.-TOCOPHEROL, DL- (UNII: 7QWA1RIO01)  
OLETH-3 (UNII: BQZ26235UC)  
BENZYL ALCOHOL (UNII: LKG8494WBH)  
WATER (UNII: 059QF0KO0R)  
EDETATE DISODIUM (UNII: 7FLD91C86K)  
TRIDECYL SALICYLATE (UNII: AZQ08K38Z1)  
TROLAMINE (UNII: 9O3K93S3TK)  
POLYAMIDE-8 (4500 MW) (UNII: 77723GV81A)  
CARBOMER COPOLYMER TYPE A (UNII: 71DD5V995L)  
BUTYL METHACRYLATE/METHYL METHACRYLATE/METHACRYLIC ACID/STYRENE CROSSPOLYMER (UNII: V5RS026Q0H)  
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:70000-0076-1237 g in 1 BOTTLE; Type 0: Not a Combination Product12/11/2020
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph not finalpart35212/11/2020
Labeler - CARDINAL HEALTH, INC. (063997360)

Revised: 11/2022
Document Id: ecb04a97-493c-b148-e053-2995a90abf15
Set id: b633198b-ae0f-4488-e053-2995a90a98e4
Version: 2
Effective Time: 20221104
 
CARDINAL HEALTH, INC.