CARDINAL HEALTH LEADER GENERAL PROTECTION SUNSCREEN SPF 50- avobenzone, homosalate, octisalate, octocrylene lotion

Cardinal Health Leader General Protection Sunscreen SPF 50 by

Drug Labeling and Warnings

Cardinal Health Leader General Protection Sunscreen SPF 50 by is a Otc medication manufactured, distributed, or labeled by CARDINAL HEALTH, INC.. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

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

INGREDIENTS AND APPEARANCE

CARDINAL HEALTH LEADER GENERAL PROTECTION SUNSCREEN SPF 50 
avobenzone, homosalate, octisalate, octocrylene lotion

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 70000-0075
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
AVOBENZONE (UNII: G63QQF2NOX) (AVOBENZONE - UNII:G63QQF2NOX)	AVOBENZONE	30 mg  in 1 g
OCTOCRYLENE (UNII: 5A68WGF6WM) (OCTOCRYLENE - UNII:5A68WGF6WM)	OCTOCRYLENE	70 mg  in 1 g
HOMOSALATE (UNII: V06SV4M95S) (HOMOSALATE - UNII:V06SV4M95S)	HOMOSALATE	150 mg  in 1 g
OCTISALATE (UNII: 4X49Y0596W) (OCTISALATE - UNII:4X49Y0596W)	OCTISALATE	50 mg  in 1 g

Inactive Ingredients
Ingredient Name	Strength
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 Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 70000-0075-1	237 g in 1 BOTTLE; Type 0: Not a Combination Product	12/10/2020

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC monograph not final	part352	12/10/2020

Labeler - CARDINAL HEALTH, INC. (063997360)