CARDINAL HEALTH LEADER KIDS SUNSCREEN SPF 50- avobenzone, homosalate, octisalate, octocrylene spray

Cardinal Health Leader Kids Sunscreen SPF 50 by

Drug Labeling and Warnings

Cardinal Health Leader Kids 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 10.0%, Octisalate 5.0%, Octocrylene 4.0%

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

FLAMMABLE

do not use near heat, flame or while smoking

avoid long term storage above 104°F (40°C)

Do not use

on damaged or broken skin.

When using this product

keep out of eyes. Rinse with water to remove.

keep away from face to avoid breathing it.

do not puncture or incinerate. Contents under pressure.

do not store at temperatures above 120° F.

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

spray liberally and spread evenly by hand 15 minutes before sun exposure

hold can 4-6 inches away from skin to apply

do not spray directly into face. Spray into hand and then apply to face.

do not apply in windy conditions

use in well-ventilated area

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

alcohol denat., butyloctyl salicylate, acrylates/octylacrylamide copolymer, panthenol, tocopherol (vitamin E), fragrance, stearoxytrimethylsilane, caprylic/capric triglyceride, glycerin

Label

INGREDIENTS AND APPEARANCE

CARDINAL HEALTH LEADER KIDS SUNSCREEN SPF 50 
avobenzone, homosalate, octisalate, octocrylene spray

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 70000-0071
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
HOMOSALATE (UNII: V06SV4M95S) (HOMOSALATE - UNII:V06SV4M95S)	HOMOSALATE	100 mg  in 1 g
OCTISALATE (UNII: 4X49Y0596W) (OCTISALATE - UNII:4X49Y0596W)	OCTISALATE	50 mg  in 1 g
AVOBENZONE (UNII: G63QQF2NOX) (AVOBENZONE - UNII:G63QQF2NOX)	AVOBENZONE	30 mg  in 1 g
OCTOCRYLENE (UNII: 5A68WGF6WM) (OCTOCRYLENE - UNII:5A68WGF6WM)	OCTOCRYLENE	40 mg  in 1 g

Inactive Ingredients
Ingredient Name	Strength
MEDIUM-CHAIN TRIGLYCERIDES (UNII: C9H2L21V7U)
ALCOHOL (UNII: 3K9958V90M)
PANTHENOL (UNII: WV9CM0O67Z)
ACRYLATE/ISOBUTYL METHACRYLATE/N-TERT-OCTYLACRYLAMIDE COPOLYMER (75000 MW) (UNII: JU3XHR8VWK)
GLYCERIN (UNII: PDC6A3C0OX)
STEAROXYTRIMETHYLSILANE (UNII: 9862TW94B2)
BUTYLOCTYL SALICYLATE (UNII: 2EH13UN8D3)
.ALPHA.-TOCOPHEROL, DL- (UNII: 7QWA1RIO01)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 70000-0071-1	156 g in 1 CAN; Type 0: Not a Combination Product	12/09/2020

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC monograph not final	part352	12/09/2020

Labeler - CARDINAL HEALTH, INC. (063997360)