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NDC 70000-0071-01 Cardinal Health Leader Kids Sunscreen SPF 50 30; 100; 50; 40 mg/g; mg/g; mg/g; mg/g Details

Cardinal Health Leader Kids Sunscreen SPF 50 30; 100; 50; 40 mg/g; mg/g; mg/g; mg/g

Cardinal Health Leader Kids Sunscreen SPF 50 is a TOPICAL SPRAY in the HUMAN OTC DRUG category. It is labeled and distributed by CARDINAL HEALTH, INC.. The primary component is AVOBENZONE; HOMOSALATE; OCTISALATE; OCTOCRYLENE.

Product Information

NDC	70000-0071
Product ID	70000-0071_e3de7290-f06e-a3e5-e053-2a95a90abf50
Associated GPIs	90920000003200
GCN Sequence Number	n/a
GCN Sequence Number Description	n/a
HIC3	n/a
HIC3 Description	n/a
GCN	n/a
HICL Sequence Number	n/a
HICL Sequence Number Description	n/a
Brand/Generic	n/a
Proprietary Name	Cardinal Health Leader Kids Sunscreen SPF 50
Proprietary Name Suffix	n/a
Non-Proprietary Name	Avobenzone, Homosalate, Octisalate, Octocrylene
Product Type	HUMAN OTC DRUG
Dosage Form	SPRAY
Route	TOPICAL
Active Ingredient Strength	30; 100; 50; 40
Active Ingredient Units	mg/g; mg/g; mg/g; mg/g
Substance Name	AVOBENZONE; HOMOSALATE; OCTISALATE; OCTOCRYLENE
Labeler Name	CARDINAL HEALTH, INC.
Pharmaceutical Class	n/a
DEA Schedule	n/a
Marketing Category	OTC MONOGRAPH NOT FINAL
Application Number	part352
Listing Certified Through	2024-12-31

Package

Package Images

NDC 70000-0071-01 (70000007101)

Pricing Information	N/A
NDC Package Code	70000-0071-1
Billing NDC	70000007101
Package	156 g in 1 CAN (70000-0071-1)
Marketing Start Date	2020-12-09
NDC Exclude Flag	N

Standard Product Labeling (SPL)/Prescribing Information SPL b60b9aa3-0fc4-3684-e053-2a95a90a0b1d Details

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

Ingredient Name	Basis of Strength	Strength
Active Ingredient/Active Moiety
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

Ingredient Name	Strength
Inactive Ingredients
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)

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

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

Labeler - CARDINAL HEALTH, INC. (063997360)

Revised: 7/2022

Document Id: e3de7290-f06e-a3e5-e053-2a95a90abf50

Set id: b60b9aa3-0fc4-3684-e053-2a95a90a0b1d

Version: 3

Effective Time: 20220715