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NDC 70000-0075-01 Cardinal Health Leader General Protection Sunscreen SPF 50 30; 150; 50; 70 mg/g; mg/g; mg/g; mg/g Details

Cardinal Health Leader General Protection Sunscreen SPF 50 30; 150; 50; 70 mg/g; mg/g; mg/g; mg/g

Cardinal Health Leader General Protection Sunscreen SPF 50 is a TOPICAL LOTION 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	70000-0075
Product ID	70000-0075_ecb04a97-493b-b148-e053-2995a90abf15
Associated GPIs	90920000004100
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 General Protection Sunscreen SPF 50
Proprietary Name Suffix	n/a
Non-Proprietary Name	Avobenzone, Homosalate, Octisalate, Octocrylene
Product Type	HUMAN OTC DRUG
Dosage Form	LOTION
Route	TOPICAL
Active Ingredient Strength	30; 150; 50; 70
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 70000-0075-01 (70000007501)

Pricing Information	N/A
NDC Package Code	70000-0075-1
Billing NDC	70000007501
Package	237 g in 1 BOTTLE (70000-0075-1)
Marketing Start Date	2020-12-10
NDC Exclude Flag	N

Standard Product Labeling (SPL)/Prescribing Information SPL b623defb-4a9d-6fc5-e053-2995a90ae846 Details

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

Ingredient Name	Basis of Strength	Strength
Active Ingredient/Active Moiety
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

Ingredient Name	Strength
Inactive Ingredients
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)

#	Item Code	Package Description	Marketing Start Date	Marketing End Date
Packaging
1	NDC:70000-0075-1	237 g in 1 BOTTLE; Type 0: Not a Combination Product	12/10/2020

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

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