CARDINAL HEALTH LEADER SPF30 General Protection Sunscreen by CARDINAL HEALTH, INC. / FRUIT OF THE EARTH, INC. Drug Facts

CARDINAL HEALTH LEADER SPF30 General Protection Sunscreen by

Drug Labeling and Warnings

CARDINAL HEALTH LEADER SPF30 General Protection Sunscreen by is a Otc medication manufactured, distributed, or labeled by CARDINAL HEALTH, INC., FRUIT OF THE EARTH, INC.. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

CARDINAL HEALTH LEADER SPF30 GENERAL PROTECTION SUNSCREEN- avobenzone, oxybenzone. 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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Drug Facts

Active ingredients

Avobenzone 2.0%
Homosalate 10.5%
Octisalate 5.0%
Octocrylene 2.0%
Oxybenzone 2.0%

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
S un 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 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-sleeve shirts, pants, hats, and sunglasses

Other information

protect this product from excessive heat and direct sun
may stain or damage some fabrics/materials or surfaces

Inactive Ingredients

Water,Sorbitan isostearate, Sorbitol, Triethanolamine,Polyglyceryl-3 distearate,Stearic acid,Octadecene/MA Copolymer,barium sulfate,benzyl alcohol,VP/eiocosene copolymer,dimethicone, carbomer,methylparaben,aloebarbedensis leaf extract,SIMMONDSIA CHINENSIS (jojoba) SEED oil,tocopherol (vitamin E),cocos nucifera (coconut oil), mineral oil, propylparaben,fragrance, disodium EDTA.

Questions or comments

Call toll free 1-800-527-7731

Principal Display Panel

Cardinal Health Leader SPF 30 General Protection Sunscreen

NDC: 70000-0413-1

COMPARE TO COPPERTONE® ULTRA GUARD® SPF 30 active ingredients*

Non-Greasy Water Resistant (80 Minutes)

active ingredients*

100% MoneyBack Guarantee

8 FL OZ (237 mL)

CARDINAL HEALTH LEADER SPF30 GENERAL PROTECTION SUNSCREEN 
avobenzone, oxybenzone. homosalate, octisalate, octocrylene lotion

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 70000-0413
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
AVOBENZONE (UNII: G63QQF2NOX) (AVOBENZONE - UNII:G63QQF2NOX)	AVOBENZONE	20 mg  in 1 mL
OXYBENZONE (UNII: 95OOS7VE0Y) (OXYBENZONE - UNII:95OOS7VE0Y)	OXYBENZONE	20 mg  in 1 mL
HOMOSALATE (UNII: V06SV4M95S) (HOMOSALATE - UNII:V06SV4M95S)	HOMOSALATE	105 mg  in 1 mL
OCTISALATE (UNII: 4X49Y0596W) (OCTISALATE - UNII:4X49Y0596W)	OCTISALATE	50 mg  in 1 mL
OCTOCRYLENE (UNII: 5A68WGF6WM) (OCTOCRYLENE - UNII:5A68WGF6WM)	OCTOCRYLENE	20 mg  in 1 mL

Inactive Ingredients
Ingredient Name	Strength
WATER (UNII: 059QF0KO0R)
SORBITAN ISOSTEARATE (UNII: 01S2G2C1E4)
SORBITOL (UNII: 506T60A25R)
TROLAMINE (UNII: 9O3K93S3TK)
POLYGLYCERYL-3 DISTEARATE (UNII: ZI1LK470XV)
STEARIC ACID (UNII: 4ELV7Z65AP)
OCTADECENE (UNII: H5ZUQ6V4AK)
BARIUM SULFATE (UNII: 25BB7EKE2E)
BENZYL ALCOHOL (UNII: LKG8494WBH)
VINYLPYRROLIDONE/EICOSENE COPOLYMER (UNII: 035MV9S1C3)
DIMETHICONE (UNII: 92RU3N3Y1O)
CARBOMER 934 (UNII: Z135WT9208)
METHYLPARABEN (UNII: A2I8C7HI9T)
SIMMONDSIA CHINENSIS SEED (UNII: D24K2Q1F6H)
TOCOPHEROL (UNII: R0ZB2556P8)
COCOS NUCIFERA WHOLE (UNII: 245J88W96L)
MINERAL OIL (UNII: T5L8T28FGP)
PROPYLPARABEN SODIUM (UNII: 625NNB0G9N)
DISODIUM EDTA-COPPER (UNII: 6V475AX06U)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 70000-0413-1	237 mL in 1 BOTTLE; Type 0: Not a Combination Product	04/03/2019	10/20/2019

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC monograph not final	part352	04/03/2019	10/20/2019

Labeler - CARDINAL HEALTH, INC. (097537435)

Registrant - FRUIT OF THE EARTH, INC. (008193513)

Establishment
Name	Address	ID/FEI	Business Operations
FRUIT OF THE EARTH, INC.		008193513	manufacture(70000-0413)

Revised: 10/2019

Document Id: 955792bb-7a84-468f-e053-2995a90a508c

34390-5

Set id: 3ec8e092-533f-40f5-aad5-bddebaf1fb4a

Version: 3

Effective Time: 20191020

 

CARDINAL HEALTH, INC.