Leader Dark Tanning SPF 4 Continuous Spray Sunscreen

Leader by

Drug Labeling and Warnings

Leader by is a Otc medication manufactured, distributed, or labeled by Cardinal Health, Fruit of the Earth. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

LEADER DARK TANNING SPF 4- octinoxate, oxybenzone aerosol, spray 
Cardinal Health

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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Leader Dark Tanning SPF 4 Continuous Spray Sunscreen

Active Ingredients

Octinoxate 2.0%, Oxybenzone 0.5%

Purpose

Sunscreen

Uses

helps prevent sunburn

Warnings

Skin Cancer / Skin Aging Alert: Spending time in the sun increases your risk of skin cancer and early skin aging. This product has been shown only to prevent sunburn, not skin cancer or early skin aging.

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. 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 product is swallowed, get medical help or contact a Poison Control Center right away.

Directions

Apply liberally 15 minutes before sun exposure

Hold can 4-6 inches away from body, spray evenly to ensure complete coverage

Do not spray into face. Spray into hand and apply to face.

Use in well ventilated, but not windy areas

Reapply:

After 80 minutes of swimming or sweating

Immediately after towel drying

At least every 2 hours

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 of 15 or higher and other sun protection measures including:

limit time in the sun, especially from 10 am - 2 pm

wear long sleeve shirts, pants, hats, and sunglasses

Children under 6 months: ask a doctor

Inactive Ingredients

Alcohol denat., C12-15 alkyl benzoate, aloe barbadensis leaf juice, retinyl palmitate (vitamin A), ascorbic acid (vitamin C), tocopheryl acetate (vitamin E), daucus carota sativa (carrot) root extract, acrylates/octylacrylamide copolymer, fragrance

Questions or Comments?

Call toll free 1-800-200-6313

Leader Dark Tanning SPF 4 Continuous Spray Sunscreen

Product NDC: 37205-722

LEADER  DARK TANNING SPF 4
octinoxate, oxybenzone aerosol, spray

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 37205-722
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
OCTINOXATE (UNII: 4Y5P7MUD51) (OCTINOXATE - UNII:4Y5P7MUD51)	OCTINOXATE	16.6 mg  in 1 mL
OXYBENZONE (UNII: 95OOS7VE0Y) (OXYBENZONE - UNII:95OOS7VE0Y)	OXYBENZONE	4.15 mg  in 1 mL

Inactive Ingredients
Ingredient Name	Strength
ACRYLATE/ISOBUTYL METHACRYLATE/N-TERT-OCTYLACRYLAMIDE COPOLYMER (75000 MW) (UNII: JU3XHR8VWK)
ALCOHOL (UNII: 3K9958V90M)
CARROT JUICE (UNII: QXF936IX43)
ALKYL (C12-15) BENZOATE (UNII: A9EJ3J61HQ)
ASCORBIC ACID (UNII: PQ6CK8PD0R)
VITAMIN A PALMITATE (UNII: 1D1K0N0VVC)
.ALPHA.-TOCOPHEROL ACETATE (UNII: 9E8X80D2L0)
ALOE (UNII: V5VD430YW9)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 37205-722-30	177 mL in 1 CAN; Type 0: Not a Combination Product	01/15/2012	11/21/2019

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC monograph not final	part352	01/15/2012	11/21/2019

Labeler - Cardinal Health (097537435)

Registrant - Fruit Of The Earth, Inc. (079559467)

Establishment
Name	Address	ID/FEI	Business Operations
Fruit Of The Earth Research Laboratories, Inc.		008193513	manufacture(37205-722)

Revised: 11/2019

Document Id: 97d9c99a-e5d6-a191-e053-2a95a90a1842

34390-5

Set id: db5f842b-7ae8-40bf-89b0-d875b31e86fb

Version: 3

Effective Time: 20191121

 

Cardinal Health