Your browser does not support JavaScript! LEADER DARK TANNING SPF 4 (OCTINOXATE, OXYBENZONE) AEROSOL, SPRAY [CARDINAL HEALTH]
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LEADER DARK TANNING SPF 4 (octinoxate, oxybenzone) aerosol, spray
[Cardinal Health]


Category DEA Schedule Marketing Status
HUMAN OTC DRUG LABEL OTC monograph not final
NOTE: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.
Drug Label Sections

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

Label

Image of labelLabel8.jpg

LEADER  DARK TANNING SPF 4
octinoxate, oxybenzone aerosol, spray
Product Information
Product TypeHUMAN OTC DRUG LABELItem Code (Source)NDC:37205-722
Route of AdministrationTopicalDEA Schedule    
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
OCTINOXATE (OCTINOXATE) OCTINOXATE16.6 mg  in 1 mL
OXYBENZONE (OXYBENZONE) OXYBENZONE4.15 mg  in 1 mL
Inactive Ingredients
Ingredient NameStrength
ALCOHOL 
CARROT JUICE 
C12-15 ALKYL BENZOATE 
ASCORBIC ACID 
VITAMIN A PALMITATE 
.ALPHA.-TOCOPHEROL ACETATE 
ALOE 
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:37205-722-30177 mL in 1 CAN
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph not finalpart35201/15/2012
Labeler - Cardinal Health (097537435)
Registrant - Fruit of the Earth (008193513)
Establishment
NameAddressID/FEIBusiness Operations
Fruit of the Earth008193513manufacture(37205-722)

Revised: 1/2013
 
Cardinal Health

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