Label: LEADER DARK TANNING SPF 4- octinoxate and oxybenzone aerosol, spray
- NDC Code(s): 37205-722-30
- Packager: Cardinal Health
- Category: HUMAN OTC DRUG LABEL
- DEA Schedule: None
- Marketing Status: OTC monograph not final
NOTE: Most over the counter (OTC) are not reviewed and approved by the FDA. However, they may be marketed if they comply with applicable regulations and policies. FDA has not evaluated whether this product complies.
Updated January 8, 2013
If you are a consumer or patient please visit this version.
- Active Ingredients
Octinoxate 2.0%, Oxybenzone 0.5%Close
• helps prevent sunburnClose
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 onlyClose
- 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 skinClose
- 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.Close
- Stop use and ask a doctor
if rash occurs.Close
- Keep out of reach of children.
If product is swallowed, get medical help or contact a Poison Control Center right away.Close
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
After 80 minutes of swimming or sweating
Immediately after towel drying
At least every 2 hoursClose
- 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 doctorClose
- 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, fragranceClose
- Questions or Comments?
Call toll free 1-800-200-6313Close
- INGREDIENTS AND APPEARANCE
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 DEA Schedule 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 ALCOHOL (UNII: 3K9958V90M) CARROT JUICE (UNII: QXF936IX43) C12-15 ALKYL 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 Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date OTC monograph not final part352 01/15/2012 Labeler - Cardinal Health (097537435) Registrant - Fruit of the Earth (008193513) Establishment Name Address ID/FEI Business Operations Fruit of the Earth 008193513 manufacture(37205-722)