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Solar Protection Formula LipTect Lip Balm/Sunscreen

Dosage form: lipstick
Ingredients: Titanium Dioxide 40mg in 1g, Zinc Oxide 55mg in 1g
Labeler: Fallien Cosmeceuticals, LTD.
NDC Code: 58892-240

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.

DRUG FACTS

Active Ingredients:

Titanium Dioxide 4.0%

Zinc Oxide 5.5%

Purpose

Sunscreen

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.

Stop use and ask a doctor if rash occurs.

When using this product, keep out of eyes. Rinse with water to remove.

Keep out of the 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: 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 10:00 a.m.-2 p.m.
    • Wear long-sleeved shirts, pants, hats, and sunglasses

Other Information:
  • Protect this product from excessive heat and direct sun
  • May stain some fabrics

Inactive Ingredients:

Alumina, Aluminum Hydroxide, Aluminum Stearate, Ascorbic Acid, Ascorbyl Palmitate, C12-15 Alkyl Benzoate, Cetearyl Isononanoate, Cetyl PEG/PPG-15/15 Butyl Ether Dimethicone, Citric Acid, Dipropylene Glycol Dicaprylate-Caprate, Ethylhexyl Palmitate, Flavor, Helianthus Annuus (Sunflower) Seed Wax, Hexyldecanol, Hexyldecyl Laurate, Iron Oxides, Lecithin, Ozokerite, PEG-8, Polyglyceryl-3 Diisostearate, Polyhydroxystearic Acid, Stearic Acid, Tocopherol, Tocopheryl Acetate, Zingiber Offinale (Ginger) Root Oil

Manufactured exclusively for: Fallien Cosmeceuticals Ltd., West Norriton, PA 19403

Principal Display Panel – 4.5g Carton Label

NDC 58892-240-45

SOLAR

PROTECTION

FORMULA®

LIPTECT

SPF 45

Broad Spectrum

UVA/UVB

Water Resistant (80 minutes)

Ultra High Sun Protection

No Chemical Sunscreen Filters

.14 oz. Net Wt. (4.5 g)

SOLAR PROTECTION FORMULA LIPTECT   LIP BALM/SUNSCREEN
titanium dioxide, zinc oxide lipstick
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:58892-240
Route of AdministrationTOPICALDEA Schedule    
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
Titanium Dioxide (Titanium Dioxide) Titanium Dioxide40 mg  in 1 g
Zinc Oxide (Zinc Oxide) Zinc Oxide55 mg  in 1 g
Inactive Ingredients
Ingredient NameStrength
Aluminum Oxide 
Aluminum Hydroxide 
Aluminum Stearate 
Ascorbic Acid 
Ascorbyl Palmitate 
C12-15 Alkyl Benzoate 
Ceresin 
Cetearyl Isononanoate 
Anhydrous Citric Acid 
Propylene Glycol Dicaprylate/Dicaprate 
Ethylhexyl Palmitate 
Kiwi Fruit 
Lime (Citrus) 
Sunflower Oil 
Hexyldecanol 
Hexyldecyl Laurate 
Ferric Oxide Red 
Lecithin, Soybean 
Polyethylene Glycol 400 
Stearic Acid 
.ALPHA.-Tocopherol 
.ALPHA.-Tocopherol Acetate, D- 
Ginger Oil 
Packaging
#Item CodePackage Description
1NDC:58892-240-451 TUBE in 1 CARTON
14.5 g in 1 TUBE
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph not finalpart35201/02/2004
Labeler - Fallien Cosmeceuticals, LTD. (958388357)
Establishment
NameAddressID/FEIOperations
Custom Analytics LLC144949372ANALYSIS(58892-240)
Establishment
NameAddressID/FEIOperations
Process Technologies & Packaging809172885MANUFACTURE(58892-240), PACK(58892-240)

Revised: 12/2012
 
Fallien Cosmeceuticals, LTD.

Disclaimer: Every effort has been made to ensure that the information provided here is accurate, up-to-date and complete, but no guarantee is made to that effect. Drug information contained herein may be time sensitive. This information has been compiled for use by healthcare practitioners and consumers in the United States. The absence of a warning for a given drug or combination thereof in no way should be construed to indicate that the drug or combination is safe, effective or appropriate for any given patient. If you have questions about the substances you are taking, check with your doctor, nurse or pharmacist.

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