Solar Protection Formula LipTect description, usages, side effects, indications, overdosage, supplying and lots more!

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Solar Protection Formula LipTect

Fallien Cosmeceuticals, LTD.


FULL PRESCRIBING INFORMATION: CONTENTS*




FULL PRESCRIBING INFORMATION

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

Titanium Dioxide, Zinc Oxide LIPSTICK

Product Information

Product Type Human otc drug label Item Code (Source) NDC:58892-240
Route of Administration TOPICAL DEA Schedule

Active Ingredient/Active Moiety

Ingredient Name Basis of Strength Strength
titanium dioxide 40 mg
Zinc Oxide Zinc oxide 55 mg

Inactive Ingredients

Ingredient Name Strength
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 Code Package Description Marketing Start Date Marketing End Date
1 4.5 in 1 TUBE
2 NDC:58892-240-45 1 in 1 CARTON

Marketing Information

Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
part part352 2004-01-02


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