FDA Label for Solar Protection Formula Liptect Lip Balm/sunscreen
View Indications, Usage & Precautions
Solar Protection Formula Liptect Lip Balm/sunscreen Product Label
The following document was submitted to the FDA by the labeler of this product Fallien Cosmeceuticals, Ltd.. The document includes published materials associated whith this product with the essential scientific information about this product as well as other prescribing information. Product labels may durg indications and usage, generic names, contraindications, active ingredients, strength dosage, routes of administration, appearance, warnings, inactive ingredients, etc.
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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.
Otc - Do Not Use
Do not use on damaged or broken skin.
Otc - Stop Use
Stop use and ask a doctor if rash occurs.
Otc - When Using
When using this product, keep out of eyes. Rinse with water to remove.
Otc - Keep Out Of Reach Of Children
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)
* Please review the disclaimer below.