Your browser does not support JavaScript! SOLAR PROTECTION FORMULA SPF 58 SUNSCREEN (TITANIUM DIOXIDE, ZINC OXIDE) CREAM [FALLIEN COSMECEUTICALS, LTD.]
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SOLAR PROTECTION FORMULA SPF 58 SUNSCREEN (titanium dioxide, zinc oxide) cream
[Fallien Cosmeceuticals, LTD.]


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

DRUG FACTS

Active Ingredients:

Titanium Dioxide 10%

Zinc Oxide 3%

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 40 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:

Acrylates C10-30 Alkyl Acrylates Crosspolymer, Butylene Glycol, Butyloctyl Salicylate, Butylparaben, Capric/Caprylic Triglyceride, Cetearyl Alcohol, Cetearyl Glucoside, Cyclomethicone, Dimethicone, Ethylhexyl Hydroxystearate Benzoate, Glyceryl Stearate, Iron Oxides, Isobutylparaben, Isopropylparaben, Melissa Officinalis (Balm Mint) Extract, Octyldodecyl Neopentanoate, PEG-100 Stearate, Phenoxyethanol, Retinyl Palmitate, Simethicone, Sorbitan Laurate, Styrene/Acrylates Copolymer, Talc, Tocopherol, Tocopheryl Acetate, Tricontanyl PVP, Trisodium EDTA, Water, Xanthan Gum

Principal Display Panel – Carton Label

NDC 58892-911-88

SOLAR
PROTECTION
FORMULA®

Gentle Mineral
Sunscreen

SPF 58
Broad Spectrum
Water Resistent
(40 minutes)

Net Wt. 2.5 Oz./ 70g

Principal Display Panel – Carton Label
SOLAR PROTECTION FORMULA SPF 58   SUNSCREEN
titanium dioxide, zinc oxide cream
Product Information
Product TypeHUMAN OTC DRUG LABELItem Code (Source)NDC:58892-911
Route of AdministrationTOPICALDEA Schedule    
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
Titanium Dioxide (Titanium Dioxide) Titanium Dioxide100 mg  in 1 g
Zinc Oxide (Zinc Oxide) Zinc Oxide30 mg  in 1 g
Inactive Ingredients
Ingredient NameStrength
Butylene Glycol 
Butylparaben 
Medium-Chain Triglycerides 
CARBOMER COPOLYMER TYPE B (ALLYL PENTAERYTHRITOL CROSSLINKED) 
Cetostearyl Alcohol 
Cyclomethicone 
Dimethicone 
Edetate Disodium 
Glyceryl Monostearate 
Ferric Oxide Yellow 
FERROSOFERRIC OXIDE 
Isobutylparaben 
Isopropylparaben 
Lemon Balm Oil 
OCTYLDODECYL NEOPENTANOATE 
Polyoxyl 100 Stearate 
Phenoxyethanol 
Vitamin A Palmitate 
Sorbitan Monolaurate 
Talc 
Alpha-Tocopherol 
.Alpha.-Tocopherol Acetate 
Water 
Xanthan Gum 
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:58892-911-881 in 1 CARTON
170 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/FEIBusiness Operations
Custom Analytics LLC144949372ANALYSIS(58892-911)
Establishment
NameAddressID/FEIBusiness Operations
Process Technologies & Packaging809172885MANUFACTURE(58892-911), PACK(58892-911)

Revised: 12/2012
 
Fallien Cosmeceuticals, LTD.

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