SOLAR PROTECTION FORMULA SPF 58  SUNSCREEN - titanium dioxide, zinc oxide cream 
Fallien Cosmeceuticals, LTD.

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.

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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:

Other Information:

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 DRUGItem Code (Source)NDC:58892-911
Route of AdministrationTOPICAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
Titanium Dioxide (UNII: 15FIX9V2JP) (Titanium Dioxide - UNII:15FIX9V2JP) Titanium Dioxide100 mg  in 1 g
Zinc Oxide (UNII: SOI2LOH54Z) (Zinc Oxide - UNII:SOI2LOH54Z) Zinc Oxide30 mg  in 1 g
Inactive Ingredients
Ingredient NameStrength
Butylene Glycol (UNII: 3XUS85K0RA)  
Butylparaben (UNII: 3QPI1U3FV8)  
Medium-Chain Triglycerides (UNII: C9H2L21V7U)  
CARBOMER COPOLYMER TYPE B (ALLYL PENTAERYTHRITOL CROSSLINKED) (UNII: 809Y72KV36)  
Cetostearyl Alcohol (UNII: 2DMT128M1S)  
Cyclomethicone (UNII: NMQ347994Z)  
Dimethicone (UNII: 92RU3N3Y1O)  
Edetate Disodium (UNII: 7FLD91C86K)  
Glyceryl Monostearate (UNII: 230OU9XXE4)  
Ferric Oxide Yellow (UNII: EX438O2MRT)  
FERROSOFERRIC OXIDE (UNII: XM0M87F357)  
Isobutylparaben (UNII: 0QQJ25X58G)  
Isopropylparaben (UNII: A6EOX47QK0)  
Lemon Balm Oil (UNII: MJ76269K9S)  
OCTYLDODECYL NEOPENTANOATE (UNII: X8725R883T)  
Polyoxyl 100 Stearate (UNII: YD01N1999R)  
Phenoxyethanol (UNII: HIE492ZZ3T)  
Vitamin A Palmitate (UNII: 1D1K0N0VVC)  
Sorbitan Monolaurate (UNII: 6W9PS8B71J)  
Talc (UNII: 7SEV7J4R1U)  
Alpha-Tocopherol (UNII: H4N855PNZ1)  
.Alpha.-Tocopherol Acetate (UNII: 9E8X80D2L0)  
Water (UNII: 059QF0KO0R)  
Xanthan Gum (UNII: TTV12P4NEE)  
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
Document Id: e5ac22f4-f5ae-4fde-9e79-eea783d371b9
Set id: 1b4f307c-29bb-4b3e-9643-e9022aee349e
Version: 2
Effective Time: 20121207
 
Fallien Cosmeceuticals, LTD.