SOLAR PROTECTION FORMULA SPF 65  SUNSCREEN - octinoxate, octocrylene, oxybenzone, titanium dioxide, zinc oxide lotion 
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:

Octinoxate 6%

Octocrylene 7%

Oxybenzone 4%

Titanium Dioxide 4%

Zinc Oxide 5%

Purpose

Sunscreen

Sunscreen

Sunscreen

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.

SHAKE WELL BEFORE USING

Other Information:

Directions:

Inactive Ingredients:

Acrylates/Octylacrylamide Copolymer, Aluminum Starch Octenylsuccinate, Ascorbyl Palmitate, 5-Bromo-5-Nitro-1, 3-Dioxane, Beta-Carotene, Butylparaben, C12-15 Alkyl Benzoate, Cetearyl Alcohol, Cetearyl Glucoside, Dimethicone, Disodium EDTA, Iron Oxides, Isobutylparaben, Isopropylparaben, Linoleamidopropyl Dimethylamine, Octyldodecyl Neopentanoate, Phenoxyethanol, Pinus Pinaster Bark Extract, Polysorbate 20, Propylene Glycol, Selenium Yeast Extract, Simethicone, Sorbitan Laurate, Talc, Tocopherol, Tocopheryl Acetate, Triethoxycaprylylsilane, Water

Solar Protection Formula combines Titanium Dioxide, Zinc Oxide, and Iron Oxide to form a complete wall of reflection against UVA/UVB damage.

Manufactured exclusively for
Fallien Ltd., West Norriton, PA
Made in USA

Principal Display Panel – 2 oz Carton Label

NDC 58892-265-59

SOLAR

PROTECTION

FORMULA®

Oil Free

Non-comedogenic

SPF 65

Broad Spectrum

UVA/UVB

2 Fl. Oz. / 58.8ml

Principal Display Panel – 2 oz Carton Label
SOLAR PROTECTION FORMULA SPF 65   SUNSCREEN
octinoxate, octocrylene, oxybenzone, titanium dioxide, zinc oxide lotion
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:58892-265
Route of AdministrationTOPICAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
Octinoxate (UNII: 4Y5P7MUD51) (Octinoxate - UNII:4Y5P7MUD51) Octinoxate60 mg  in 1 mL
Octocrylene (UNII: 5A68WGF6WM) (Octocrylene - UNII:5A68WGF6WM) Octocrylene70 mg  in 1 mL
Oxybenzone (UNII: 95OOS7VE0Y) (Oxybenzone - UNII:95OOS7VE0Y) Oxybenzone40 mg  in 1 mL
Titanium Dioxide (UNII: 15FIX9V2JP) (Titanium Dioxide - UNII:15FIX9V2JP) Titanium Dioxide40 mg  in 1 mL
Zinc Oxide (UNII: SOI2LOH54Z) (Zinc Oxide - UNII:SOI2LOH54Z) Zinc Oxide50 mg  in 1 mL
Inactive Ingredients
Ingredient NameStrength
Alkyl (C12-15) Benzoate (UNII: A9EJ3J61HQ)  
Aluminum Starch Octenylsuccinate (UNII: I9PJ0O6294)  
Ascorbyl Palmitate (UNII: QN83US2B0N)  
5-Bromo-5-Nitro-1,3-Dioxane (UNII: U184I9QBNM)  
.Beta.-Carotene (UNII: 01YAE03M7J)  
Butylparaben (UNII: 3QPI1U3FV8)  
Cetostearyl Alcohol (UNII: 2DMT128M1S)  
Cetearyl Glucoside (UNII: 09FUA47KNA)  
Dimethicone (UNII: 92RU3N3Y1O)  
Edetate Disodium (UNII: 7FLD91C86K)  
Ferric Oxide Red (UNII: 1K09F3G675)  
Isobutylparaben (UNII: 0QQJ25X58G)  
Isopropylparaben (UNII: A6EOX47QK0)  
Linoleamidopropyl Dimethylamine (UNII: W142CF4WLF)  
Octyldodecyl Neopentanoate (UNII: X8725R883T)  
Phenoxyethanol (UNII: HIE492ZZ3T)  
Maritime Pine (UNII: 50JZ5Z98QY)  
Polysorbate 20 (UNII: 7T1F30V5YH)  
Propylene Glycol (UNII: 6DC9Q167V3)  
Sorbitan Monolaurate (UNII: 6W9PS8B71J)  
Talc (UNII: 7SEV7J4R1U)  
Tocopherol (UNII: R0ZB2556P8)  
.Alpha.-Tocopherol Acetate (UNII: 9E8X80D2L0)  
Triethoxycaprylylsilane (UNII: LDC331P08E)  
Water (UNII: 059QF0KO0R)  
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:58892-265-591 in 1 CARTON
158.8 mL in 1 BOTTLE
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(58892-265)
Establishment
NameAddressID/FEIBusiness Operations
Process Technologies & Packaging809172885MANUFACTURE(58892-265)

Revised: 12/2012
Document Id: 0c5df784-589a-48e8-a719-f8e79609215b
Set id: b2f7624f-a5ca-42b3-88eb-1af10be4f291
Version: 1
Effective Time: 20121227
 
Fallien Cosmeceuticals, LTD.