STOP THE CLOCK BROAD SPECTRUM SPF 50 - avobenzone, homosalate, titanium dioxide, zinc oxide cream 
Biopelle, Inc.

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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Stop the Clock Broad Spectrum SPF 50

Active Ingredients

Avobenzone 3%

Homosalate 7%

Titanium Dioxide 3.5%

Zinc Oxide 1%

Purpose

Sunscreen

Uses

Warnings

For external use only

Do not use on damaged or broken skin

When using this product keep out of eyes. Rinse with water to remove.

Stop use and ask a doctor if rash occurs

Keep out of reach of children. If product is swallowed, get medical help or contact a Poison Control Center right away.

Directions

Inactive ingredients

water, butylene glycol dicaprylate/dicaprate, c12-15 alkyl benzoate, sodium hyaluronate, hydrolyzed potato protein, gamma aminobutyric acid, decamethylcyclopentasiloxane, polysilicone-15, c18-36 acid triglyceride, hexapeptide-11, silica, dipalmitoyl hydroxyproline, polyacrylate-13, hexanoyl dipeptide-3 norleucine acetate, thermus thermophillus ferment, uncaria tomentosa extract, porphyra umbilicalis extract, sodium tocopheryl phosphate, hydrolyzed vegetable protein, adenosine triphosphate, acetyl tyrosine, proline, sodium stearoyl glutamate, dimethicone, dimethiconol, cyclopentasiloxane, lecithin, sodium lactate, triethoxycaprylylsilane, cyclomethicone, peg-10 dimethicone, silica dimethyl silylate, glycerin, polyisobutene, polysorbate 20, phenoxyethanol, caprylyl glycol, butylene glycol, citric acid, xantham gum, hexylene glycol, disodium edta, methicone, alcohol, eugenol

Other Information

Questions or comments?

Call toll free - 1-866-424-6735 (weekdays)


PRESCRIBEDsolutions is DISTRIBUTED BY BIOPELLE, INC., A FERNDALE PHARMA GROUP COMPANY, FERNDALE, MI 48220.

www.BIOPELLE.com

MADE IN USA

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STOP THE CLOCK BROAD SPECTRUM SPF 50 
avobenzone, homosalate, titanium dioxide, zinc oxide cream
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:42485-006
Route of AdministrationTOPICAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
AVOBENZONE (UNII: G63QQF2NOX) (AVOBENZONE - UNII:G63QQF2NOX) AVOBENZONE30 mg  in 1 mL
HOMOSALATE (UNII: V06SV4M95S) (HOMOSALATE - UNII:V06SV4M95S) HOMOSALATE70 mg  in 1 mL
TITANIUM DIOXIDE (UNII: 15FIX9V2JP) (TITANIUM DIOXIDE - UNII:15FIX9V2JP) TITANIUM DIOXIDE35 mg  in 1 mL
ZINC OXIDE (UNII: SOI2LOH54Z) (ZINC OXIDE - UNII:SOI2LOH54Z) ZINC OXIDE10 mg  in 1 mL
Inactive Ingredients
Ingredient NameStrength
WATER (UNII: 059QF0KO0R)  
BUTYLENE GLYCOL (UNII: 3XUS85K0RA)  
ALKYL (C12-15) BENZOATE (UNII: A9EJ3J61HQ)  
HYALURONATE SODIUM (UNII: YSE9PPT4TH)  
POTATO (UNII: CFE1S8DYWD)  
.GAMMA.-AMINOBUTYRIC ACID (UNII: 2ACZ6IPC6I)  
CYCLOMETHICONE 5 (UNII: 0THT5PCI0R)  
POLYSILICONE-15 (UNII: F8DRP5BB29)  
C18-36 ACID TRIGLYCERIDE (UNII: ZRA72DR3R7)  
SILICON DIOXIDE (UNII: ETJ7Z6XBU4)  
DIPALMITOYL HYDROXYPROLINE (UNII: E6AHA53N1H)  
HEXANOYL DIPEPTIDE-3 NORLEUCINE ACETATE (UNII: P8A02Z93M6)  
CAT'S CLAW (UNII: 9060PRM18Q)  
PORPHYRA UMBILICALIS (UNII: 14AN0J70WO)  
ADENOSINE TRIPHOSPHATE (UNII: 8L70Q75FXE)  
N-ACETYL-TYROSINE (UNII: DA8G610ZO5)  
PROLINE (UNII: 9DLQ4CIU6V)  
SODIUM STEAROYL GLUTAMATE (UNII: 65A9F4P024)  
DIMETHICONE (UNII: 92RU3N3Y1O)  
CYCLOMETHICONE 5 (UNII: 0THT5PCI0R)  
SODIUM LACTATE (UNII: TU7HW0W0QT)  
TRIETHOXYCAPRYLYLSILANE (UNII: LDC331P08E)  
CYCLOMETHICONE (UNII: NMQ347994Z)  
GLYCERIN (UNII: PDC6A3C0OX)  
POLYSORBATE 20 (UNII: 7T1F30V5YH)  
PHENOXYETHANOL (UNII: HIE492ZZ3T)  
CAPRYLYL GLYCOL (UNII: 00YIU5438U)  
BUTYLENE GLYCOL (UNII: 3XUS85K0RA)  
CITRIC ACID MONOHYDRATE (UNII: 2968PHW8QP)  
XANTHAN GUM (UNII: TTV12P4NEE)  
HEXYLENE GLYCOL (UNII: KEH0A3F75J)  
EDETATE DISODIUM (UNII: 7FLD91C86K)  
ALCOHOL (UNII: 3K9958V90M)  
EUGENOL (UNII: 3T8H1794QW)  
POLYISOBUTYLENE (1000 MW) (UNII: 5XB3A63Y52)  
DIMETHICONOL (41 MPA.S) (UNII: 343C7U75XW)  
LECITHIN, SOYBEAN (UNII: 1DI56QDM62)  
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:42485-006-0150 mL in 1 JAR
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph finalpart35208/01/2009
Labeler - Biopelle, Inc. (808158823)
Registrant - Biopelle, Inc. (808158823)
Establishment
NameAddressID/FEIBusiness Operations
Biogenesis Inc.069117328manufacture

Revised: 9/2011
Document Id: 3aca1373-e465-44ff-8379-0366d682e837
Set id: 1725b5af-fe03-4372-beaf-d6fd9088a1f1
Version: 1
Effective Time: 20110912
 
Biopelle, Inc.