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

STOP THE CLOCK BROAD SPECTRUM SPF 50 by

Drug Labeling and Warnings

STOP THE CLOCK BROAD SPECTRUM SPF 50 by is a Otc medication manufactured, distributed, or labeled by Biopelle, Inc., Biogenesis Inc.. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

Active Ingredients

Avobenzone 3%

Homosalate 7%

Titanium Dioxide 3.5%

Zinc Oxide 1%

Purpose

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

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

• apply to face and under throat after cleansing
• reapply:
• • after excessive perspiration
• 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 15 or higher and other sun protection measures including:
• • limit time in the sun, especially from 10 a.m. - 2 p.m.
• • wear long-sleeve shirts, pants, hats and sunglasses
• children under 6 months:  Ask a doctor
  

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

• protect this product from excessive heat and direct sun
  

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

Package Label

Principal Display

Peel Label-Left

Peel Label-Right

INGREDIENTS AND APPEARANCE

STOP THE CLOCK BROAD SPECTRUM SPF 50 
avobenzone, homosalate, titanium dioxide, zinc oxide cream

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 42485-006
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
AVOBENZONE (UNII: G63QQF2NOX) (AVOBENZONE - UNII:G63QQF2NOX)	AVOBENZONE	30 mg  in 1 mL
HOMOSALATE (UNII: V06SV4M95S) (HOMOSALATE - UNII:V06SV4M95S)	HOMOSALATE	70 mg  in 1 mL
TITANIUM DIOXIDE (UNII: 15FIX9V2JP) (TITANIUM DIOXIDE - UNII:15FIX9V2JP)	TITANIUM DIOXIDE	35 mg  in 1 mL
ZINC OXIDE (UNII: SOI2LOH54Z) (ZINC OXIDE - UNII:SOI2LOH54Z)	ZINC OXIDE	10 mg  in 1 mL

Inactive Ingredients
Ingredient Name	Strength
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 Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 42485-006-01	50 mL in 1 JAR

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC monograph final	part352	08/01/2009

Labeler - Biopelle, Inc. (808158823)

Registrant - Biopelle, Inc. (808158823)

Establishment
Name	Address	ID/FEI	Business Operations
Biogenesis Inc.		069117328	manufacture