POWERPATCH DARK SPOT PROTECTOR- avobenzone, homosalate, octisalate, octocrylene, oxbenzone gel 
Raining Rose

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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RR Dark Spot Corrector - 0588

DARK SPOT PROTECTIOR SUNSCREEN GEL
BROAD SPECTRUM SPF 30:
Drug Facts
Active ingredient(s)

Avobenzone 3%

Homosalate 8%

Octisalate 5%

Octocrylene 2.8%

Oxybenzone 3%

Purpose

Sunscreen

Keep out of reach of children

Keep out of reach of children.

If swallowed, get medical help or contact a Poison Control Center right away.

Uses

Warnings

For external use only

Do not use

on damaged or broken skin

When using this product

keep out of the eyes. Rinse with water to remove.

Stop use and ask a doctor

if rash occurs

Directions

For sunscreen use

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 of 15 or higher and other sun protection measures including:

Inactive ingredients

Alcohol, Algae Extract, BHT, Butylene Glycol, Butyloctyl Salicylate, Hydrogenated Glyceryl Abietate, Isododecane & Dimethicone/Bis-isobutyl PPG-copolymer, Isoarryl Cocoate, Isoamyl Laurate, Kiwi fruit Water, Lemon Oil, Licorice Root Extract, Menthone Glycerin Acetyl, Pomegranate Oil, Sophora Flavescens Root Extract, Tumeric Extract

Other information

Protect this product from excessive heat and direct sun

Questions or comments?

Call toll free 1-888-243-0646

Dark Spot Corrector product label

patchology®

POWERPATCH™

DARK SPOT PROTECTOR
SUNSCREEN GEL
BROAD SPECTRUM SPF 30

20 mL

DARK SPOT PROTECTOR SUNSCREEN GEL

BROAD SPECTRUM SPF 30

Shades spots from skin-damaging rays during the day.

For use withPowerPatch Dark Spot Corrector Patches.

DIRECTIONS

Apply a thin layer of gel over treatment area only. Use every morning after cleansing.

IF IRRITATION OCCURS, STOP USE AND RINSE THOROUGHLY WITH WATER.

DIST. BY/PAR IONTERA, INC.,

DEDHAM, MA 02026
ALL RIGHTS RESERVED
MADE IN THE USA

QUESTIONS?
1-888-243-0646
PATCHOLOGY.COM

RR PPP Dark Spot

RR PPP Dark Spot 2

POWERPATCH DARK SPOT PROTECTOR 
avobenzone, homosalate, octisalate, octocrylene, oxbenzone gel
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:65692-0588
Route of AdministrationTOPICAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
AVOBENZONE (UNII: G63QQF2NOX) (AVOBENZONE - UNII:G63QQF2NOX) AVOBENZONE0.6 g  in 20 mL
HOMOSALATE (UNII: V06SV4M95S) (HOMOSALATE - UNII:V06SV4M95S) HOMOSALATE1.6 g  in 20 mL
OCTISALATE (UNII: 4X49Y0596W) (OCTISALATE - UNII:4X49Y0596W) OCTISALATE1.0 g  in 20 mL
OCTOCRYLENE (UNII: 5A68WGF6WM) (OCTOCRYLENE - UNII:5A68WGF6WM) OCTOCRYLENE0.56 g  in 20 mL
OXYBENZONE (UNII: 95OOS7VE0Y) (OXYBENZONE - UNII:95OOS7VE0Y) OXYBENZONE0.6 g  in 20 mL
Inactive Ingredients
Ingredient NameStrength
ALCOHOL (UNII: 3K9958V90M)  
LAMINARIA ANGUSTATA (UNII: 2J2UIK8XBZ)  
BUTYLATED HYDROXYTOLUENE (UNII: 1P9D0Z171K)  
BUTYLENE GLYCOL (UNII: 3XUS85K0RA)  
BUTYLOCTYL SALICYLATE (UNII: 2EH13UN8D3)  
GLYCERYL ABIETATE (UNII: 2F22LY70Q1)  
ISODODECANE (UNII: A8289P68Y2)  
DIMETHICONE/BIS-ISOBUTYL PPG-20 CROSSPOLYMER (UNII: O4I3UFO6ZF)  
ISOAMYL COCOATE (UNII: 14OG46E98E)  
ISOAMYL LAURATE (UNII: M1SLX00M3M)  
KIWI FRUIT (UNII: 71ES77LGJC)  
LEMON OIL (UNII: I9GRO824LL)  
LICORICE (UNII: 61ZBX54883)  
MENTHONE 1,2-GLYCEROL KETAL, (+/-)- (UNII: 7QQ1EE6RCP)  
POMEGRANATE SEED OIL (UNII: 0UI45XV0T6)  
SOPHORA FLAVESCENS ROOT (UNII: IYR6K8KQ5K)  
TURMERIC (UNII: 856YO1Z64F)  
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:65692-0588-120 mL in 1 TUBE; Type 0: Not a Combination Product09/01/2016
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph finalpart35209/01/2016
Labeler - Raining Rose (083819404)
Registrant - Raining Rose (083819404)
Establishment
NameAddressID/FEIBusiness Operations
Raining Rose083819404manufacture(65692-0588)

Revised: 7/2016
Document Id: f234a643-d321-42ce-9e8c-54e13870d2b2
Set id: 3283c64b-ad5a-48f7-8f92-d43aa16eb17b
Version: 1
Effective Time: 20160722
 
Raining Rose